Clinical Trial Ethics

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 known as “seeding trials.”

These “seeding trials” were criticized by various stakeholders in healthcare, and were quickly eliminated by the sponsoring companies. Yet, the lingo lingers on. What was once a marketing initiative that became known as a  “seeding trial” has now come to mean any “marketing trial” sponsored by a company that in not a true clinical study. However, with most academic institutions and large medical practices coming under the scrutiny of Institutional Review Boards (IRBs) and Ethical Review Committees, there are almost no “marketing” or “seeding” trials conducted any longer in this country. There are Phase IV studies and surveillance studies that can be conducted by pharmaceutical companies, but they are legitimate studies with valid protocols and data collection. So when the author from the aforementioned article refers to “seeding” trials,  perhaps greater clarity is needed. If this trial was reviewed by an IRB, then I am sure careful consideration was given to the design. There could very well be studies designed by pharmaceutical companies to look at prescribing patterns, as the authors state, but that would hardly make them “seeding” trials.

Today, under the rules of accountability and transparency, most physicians involved in any kind of clinical study will likely have the design of the trial pass through an IRB and an Ethics Committee. If not, then those physicians participating in such studies should use their best ethical judgment as to the validity of such an initiative before agreeing to participate in it. I would be very hesitant to label a study as unethical, unless it was truly a bogus one. Just because a company wishes to understand prescribing habits of physicians, or look at some epidemiological aspects of physician behaviors, does not mean the study is unethical. To call a study a clinical trial when it is not one is misleading, but the intentions may not have been unethical.

So, when is a clinical trial unethical? When the IRBs and the Ethic Committees deem it to be so. And in the absence of such review groups, those wishing to participate in it should determine the ethics of a study. But I believe it to be unfair to point fingers at a pharmaceutical company and claim a study to be unethical.

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