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!

Celebrate 50 Years of DIA with CAHG in San Diego

Join CAHG next month in San Diego as we celebrate 50 years of DIA.

The DIA Annual Meeting brings together over 7,000 drug development industry professionals from around the globe to discuss pressing issues facing the industry over four days of educational sessions and networking opportunities. The 2014 meeting will be held at the San Diego Convention Center from June 15-19. 

Like DIA, CAHG brings over 50 years of experience in the pharmaceutical industry, with a deep and rich tradition of excellence across the entire spectrum of drug development. We pride ourselves on innovation and unmatched creativity in our patient recruitment campaigns and other work that sets us apart from our competitors.

If you will be attending the conference, please stop by the CAHG booth (326) to discuss your enrollment needs with our patient recruitment strategists. Or, feel free to pop in and load up on all of the goodies we will have on hand, including a raffle items and other surprises (We know your kids will be clamoring for your flashlights, pens, and other swag when you get home!).

Our goal for the meeting is to share our insights and vision with other meeting attendees in an effort to fortify another 50 years of collaboration under the banner of DIA. We hope to see you there!

Patient Centricity at DIA 2014

Looking at the program for this year's DIA conference, one thing seems certain: we have undergone a seismic shift in our buzzword usage.

Many of last year's hot topics - notably "Big Data" and "Mobile/mHealth" - have apparently cooled down considerably, with only a few session devoted to them. Even Risk Based Monitoring has seen a big drop in the number of presentations addressing it.

This year's Next Big Thing is clearly Patient Centricity. This makes us excited - we've been talking to sponsors for years about how to improve clinical trial design and communication by engaging directly with patients. However, it also makes us a bit concerned - will the industry treat this as just another passing fad?

With that in mind, we've put together a list of sessions on patient centricity we will definitely be attending. The questions we'll be asking include:

CAHG Attendees at DIA
Come talk Patient Centricity with us

 

Paul Ivsin
Consulting Director
Ask me about: patient interviews,
Patient Aided Design

 

Emily Cortez
Group Account Supervisor
Ask me about: ePatient engagement in
MS, fibromyalgia, and IVF trials

 

Don Sickler
Group Account Supervisor
Ask me about: Parent engagement
in pediatric research

• How actionable are the ideas presented?
• Are new perspectives being offered?
• Can sponsors actually commit to clear, open communication on these topics?

Most of all, we look forward to discussing these ideas with our fellow attendees. Want to talk in depth on patient engagement strategies for clinical trials? Stop by our booth (#326) - we'd love to share experiences on this!

Monday

• 8:30 am - Room 3: Bringing the Patient Voice to Clinical Development
• 11:00 am - Room 2: Engaging Patients through Digital and Social Media Communities
• 11:00 am - Room 30AB: Fact or Fiction: Patient Engagement in the Drug Development Process

Tuesday

• 10:30 am - Room 3: Social Listening as a Tool to Inform Study Teams on Social Media Strategy for Recruitment and Building Patient-Centric Trials
• 1:30 pm - Room 30CD: Enabling Participants’ Access to the Electronic Clinical Trial Data: The Blue Button Project

Wednesday

• 8:00 am - Room 33AB: Clinical Trials Technology Implementation: Bringing Together Patient- and Site-Centric Approaches
• 10:30 am - Room 9: The Patient Point-of-View: An Unrehearsed but Revealing Conversation to Rectify Patient Enrollment
• 1:30 pm - Room 2: Social Media in Patient Recruitment: How to Best Leverage the Digital Ecosystem
• 3:30 pm - Room 3: Filling the Gaps and Speeding Up Results: What an Educated, Sophisticated Patient Population Can Do for You

Thursday

• 10:45 am - Room 9: Parents as Partners: Overcoming Unique Challenges to Pediatric Recruitment and Retention

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.

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.

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.

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.