Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics
| Autor: | Audrey D Zhang, Joshua D. Wallach, Jennifer E. Miller, Michaela A. Dinan, Joseph S. Ross, Tanvee Varma, Joshua J. Skydel, Dominic Schnabel, Cary P. Gross |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
education.field_of_study
medicine.medical_specialty business.industry United States Food and Drug Administration Fda approval Research Health Policy Population Cancer type Cancer General Medicine Demographic data medicine.disease United States Food and drug administration Online Only Internal medicine Research participant medicine Product Surveillance Postmarketing Humans business education Cancer death Original Investigation |
| Zdroj: | JAMA Network Open |
| ISSN: | 2574-3805 |
| Popis: | This cross-sectional study investigates demographic data reporting and demographic representation by sex, age, and race/ethnicity in premarketing and postmarketing studies of novel cancer therapeutics. Key Points Question Are the demographic characteristics of patients enrolled in premarketing and postmarketing studies used by the US Food and Drug Administration (FDA) to evaluate the safety and efficacy of novel cancer therapeutics clearly reported and representative of the US cancer population? Findings In this cross-sectional study of 77 premarketing studies and 56 postmarketing studies for FDA-approved cancer therapeutics, there was inconsistent reporting of demographic data and underrepresentation of older adults and Black patients in premarketing and postmarketing studies of cancer therapeutics. Meaning Premarketing and postmarketing studies used by the FDA to evaluate novel cancer therapeutics may not adequately represent the US cancer population. Importance Adequate representation of demographic subgroups in premarketing and postmarketing clinical studies is necessary for understanding the safety and efficacy associated with novel cancer therapeutics. Objective To characterize and compare the reporting of demographic data and the representation of individuals by sex, age, and race in premarketing and postmarketing studies used by the Food and Drug Administration (FDA) to evaluate novel cancer therapeutics. Design, Setting, and Participants In this cross-sectional study, premarketing and postmarketing studies for novel cancer therapeutics approved by the FDA from 2012 through 2016 were identified. Study demographic information was abstracted from publicly available sources, and US cancer population demographic data was abstracted from US Cancer Statistics. Analyses were conducted from February 25 through September 21, 2020. Main Outcomes and Measures The percentages of trials reporting sex, age, and race/ethnicity were calculated, and participation to prevalence ratios (PPRs) were calculated by dividing the percentage of study participants in each demographic group by the percentage of the US cancer population in each group. PPRs were constructed for premarketing and postmarketing studies and by cancer type. Underrepresentation was defined as PPR less than 0.8. Results From 2012 through 2016, the FDA approved 45 cancer therapeutics. The study sample included 77 premarketing studies and 56 postmarketing studies. Postmarketing studies, compared with premarketing studies, were less likely to report patient sex (42 studies reporting [75.0%] vs 77 studies reporting [100%]; P |
| Databáze: | OpenAIRE |
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