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Medelis: It seems that the responsibility for patient safety is spread across the board — the sponsor, the CRO, the IRB, the FDA, the DMC, if there is one. And that a mechanism for improved patient safety is greater monitoring and thorough real-time analysis of that data—all of which means rising costs.
Dr. Gourzis: Given the complexity of oncology studies, costs are a substantial concern. In this regard, I think the CRO will play a greater and greater role in patient safety given the sheer volume of trials that are now underway. A CRO whose monitors have deep experience in an indication, particularly oncology, are the best hedge against rising costs. Experienced, objective monitors who can properly review the files can generate higher quality data for sponsors and DMCs. Of course, patient safety will always continue to be the responsibility of the sponsor and study site.
The FDA: refocusing on post-marketing studies as regulations continue to evolve
Medelis: What’s on the horizon at the FDA?
Dr. Gourzis: The FDA has talked about mandating post-marketing studies but nothing has been done so far except in very select cases, such as pediatric safety trials. Post-marketing studies obviously involve a much larger patient population than a clinical trial; the goal is to bring rare toxicities to light more quickly.
Most of the issues with safety post-marketing have been with new state-of-the-art drugs. Powerful patient advocacy groups are increasingly demanding access to emerging novel compounds outside of clinical trials. As they push for expedited approval of these drugs, there may be greater political will to push through required post-marketing monitoring since these novel compounds are more likely to be associated with hidden toxicities.
If post-marketing studies are mandated, a sponsor may have to shoulder the costs of collecting more rigorous safety data on the patients who are, for example, in the first cohort of 15,000 new users.
Medelis: Do you believe that post-marketing requirements will become a reality? Are there any other changes you see ahead?
Dr. Gourzis: Yes, I do think the formal post-marketing studies and reports will be our next major regulatory change. In addition, patients are demanding full disclosure and access to trial results and, more specifically, to their data.
Trials have become exponentially more complex since the first regulations emerged in the 1960s. It’s like comparing a Model T to a Mercedes SLK. As our industry evolves, regulations will evolve as well.
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