With the need to avoid even the suggestion of inducement in studies on marketed drugs, economic incentives for post-approval
studies are significantly constrained. Therefore, convincing sites to participate in post-approval studies centers on understanding
what motivates a practice or hospital to participate in a study, as well as the barriers to participation, and then identifying
how to optimize study design and execution around both.
To Enroll or Not to Enroll
The primary motivating factors for post-approval investigators are based on the direct relevance of the study to the office
practice or hospital. The largest barrier is the fear of practice disruption and potential loss of productivity. The most
successful post-approval studies offer additional secondary gain to further offset that barrier. The secondary gain is not
economic, but rather, derived from such things as the pride of participation in a large and recognized study.
"Real-world doctors are busy and a Phase IV research study needs to grab their attention," says Tom Marshall, executive director
of the American Association of Neurological Surgeons. "The way to do that is through relevance and value," he says. Delivering
additional value to the sites is a strategic differentiator in recruiting for post-approval studies and to building networks
of investigators for comprehensive post-approval programs. A goal of a post-approval study, through design, execution, and
technology, should be to delight the sites.
Real-World Relevance
Most physicians and hospitals participate in post-approval studies because they are interested in the disease area and they
want to learn something from the study. A good post-approval study design is positioned around the relevancy needs of the
sites—these concerns should be the focus of the initial design phase. Not only should the design team include research advisors,
but representatives of the targeted clinical practice settings also need to take part.
Relevance
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To be relevant to a busy practitioner, the data should also be useful. In an article entitled "Practical Clinical Trials,"
which appeared in the Journal of the American Medical Association in 2003, Carolyn Clancy, MD, director of the Agency for Health Research and Quality, and other colleagues called upon both
industry and academia to design studies that would have practical relevance to clinical decision making. In addition, physicians
and hospitals have other uses for data, ranging from justifying their processes to third party payers to demonstrating quality
improvement. Having the ability to download their own portion of the dataset can also be a big differentiator for sites that
need their data for negotiations or their own research purposes. [See "Relevance"]
Keep it Simple
Convincing a site to participate in a post-approval study means convincing the doctor and the office staff that the program
will not impose undue burden, or distract or disrupt the office practice. Case report forms have to be streamlined; every
data element should be justified. Technology can greatly assist these tasks, but it has to be user-friendly, highly intuitive,
and geared toward research-naļ sites that are likely to use the systems on a limited basis.
"Electronic data capture [EDC] allows geographically diverse sites to manage their own data, which works well in the less-monitored
registry setting," says Karen Stein, MD, MPH, director, medical affairs, Sanofi-Aventis. "The advantage of EDC over individual
site databases is the cleaning, processing, digesting, and synthesis of a central database and the benchmarking standardized
and centralized data collection facilitates. One huge advantage of electronic data capture is the mobility of questionnaire
design, that is, individual responses can allow tailoring of subsequent questions, resulting in improved sensitivity and specificity
and far greater efficiency," she says.
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