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.