Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics

• Published in: JAMA network open Vol. 4; no. 4; p. e217063
• Main Authors: Varma, Tanvee, Wallach, Joshua D., Miller, Jennifer E., Schnabel, Dominic, Skydel, Joshua J., Zhang, Audrey D., Dinan, Michaela A., Ross, Joseph S., Gross, Cary P.
• Format: Journal Article
• Language: English
• Published: United States American Medical Association 01.04.2021
• Subjects: Adult; Age Distribution; Aged; Antineoplastic Agents - therapeutic use; Asian - statistics & numerical data; Black or African American - statistics & numerical data; Cancer; Cross-Sectional Studies; Drug Evaluation; FDA approval; Female; Health Policy; Humans; Male; Middle Aged; Neoplasms - drug therapy; Neoplasms - epidemiology; Older people; Online Only; Original Investigation; Product Surveillance, Postmarketing; Research Subjects - statistics & numerical data; Sex Distribution; United States - epidemiology; United States Food and Drug Administration; White People - statistics & numerical data; United States; United States > US

Adequate representation of demographic subgroups in premarketing and postmarketing clinical studies is necessary for understanding the safety and efficacy associated with novel cancer therapeutics. To characterize and compare the reporting of demographic data and the representation of individuals by...