Patient Recruitment and the Sponsor-Site Relationship

Build Intentional Relationships & Increase Recruitment Budgets to Improve Sponsor-Site Relationships

The relationship between clinical trial sponsor and the investigative site is complex and not always optimized for successful patient recruitment. For many sites and sponsors, the relationship is strained, at best.

From the site’s perspective, sponsors don’t recognize their hard work for increasingly complex protocols, have a difficult contract and budget negotiation process, and set unrealistic goals for patient recruitment. From the sponsor’s perspective, sites’ inability to attract sufficient trial patients and the slowdown this causes for clinical trials amounts to a significant amount of money lost in opportunity costs. This tension is intensified as trial protocols become increasingly complex and competition for trial patients is magnified, all while the budgets allocated for patient recruitment have largely remained stagnant.

Accelerated patient recruitment benefits all clinical trial stakeholders, from the sponsor to CROs, to sites, patients, and the public at large. The strained sponsor/site relationship is a hindrance to patient recruitment, but can be overcome by putting two key elements in place: building intentional relationships and increasing patient recruitment budgets.

Building Intentional Relationships

Sites desire intentional relationships, especially with sponsors. For many sites, it feels like sponsors are distant, hard to reach, and uncaring about individual sites (unless site performance is bad).

In general, increased communication is needed between the site, CRO, and sponsor. This will help sites feel closer to the sponsor and more in-the-know about the clinical trial. When sponsors reach out to sites via newsletters, checkups, etc., sites feel included and valued, strengthening the sponsor/site relationship. Sponsors also need to ensure that when sites reach out, communication is facilitated toward finding answers instead of reaching dead ends. With too many levels of communication, sites are confused about whom to contact and when. Simplifying or decreasing these levels will allow for easier access to the sponsor and better communication in the sponsor/site relationship.

To further build relationships with sites, sponsors should make sure that the sites are properly prepared for clinical trials. This includes providing assistance with study start-up, improving training of site staff on the trial protocol, administering training throughout the duration of the study, and keeping investigator payments on time. When sites are cared for by the sponsor, they are better prepared and motivated to recruit patients for clinical trials.

Increasing Patient Recruitment Budgets

According to a 2014 Industry Standard Research (ISR) whitepaper, “For each day a company goes beyond the planned deadline for a clinical trial, that company could be losing as much as $600,000 in foregone sales of smaller products and as much as $8 million on blockbuster drugs.” Considering that 80% of trials fail to meet enrollment goals on time, that is a significant amount of money lost, and is a cause for sponsor frustration with investigative sites.

Currently, sites are not free to innovate when it comes to patient recruitment because of the small patient recruitment budget allocated for each study. This causes sites to defer back to tried-and-true methods of advertising via newspaper, radio, and waiting rooms out of fear of running out of funds for recruitment. The problem with using these traditional advertising methods is that they are becoming increasingly ineffective as society moves to an ever-increasing digital world.

Sites need to be supported in a move toward using technology for advertising and implementing creative advertising strategies. Financial support is a simple way for sponsors to ensure that sites have the tools they need to recruit the set number of patients in a timely fashion. By increasing patient recruitment budgets, sponsors will see a big-picture increase in revenue as enrollment deadlines are met.

The sponsor-site relationship is complicated and frustrating for both parties. However, by building intentional relationships and increasing patient recruitment budgets, sponsor/site relations can be repaired, leading to better patient recruitment, met deadlines, and increased profits. All clinical trial stakeholders will benefit.