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Matt Kibby, leader of global operations for BBK Worldwide, discusses why country study managers hold the key to global enrollment success but are afraid to use it.
Country study managers (CSMs) are pivotal players in patient recruitment for multinational clinical trials. They are the gatekeepers who can make decisions that affect which recruitment tactics and materials are submitted to ethics committees and ultimately implemented. These individuals hold a world of invaluable knowledge about their countries and cultures that can positively inform a recruitment strategy. Ironically, it is this body of knowledge that can make a small number of CSMs impediments to successful patient recruitment. Their reliance on cultural precedent or tradition can limit success.
During collaborations with CSMs in recent years, my colleagues and I began to notice certain resistance among them to consider or condone patient recruitment approaches that they had not personally seen used. "That won't work here," was a familiar refrain. In the absence of laws or cultural taboos against practices we might suggest (should they be necessary or appropriate), such as radio, television or the Web, CSMs might still point to convention and veto submission of these viable and necessary tactics to ethics committees.
The larger problem is a tendency to simply equate patient recruitment with advertising. Patient recruitment is a discipline—a considered set of practices in response to a problem or set of risks—and direct-to-patient (DTP) outreach is just one of those practices. However, this belief may also cause CSMs to mistakenly equate DTP outreach to pharmaceutical advertising (direct-to-consumer advertising of approved drugs), a practice that is illegal in most countries and widely considered unethical. The mere mention of advertising, even if it is the logical strategy for patient recruitment, may be immediately rejected. What many CSMs may not realize is that DTP outreach for clinical studies is most often legal and conducted using strict ethical guidelines. Its purpose is to educate and inform patients about trials, a particular condition, and a particular study—not to coerce or misinform.
The CSM conundrum led BBK to conduct research on this group. The company used a methodology in which CSMs from 16 different companies and 10 different countries completed a behavioral assessment survey to uncover their core work styles. Among other findings, data revealed that about 80% of CSMs surveyed have a work style or trait that causes them to "seek to minimize risk" [BBK Worldwide, Maximizing Clinical Research Talent for Successful Multinational Trials: A Case for a New Approach to the Work of the Country Study Manager (2006)].
This representative sample may explain their resistance to trying new methods of patient recruitment—especially those that they believe may be unethical or questioned and rejected by site staff, ethics committees or patients.
This tension may also be explained by another human trait: the tension and resistance that is created when an outside party makes suggestions about how to do your job. This may be compounded when the methods and materials suggested to CSMs are new and not well understood.
The challenge for patient recruitment experts is to build good relationships with CSMs and to educate them on effective new ways of reaching out to patients using ethical guidelines in this changing clinical trial climate. At the same time, there is an opportunity for CSMs to become true pioneers of patient recruitment and to gain more success in their roles by using innovative recruitment tactics and materials. Their challenge is to continue to share their country and cultural knowledge with colleagues in the field who rely on it, while also understanding the changing environment and then allowing themselves to step outside of their comfort zones.