More than 80 percent of patients say they are willing to participate in clinical research studies, but only around 10 percent actually do so.1 Meanwhile, from an investigative site perspective, it is realistic to assume that at least one-third of principal investigators and their staff for a given study will fail to randomize a single patient.2 These are just two factors that make more than 76 percent of all Phase II and III studies enroll more than 90 days late; how can we develop standard procedures to address these shortfalls proactively?2 More specifically, how can sponsors accurately measure the feasibility of a protocol and plan accordingly to achieve timely and cost-effective enrollment and the quality data to advance their pipelines?
"Recruitment feasibility is not as ambiguous as the broader term of clinical trial feasibility," said Mike Neidl, Vice President of Clinical Research at Genzyme Corporation. "Seems to me, five years ago feasibility meant sending out surveys. So formal, up-front feasibility is a relatively new concept, and this is an ideal time to address it."True clinical trial feasibility includes strategic, scientific, operational, and patient recruitment considerations—an exploration that is worthy of a series of articles. However, if we focus on establishing a platform for study feasibility through an acceptable definition and general parameters regarding the "enrollability" of a clinical trial—particularly a large-scale, multicenter, global trial—this will benefit sponsor companies and the clinical trial industry as a whole through supporting proactive, early, and efficient recruitment feasibility assessments.
This article will focus on exploring the definitions and parameters of recruitment feasibility, touching on some key considerations for all trials, and propose a flexible formula to help sponsors be more proactive with regard to their specific protocol scenarios. The goal is to establish components of recruitment feasibility and lay the groundwork for the industry-at-large to collaborate and develop a standard set of best practices—and for each sponsor to modify the standards for their own benefit based on the unique demands of their individual research pipelines.
How the road forks
Perhaps the best place to start is by establishing where sponsors are frequently misled and misinformed—both internally and through strategic partnerships. Whether recruitment feasibility is considered on its own or bundled in with operational feasibility, the current "standard" often consists of the following steps:
Unfortunately, from a recruitment point of view, these steps are very broad and can be defined differently by each sponsor. Likewise, each sponsor will vary in the number and type of processes they will then use within each step. Perhaps most importantly, there is no consistent application of a recruitment perspective, or "lens," to the steps. As such, these are all contributing factors that hinder up to 70 percent of trials from meeting their original recruitment targets. Ultimately sponsors pay for inaccurate forecasts either in additional time and/or money, not to mention the costliness of miscalculating the power of a study.3
"Before, the feasibility result was mainly the number of patients and the number of sites that a country can commit to," said Jurek Bojanowski, International Clinical Trial Manager at sanofi-aventis. "But this is not real feasibility. Corporate management must do some validation to check not just how many patients and sites a country can provide, but also when and how fast this enrollment can be performed."