T 03: Sponsor Attitudes and Behaviors on Patient Recruitment: Insights from Line Management Clinical Operations Personnel
Vice President, Business Development
Imperial United States
Understand the current behaviors of clinical operations personnel at sponsor companies as it relates to patient recruitment
Identify decision-making and accountability roles with regards to patient recruitment at sponsor companies
Compare sponsor company attitudes and behaviors to industry perception, as well as the behaviors of other clinical trial stakeholders (sites, CROs, etc.)
The method used was a survey. We sent out links to the appropriate sponsor personnel and also used 3rd party media to publish/distribute the survey. Included personnel were sponsor employees working as managers or directors of clinical operations, project managers, lead/senior CRAs, and patient recruitment specialists.
Authors: Melynda Geurts, Dan Mc Donald
On average, 50% of the trials managed by those surveyed were delayed due to slow enrollment. Interestingly, however, half of those surveyed felt that a reasonable additional per-patient cost for recruitment on their most pivotal trials was $500 or less. The majority also felt that a site’s lack of enrollment post-initiation was not unacceptable unless 90 days or more had passed. Nearly 90% of those surveyed said they selected “backup” sites but only 14% develop conditional contracts. The survey found that sponsors expect the sites or CROs to enroll patients as the majority of sponsors do not develop formal recruitment plans. In addition, over 50% of sponsor personnel rated their level of pressure or stress related to patient recruitment as very stressful. Most sponsor personnel feel empowered to make changes to boost enrollment and say that their firms are increasingly conducting trials internationally in order to help drive enrollment. The overwhelming majority feel patient recruitment is not getting any easier and just over half feel it is getting harder. Another issue they cited was that most trials have up to 3 protocol changes that impact enrollment. Only half of those surveyed said that they actually measure the impact of recruitment campaigns.
When it comes to disruptive innovations that will help to drive down enrollment timelines, the majority felt that mobile/wearables, non-site trials, and in-home study visits would be the top causes.
In summary, patient recruitment and enrollment continues to be one of the key contributors to why clinical trials do not complete on time. Furthermore, the majority of the respondents indicated that they still rely on the sites to enroll. And while amending the protocol and expanding sites globally are ways intended to accelerate enrollment they do not come without delays and heavy costs. The competitive landscape within clinical research is growing exponentially. Solely relying on sites to meet enrollment goals is a flawed approach. Very few studies and sites have the ability to achieve successful enrollment without some level of outside support. Sponsors will need to re-evaluate their approach to clinical trial design and planning.