Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers December 15, 2017
Pharmacy Choice - Pharmaceutical News - Are women and minorities adequately represented in new drug testing? - December 15, 2017

Pharmacy News Article

 11/26/17 - Are women and minorities adequately represented in new drug testing?

By a News Reporter-Staff News Editor at Medical Letter on the CDC & FDA New Rochelle, NY, A new study to assess the effects of U.S. Food and Drug Administration (FDA) regulations and guidance, intended to encourage greater inclusion of women and minorities in clinical drug trials, has shown appropriate levels of female participation based on the estimated sex ratio of people affected by a particular disease. In contrast, some racial minorities, and especially African Americans, remain under-represented in most drug development programs, according to the study published in Journal of Women's Health, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. The article is available free on the Journal of Women's Health website (see also Clinical Research - Clinical Trials and Studies).

Emmanuel Fadiran, PhD and colleagues from the Center for Drug Evaluation and Research (CDER), and the Office of Women's Health, Office of the Commissioner of the FDA examined the demographic make-up of clinical trial participants and whether efficacy and safety data were obtained for both men and women for new drugs approved between 2013-2015 by CDER. To assess sex-based representation in drug efficacy and safety testing, the researchers determined the ratio of the proportion of women in clinical trials for a particular disease population relative to the estimated proportion of women in the disease population (PPR) for a new drug indication.

The authors reported that sex-based analyses for both efficacy and safety were conducted for the majority of new drug applications during the study period. Furthermore, representation of women in clinical trials was appropriate for more new drugs when the estimated disease prevalence by sex (PPR) was considered. These findings are presented in the article entitled "Representation of Women and Minorities in Clinical Trials for New Molecular Entities and Original Therapeutic Biologics Approved by FDA CDER from 2013 to 2015".

"The results presented by Fadiran et al. help to reassure us that women are being included at an appropriate level in all phases of clinical drug studies. However, it will be important going forward to remain vigilant to the potential for sex-based disparities in new drug development, and to address the ongoing under-representation of some racial minorities, especially when they may have a relatively high prevalence for a particular drug indication," says Susan G. Kornstein, MD, Editor-in-Chief of Journal of Women's Health, Executive Director of the Virginia Commonwealth University Institute for Women's Health, Richmond, VA, and President of the Academy of Women's Health.

Keywords for this news article include: Women's Health, Drugs and Therapies, Mary Ann Liebert Inc./Genetic Engineering News, Clinical Research - Clinical Trials and Studies.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2017, NewsRx LLC



(c) 2017 NewsRx LLC

Pharmacy News Index
  Drug Delivery Systems
  Drugstores
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry

LIVE ONLINE CE

Last Chance
Dec 15: Mobile Applications for Pharmacists: Tools That Help Pharmacies be Successful
Dec 17: NSAIDs, Acetaminophen and Adjuvants in Pain Management
Dec 18: Management of Alcohol Use Disorders
Dec 19: Medication Adherence: To Take or Not to Take…That is the Problem
Dec 20: Type II Diabetes: Case Studies and Management Options
Click for entire Webinar Calendar

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...

Nursing Jobs
Are you a nurse looking for a job?

Check out the Nursing Job Source.

Your number one choice for nursing jobs.



Websites » RxCareerCenter.comRxSchool.comClubStaffing.comNursingJobSource.comRN.com
Copyright © 2017 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement
888-682-4415