Clinical Engagement Network

FDA Finalizes Widely Anticipated Guidance on Use of Electronic Source Data in Clinical Investigations

FDA Finalizes Widely Anticipated Guidance on Use of Electronic Source Data in Clinical Investigations

Regulatory Affairs Professionals Society: September 19, 2013 US Food and Drug Administration (FDA) officials have finalized a November 2012 draft guidance on the use of electronic source data in clinical investigations, calling for its greater use to promote the reliability, quality, integrity and traceability of clinical data. Background The guidance, Electronic Source Data in Clinical Investigations, was […]

 Clinical Engagement Network

Non-publication of large randomized clinical trials: cross sectional analysis

Non-publication of large randomized clinical trials: cross sectional analysis

BMJ: 10/29/13 Objective To estimate the frequency with which results of large randomized clinical trials registered with ClinicalTrials.gov are not available to the public. Design Cross sectional analysis Setting Trials with at least 500 participants that were prospectively registered with ClinicalTrials.gov and completed prior to January 2009. Data sources PubMed, Google Scholar, and Embase were searched to identify published manuscripts containing trial […]

 Clinical Engagement Network

FDA Helping to Advance Treatments Tailored to You

FDA Helping to Advance Treatments Tailored to You

FDA: 10/29/13 Personalized medicine is the tailoring of a medical treatment to the individual characteristics, needs and preferences of a patient. Many recent advances involve using a patient’s genetic information to guide his or her treatment. Developing a truly personalized approach to patient care will require fundamental advances in the understanding of the biological, anatomical and […]

 Clinical Engagement Network

Design Considerations for Pivotal Clinical Investigations for Medical Devices – Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff

Design Considerations for Pivotal Clinical Investigations for Medical Devices – Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff

FDA: 11/713 This document is intended to provide guidance to those involved in designing clinical studies intended to support pre-market submissions for medical devices and FDA staff who review those submissions. Although the Agency has articulated policies related to design of studies intended to support specific device types, and a general policy of tailoring the evidentiary […]

 Clinical Engagement Network

HPV strains that affect black women differ from those targeted by cancer-preventing vaccines, researchers say

HPV strains that affect black women differ from those targeted by cancer-preventing vaccines, researchers say

Cleveland: 10/28/13 Black women are less likely than white women to be affected by the most common strains of human papillomavirus, and may be less likely to benefit from the available HPV vaccines that offer protection, according to new findings from researchers at Duke University School of Medicine. The findings were presented today at the annualInternational Conference on […]

1 2 3 8
 

 

National Minority Quality Forum
1201 15th Street, NW
Suite 340
Washington, DC 20005

 

Tel: 202.223.7560
Fax: 202.223.7567
www.nmqf.org

Terms of Use     l    Privacy Policy