Practical Pointers: Product Development and Medical Affairs
Written by: Gerald L. Klein, MD; Burak Pakkal, MD, Roger E. Morgan, MD; Renu Jain, PhD; Shabnam Vaezzadeh, MD; Pavle Vukojevic, MD; Larry Florin, MBA; Victoria Manax, MD
Product Development
Data Monitoring Committees in Clinical Trials: The new FDA Guidance on “Use of Data Monitoring Committees in Clinical Trials” (DMC) just came out in February 2024. [1] The FDA strongly recommends using a DMC if there is a risk of a serious mortality or morbidity due to the participant’s medical condition or if the investigation may cause serious unexpected adverse events during the trial. The agency further states that the use of such a committee is practical.
MedSurgPI suggests that when the study is short in duration, a Safety Review Committee, (SRC) may be a more practical approach to further ensure safety of the clinical trial. This consists of a medical monitor, the principal investigator, and another medical safety expert.
Overview of Device Regulation: The FDA has just issued the “Quality Management System Regulation (QMSR) Final Rule”, which amends the good manufacturing practices requirements of the Quality System Regulation (21 CFR Part 820).[2]
Medical device manufacturers of US medical devices must adhere to the following:
US FDA Registration Guidance | US Medical Device Registration
Device Registration and Listing
Premarket Notification 510(k) unless exempt, or Premarket Approval (PMA)
Investigational Device Exemption (IDE) for clinical studies
Still a Need to Improve More Diverse Populations in Clinical Trials: Clinical Trials need to involve more diverse populations such as racial and ethnic minorities, the elderly, rural populations, women, etc.[3] The FDA has published a new guidance document that explains how this data is to be collected during a clinical trial: “Collection of Race and Ethnicity Data in Clinical Trials, and Clinical Studies for FDA-Regulated Medical Products: Draft Guidance for Industry.”[4] One resource, with tools and other information to help improve this situation, may be found at the National Institute of Minority Health and Health Disparities website.
Medical Affairs
Keeping Current: Presenting yourself as an expert goes beyond just understanding your product; it’s crucial to be deeply knowledgeable about the conditions it treats. This requires a commitment to continuously monitoring and analyzing relevant medical literature, including newsletters, attending conferences, and reviewing clinical trial data. Keeping abreast of advancements in the field ensures that you remain a comprehensive resource for both your product and its application. This ensures that your team can provide accurate and up-to-date information, establishing yourself as a reliable source.
AI Chatbots for Medical Education: Some medical information tasks can be automated by the use of AI chatbots for providing such information to health professionals and patients about medication and device indications, adverse effects, dosages, and drug interactions.
Medical Affairs Microgrants: Our experience suggests that a ‘microgrant’ program can be a useful tool in obtaining greater healthcare professional (HCP) engagement. This entails establishing a very modest grant program that allows HCPs who do not conduct formal clinical trials to defray the cost of such activities as creating an article (case history), small study (observational, history, etc.) of interest to your company.
[1] https://www.fda.gov/media/176107/download.
[3] Kim J and McDaniel D. From Words to Action: Advancing Efforts to Reduce the Racial Gap in Clinical Research. Applied Clinical Trials. Feb 7, 2024.