Navigation Links
Gender Issues in Clinical Trials, New Life Science Webinar Hosted by Xtalks and IRB Services
Date:9/30/2013

Toronto, Canada (PRWEB) September 30, 2013

Meeting subject recruitment targets in clinical trials in this “hurry-up” era of global competitive clinical trial enrolment is already a major challenge for sponsors and researchers. At the same time, fuller understanding of the genetic, metabolic and physiologic differences between genders is crucial to the development of safer and more effective drugs and medical devices for both men and women. These two imperatives are not mutually exclusive.

FDA, ICH, and most recently Health Canada, have all issued guidance to encourage, if not actually require, sponsors to include more women in clinical trials. IRBs are both ethically and legally bound to ensure that subject selection is equitable, and that both men and women are represented.

Yet, despite the ethical necessity and regulatory encouragement, most available evidence shows there still are significant gender inequalities in clinical trial participation – women continue to be underrepresented, and equitable participation of both sexes remains an elusive yet necessary goal.

Dr. Gordon DuVal will briefly discuss the principle of distributive justice, the ethical requirements for equitable subject selection, specifically as applied to women in research. Dr. Agnes Klein will discuss the issues from Health Canada’s perspective as the regulatory agency with the most recent and perhaps most progressive guidance in the world on the inclusion of women in clinical trials. CISCRP’s Mr. Zach Hallinan will offer specific insights into the practical barriers to overcome, and some strategies that can be successfully employed by sponsors and sites to encourage better engagement and improved recruitment and retention of women in clinical trials, a legal, moral and pragmatic imperative.

Mr. Jack Corman, President and Founder of IRB Services (Institutional Review Board Services), will join the panel for a live Q&A with the audience following the main presentation.

For more information about this event or to register, visit: http://xtalks.com/Gender-Issues-in-Clinical-Trials.ashx

About IRB Services Founded in 1993, IRB Services is an independent organization dedicated to protecting the rights and safety of human research subjects. As one of the largest central institutional review boards in North America, IRB Services is an experienced, service-driven organization dedicated to excellence in human research participant protection and committed to providing industry leading efficient customer-oriented services. IRB Services provides ethical review of clinical trials and behavioral science research and operates ethics committees in Boca Raton, Florida; Montréal, Québec; and Toronto, Ontario; which review a wide range of both industry and publicly funded human subject research across multiple disciplines, including Food and Drug Administration, US Department of Health and Human Services, and Health Canada regulated research. IRB Services has received full accreditation from the Association for the Accreditation of Human Research Protection Programs. For more information please visit http://www.irbservices.com.

About Xtalks: powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com/ContactUs.ashx

Contact:
Karen Lim (416) 977-6555 ext 227
clientservices(at)xtalks(dot)com

Read the full story at http://www.prweb.com/releases/2013/9/prweb11171980.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Midwest Specialty Distribution Plant Expanding as Companies Focus on Sales and Distribution Issues
2. The FSH Society Issues Research Grant for Developing New Facioscapulohumeral Dystrophy Muscular Measurement Tool
3. Damaged Tissues and Organs Could be Repaired With New Scaffolding Technique
4. Vaginal Ring Provides “Radically New” Drug Delivery Platform for Health Issues, Including Infertility
5. Signal-Health Develops Easy Checklist to Identify Possible Sweating Issues in Horses
6. The 2013 Bioprocessing Summit to Bring Together International Leaders to Discuss Today's Bioprocess Issues From Cell Line Selection to Manufacturing in Boston, MA
7. First patent issues on TAL effector technology
8. Crystal Research Associates, LLC Issues Quarterly Update on MetaStat, Inc.
9. UCB and Emory partner to address pressing public health issues for people living with epilepsy
10. EAS Consulting Group, Experts in Quality Regulatory Services Related to FDA Issues, Announces Upcoming Dietary Supplement Seminars in Salt Lake City
11. New MRI method fingerprints tissues and diseases
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... ... May 26, 2016 , ... FireflySci has been ... leading laboratories all over the globe. Their cute firefly logo has been spreading ... cuvettes, FireflySci makes spectrophotometer calibration standards that never require recalibration. These revolutionary ...
(Date:5/25/2016)... Bethesda, Md. (PRWEB) , ... May 25, 2016 ... ... a request for information (RFI) issued by the Office of the National Coordinator ... the patient experience, and determines if clinically relevant data were available when and ...
(Date:5/24/2016)... (PRWEB) , ... May 24, 2016 , ... ... attacks, diabetes, and traumatic injuries, will be accelerated by research at Worcester Polytechnic ... into engines of wound healing and tissue regeneration. , The novel method, developed ...
(Date:5/23/2016)... ... May 23, 2016 , ... PrecisionAg® ... Farming in 2017 and Beyond. The paper outlines the key trends that are ... industry. , “We’ve witnessed a lot of highs and lows as the precision ...
Breaking Biology Technology:
(Date:4/15/2016)... , April 15, 2016 ... "Global Gait Biometrics Market 2016-2020,"  report to their ... ) , ,The global gait biometrics market ... 13.98% during the period 2016-2020. Gait ... which can be used to compute factors that ...
(Date:3/31/2016)... , March 31, 2016  Genomics firm Nabsys ... founding CEO, Barrett Bready , M.D., who returned ... of the original technical leadership team, including Chief Technology ... of Product Development, Steve Nurnberg and Vice President of ... to the company. Dr. Bready served as ...
(Date:3/22/2016)... and SANDY, Utah , ... which operates the highest sample volume laboratory in ... Genomics and UNIConnect, leaders in clinical sequencing informatics and ... launch of a project to establish the informatics infrastructure ... NSO has been contracted by the Ontario ...
Breaking Biology News(10 mins):