Bottleneck. Roadblock. Whatever you want to call it, patient recruitment for clinical trials remains a major challenge for just about everyone associated with drug development. We work with clinical teams of all stripes, and recruitment almost always comes up as a pain point. At the same time, it’s tough to nail down specific solutions to the problem.
I was reminded of all this while preparing for the Patient Recruitment Outsourcing conference, coming later this month in Boston. The conference organizers brought me in on a couple of podcasts — one that focused on recruitment outsourcing and another on changes in the recruitment landscape — and the questions took us all over the map, from emerging markets to social media.
|By Eric Bolesh,
Director of Research
Though I discuss the advantages of dedicated recruitment teams in those recordings, I don’t address recruitment budgets. Some podcast listeners have asked about how recruitment (in general) and these teams (specifically) are funded.
First of all, it will come as little surprise that relatively few companies field a group whose sole specialization is recruitment. Many more, of course, allocate dollars to trial marketing. For Phase III trials, sponsors and CROs dedicated an average of 9% of their trial budgets to patient recruitment. On a per-patient basis, most of the companies we surveyed budgeted less than $400 per patient to recruitment. Every trial is different, and myriad factors will swing those figures in either direction. Two of the companies did not earmark any funding whatsoever, and another five reserved only 1% of their budgets for attracting patients. In the end, most companies used between 3% and 10% of their budgets for clinical trials patient recruitment.
Is it enough? In some cases, yes. In others, teams encountered the delays and setbacks that trial planners always fear. In other words, teams that take a “If you build it, they will come” approach to recruiting may find frustration. The problem, according to several of the people we interviewed, is one of prioritization. They advocate a greater focus on the challenge of enrollment and retention, which often seem to take too much of a backseat to other issues. “Within (our company) at the moment, there is not much time and attention paid to patient recruitment,” said one global head of site management and monitoring. “I am trying to change that.”
Others echoed this sentiment, but it’s a difficult change to make. Sponsors tend to hand off recruiting concerns to CROs and sites. Many vendor teams, for their part, play the cards they’re dealt in terms of protocol, budgets and goals. Meanwhile, myriad other concerns occupy all stakeholders at one time or another, and a realistic approach to patient enrollment falls through the gaps.
Providing adequate funding for recruiting is an important step, even if there’s no dedicated group in place to support recruitment and enrollment. The next steps may take a little more legwork. In the lead-up to the conference, I’ll use this blog to discuss some of the other recommendations we uncovered in our research, from increased patient demographic research to changes in protocol development to a willingness to send trials overseas.