Drug Development
It is absolutely an essential part of the clinical research process in providing Informed Consent, and having the potential participant sign the forms (ICF).1 It may help foster enrollment by also explaining to potential study participants not only why the research is being conducted, but also how their individual participation will help in product development and what this product has the potential to accomplish.
It is more difficult than ever to enroll patients in Phase I oncology clinical trials.2 One partial solution, when feasible, is to make this a multi-center semi-decentralized clinical trial rather than one inhouse unit.
Making some of these visits home visits may further enhance enrollment.
This will open up a wider enrollment area.
This may decrease subject travel time and costs.
The FDA will now start in-person meetings.
This gives companies the ability to have face-to-face dialogue with the agency.
Such meetings may provide a better chance for companies to present their data and reasoning.
Proper preparation with an experienced team is critical to success at these meetings.
Medical Affairs
Writing medical case studies is an excellent method to demonstrate your products’ attributes in an actual clinical example. It shows clinicians the practical aspects of the diagnostic or therapeutic intervention.3
According to Erica Dankiewicz, “The promotional review committee is a multi-disciplinary group with representatives from Medical, Legal and Regulatory and is often referred to as MLR.” Together, as a team, they ensure materials are fair balanced and meet function-specific standards while achieving marketing’s goals. In the US, the Federal Food, Drug, and Cosmetic Act (FD&CA) and Title 21 of the Code of Federal Regulations (CFR) predominantly govern prescription drug advertising and promotion”4 When conducting Legal, Medical, Regulatory Review, it is important to be conservative and follow the exact wording of the package insert.
Clinicians frequently come up with new potential uses for approved products. Allowing these physicians to conduct an investigator-initiated trial (IIT) may be a cost-effective way to test these concepts in a pilot study
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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent
Why is it so difficult to enroll patients in clinical trials? Normal Kanarek, Dina Lansey, Harold C. Agbahiwe, Julie R. Brahmer, Elizabeth M. Jaffee, Antonio C. Wolff, Vered Stearns, Michael Anthony Carducci, and Richard C. Zellars J of Clin Onc 2014: 32: 15 suppl
Riley DS, Barber MS, Kienle GS, Aronson JK, von Schoen-Angerer T, Tugwell P, Kiene H, Helfand M, Altman DG, Sox H, Werthmann PG, Moher D, Rison RA, Shamseer L, Koch A, Sun GH, Hanaway P, Sudak NL, Kaszkin-Bettag M, Carpenter JE, Gagnier JJ, CARE guidelines for case reports: explanation and elaboration.
https://globalforum.diaglobal.org/issue/april-2021/time-to-review-your-promotional-review/by Erica Dankiewicz