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Society: September 19, 2013 US Food and Drug Administration (FDA) officials have finalized a November 2012 draft guidance on the use of electronic source data in clinical investigations, calling for its greater use to promote the reliability, quality, integrity and traceability of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 […]
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 […]
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 […]
The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice
Health and Quality of Life Outcomes: 10/29/13 To inform clinical guidelines and patient care we need high quality evidence on the relative benefits and harms of intervention. Patient reported outcome (PRO) data from clinical trials can “empower patients to make decisions based on their values” and “level the playing field between physician and patient”. While clinicians […]
Recruiting clinical personnel as research participants: a framework for assessing feasibility
BMC: October 24, 2013 Increasing numbers of research studies test interventions for clinicians in addition to or instead of interventions for patients. Although previous studies have enumerated barriers to patient enrolment in clinical trials, corresponding barriers have not been identified for enrollingclinicians as subjects. We propose a framework of metrics for evidence-based estimation of time and […]
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 […]
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 […]