Abstract:
:Few recent data are available from formal evaluations of approved new drug applications to address perceptions that racial and ethnic groups are under-represented in clinical trials of new drugs. This study reviews racial and ethnic group participation in clinical trials and race-related labeling for new molecular entities approved during a five-year period by the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). This was a retrospective review of FDA medical officers' reviews of clinical trial protocols and product labeling for 185 new molecular entities (NME's) approved by CDER between January 1,1995, and December 31, 1999. Enrollment data were obtained from the reviews and tabulated according to race/ethnicity. The approved product labeling was searched for statements related to product testing in various racial/ethnic groups. All data were compiled and analyzed using Microsoft Access. This study quantifies the participation of racial/ethnic groups in clinical trials by year and therapeutic category. Additionally, the study categorizes labeling based on the types of effects described as related to race/ethnicity. Racial and ethnic groups appear to participate in clinical trials to varying degrees. African Americans participated in trials to the greatest extent; however, their participation steadily declined from 12% in 1995 to 6% in 1999. Among trials known to be conducted only in the U.S., African-American participation is comparable to their representation in the U.S. population. In all cases, participants designated as Hispanic appear to be far below their representation in the population. Some differences in participation for all racial and ethnic groups are seen when comparisons from year-to-year or among drug classes are made. Labeling for 45% (84/185) of the products contained some statement about race, although in only 8% (15/185) were differences related to race described. Fifty percent (50%) of the effects were pharmacokinetic, 39% were efficacy, and 11% were safety. One product label recommended a change in dosage based on racial differences.
journal_name
J Natl Med Assocjournal_title
Journal of the National Medical Associationauthors
Evelyn B,Toigo T,Banks D,Pohl D,Gray K,Robins B,Ernat Jkeywords:
subject
Has Abstractpub_date
2001-12-01 00:00:00pages
18S-24Sissue
12 Suppleissn
0027-9684issn
1943-4693journal_volume
93pub_type
杂志文章,评审abstract::The Masterson curette was used to sample the endometrial cavity of 25 women prior to scheduled hysterectomy for benign or malignant pathology. Adequate amount of tissue was obtained in 20 (87%) of 23 patients who did not have endometrial atrophy. The Masterson curettage detected all seven cases of endometrial hyperpla...
journal_title:Journal of the National Medical Association
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journal_title:Journal of the National Medical Association
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journal_title:Journal of the National Medical Association
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journal_title:Journal of the National Medical Association
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journal_title:Journal of the National Medical Association
pub_type: 杂志文章
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pub_type: 杂志文章
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journal_title:Journal of the National Medical Association
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journal_title:Journal of the National Medical Association
pub_type: 杂志文章
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journal_title:Journal of the National Medical Association
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journal_title:Journal of the National Medical Association
pub_type: 杂志文章,评审
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journal_title:Journal of the National Medical Association
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journal_title:Journal of the National Medical Association
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journal_title:Journal of the National Medical Association
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journal_title:Journal of the National Medical Association
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