Ken Getz, Chairman, CISCRP
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The FDA's Critical Path Initiative acknowledges long-standing and widely accepted challenges facing the clinical research
enterprise and identifies several opportunity areas that may help to address these challenges. One primary opportunity area
relies heavily on more effective collaboration among the scientific and drug development communities in order to improve the
translation of biomedical information from molecule to market. I believe that this opportunity holds significant promise.
But that promise will be magnitudes greater—and its realization better assured—when the FDA broadens the Initiative's scope
to include the public community as a more central and critical partner in this collaboration.
Poor patient enrollment and retention is a major contributor to development inefficiency—indeed it is the largest source of
delays in clinical research. Investigative sites report that more than 90% of all clinical trials must extend their original
study timelines in order to enroll the requisite number of volunteers. And more than one-out-of-four randomized study volunteers
drops-out before completing participation. Despite the fact that more than two-thirds of Americans see or hear patient recruitment
advertisements regularly, less than 20% of those diagnosed with severe and life threatening illnesses report ever considering
clinical trials as a health care option. And less than 6% of eligible patient populations participate in trials on illnesses
for which there are few, if any, treatments currently available.
Building awareness At this time, the public knows nearly nothing about clinical research and the valuable, albeit essential, role that volunteer
participation plays in supporting medical innovation and advancing public health. Public trust in the FDA and the research
enterprise has eroded sharply according to recent national opinion polls. Without fundamental public awareness and education,
increasingly higher levels of resources will be spent on patient recruitment and retention and on consumer advertising with
marginal—if not diminishing—results. Without public support and engagement in clinical research, a new generation of performance
standards and predictive tools will offer limited to no value. The FDA and clinical research professionals must find new ways
to inform and engage the public.
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The FDA is well aware of the need to educate the public and is taking steps to do so just as the NIH Roadmap has called for
the establishment of stronger collaboration with the public. But the Critical Path Initiative has not made its partnership
and ongoing communication plans between professional and patient communities more explicit. The Initiative offers cursory
details of the agency's expected role for the public. The FDA notes that it is critical to enlist relevant stakeholders and
suggests that advisory committees serve as the public's major feedback mechanism. Arguably, public input primarily through
advisory committees will be limited. Distillation and filtering of information is a frequent byproduct of public advisory
committees. In addition, advisory committees often redirect feedback according to widely differing agendas. As a result,
the essence of broad public feedback is often lost and its urgency diminished.
To support the mission of the Critical Path Initiative, the FDA—in coordination with the clinical research community—will
need to make a long-term commitment to focusing energy and resources on broadly based national and grass roots public education
and outreach. Doing so will ensure more meaningful feedback from the public as they will be more informed and engaged in the
process.
Along with advisory committee input, the FDA will need to establish feedback mechanisms that manageably allow more direct,
ongoing interaction with the public. These might include more systematic and active use of messaging, interviews, survey assessments,
and group interactions that utilize real-time communication technologies such as the Internet, mobile devices, and the telephone.
The FDA will need to assist in facilitating the communication of public education through the medical community. This will
require more actively educating and involving academic and community-based health professionals in the clinical research process
and in nurturing belief in the importance of collective and coordinated efforts to engage the public in medical innovation.
