In an effort to make information about clinical trials widely available to the public, the U.S. Department of Health and Human Services today issued a final rule (link is external) that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration […]
ClinicalTrials.Gov
Publication and Reporting of Clinical Trial Results Across Academic Medical Centers
Randomized clinical trials are the ideal means for evaluating the efficacy and safety of medical drugs and devices. Timely dissemination of the findings from clinical trials is a prerequisite for ensuring that clinical decisions made by patients and physicians reflect the best scientific evidence, and that future scientific investigation benefits from previous inquiry. Dissemination is […]
CT.Gov Offers New Individualized Training to Investigators for Results Module
ClinicalTrials.Gov is piloting a process to provide one-on-one assistance for investigators throughout the results submission process. As part of the process, a member of the ClinicalTrials.Gov results team will be available to help prepare you for results submission, orient you to the PRS (Protocol Registration and Results System), and walk you through the data entry […]
WHO calls for increased transparency in medical research
WHO today issued a public statement calling for the disclosure of results from clinical trials for medical products, whatever the result. The move aims to ensure that decisions related to the safety and efficacy of vaccines, drugs and medical devices for use by populations are supported by the best available evidence. Click here to read […]
23 Million Hours Spent Each Year Complying With Clinical Trial Requirements, FDA Estimates
Conducting clinical research is difficult. Patients need to be protected, protocols adhered to, results meticulously recorded and hundreds of regulations followed. And when all is said and done, the US Food and Drug Administration (FDA) estimates that complying with its clinical trial regulations takes almost 23 million hours each year.
Comment Period Extended for NPRM on ClinicalTrials.Gov
The Department of Health and Human Services (HHS) is extending the public comment period for the Notice of Proposed Rulemaking (NPRM) on ClinicalTrials Registration and Results Submission. The proposed rule was published on November 21, 2014 (79 FR 69566) with a deadline for public comments of February 19, 2015. The comment period is being extended […]
NIH Issues NPRM for ClinicalTrials.Gov
In late November 2014, the National Institutes of Health issued the Notice of Proposed Rule Making (NPRM) and a revised NIH policy regarding the ClinicalTrials.Gov database