Parents as Partners – Engaging Caregivers for Pediatric Trials at the Upcoming DIA Annual Meeting

Parents as Partners Preview Video

If you have ever struggled with patient recruitment for a pediatric study, Parents as Partners: Engaging Caregivers for Pediatric Trials, a presentation at the upcoming DIA Annual Meeting in Washington, DC, is not to be missed.

The presentation will highlight many of the challenges sponsors and CROs face when trying to recruit and retain patients for these unique studies, while offering suggestions on how to overcome these challenges from a variety of different perspectives.

Watch the preview video above for more information about the presentation, including a review of the goals and highlights of specific issues that will be discussed.

The session is on Monday, June 15, at 11 am in Room 145A at the Washington Convention Center.

See you in Washington, DC!

If you can’t attend the session in person, please feel free to contact me to discuss the presentation in more detail and answer any questions you may have about pediatric trial recruitment. 

CAHG at DIA

The recent DIA 50^th Annual Meeting in San Diego provided an excellent forum for learning about current trends in clinical research. As an exhibitor at the conference, we were afforded a great opportunity to engage with the drug development community and share patient recruitment best practices. The various sessions offered valuable insights from sponsors, CROs, and other vendors, who help comprise the key stakeholders in clinical research.

Some sessions of note attended by the CAHG team during the conference included:

·         A presentation on social listening by Melissa Mottolo of Genentech.

o   Our insight: Social listening is one valuable way to tap into patient sentiments that can help inform how to recruit for a research study. There is still a lot of work to do, even within sponsors with dedicated patient recruitment teams, to show the value of this intelligence gathering tactic.

·         A case study around a new patient social media platform, MyHealthTeams, by Eric Peacock.

o   Our insight: One critical important question about online patient communities is whether they will be primarily used for collaboration and research (in the Patients Like Me model), or whether patients are more interested in support and empathy (more the model of myHealthTeams). Both approaches may be needed to fully reach and engage the maximum number of patients.

·         Presentations on the new breed of online patient communities from Inspire CEO Brian Loew.

o   Our insight: Dedicated online communities are still small, but growing. Not all patients will be comfortable discussing their condition online – even anonymously – but it will be important to measure how these active “hand-raisers” can influence other patients, even those outside the community.

I was happy to have the opportunity to again chair a session on pediatric patient recruitment that started a conversation around best practices for engaging parents about their children participating in clinical trials. Drs. Sue Tansey from Premier Research and Larry Eichenfield from Rady Children’s Hospital also presented during the session and provided invaluable insights from the CRO and site perspective. Dr. Tansey did an excellent job of highlighting research alliance groups working in both Europe and the US to engage parents about pediatric studies, while Dr. Eichenfield expertly related how a busy site is able excel by using a myriad of tactics to build awareness for trials in the local community. Both speakers sparked conversations with the numerous session attendees that will surely keep the discussion of this important topic moving forward beyond San Diego.

Overall, the DIA Annual Meeting was a fabulous platform for meeting other members of the pharmaceutical research industry and engaging in valuable discussions on how to move the industry forward in the coming years and beyond. We are already looking forward to next year’s meeting in Washington, DC!

Parents as Partners - A Pediatric Patient Recruitment Session at the Upcoming DIA Annual Meeting

If you have ever struggled with patient recruitment for a pediatric study, Parents as Partners: Overcoming Unique Challenges to Pediatric Recruitment and Retention, a session at the upcoming DIA 50^th Annual Meeting in San Diego is a presentation that is not to be missed.

The session will highlight many of the challenges sponsors and CROs face when trying to recruit and retain patients for these unique studies, while offering suggestions on how to overcome these challenges from a variety of different perspectives.

Watch the preview video above for more information about the session, including a review of the goals and details on the impressive lineup of speakers that will be participating.

See you in San Diego!

If you can’t attend the session in person, please feel free to contact me to discuss the presentation in more detail and answer any questions you may have about pediatric trial recruitment. 

The Importance of Post-Study Recruitment Reporting and Analyses

There is a common trend in clinical research patient recruitment to tout the next big thing or widget that will most certainly help a sponsor fully enroll their next study on-time and budget. While it is certainly worthwhile to try and find new approaches to improve enrollment rates, I have found that it is prudent to pay more attention to basic principles in crafting a cohesive recruitment strategy for your trial.

While many studies and vendors at least pay lip service to the practice of collecting metrics during a recruitment campaign, the number of studies where this data is properly analyzed is relatively small. The rationale for this assertion is certainly anecdotal, but plausible in part because of the number of times that I have seen a sponsor or CRO communicate actionable intelligence from a previous study (maybe three times in ten years).

There are several steps you can take to ensure that your study is set up to produce actionable lessons learned at the end of enrollment:

      Design a data capture infrastructure to collect key metrics in advance of study launch

This seems intuitive enough, but often recruitment metrics are not planned far enough in advance to accommodate any special considerations for a specific study.  If you are relying solely on site-based reporting to measure the success of any initiatives, then it is vital to try and standardize your metrics to some degree up front. Otherwise, you may be stuck trying to aggregate varying levels of data between your sites.

For instance, some sites will precisely record every minor detail in the patient engagement process on a spreadsheet or other database, from first contact, the numbers of times they have followed up with the contact, to any appointment no-shows. Some sites, on the other hand, will be less exact with how they record this information. It is important to make sure you know what metrics you want to capture and communicate the expectations to all sites before FPFV.

Even if you are employing a CRO or patient recruitment vendor to capture data for a centralized campaign, it is still a good idea to finalize what they will be measuring and how in advance of study launch. These organizations often have template systems in place that capture the same metrics for every campaign they support. Be sure to ask about this up front and ensure that their metrics platforms meet your needs.

Ensure that reporting begins early and often in the recruitment campaign

It is a good idea to set the standards for reporting early before the study begins, as well. Most studies have regular check-in meetings between sponsor and vendor and/or sites. Use these discussions as an opportunity to create a reporting interval where current recruitment data can be shared and analyzed by the team. These forums can also be a valuable way to dig deeper into the data by generating regular reports that will allow you to make course corrections to enrollment strategy, if needed.

There are a number of ways to accomplish this within the confines of a study. It all depends on what your data requirements are. Perhaps you want to keep close tabs on cost per referral or screening. Or maybe you are curious about the relationship between site communication (eBlast, phone call, etc.) and screening activity. These are all things that can be measured and reported on throughout enrollment if planned for.

Don’t be afraid to call more frequent meetings or create reports outside of the normal schedule if it will benefit enrollment by prompting timely strategy decision-making. Your enrollment campaign should not be created in a vacuum. Use metrics and reporting to inform how you spend your recruitment dollars.

Insist on a robust final analysis meeting

On more than one occasion, I have encountered objections from key study leaders about the need or benefit of a final analysis meeting.

But why have one in the first place?

Even if recruitment goes exceedingly well for a study, any final analysis should be able to determine some lessons learned from a recruitment campaign, if the right metrics were captured from the beginning. Whether you are a project manager at a sponsor, CRO, site or recruitment vendor, the end of enrollment for any study should include a thorough review of every action that took place in trying to recruit patients to the trial, in an effort to improve those efforts in future campaigns.

Invariably, there will be naysayers who might decry the need for a long meeting to review reports and discuss lessons learned. Ignore these detractors and insist on conducting a thorough final analysis meeting. It will be time well-spent.

Deliver a thorough after-action report, including any key learnings from the final analysis meeting

At the end of any meeting, it is supremely important to recap the discussion and highlight any pertinent action items that were flagged. Once all key learnings are catalogued, a final report should be compiled, including any and all data and takeaways, for distribution to the entire team. If you are talking about a Phase II trial, the report should detail how these learnings can be applied to the next trial. If there are no further studies to leverage, then you should go the extra mile to apply the lessons learned to a therapeutic area or similar type of study where appropriate.

Paying close attention to metrics and reporting is not quite as sexy and cutting edge as touting the latest new trends in patient recruitment. And yet, all too often, data is overlooked or not emphasized enough when developing strategy for completing enrollment on time. If used effectively, reporting can be a way to build rapport and engage the entire study team that will benefit your entire clinical operations infrastructure.

Making the Most of Your Investigator Meeting

An investigator meeting usually signals the kick-off of a clinical trial.  As the industry has evolved and regulations have been put in place, sponsors often feel constrained with their meeting planning compared to years ago. Long gone are the days of lavish meetings with extravagant meals and pricey offsite team-building trips. Investigator meetings have become very predictable, and as result sites are familiar with the typical agenda. 

With all of these restrictions, how can you make your IM memorable and engaging for the attendees?

 Your sites are one of the most critical components to successfully enrolling your trial so you should make sure they leave the meeting enthused to be part of the study.  The investigator meeting is often the starting point of a relationship the study team will continue to build over the course of the study.

Some ideas to consider when planning your next investigator meeting:

• Create a theme for the meeting: In past meetings we have used themes such as Amazing Race and Survivor, which included imagery and activities that carried throughout the meeting.

• Designate study team members to meet each attendee: One sponsor I have worked with assigns each study team member to a certain number of sites to ensure every meeting attendee gets direct personal contact from the sponsor.

• Hold interactive breakout sessions: Facilitating smaller group discussion allows the sites to both share ideas and learn from each other.

• Form a panel of experienced sites to answer questions: If you have a lot of sites that are new to the study indication, creating a panel of ‘expert’ sites can be a valuable forum for lessons learned.

• Incorporate a game or trivia during the meeting: Using a game show or trivia game can break up the meeting creating an interactive session where you can test sites on the information they have learned.

The dynamic of the investigator meeting has changed over the years, but that does not mean you cannot make your meeting stand out. Take advantage of the opportunity to strengthen your relationships with the sites and build motivation for the study that will set the proper tone as you get your trial up and running.

TV Advertising in Clinical Trial Recruitment: Overcoming Fear of Desensitization

No one wants to waste money on advertising. When talking with study sponsors about recruiting patients for clinical trials, we are routinely asked whether advertising campaigns – specifically TV campaigns – would become exorbitantly expensive as the market becomes saturated with ads.

In the time that I have been analyzing effectiveness of patient recruitment campaigns, I have never seen TV advertising campaigns become less effective over time.

Just the other day, a fellow clinical trials strategist asked me: How do we measure desensitization to a TV ad?

We test for diminishing returns by breaking out the average costs per referral by market and by TV buy. In order to adjust for differences in the size of the TV buy and the cost of buying TV ads in various markets, we calculate the cost per referral in each media buy as a percentage of the average cost per referral in that DMA. We then run single factor ANOVAs to test for significant differences between groups (media buys).

Costs per referral remained consistent with multiple weeks of TV advertising

I have yet to see the cost per referral increase significantly with recurring media buys. It is important to consider the context: TV remains the largest advertising medium in the US, with annual spending of roughly $60 billion dollars. Our targeted ad campaigns are a drop in the bucket compared to national branding campaigns aired by a huge retailer such as Target. While a strategically targeted media buy can certainly make up a sizeable portion of a patient recruitment budget, these types of ad campaigns just don’t run long enough to desensitize TV viewers.

In our experience, TV advertising can represent a hefty investment for clinical trial enrollment, which means it isn’t right for every trial. Nevertheless, its reach and reliability in generating qualified leads can’t be beat!

How to Deal With Inconsistent IRB Requirements When Designing Recruitment Materials

One thing I like about working in patient recruitment for clinical trials is that no two trials are the same. Every study brings new challenges to overcome, resulting in new learning opportunities. One challenge that can be particularly daunting is drafting study recruitment materials for multiple institutional review boards (IRBs), or the independent ethics committees that approve the use of materials in clinical trials. Normally, inconsistent requirements happen when you are dealing with a central IRB and at least one local IRB. Local IRBs, functioning in support of academic institutions, generally have differing standards when it comes to messaging, terminology and tone. In most cases, any differences are very minor and attributed to simple word choices (think clinical trial vs. clinical study).

This can be an issue when you are drafting centralized materials or advertisements designed to support multiple sites in a research study. How do you standardize your copy so that it can be approved by all regulatory bodies? Following are a few hints on how to avoid IRB issues that can stall production of key recruitment materials.

1) Write any copy like it is being reviewed by the most conservative local IRB

The most important consideration when designing materials that will be reviewed by multiple IRBs is to ensure you do not take too many risks with your writing. Edgy copy might be inspiring to the reader, but could wind up passing through a central IRB while being scrutinized by a local one. While not a universal truth, it is usually the local IRB that will push back aggressively on any language that might be too speculative or promissory.

This is truly the worst-case scenario, because as we often find, academic centers traditionally are activated after dedicated clinical trial sites during study start-up. In that case you may have already had your materials approved by a central IRB and produced (which, in the case of a TV ad can be a significant investment), only to find that a local IRB has a problem with some of the wording. It is much better to write your copy to the most conservative review you can think of so that this is never an issue.

Ultimately, here are a few general tenets to adhere to when drafting copy for patient recruitment ads or materials:

• Do not use the word free when describing anything associated with the study
• Avoid phrases that speculate at all about the potential benefit or efficacy of a study medication
• Be mindful of key words in your copy that could be scrutinized, and limit their use (including clinical trial, study drug, etc.)
• Use limited reference to compensation for participation, including the amount of money someone could be reimbursed for travel (as this may vary by site)

2) Make your materials format as flexible as possible

It pays to have materials that can be easily reformatted to accommodate variable content, should you run into a situation where IRB standards conflict. This is not always easy, especially when it comes to broadcast ads. A good rule of thumb here is to always avoid live action commercials where you have actors with speaking parts. I know that very few clinical recruitment campaigns employ such a sophisticated level of ad, but the cost of reshooting a live action ad would most certainly be prohibitive for a sponsor. Even when using lower cost mediums (print ads, flyers, etc.), it is smart to make sure your creative files can be easily edited by a third-party designer, should you need to have something reformatted on the fly.

3) Communicate with your IRB if there are discrepancies

IRBs can sometimes seem like intractable, soulless bodies that rule with heavy-handed authority. However, if you find an IRB is mandating an edit that contradicts something another body has approved, it might be worthwhile to reach out to the reviewer and discuss the recommendation. Showing an IRB that another IRB has approved copy they are not comfortable with can sometimes result in a change in the ruling.

I recently ran across a situation where two different reviewers at the same IRB had different opinions about the same phrase used in a study flyer. One reviewer approved it, while a few months later, a different reviewer recommended a change. So, even within the same IRB, sometimes you can find variable standards. Ultimately, it never hurts to inquire about a specific decision, especially if not questioning it would result in having to reproduce materials at a significant cost to a sponsor.

Variable decisions by IRBs are something that everyone runs into at some point or another. Poor planning for unexpected deviations in approvals are an easy way to incur unexpected costs in for a study. Make sure you plan accordingly so that any surprise IRB issues don’t derail your recruitment budget or timeline.

Test driving a media campaign

In many situations, you are given the opportunity to test something before you commit.  Most people want to test drive a few cars before they settle on a final decision. Gyms often offer 2 weeks free to test the gym before signing a contract. This gives you an opportunity to evaluate the situation before you fully commit and ensure your money is being well spent.

In the clinical trial world, we always jump on any opportunity to test an initiative before launching a full program. One of the most valuable tests we conduct are pilot media campaigns.  A pilot media campaign can provide valuable information, helping to formulate a comprehensive media strategy.

There are some key reasons why running a pilot campaign can be beneficial:

1. The world of media is always changing. An advertising schedule that worked 3 years ago for a particular indication may not be the best fit for a current study.  New sources continue to sprout up and other sources may lose their impact so it is important to evaluate your current options as well as what has worked in the past.

1. Advertising budgets can vary. It is important to consider the past budget to provide the appropriate context. The site advertising budgets provided by the sponsor are generally not very generous and usually differ from an ad buy developed as part of a larger campaign. While site feedback is helpful, it is important to weigh all information when developing a media strategy.

1. Site responsiveness can be evaluated.  A pilot campaign can not only gauge the response we receive from the media but also it can test how sites are able to handle those referrals. Based on the site activity, you can determine an ideal media buying level and schedule.

A pilot campaign may demonstrate that advertising is not the answer

In a recent project with a small patient population, enrollment was lagging behind sponsor timelines.  The CRO and several sites insisted a radio campaign would accelerate enrollment.  We were hesitant to place a radio campaign because we were not confident broadcast advertising was the right fit for the target population.  Before launching a large campaign, we recommended a pilot campaign.  We placed radio advertising in 3 markets of varying size.

Though the pilot campaign yielded a decent response, only generated 2 screened patients.  Most of the respondents from the campaign clearly did not qualify but still inquired about participation. Ultimately, the high cost per screened patient confirmed that broadcast media did not provide the best ROI for this study population.  The pilot campaign allowed us to present data to the client and saved them the money they would have spent on a full-scale campaign.

A pilot campaign can help you develop a cost-effective comprehensive media strategy

A few years ago, we were engaged in a clinical trial where enrollment was slower than anticipated due to slow site start-up and challenging inclusion and exclusion criteria.  CAHG proposed a media campaign but the sponsor and most of the sites had no experience advertising for this specific indication.  We recommended a pilot campaign in 5 markets testing print, radio and television advertising. 

The pilot campaign provided us some key information:

• Television by far was the most cost effective medium over radio and print
• Sites became overwhelmed with too many referrals in a short amount of time, so we knew we needed to adjust future placements to match the site intake capabilities
• A question on the prescreen questionnaire at the call center and website was being misunderstood, so we proposed a small revision resulting in more referrals

Based on our analysis of the pilot campaign, we developed a full media strategy that successfully enrolled the trial.  The pilot campaign provided insights for us to make a sound strategy and develop a more cost effective campaign.  The graph below highlights the reduction of the cost per screen from the pilot campaign to the full-scale campaign.

We do not always have the luxury of conducting a pilot campaign for every clinical trial. However, if the budget and timeline allows, it can be an essential step in launching a successful advertising strategy. Next time you are ready to kick-off a patient recruitment media campaign, weigh the options of a pilot campaign.  Testing your campaign will lead to more cost-effective recruitment spending, which will likely result in accelerated enrollment timelines.

What are the right tools for the recruitment toolkit?

Last month, I discussed the question of what mix of recruitment initiatives are right for your clinical trial. Ultimately, I concluded that there are too many variables in an individual research study to make a blanket assumption about which tactics to use every time out.

The same question is often asked regarding which materials to develop for recruitment kits for sites. Some of the most commonly used items include:

• Study fliers

• Patient/caregiver brochures

• Physician brochures (for local outreach)

• Study overview cards (for site staff)

• Appointment reminder cards

• Physician-to-physician letter templates 

• Physician-to-patient letter templates 

• Patient email templates

• Social media posting templates (Facebook, Twitter, Craigslist, etc.)

• Site website posting templates

In many cases, these materials are given to the sites en masse so that each study center can use them as appropriate. While that can be a sensible strategy, it bears further investigation as to whether throwing the “kitchen sink” at a site can do more harm than good.

If you give the sites an overwhelming amount of toolkit items to choose from, even with the guidance that they can use the materials at their discretion, they may waste time and energy pursuing initiatives (like sending out letters to local physicians) that do not ultimately pan out. This can create frustration for sites without providing any tangible benefit to enrollment. In some cases, a robust toolkit can make sense, but it should be scrutinized to determine if the materials truly will be effective.

One way to ensure the materials will help bolster enrollment is to engage your sites up front and get direct feedback about what they actually want. It can also be helpful to develop multiple electronic toolkit options and customize their distribution as needed. What I mean by that is to develop materials that can be printed per site in short runs, as opposed to legacy production processes where you print a gross of study brochures or flyers all at once. In the virtual world we now live in, this is an increasingly attractive option, as it allows you to warehouse multiple materials for a study and provide it on-demand on an individual basis, in some cases customizing items to meet specific site needs. 

While this seems like a sensible choice, there is a lot to be said for actually sending an actual toolkit to a site, as a means for branding your study and keeping awareness elevated at the site level. The question of whether to actually produce a toolkit or distribute all of the materials electronically is something that might be dictated by your study budget, timeline, and the need for branding and awareness.

Site materials usage rates from a past CAHG pediatric study 

While every study is different, site adoption will be dictated by the relevance of the study materials and the needs of your individual sites. Anecdotally, CAHG has found that adoption rates for site materials are higher in pediatric studies (see the accompanying table for usage rates from a past study). The graph shown illustrates site responses to a question in a post-study questionnaire (another good exercise that should be used after every recruitment campaign) polling their use of study materials offered as part of a centralized recruitment campaign.

Much like developing an enrollment strategy for a clinical study, a one size fits all approach is not something that should be applied when determining what materials to include in a recruitment toolkit. There are a number of different strategies you can use, and it is important to ensure that you think things through so that you maximize the benefit of the selected materials. The toolkit is an excellent opportunity to engage with your sites and create a sense of investment in your study for them. Do not waste this chance by unilaterally developing items without significant input from all of your study stakeholders.

Be part of your patient community

During the month of March, you may see yellow ribbons promoting Endometriosis Awareness Month or flyers for walks to support Multiple Sclerosis.  Throughout the year, we are familiar with having every month tied to a condition or disease with the goal of raising awareness.  These designated months often find us surrounded by ribbons, events and fundraising efforts to support the various causes.

It is no surprise, then, that sites and sponsors often urge us to take advantage of these awareness events to recruit patients for a clinical trial. Though these designated months and events are positive ways to raise awareness about a health condition, they are not necessarily an ideal opportunity to recruit patients. These events are mainly focused on promoting awareness of the condition and most importantly raising money. While they are all great causes, we have found that using these opportunities to recruit patients rarely is successful.

Instead of focusing on a local event or specific disease awareness month, your time is better spent developing a community outreach and social media plan that focuses on building awareness over time.  Though you may not be inundated with responses from your outreach efforts similar to a typical advertising campaign, social media can be a useful recruitment tactic.  When developing a social media plan, it is imperative to develop a thought out plan that does not focus solely on one event or timeframe.

But where do you start? Disease advocacy has exploded in recent years and it can be difficult to break through the clutter to find the best way to reach your target audience. Following are some simple strategy processes that will get you on the right track.

One of the key components to any campaign is to know your audience. Social media provides an opportunity to listen to your target audience and even be part of their conversation.  In a Rebar Interactive post from 2012, there is a good overview of the different engagement options to consider when entering the world of clinical trial recruitment via social media.

As the Rebar post mentions, the first step in creating a social media campaign is to identify where your patient population is talking about their condition:

• Blogs
• Facebook
• Instagram
• Message Boards
• Twitter
• YouTube

Once you start your search, you will find that many of the blogs and social media pages will lead you to additional sources that patients are following.  Bloggers and Facebook pages often have a list of other online sources they follow.   

It is also beneficial to sign-up to receive email newsletters and updates from the larger online communities so you can stay on top of the current news and conversations.

Once you identify the venues where your patients are talking, become a regular visitor in these spaces. Like their Facebook pages. Follow them on Twitter, and read the blogs on a regular basis.  Reading the discussions will give you a better perspective on the conversations happening in the patient community and will help to craft messaging for social media that will resonate with your target audience. Conversations can move very quickly on some of these forums, so it can be a little overwhelming at first.  You do not have to read every single thread and discussion, but try to continually check-in with your online patient community.

This can be a bit more time consuming then putting together some flyers and a poster at a community event, but it is an essential step in understanding the patient community you are trying to reach.

When developing your plan, there are some questions you should always keep in mind:

• What venues are you going to target?
• What message do you want to convey?
• Does the message need to differ based on your audience?
• How often do you want to reach out?
• Who will be responsible for monitoring the online community?

For a recent clinical trial that had a large online community, we developed an outreach strategy that included a Facebook page, blogger outreach and relationships with other condition-specific websites.

Through our efforts, a few blogs mentioned our study, people shared information about the study on Facebook and Twitter, and we created a few ongoing relationships within the online community.These posts helped spread the word about the study as followers of these online outlets then took the study information and shared it via social media. 

You may not be able to track the results of an online outreach campaign the same way you track an advertising campaign, counting incoming calls and referrals.  But, you can track your online activity and monitor where your website visitors are coming from.  As a result of our social media efforts, we did see an increase in website visitors and continued to see the information shared with additional online communities.

An online community outreach plan often evolves over the course of the study.  You will find new sources, and you may create relationships with some of the contacts that make it necessary to change your strategy or tactics in the middle of the campaign.  You should be prepared to alter your plan based on interest and feedback from the patient community.

Due to the nature of the Internet, patients can easily spread the word about a clinical trial, so it is important for you to develop a plan that targets your patients online.  Though it is tempting to focus your recruitment efforts around a single event, in the end, your time and money are better spent focusing on a comprehensive online outreach strategy spread across many different platforms over a longer period of time. This approach will help you engage your patient audience more effectively and gives you greater flexibility to take advantage of the dynamic medium that is social media.

Data Versus Conventional Wisdom: Lessons from a Recent Patient Recruitment Campaign

Shortly after I completed my master’s in social work, I met with a statistician as part of an interview for a research assistant position. Giddy with nervous energy, and fresh out of social work school, at one point I blurted out a question along the lines of asking him how he felt about statistics. (It’s true. I did.) He answered: Statistics is the stuff of life.

The statistician’s answer stayed with me over the years. I pictured mathematicians making decisions from the clear-eyed vantage point of probabilities: daily life as odds ratio. Pay more for organic produce? Decide which of your kids gets to go to college? All questions of calculation. While I have been working with data daily for a number of years now, I am still awed by how many questions can be answered by a little thinking and some simple math.

As part of a recent recruitment effort for a clinical trial involving patients who had significant pain, we implemented a strategy of distributing TV advertising throughout the day in order to reach a greater breadth of viewers. As a result, we aired TV ads as early as 5 to 8 AM. A few study coordinators at the study sites warned that this would be a waste of advertising dollars, as their own local efforts with early morning advertising had not brought in study patients. Prospective study patients with significant pain were unlikely to be watching television in the early morning hours, they argued, both because they were less likely to work 9-5 and because they were less likely to sleep comfortably at night (and therefore be up early in the morning).

After the study had successfully completed enrollment, our resident data guru at CAHG and I followed up on the sites’ initial concerns about early morning advertising with some data analysis. We first established that the response to TV ads tended to be immediate; local call activity spiked at the call center in the hour or so after a TV ad aired in that market. Using the study-wide average cost per TV referral, we then estimated the number of referrals we could expect in each market based on the size of the TV buy (e.g., the total spent). Finally, we compared this estimate to the actual number of referrals each market received. We found that the difference between the actual and expected number of referrals was essentially random. There was natural fluctuation in actual vs. expected referrals in each market, but no trend relative to the amount spent.

In other words, patients with significant pain were as responsive to TV ads in the early morning hours as they were the rest of the day.

Equipped with this data, we were able to let the study sponsor know that early morning advertising had been worth the investment for this study, and could safely be added to our arsenal for the next phase of clinical research for that drug.

I continue to be amazed by the extent to which logic and a little math can transform decision-making, particularly in the often hazy world of advertising. If the power of data-based decision-making can make a believer out of someone who once planned to practice social work for a living, it must have some value!

Predicting Referral Conversion in Clinical Trial Advertising

Today we'll cover an issue that we've found to be vexing for a large number of study sponsors: modeling the rate at which pre-qualified potential trial participants will actually consent into the trial.

This issue has implications both for managing advertising budgets and assessing site enrollment performance. In this short video, I'll take you through a couple pitfalls in the standard approach to analyzing referral conversions, and lay out what we believe to be a clearer, fairer, and more reliable approach.

Comments and questions, of course, are welcome.

What Is the Right Mix of Recruitment Tactics for a Study?

As an avid runner, I am constantly obsessing about race times, trying to find ways to get faster even though I am nearing the tail-end of my running “prime”. In spite of professional and family demands, I sometimes think I can still run fast without putting in the training needed to shave minutes or seconds off of my personal best times, from 5K to marathon. However, with years of racing experience under my belt, I know that it just isn’t possible to make significant time gains without the proper work. Unfortunately, too often clinical trial sponsors make the same mistaken assumption when it comes to recruitment planning for their studies.

There continues to be a pervasive belief among sponsors and CROs that every therapeutic area has a predetermined selection of tactics that will help enroll a trial on time. Similarly, those same beliefs hold that you are not qualified to provide successful enrollment support for a study unless you have had previous experience on another similar trial. Instead, the focus should be on the process of developing a strategy that is best suited to maximize ROI and meet enrollment goals on time and on budget.

So, even generally speaking, what is the right mix of tactics to use to efficiently enroll your next study? Since we have established that there are no magic bullets to apply (i.e. print should be used on any patient audience over the age of 60+, etc.) universally across trials, there are some general tenets that should be adhered to when deciding what recruitment initiatives are going to work best for your study.

1)      Know your target audience

More than anything, it is imperative that everything you do, from messaging to engagement medium (media or online advertising, outreach, etc.), should be executed with the target audience in mind. Things like age, gender, ethnicity, and other demographics should be top of mind when developing study materials or advertisements. While there are certainly several other factors to consider, this is the most important in determining your recruitment strategy. Really knowing your target audience is not the same as simply having executed a recruitment campaign for a similar indication. The variables noted above change with every study, and it is critical that you understand them in an effort to know who the patient audience truly is for a given study.

2)      Never go ‘all-in’ with one initiative

Even in the most desperate rescue situations, it is never smart to put all of your eggs in one basket and rely on a single recruitment initiative to enroll your trial. Even in situations where you are confident that one medium (say, TV advertising) is going to provide enough referrals to meet your goal, until you have empirical evidence that an initiative is definitively performing the way you need it to, it does not make sense to spend significant amounts of money on one tactic. It is better strategy to pilot an initiative when possible. When that is not feasible, it still makes sense to stagger the rollout of your tactic in a way that allows you to collect data on its effectiveness before investing large amounts of money that could result in a poor return on investment.

Avoiding an ‘all-in’ strategy does not mean that it makes sense to throw money at a number of different tactics simultaneously. It is still prudent to do your homework and settle on a focused strategy that will efficiently enroll your study. My experience has been that a diversified suite of 2-3 tactics are generally sufficient to accommodate variable site capacity and ensure you are effectively attracting patients to a trial without breaking your budget.

One of the biggest reasons that it is next to impossible to accurately predict the performance of a given initiative is that no matter how successful you are in generating clicks, calls or referrals, unless the sites act on those leads and convert referrals into screenings and enrollments, your tactic may fall short of expectations. Which means you should…

3)      Communicate with your sites

As any seasoned clinical research professional can attest, no two sites are created equal. Some sites have robust recruitment teams that can handle dozens of referrals per day, while there are still some study centers that struggle to triage a dozen leads in a week. This disparity can be frustrating, but some simple upfront work to understand site capabilities along with robust engagement to manage expectations can go a long way in mitigating this issue. Any recruitment tactics you move forward with should be done so with these issues in mind. As an example, don’t run TV ads in a large market where you know you will get a lot of referrals, but have a site that might not be able to handle them.

Reaching out to the sites ahead of a recruitment campaign will not only allow you to determine their capabilities, but will also help you build rapport that can keep your trial top of mind and ultimately result in those sites working harder to enroll your study. You can make the sites feel even more invested by working with them to customize a given tactic in their market. Whether that is taking their feedback on which broadcast outlets to use or local patient advocacy groups to engage, this can go a long way in motivating your sites to go the extra mile for your study.

One potential communication pitfall to be mindful of when talking to sites is that they can sometimes tell you what they think you want to hear. This is where having data about how well your sites are executing on a given recruitment initiative can be very beneficial to give you the full picture, and objectively assess site performance. 

When a site or recruitment vendor says, “We’ve got lots of experience recruiting in this therapeutic area. We know exactly what will work to enroll your study”, you should be wary. No two studies are the same, and ultimately it comes down to carefully developing and executing a plan based on the myriad of variables that exist in any given study. While experience is helpful, it is more important to focus on the process of developing a sound strategy to ensure a successful recruitment campaign. Being mindful of this will help you cross the enrollment finish line of your next clinical trial in record time.      

Don’t Overlook a Critical Component to Study Start-up

Working at a clinical trial site early in my career, I remember the frustration felt by both the sponsor and site when we did not enroll a patient within a few days of receiving the go-ahead to start recruiting.  After weeks of contract negotiations, drug shipment confirmations and CRF development the sponsor believed we had everything needed to enroll a patient immediately. Often times the sponsor had failed to provide us with a recruitment plan and the enrollment materials until after the study started, which greatly impacted our patient recruitment efforts in the first few weeks.

The study start-up phase of a clinical trial can be chaotic with vendor set-up, budget negotiations, contract finalizations and investigator meeting preparation.  Of course, all of these factors are critical for the launch of the clinical trial but frequently a key component is overlooked, patient recruitment.

During the initial set-up of a clinical trial, it can be very beneficial to include patient recruitment in your early planning. When developing your study start-up checklist ask yourself the following patient recruitment questions:

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• What database query resources can be deployed to help sites proactively start identifying patients before the investigator meeting?
• What recruitment materials can the site use to reach out to their current patients?
• When and how can you use site communications to roll out a recruitment plan prior to the investigator meeting?

After a successful investigator meeting, the expectation is for sites to go home and immediately screen their first patient. But for many studies it can take a few weeks for the study to gain momentum and enrollment to really take-off.  Sites usually wait until after the investigator meeting to even start identifying potential patients.  Sites may need a couple of weeks to go through their database, send out an email blast and put an advertising plan together.  By the time all of this is done, it has been 3 weeks since the investigator meeting and the site may only have one or two patients scheduled.

Also, sites can be hesitant to screen their first patient in a study, as they want to avoid any errors, which may result with some back and forth with the sponsor and CRO.  If a recruitment plan is in place before the investigator meeting, these questions can be addressed via in-person conversations at the meeting.

• Launching a recruitment plan prior to the investigator meeting can help jump start enrollment and boost enthusiasm for the study. 
• Be upfront with sites about the recruitment plan timeline, including dates and expectations
• Work backwards from the investigator meeting, to see when you need to have your study materials IRB approved and sent to the sites
• Find additional resources, if needed, to roll out the plan, to conduct one-on-one site phone calls and/or scheduling of webinars
• Share the results of the patient recruitment efforts at the investigator meeting so sites can see the benefit of the early planning

The biggest challenge of early recruitment planning is carving out the time and resources when everyone is already stretched thin.  Identifying a dedicated team member or vendor to the task can greatly help the team and end result.  Another issue you may encounter is sites not wanting to start identifying patients prior to the investigator meeting.  If you can lay out the entire plan, highlighting the end objective such as a desired number of patients scheduled, it makes the plan much easier for the site to grasp.

For a cardiovascular study with very aggressive timelines, CAHG rolled out a comprehensive recruitment plan one month prior to the investigator meeting.  The study was going to be heavily reliant on patient recruitment within the site’s practice. We sent the essential recruitment materials and conducted webinars and one-on-one enrollment plan calls with all of the sites to introduce the recruitment campaign and educate them on how to best utilize the patient recruitment tools.

The communications outlined the recruitment expectations and set the goal for sites to have at least one patient scheduled by the time they attended the investigator meeting. To hold sites accountable, they were asked to complete a simple form detailing all of their patient identification efforts and how many patients were screened.

The study had its first screened patient the day after the investigator meeting and screening activity quickly gained momentum within the first few weeks. The sites maintained robust screening activity the entire study which led to the study exceeding the original enrollment goal almost four months ahead of schedule.  The early recruitment planning not only impacted the first few weeks but set the bar for the entire study duration.

The early recruitment planning led to several successful outcomes:

• Patients were scheduled for screening immediately after the investigator meeting
• The sites engaged in more productive patient recruitment discussions at the investigator meeting since sites already were in the middle of identifying patients
• Sites came to the investigator meeting very motivated and enthused about the study
• The enrollment rate immediately jumped up and held at a steady rate for the entire study

For your next trial, do not overlook patient recruitment in your study start-up planning.  Spending some time laying out an early patient recruitment plan can go a long way towards meeting your enrollment timelines.

How to Catalyze a Clinical Trial

Why we're launching this blog

Engaging enough patients to participate in clinical trials is consistently identified as the single largest source of delay in drug development. This hurts not only our ability to bring new treatments forward, but also delays the collection and publication of evidence for the long-term safety and efficacy of many treatments already in use.

Understanding and fixing that delay is our singular focus.

However, we believe that the reasons for the current disconnect between patients, physicians, researchers, and regulators are incredibly complex. There are multiple, major issues of awareness, trust, and understanding that block our way forward. No single trick or shiny new tech widget is going to be nearly enough to get us where we need to go.

So we're launching this blog in an attempt to share our thinking and collaborate openly with others who are attacking the same problems. We promise no ads, only ideas - and we will strive to make our ideas concrete and practical.

Specifically, we believe that any hope at improving enrollment in clinical trials will require progress on 3 levels:

• Stronger empathy and connection with patients
• Mastery of both traditional and novel modes of communications 
• Rigorous and unbiased analysis of data

Posts on this blog will come out on a weekly schedule from multiple contributors within CAHG Trials as well as guest authors. Out first post comes out today: our Senior Data Analyst Sandra Richman tackles the morass of configuration options behind online banner advertising in Dependable or Dispensable? Using Banner Advertising for Patient Recruitment.

We look forward to engaging with you, and truly welcome your feedback - and your objections, second thoughts, counterexamples, improvements, and flat-out disagreements, too! Open, honest, and thoughtful communication is the best way forward.