Critical Questions to Ask Your IRB

A top 5 sponsor turned to WCG to recruit expecting mothers for its Phase III RSV vaccine trial. WCG support covered multiple countries and contributed almost one third of overall randomizations in the supported countries, bringing the study in ahead of schedule despite delays due to COVID-19 impacts on RSV seasonality. The sponsor met study timeline past enrollment by continuing to work with WCG’s retention support.

A sponsor needed to get their Phase II dermatology study enrollment back on track. The study was underway for 11 months across 32 sites globally with only 20 subjects enrolled to date. With WCG support, enrollment was concluded 24 months ahead of schedule.

A top 5 sponsor was falling behind on data entry for their global oncology portfolio, which included 130+ sites and 100+ protocols. WCG supported data entry and query resolution for 130+ sites, resolving data entry backlog in time for interim analyses.

A sponsor’s glaucoma and ocular hypertension studies were behind on enrollment. The sponsor had started an outreach campaign which was not providing the desired results. WCG developed a new recruitment strategy mid-study comprised of a multi-channel outreach campaign.

Get the initial IRB submission right the first time.

Recruitment and retention may appear to be simplistic in their primary functions. However, for these two processes to be successful, they must be applied in a way that resonates with the individuals that are stepping up to participate, whether that be out of a desire to impact the health of others or to provide treatment options for their own health condition. By adding people to the equation, we are adding variables of infinite complexity. Thus, an absence of process or lack of experience in one area can significantly affect others, leading to a cascade of problems that undermine recruitment and retention plans.