Clinical Trial Issues

2008
Society Volunteers Participate in FDA Workshop on Women in Device Clinical Trials (06/02/2008) — On Monday, June 2, Sana Al-Khatib MD, FHRS and Mina Chung MD, FHRS served as panelists on behalf of the Heart Rhythm Society at a workshop sponsored by the U.S. Food & Drug Administration (FDA) Office of Women's Health and the Center for Devices and Radiological Health. "Exploration of Public Policy Development Regarding the Study and Analysis of Sex Differences in the Clinical Evaluation of Cardiovascular Medical Products" focused on strategies for improving the proportion of women in CV trials and developing recommendations for the analysis and reporting of safety and effectiveness by sex. Learn more »

Research News

2006
New Federally Funded Research Program Aims to Improve Survival from Cardiac Arrest and Severe Trauma (09/12/2006) —  The Resuscitation Outcomes Consortium (ROC) will conduct collaborative clinical trials of promising new treatments for cardiac arrest and severe traumatic injury . Visit the NIH article to learn more about this program.

2005
Duke Study Finds ICD Therapy Economically Attractive Compared to Conventional Therapy for SCD (04/19/2005 ) — This study by Duke University investigated the cost-effectiveness of implanting ICDs in patients who met MADIT-II eligibility criteria and were enrolled in the Duke Cardiovascular Database between 1 January 1986 and 31 December 2001. The study found that ICD Therapy is economically attractive when compared with conventional medical therapy for sudden cardiac death. Learn more »

2004
The Society's Comments on NIH Draft Proposal for Enhanced Public Access to NIH Research Information (11/15/2004) — In order to enhanced public access to NIH Research information, NIH seeked public comments on his plan which will make available final research manuscripts at no cost to the public through PMC (PubMed Central (PMC), NIH’s digital repository for biomedical research). The Society gave 2 recommandations regarding the commercial access to research info and the six months timeframe. Learn more »