Patient recruitment is a well-known bottleneck in clinical trial process but despite this some companies only carry out a strategy when a problem occurs, instead of planning ahead.
“Taking a wait-and-see approach is far more costly”, said Gretchen Goller, patient recruitment and compliance strategist, Sanofi-aventis, at a session at Partnerships in Clinical Trials (PCT) 2011.
Being proactive and developing a recruitment strategy is more effective, said Goller, but it can be a struggle to convince management. To win this struggle those controlling budgets must be convinced of the value of drafting a recruitment plan early in the trial process.
Jeffrey Zucker, senior director and global head, patient recruitment at Kendle, recommended forming a plan with milestones and contingency triggers. Zucker is “not a fan of wait-and-see” and said being proactive is a vital part of efforts to improve patient recruitment and retention.
Improving relationships with clinical investigators and their sites was the other recommendation made by Zucker. There has been a shift away from dealing directly with investigators, said Zucker, and this trend should be reversed to improve clinical trial recruitment and retention.
Re-establishing closer links with investigators helps make sure they are motivated and there are knock-on benefits from improving communication. “I like it when a site comes to me with a costed plan for patient recruitment”, said Zucker.
However, investigators can be unsure how to ask for money for patient recruitment and retention strategies, said Nariman Nasser, director, participant recruitment service at the UCSF (University of California, San Francisco) clinical and translational science institute.
Re-establishing close relationships and communication increases the likelihood and investigator will propose a recruitment strategy. Investigators and others at their trial site will understand the local patient population and can therefore propose better, more tailored strategies.
Clinical trial coordinators have a lot of information to share, said Goller, and recruitment can be improved by taking the time to learn what they need. As such, Goller, who used to work as a coordinator, always seeks comments from trial site staff.
With strong relationships in place trial sites will communicate problems with patient recruitment and retention earlier, said Nasser. This gives sponsors and contract research organisations (CRO) time to carry out the proactive contingency plans recommended by the panellists.