Written by: Gerald L. Klein, MD; Roger E. Morgan, MD; Shabnam Vaezzadeh, MD; Burak Pakkal, MD; Michael Fath, PhD; Larry Florin, MBA
Product Development
Developing a Diversity Action Plan: The FDA now requires sponsors to submit Diversity Action Plans for certain clinical studies. These plans should outline the sponsor’s goals for enrolling participants from underrepresented populations, including specific targets for age, ethnicity, sex, and race. The plan should also describe the strategies and methods the sponsor will use to achieve these goals.[1]
Informed Consent Form Design: The importance of ensuring that your IRB is following the recent regulations, ethics, and patient protection policies is tantamount to conducting good clinical trials.[2] In June 2024, the FDAs issuance of a 483 highlighting issues with informed consent at a leading US research institution was one among several noted failures:
Failure to ensure that information given to subjects as part of informed consent is in accordance with 21 CFR 50.25 [21 CFR § 56.109(b)]:
Failure to disclose appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject, as required by 21 CFR 50.25(a)(4).
Failure to provide an explanation as to whether any compensation is available if injury occurs and, if so, what it consists of, or where further information may be obtained as required by 21 CFR 50.25(a)(6).
Failure for a statement that notes the possibility that the FDA may inspect the records, as required by 21 CFR 50.25(a)(5).
This is a wakeup call for all IRBs, research institutions, sponsors, and CROs, to ensure that the IRB is doing their job properly.
The new FDA guidance on Use Related Risk Analysis (URRA) is now required for device drug combination, and also to determine if human factors (HF) data will be required to support an NDA or BLA.[3] This plan should include the following:
A comprehensive list of all tasks required for the use of the product
The potential use errors and harms that may occur with those tasks
A determination whether each task is a critical task
Risk controls employed in the user interface designed to mitigate use errors
Evaluation methods that have been used (or will be used) to evaluate the effectiveness of the risk controls
Medical Affairs
Enhancing Patient-Centric Medical Communication: In today’s information-saturated environment, delivering effective patient-centric medical communication is more crucial than ever. The influx of information, much of it potentially false or misleading, can dilute essential messages from drug manufacturers and distributors. To counter this, medical communication professionals must craft messages that are creative and impactful, helping to overcome any negative attitudes towards pharmaceutical discussions. To achieve this, communication materials should include the following key elements:
Clear and accessible language:
Avoid using jargon and technical terminology.
Ensure the language is simple and easy to understand for all audiences.
Conciseness and precision:
Present information in a clear, concise manner.
Keep messages focused to prevent overwhelming the audience.
Factual and substantiated content:
Ensure all statements are based on verified data and research.
Provide references to credible sources to enhance trust and reliability.
Enhanced visualization:
Utilize appropriate drawings, photos, tables, and figures to illustrate key points.
Visual aids significantly improve comprehension and retention.
Resources for further information:
Offer additional resources and follow-up options for those seeking more details.
Include links to reputable websites, support groups, and detailed guides.
Leveraging artificial intelligence (AI):
Use AI to develop engaging multimedia programs that capture the attention of younger and broader audiences.
AI can create dynamic platforms that simplify understanding of disease processes and therapeutic approaches.
The use of AI may assist in the development of multimedia programs that capture the attention of a younger and/or a wider audience. This can provide a dynamic platform to address the better understanding of disease processes and your therapeutic approach. The benefits and adverse effects of your product(s) should be clearly articulated in an easy to understand manner.
Maximize the Effectiveness of Medical Science Liaisons (MSLs). In order to fully utilize your MSL team, consider implementing a creative approach with the following strategies:
Advanced training: Provide comprehensive and ongoing training programs to keep MSLs updated on the latest medical and scientific developments.
Mentoring programs: Pair less experienced MSLs with seasoned mentors to foster professional growth and knowledge sharing.
Unique challenges: Offer opportunities that encourage MSLs to develop innovative solutions and think outside the box.
Innovative technology: Equip MSLs with cutting-edge tools and technologies to enhance their efficiency and effectiveness in the field.
Individual techniques: Encourage MSLs to develop and utilize their unique approaches and techniques tailored to their strengths and preferences.
Flexible work schedules: Allow flexibility in work schedules to accommodate personal and professional needs, promoting a healthy work-life balance.
Scientific stimulation: Provide continuous scientific stimulation through access to the latest research, conferences, and collaborative opportunities.
Competitive compensation: Ensure competitive compensation packages with incentive opportunities to attract and retain top talent in the industry.
By focusing on these elements, medical communication professionals can create impactful and trustworthy messages that resonate with patients while also empowering MSL teams to excel in their roles.
[1]https://www.fda.gov/news-events/press-announcements/fda-guidance-provides-new-details-diversity-action-plans-required-certain-clinical-studies.
[2]Rogers, C.A., Ahearn, J.D. & Bartlett, M.G. Data Integrity in the Pharmaceutical Industry: Analysis of Inspections and Warning Letters Issued by the Bioresearch Monitoring Program Between Fiscal Years 2007–2018. Ther Innov Regul Sci 54, 1123–1133 (2020).
[3]https://www.fda.gov/regulatory-information/search-fda-guidance-documents/purpose-and-content-use-related-risk-analyses-drugs-biological-products-and-combination-products.