Literature DB >> 9475131

Inclusion of women in clinical trials: a historical overview of scientific, ethical, and legal issues.

R B Merkatz1.   

Abstract

During the past 20 years, there has been a dramatic shift in scientific, ethical, and legal perspectives regarding the inclusion of women in clinical trials conducted in the United States. A historical overview of why women previously were excluded from clinical trials is presented, and the reasons for current policy changes are discussed. The clinical necessity for testing drugs in specific populations (e.g., women) to ensure appropriate dose regimens and to minimize the likelihood of adverse effects is discussed. The difficult issue of prescribing drugs for pregnant women is highlighted.

Entities:  

Keywords:  Biomedical and Behavioral Research; National Institutes of Health

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Substances：

Year:  1998        PMID： 9475131     DOI： 10.1111/j.1552-6909.1998.tb02594.x

Source DB:  PubMed          Journal:  J Obstet Gynecol Neonatal Nurs        ISSN： 0090-0311


  10 in total

Review 1.  Drugs and Medical Devices: Adverse Events and the Impact on Women's Health.

Authors:  Jennifer L Carey; Nathalie Nader; Peter R Chai; Stephanie Carreiro; Matthew K Griswold; Katherine L Boyle
Journal:  Clin Ther       Date:  2017-01-07       Impact factor: 3.393

Review 2.  Sex and the Lab: An Alcohol-Focused Commentary on the NIH Initiative to Balance Sex in Cell and Animal Studies.

Authors:  Marina Guizzetti; Daryl L Davies; Mark Egli; Deborah A Finn; Patricia Molina; Soundar Regunathan; Donita L Robinson; Farida Sohrabji
Journal:  Alcohol Clin Exp Res       Date:  2016-05-07       Impact factor: 3.455

3.  Clinical trials in pregnancy and the "shadows of thalidomide": Revisiting the legacy of Frances Kelsey.

Authors:  Miranda R Waggoner; Anne Drapkin Lyerly
Journal:  Contemp Clin Trials       Date:  2022-05-30       Impact factor: 2.261

4.  Representation of women, older patients, ethnic, and racial minorities in trials of atrial fibrillation.

Authors:  Muhammad Zia Khan; Muhammad Bilal Munir; Safi U Khan; Charumathi Raghu Subramanian; Muhammad Usman Khan; Zain Ul Abideen Asad; Swapna Talluri; Aarthi Madhanakumar; Ahmad Naeem Lone; Muhammad Shahzeb Khan; Erin D Michos; Mohamad Alkhouli
Journal:  Pacing Clin Electrophysiol       Date:  2021-02-03       Impact factor: 1.976

5.  Women in HIV cure research: multilevel interventions to improve sex equity in recruitment.

Authors:  Mary E Grewe; Yuntong Ma; Adam Gilbertson; Stuart Rennie; Joseph D Tucker
Journal:  J Virus Erad       Date:  2016

6.  Protected to death: systematic exclusion of pregnant women from Ebola virus disease trials.

Authors:  Melba F Gomes; Vânia de la Fuente-Núñez; Abha Saxena; Annette C Kuesel
Journal:  Reprod Health       Date:  2017-12-14       Impact factor: 3.223

7.  Representation of women in heart failure clinical trials: Barriers to enrollment and strategies to close the gap.

Authors:  Nosheen Reza; Jadry Gruen; Biykem Bozkurt
Journal:  Am Heart J Plus       Date:  2022-01-30

8.  Effective Communication About Pregnancy, Birth, Lactation, Breastfeeding and Newborn Care: The Importance of Sexed Language.

Authors:  Karleen D Gribble; Susan Bewley; Melissa C Bartick; Roger Mathisen; Shawn Walker; Jenny Gamble; Nils J Bergman; Arun Gupta; Jennifer J Hocking; Hannah G Dahlen
Journal:  Front Glob Womens Health       Date:  2022-02-07

9.  The challenges of including sex/gender analysis in systematic reviews: a qualitative survey.

Authors:  Vivien Runnels; Sari Tudiver; Marion Doull; Madeline Boscoe
Journal:  Syst Rev       Date:  2014-04-10

10.  Reasons for participation and non-participation in a diabetes prevention trial among women with prior gestational diabetes mellitus (GDM).

Authors:  Jennifer J Infanti; Angela O'Dea; Irene Gibson; Brian E McGuire; John Newell; Liam G Glynn; Ciaran O'Neill; Susan B Connolly; Fidelma P Dunne
Journal:  BMC Med Res Methodol       Date:  2014-01-24       Impact factor: 4.615
  10 in total

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