- December 16, 2020
FDA will share CDER’s most recent assessment of clinical trial diversity and discuss efforts to advance diverse participation in clinical trials to include relevant FDA guidance and regulations.
In this era of globalization, meeting various regulatory authorities’ expectations in recruitment of diverse trial population is challenging. The need for faster drug development and shorter recruitment timelines make this important part of drug development even harder. CDER has pooled and analyzed 5-year’s worth of demographic data from NME and original BLA approvals presented in Drug Trials Snapshot 2015-2019. In addition to sharing the observations and trends from trials of over 290,000 participants, the webinar will provide FDAs expectations when it comes to representation in the trials and various initiatives that were developed to help industry, recruitment sites and the public in general achieving these expectations.
- FDA guidance that supports diverse participation in clinical trials
- Status of trial diversity after 5 years of Drug Trials Snapshots reporting
- FDA’s efforts that support clinical trial diversity
- Regulatory affairs professionals working on IND annual reports and NDA/BLA submissions
- Researchers working on trial demographics and health equity
- Foreign regulators
- Clinical research coordinators and recruiters
- Health policy and management experts interested in clinical trial participation Topics Covered
Milena Lolic, M.D., M.S
Lead Medical Officer
PASE | OCD | CDER | FDA
Melvyn Okeke, M.P.H.
PASE | OCD | CDER | FDA
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
OWH| OC | FDA
RADM Richardae Araojo, Pharm.D., M.S.
Associate Commissioner for Minority Health
OMHHE I OC I FDA
- Collection of Race and Ethnicity Data in Clinical Trials, Guidance for Industry and Food and Drug Administration Staff
- Evaluation and Reporting of Age, Race and Ethnicity-Specific Data in Medical Device Clinical Studies, Guidance for Industry and Food and Drug Administration Staff
- Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trials Designs, DRAFT Guidance for Industry
- Drug Trials Snapshots
Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course:
- has been approved for continuing medical, pharmacy, and nursing credit. Please see detailed announcement for more details.
- has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.
- has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
- has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
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