The Department of Health and Human Services and the National Institutes of Health (NIH) are releasing for public comment two proposals to increase the transparency of clinical trials via information submitted to ClinicalTrials.gov, a publicly accessible database operated by the National Library of Medicine (NLM), part of the NIH.
Dr. Robert Califf, a Duke cardiologist and the co-principal investigator for PCORnet, led a six-year study of a new cholesterol-lowering drug in the IMPROVE-IT trial.
In this recent Institute of Medicine report, 17 domains were identified by a committee (featuring some PCORnet members, including Eric Larson from the Coordinating Center and Chris Forrest from PEDSnet). These domains were considered to be good candidates for inclusion in Electronic Health Records (EHRs). This report highlights 12 measures related to 11 of the initial domains and considers the implications of incorporating them into all EHRs.
The National Diabetes Education Program (NDEP) has recently published Guiding Principles for the Care of People With or at Risk for Diabetes …highlighting a set of 10 guiding principles focused on areas of agreement for diabetes care that could be clinically useful in diabetes management and prevention.
These are aimed at assisting with identification and management of the disease, self-management support for patients, physical activity and blood glucose control, among other topics. More than a dozen federal agencies and professional organizations support the document.
Getting a firm handle on what’s best for whom is a pressing quest of national healthcare reform — and Temple is working at its leading edge. Anuradha Paranjape, MD, MPH, FACP, Professor of Medicine and Chief of General Internal Medicine at Temple is lead investigator within a four-university consortium awarded a $7 million grant to … Continue reading In the News: Data Driven Medicine – Informing the Cure
Rachel L. Richesson, PhD, with the PCORnet Rare Disease task force and the NIH Collaboratory Phenotype Core lead, has been elected a Fellow of the American College of Medical Informatics (ACMI), one of 19 people given this honor in 2014. ACMI is a college of elected Fellows from the U.S. and abroad who have made … Continue reading PCORnet’s Richesson Elected Fellow of ACMI
Therapeutic Innovation and Regulatory Science, DIA ClinicalTrials.gov: An Underutilized Source of Research Data About the Design and Conduct of Commercial Clinical Trials Abstract Since 2007, the US federal government has required that organizations sponsoring clinical trials with a least one site in the United States submit information on these clinical trials to an existing database: … Continue reading In the News: ClinicalTrials.gov: An Underutilized Source of Research Data
The NIH has revised its definition of “clinical trial.” The revision is designed to make the distinction between clinical trials and clinical research studies clearer. It is not intended to expand the scope of the category of clinical trials. Notice of Revised NIH Definition of Clinical Trial (NOT-OD-15-015) National Institutes of Health
U.S. News & World Report, Kate Green, posted 10-3/14 Can analytics produce better outcomes? PCORI’s Joe Selby and Rachael Fleurence are featured in this article highlighting PCORnet as a leader in the movement to use electronic health records and other data sources to improve medical treatment. Read the full article …
Scientists regularly sign up patients in clinical trials to test new treatments. Now, they are seeking patients to help them design some of those trials.
Patients and researchers can bring different perspectives to treating disease. In a trial of a potential prostate-cancer drug getting underway at the Icahn School of Medicine at Mount Sinai in New York, doctors had planned to ask patients periodically about side effects such as nausea. But patient input convinced them to ask additional questions, including how many days patients felt well enough to go to work.