Drugs

2023 Trial Diversity Workshop Report

FDA has published a report on the topics discussed at an 11/29-30/2023 public workshop it held with the Clinical Trials Transformation Initiative to solicit input on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups, where appropriate. The report emphasizes these topics from the discussion:

how and when to collect and present the prevalence or incidence data on a disease or condition by demographic subgroup, including possible sources for such data and methodologies for assessing such data;
considerations for the dissemination, as appropriate, after approval, of information to the public on clinical study enrollment demographic data;
the establishment of goals for enrollment in clinical trials, including the relevance of the estimated prevalence or incidence, as applicable, in the United States of the disease or condition for which the drug or device is being developed;
approaches to support inclusion of underrepresented populations and to encourage clinical study participation that reflects the population expected to use the drug or device under study, including concerning the establishment of inclusion and exclusion criteria that do not hinder enrollment for certain subgroups, such as pregnant and lactating women and individuals with disabilities, including intellectual or development disabilities or mental illness;
considerations regarding informed consent for individuals with intellectual or developmental disabilities or mental illness, including ethical and scientific considerations; and
the appropriate use of decentralized trials or digital health tools, clinical endpoints, biomarker selection, and study analysis.

Workshop attendees represented drug sponsors, medical device sponsors, clinical research organizations, academics, patients and patient advocacy groups, and other interested parties, the report says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome