To hear sponsors tell it, the complex business of conducting clinical trials is fraught with challenges, perhaps none bigger
than the slowdown caused by underperforming investigative sites. From the site's perspective, clinical trials are characterized
by demanding protocols, tough deadlines, grant payment problems, and enrollment pressures—difficulties all caused by the sponsor.
Each side has been pointing the finger at the other for a long time. But now, with so much at stake, namely patent expirations,
intense global competition, and heightened emphasis on safety, there is keen interest in making things better, in listening
and learning from each other—essentially building a relationship.
Table 1: Some key issues that sites have with sponsors.
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Some sponsors are becoming intentional in their efforts to build relationships with sites, hoping to turn more of them into
predictably high performers. They are reaching out to sites to identify the issues they have with sponsors that create stumbling
blocks and stall performance (see Table 1). The current thinking is that addressing these issues has tremendous potential
for improving outcomes.1 A number of forward-thinking sponsors are investing resources to identify the issues and then retooling and implementing
processes to make substantive and measurable changes needed to make site performance more predictable.
The subject of improving sponsor–site relations as a way to improve performance has been a topic of discussion since the late
1990s. At that time, articles and surveys highlighting the frustrations of investigative sites and their opinions of various
sponsors started appearing in the literature.2–4 What is different this time is that sponsors are responding by making strong commitments of time and manpower in a way they
have not done before.
This article explores that commitment to intentional relationship building, sometimes known as investigator relationship management
(IRM) or site relationship management (SRM)—all buzz phrases in the clinical trials industry referring to focused efforts
by sponsors to intentionally improve relationships with sites for mutual benefit. Sponsors are moving ahead with these initiatives
because inadequate site performance continues to be a major drain on industry resources, despite growing use of electronic
solutions. There are data to suggest that 26% of sites recruit 80% of patients, and on average, 14% to 19% of investigators enroll one
subject or no subjects.5 Much of this unsettling picture is attributed to insufficient infrastructure at the site, untrained staff linked to rampant
turnover of study coordinators, and the high dropout rate of investigators after having completed a handful of clinical trials.6,7 This business model is not sustainable in today's highly pressured environment, so changes are in order.
Building intentional relationships
Throughout the past few decades, industry has paid a lot of attention to improving relationships among business partners.
They emphasize adopting a customer-centric business model8 along with tactics that enable work groups to improve output, such as clearly defining roles, streamlining internal and
external processes, and improving communication among team members. This common sense approach is most effective when it strikes
a healthy balance between the cold, hard effort needed to complete a task and the softer people skills necessary to forge
a committed relationship in an engaging, quality-driven working environment.
Ruth Dubinsky, principal of Clarity Consulting (Ambler, PA), a team building organization, says that sponsors and sites are
happier and do better work when they intentionally form relationships. "When all people do is focus on the task that needs
to get done, and they take out the human element, so much is lost and people are less productive, yet that's what people do.
When people are relegated to just being taskmasters, and the human element gets stripped away, everything is very robotic,
often leading to continual problems with turnover, lack of commitment, and less quality," Dubinsky says.
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