PMID- 30890465
OWN - NLM
STAT- MEDLINE
DCOM- 20200731
LR  - 20200731
IS  - 1559-2030 (Electronic)
IS  - 1551-7144 (Linking)
VI  - 80
DP  - 2019 May
TI  - Evaluation of worldwide clinical trials by gender: An FDA perspective.
PG  - 16-21
LID - S1551-7144(18)30670-0 [pii]
LID - 10.1016/j.cct.2019.03.007 [doi]
AB  - INTRODUCTION: The US Food and Drug Administration (FDA) has undertaken efforts to 
      promote representation of women in clinical trials. The objectives of this 
      research are to assess women's participation in clinical trials from a global 
      perspective and to analyze the demographic characteristics of clinical trial 
      participants. METHODS: FDA's Center for Drug Evaluation and Research-Professional 
      Affairs and Stakeholder Engagement (CDER/PASE) and Office of Women's Health (OWH) 
      collaborated to evaluate demographic data (race, ethnicity, gender, and age) of 
      pivotal trials of New Molecular Entities (NMEs) approved in 2015-2016 by 
      geographic location. One hundred fifty-four pivotal clinical trials supporting 66 
      NMEs were identified, and the research team analyzed demographic characteristics 
      of 131,749 participants from 70 countries. RESULTS: U.S. sites contributed 31% of 
      the 131,749 study participants. On the country level, the United States 
      contributed the largest number of participants and other individual countries 
      contributed 5% or less of the total trial population. Overall, 43% (n = 56,272) 
      of the 131,747 clinical trial participants were women. Of the 40,833 U.S. 
      participants, 49% were women as compared to 40% of the 90,914 non-U.S. 
      PARTICIPANTS: Similar levels of participation were seen after the exclusion of 
      sex-specific drug indications, and by therapeutic area for U.S. and non-U.S. 
      sites. CONCLUSIONS: Clinical trials are becoming increasingly multi-national, and 
      the increasing representation of women across countries is promising. FDA 
      approval processes ensure that global data used in the drug approval process 
      meets regulatory standards and that data can be generalized to the U.S.
CI  - Copyright (c) 2019. Published by Elsevier Inc.
FAU - Ayuso, Emily
AU  - Ayuso E
AD  - Office of Women's Health, OC, FDA (Address: 10903 New Hampshire Avenue, 
      WO32-2333, Silver Spring, MD 20993, USA. Electronic address: 
      Emily.ayuso@fda.hhs.gov.
FAU - Geller, Ruth J
AU  - Geller RJ
AD  - Office of Women's Health, OC, FDA (Address: 10903 New Hampshire Avenue, 
      WO32-2333, Silver Spring, MD 20993, USA. Electronic address: 
      ruthjgeller@gmail.com.
FAU - Wang, Junyang
AU  - Wang J
AD  - Professional Affairs and Stakeholder Engagement, CDER, FDA (Address: 10903 New 
      Hampshire Avenue, Bldg. 51, Rm 2341, Silver Spring, MD 20993-0002, USA. 
      Electronic address: Junyang.Wang@fda.hhs.gov.
FAU - Whyte, John
AU  - Whyte J
AD  - Professional Affairs and Stakeholder Engagement, CDER, FDA (Address: 10903 New 
      Hampshire Avenue, Bldg. 51, Rm 2341, Silver Spring, MD 20993-0002, USA. 
      Electronic address: Jwhyte@webmd.net.
FAU - Jenkins, Marjorie
AU  - Jenkins M
AD  - Office of Women's Health, OC, FDA (Address: 10903 New Hampshire Avenue, 
      WO32-2333, Silver Spring, MD 20993, USA. Electronic address: 
      Marjorie.jenkins@fda.hhs.gov.
LA  - eng
PT  - Journal Article
DEP - 20190316
PL  - United States
TA  - Contemp Clin Trials
JT  - Contemporary clinical trials
JID - 101242342
SB  - IM
MH  - Adult
MH  - Clinical Trials as Topic
MH  - *Drug Approval/methods/statistics & numerical data
MH  - Female
MH  - Global Health/standards/statistics & numerical data
MH  - Humans
MH  - Male
MH  - *Patient Selection
MH  - Sex Factors
MH  - United States
MH  - United States Food and Drug Administration/*statistics & numerical data
MH  - *Women's Health/standards/statistics & numerical data
OTO - NOTNLM
OT  - Demographic data
OT  - Diversity
OT  - Global clinical trials
OT  - Participation
OT  - Sex-specific
OT  - Women
EDAT- 2019/03/21 06:00
MHDA- 2020/08/01 06:00
CRDT- 2019/03/21 06:00
PHST- 2018/11/08 00:00 [received]
PHST- 2019/02/11 00:00 [revised]
PHST- 2019/03/15 00:00 [accepted]
PHST- 2019/03/21 06:00 [pubmed]
PHST- 2020/08/01 06:00 [medline]
PHST- 2019/03/21 06:00 [entrez]
AID - S1551-7144(18)30670-0 [pii]
AID - 10.1016/j.cct.2019.03.007 [doi]
PST - ppublish
SO  - Contemp Clin Trials. 2019 May;80:16-21. doi: 10.1016/j.cct.2019.03.007. Epub 2019 
      Mar 16.