Demographics of clinical trials participants in pivotal clinical trials for new molecular entity drugs and biologics approved by FDA from 2010 to 2012

American Journal of Therapeutics

Volumn 22, Issue 6, 2015, Pages 435-455

  Eshera, Noha ^a   Itana, Hawi ^a   Zhang, Lei ^a   Soon, Greg ^a   Fadiran, Emmanuel O ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Demographics; FDA reviews; Pivotal clinical trials; PPR; Sex analysis

Indexed keywords

BIOLOGICAL PRODUCT; NEW DRUG;

CLINICAL TRIAL; DATA BASE; DEMOGRAPHY; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; ETHNIC GROUP; FEMALE; FOOD AND DRUG ADMINISTRATION; HEALTH SURVEY; HUMAN; MALE; PACKAGING; PATIENT PARTICIPATION; PREVALENCE; PRIORITY JOURNAL; REVIEW; SEX RATIO; ADOLESCENT; ADULT; AGED; CHILD; CLINICAL TRIAL (TOPIC); MIDDLE AGED; TIME FACTOR; UNITED STATES;

ADOLESCENT; ADULT; AGED; BIOLOGICAL PRODUCTS; CHILD; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; FEMALE; HUMANS; MALE; MIDDLE AGED; PATIENT PARTICIPATION; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84947077364     PISSN: 10752765     EISSN: 15363686     Source Type: Journal    
DOI: 10.1097/MJT.0000000000000177     Document Type: Review

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