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Embarking on a multimillion dollar project without first identifying and assessing the risks involved and then creating a
risk–response strategy would be like sending a blindfolded person out into a foreign city with no seeing eye dog, no cane,
and no prior training on what to expect.
A risk–response planning strategy encompasses those efforts necessary to identify risks, lower the likelihood of those risks
occurring, and minimize their potential impact on the project if they do occur. Although risks can never be totally eliminated,
they can be managed to lessen the likelihood of occurrence and/or impact on the project. In the clinical research industry,
although study enrollment is only a piece of the overall clinical R&D process, it is one of the most pivotal projects and
deserves the same rigorous protection.
Taking responsibility
Historically, when it comes to subject enrollment, sponsors have practiced what risk management experts would call risk "transfer"—giving
the entire responsibility and accountability for enrollment solely to the sites. As subject recruitment knowledge and practices
have developed and become more sophisticated, sponsors practiced transferring the risk to CROs and subject recruitment companies.
Today, however, sponsors are realizing that financial accountability remains squarely in their camp. If enrollment numbers
aren't materializing fast enough, or at all, it is their company's potential profit that may suffer. Consequently, top executives
are choosing to take more control of subject enrollment internally. With that decision comes a daunting challenge for sponsors.
First they need to understand the complexities of subject recruitment well enough to spot the unique risks or threats to enrollment,
and then they need to be capable of carefully weighing their impact and making sound decisions about the actions they will
take to respond most effectively. After all, subject recruitment has now become a full discipline—a field of study worthy
of specialized expertise that may or may not exist in its entirety within sponsor organizations.
This article provides a framework that sponsors can use for recognizing and addressing the common threats to recruitment success
through six universal risk areas of patient enrollment and illustrates how they can be analyzed and managed in a clinical
study environment.
Six risk areas
The field of subject recruitment recognizes that every study faces its own unique challenges, and there is no single solution
for ensuring that every clinical trial enrolls on time and on budget. It is critical to have methodologies in place that hone
in on how to develop the ideal approach in any given recruitment situation.
Experts that have originated the development of subject recruitment as a field have identified and articulated six distinct
threats to on-time enrollment:
- Poor study community communications or infrastructure
- Inadequate planning, monitoring or redeployment of enrollment efforts
- Poor site selection or performance
- Ineffective materials or inefficient approval of materials
- Ineffective recruitment of subjects from site panels and the general public
- Subject attrition or noncompliance with the protocol.1
Figure 1
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The definition of subject recruitment as a field goes far beyond generating interest in a trial through outreach. The discipline
has expanded to include early assessment of the protocol from a recruitment perspective, site and country selection, outreach
strategies and implementation, and retention programs, among other activities (see Figure 1).
