Hand holding globe - diversity

AdvaMed Releases New Resource on Diversity in Clinical Research

Hand holding globe - diversity

“Approaches to Increasing Diversity in Clinical Research and Addressing Health Inequities” offers key recommendations for device manufacturers and developers on steps they can take to increase diversity in clinical research and address health equity.

The Advanced Medical Technology Association (AdvaMed) has released “Approaches to Increasing Diversity in Clinical Research and Addressing Health Inequities”, a new document intended to outline considerations and approaches to improving representation in clinical research with the goal of reducing and eliminating health disparities.

The insights in this new report come from a workshop series hosted by Meharry Medical College and AdvaMed over the course of three months in 2021. Workshop topics included Ethics, Trust, & Engagement: Addressing the Challenges of Clinical Trial Diversity, Building Trusted Networks, and Addressing Diversity Through Patient Centered Trials.

“One of the principles guiding our health equity work recognizes the impact of clinical trial diversity on the ability to bring devices to market that improve the health outcomes for the full range of intended patients,” said DeChane Dorsey, executive director of AdvaMed Accel and the lead on AdvaMed’s health equity workstream. “The information coming out of the workshops coupled with the report findings will hopefully assist our members and others in advancing the promotion of research equity.”

Key Recommendations include:

  • Be aware of historical biases that exist in clinical research and potential mistrust of the healthcare system by underrepresented populations.
  • Have intentional conversations with company leadership and various stakeholders to highlight the potential impact of the lack of diversity in current trials. Develop goals to broaden evidence generation efforts to include a more diverse patient population in clinical research and measure your progress.
  • Use a variety of available tools to adequately define the targeted patient population, including leveraging RWD sources.
  • Create a sustainable community of researchers. Partner with more community-based clinicians. Coordinate with clinical investigators to inform other local clinicians of study opportunities to support diverse enrollment.
  • Be prepared to go to the patient by broadening the types and locations of the trial sites and diversity of investigators.
  • Understand the importance of building trust in recruiting diverse participants: between patients and clinicians, companies and clinical investigators/sites, and companies and communities.

Related Articles

  • John Schwope

    AI not only improves data collection and analysis, it impacts which products are engaged in clinical trials, determines necessary medical criteria, helps design the trials and can even choose the best participating facilities. The result is, organizations that leverage AI…

  • Mother child and doctor

    The guidance seeks to balance the need to obtain data on the safety and effectiveness of drugs, biological products and medical devices in the pediatric population with risks associated with exposure to such products and the reality that children cannot…

  • RQM plus logo

    Jordi labs and its team of Ph.D. analytical chemists developed a proprietary, multi-detector approach to ensure that all extractables are accurately characterized to comply with global materials testing regulatory requirements.

  • FDA Logo

    The draft guidance covers DCT design, informed consent, the use of remote clinical trial visits, safety monitoring and software used in conducting DCTs for drugs, biological products, and devices. The comment period is open until August 1, 2023.