DEI

Investigators find that most exclusion criteria in critical care randomized clinical trials are justifiable, but 60% include at least one poorly justified exclusion, most commonly affecting pregnant or lactating individuals.

Recent research from the Tufts CSDD gauged progress in the context of the “Chief Diversity Officer” role at top pharmaceutical companies.

While there has been a number of recent initiatives put into place to support diversity, equity, and inclusion in clinical trials, there is still a considerable amount of room for improvement.

Study finds that addressing racial disparities in lupus clinical trials requires targeted education, increased diversity among trial staff, culturally sensitive recruitment strategies, and addressing social determinants of health to improve Black patient participation.

The complexities behind these translations require specialized personnel who are nuanced in both medical cultures.

Strategies for sponsors to utilize technology in reaching diverse patient populations.

Sponsors and CROs that work with these sites can better reach marginalized communities.

To meet the growing demands of clinical research, sponsors must prioritize comprehensive support models, such as clinical site ambassadors and patient journey coordinators, who can address operational challenges and improve site relationships, patient satisfaction, and overall trial efficiency.

The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.

New paper features insights from nearly 100 experts on four key barriers to clinical trial access.

How the inclusion of measures centered on net treatment benefit can drive an effective multifaceted approach.

With universal adoption of health literacy best practices slow going over the years, advocates are redefining the term to encompass much more of what health-related communication requires beyond simply words.

Understanding how the dynamics between the two play hand in hand in influencing patient recruitment and retention.

In this video interview, Rebecca Metcalfe, principal scientist, patient-centered research, Core Clinical Sciences, highlights the consequences of focusing solely on enrollment targets.

An overview of key trends in communication, logistical preferences, and demographic influences that shape patient engagement and retention in clinical trials.

In this video interview, Jay Park, founder & scientific lead; and Rebecca Metcalfe, principal scientist, patient-centered research; both with Core Clinical Sciences, share their reactions to the FDA releasing its Diversity Action Plan Guidance.

In this video interview, Jay Park, founder & scientific lead; and Rebecca Metcalfe, principal scientist, patient-centered research; both with Core Clinical Sciences, discuss a recent article they authored on the guidance.

In this video interview, Jimmy Bechtel, vice president, site engagement, SCRS, discusses some key initiatives around decentralized capabilities and underrepresented patient populations.

Phase IV ELEVATUM trial results show that one year of treatment with Vabysmo significantly improved vision in underrepresented racial and ethnic groups with diabetic macular edema, supporting the drug's efficacy and safety across diverse populations.

Industry leaders share their perspectives on the guidance and how it will affect sponsors moving forward.

From design and trial start-up to conduct and analysis, there is enormous potential for applications of artificial intelligence within clinical trials to have a profound impact on human health.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discusses how the guidance should prompt better-designed oncology trials and greater diversity.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, touches on challenges that may be created by the guidance such as meeting multiple regulatory requirements.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discusses how sponsors will need to plan ahead even further for their oncology trials.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, highlights how FDA’s multiregional clinical trials in oncology guidance encourages more diverse site locations and patient populations.

In this video interview with ACT editor Andy Studna, Kashoki, SVP, global head of regulatory strategy, discusses the new draft guidance and its emphasis on proactive planning.

Twice-yearly lenacapavir, a long-acting HIV-1 capsid inhibitor, reduced HIV infections by 96% in the Phase III PURPOSE 2 trial while showing superior efficacy over daily Truvada.

Findings from two Baltimore medical centers presented at the American Society for Radiation Oncology Annual Meeting suggest spiritual themes and distrust may be behind the decline in trial participation.

Cohort study of over 290,000 patients found disparities in cancer stage at diagnosis and survival.

Despite the substantial advertising dollars spent annually, patient recruitment remains one of the most difficult challenges that clinical research professionals encounter.