Clinical Trial Ethics
July 7, 2011 · 2 comments
Industry Insights from Paul Meade, M. Sc, MPH
According to an article published in the Archives of Internal Medicine, Dr Joseph Ross claimed a study conducted by Parke-Davis, before it was acquired by Pfizer, using gabapentin (Neurontin), as the drug under investigation, appeared to be a “seeding” trial. And while the author states that seeding trials are not illegal, he states that they are unethical. There are really two separate issues at stake here: first, what is really an unethical trial, and second, what is really a “seeding” trial?
About 25 years ago, when a pharmaceutical company launched a new drug and wanted to get as many physicians as possible to have some experience in using this drug for appropriate patients, they would provide samples packaged in a box to resemble supplies you might receive if you were a clinical investigator. There would be cards to report on one’s experience with the new drug, such as efficacy and side effects. But these sample cards were rarely collected and reported back to the head office. The goal was really to have physicians become familiar with this new drug, and for their own information record some information. These were not formal clinical trials, not required by the regulatory authorities, and did not need the scrutiny of an Institutional Review Board. These ersatz trials became ... read more »
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academic institutions Archives of Internal Medicine clinical investigators clinical trial clinical trial data collection clinical trial design clinical trial protocol Dr Joseph Ross drug efficacy drug samples drug side effects drugs ethical review committees ethics in healthcare gabapentin healthcare hospitals institutional review board marketing trial medical ethics Neurontin Parke-Davis patients Paul Meade Pfizer pharmaceutical Phase IV clinical studies physician behaviors physicians prescribing habits of physicians sample cards seeding trial surveillance studies Thought Leader Select