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 […]
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 […]
Failure to Report: A STAT Investigation on ClinicalTrials.gov
Stanford University, Memorial Sloan Kettering Cancer Center, and other prestigious medical research institutions have flagrantly violated a federal law requiring public reporting of study results, depriving patients and doctors of complete data to gauge the safety and benefits of treatments, a STAT investigation has found. The violations have left gaping holes in a federal database […]
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 […]
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
Reliable approaches to monitoring are critical, and although a variety of monitoring approaches are available for overseeing clinical trial conduct, the most common approach remains frequent visits to each clinical trial site. During the past two decades, there has been a dramatic global increase in the number and complexity of clinical trials. In 2013, the […]
GCPartner App Now Available
The new GCPartner app is now the must have app for all researchers involved in Good Clinical Practices (GCPs). Have the GCP’s at your finger tips no matter where you are at. For more information on how to get this free app click here…..
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 Clinical Trials 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 […]
FDA Issues Guidance on Laboratory Developed Tests (LDT’s)
Laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. LDTs can be used to measure or detect a wide variety of analytes (substances such as proteins, chemical compounds like glucose or cholesterol, or DNA), in a sample taken from a human body. […]