From The Editor | February 17, 2015

"Virtual" Recruitment Roundtable: 6 Practices To Avoid In Clinical Trial Recruitment

By Anna Rose Welch, Director, Cell & Gene Collaborative
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clinical trials

Patient recruitment is a work in progress. There are best practices that will help move a clinical trial forward, and then there are “bad practices”, which can only slow down a trial’s progress and cost sponsors more money. In this segment of our “virtual” roundtable, Clinical Leader’s recruitment experts discuss several practices to avoid in the clinical space that will hinder rather than help a trial reach a timely conclusion.

AR Welch: What practices do you suggest that pharma avoid in the recruitment process, and why?

One of the common mistakes that sponsors make when developing a recruitment and retention plan is that they neglect getting buy-in from the study sites. The investigative sites’ ability to proactively identify, enroll, and develop a connection with study subjects will ultimately impact the overall success of the program. Additionally, because of their day-to-day experience with patients and the fact that most sites will have performed similar types of studies, they will have unique perspectives, expertise, and best practices, which can prove invaluable to the recruitment plan. Too often, sponsors don’t leverage this expertise effectively and rely solely on their CRO for recruitment guidance. The ramifications of this mistake can be exaggerated if a patient recruitment firm is hired, but sites are not consulted, informed, or properly educated on the recruitment campaigns that will be used in the study. The result is that sites are much less engaged and far less likely to adopt and effectively use the various tools and resources being provided by the sponsor. Sites want to be part of the recruitment planning process, and they should be. — Dan McDonald, director, business development, DAC Patient Recruitment Services

Direct-to-patient is a dangerous recruitment strategy, because it takes the learned intermediary with an in-depth knowledge of the disease state and treatment options out of the equation. There are multiple clinical nuances to each disease, study, and patient that require careful interpretation, and direct-to-patient techniques may create irrational exuberance and false hope. — Marc Hoffman, MD, CMO, Theorem

There continue to be two major areas that sponsors should avoid when approaching patient recruitment. The first is the practice of simply giving money to each site for the purpose of conducting local recruitment campaigns. Some sites use these recruitment funds well, but others are unable to utilize funds in the most cost-efficient manner, and often there is little accountability for recruitment results. While this has been a standard practice, it was more acceptable when sponsors had no other recruitment provider options to utilize. The second is the practice of giving a specialized recruitment provider an overall program budget with no metrics or accountability built into the pricing structure or contract. For many indications, patient recruitment providers should be able to price on results and have the infrastructure and technology in place to articulate metrics in a proposal, and certainly within the context of an active project. Sponsors that continue to give money blindly to sites or recruitment providers are doing themselves a disservice. — Roger Smith, SVP, global clinical operations, Acurian

Sponsors need to adjust their budgeting of patient recruitment activities to account for regional differences across both central and site-centered campaign strategies. “One budget fits all” is not realistic given economic differences within and across countries. In addition, sponsors should not mandate that all sites utilize all tactics available to them through a central campaign, as most professional research sites do well on their own; they know their audience and how to best engage patients, and therefore don’t require as much assistance as investigators whose primary business is not clinical research. — Kurt Mussina, VP and general manager, Frenova Renal Research

Tune into the previous two articles in this roundtable series below: