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.

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.

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