Framework
Released in: February 2020
Developed by: Joint Task Force for Clinical Trial Competency
Leveled Core Competency Framework for the Clinical Research Professional Version 3.1 (English)
Language: English
Drug Researchers Refuse To Follow The Law. The Government Isn’t Stopping Them
Podcast
Broadcast on: January 24, 2020
Podcast: Science Friday
Before any new drug comes to market, it goes through a time-consuming process. Researchers have to recruit human subjects for a clinical trial, collect all the data, and analyze the results. All of that can take years to complete, but the end result could be worth it: a drug that treats a rare disease or improves patients lives with fewer side effects.
Committing to the Inclusion of Diverse Populations in Clinical Research
Publication
Published on: January 2, 2020
Published in: Therapeutic Innovation & Regulatory Science
Clinical Research Glossary website
Project-Specific Website
In 2020, the MRCT Center launched a pilot project to develop a plain language clinical research glossary with an amazing workgroup of patient advocates and other representatives from across the clinical research industry.
The team worked together to create clinical research definitions and explanations that are:
- plain language
- understandable to a wide audience
- in line with industry and regulatory standards
For more information, please visit the MRCT Center Clinical Research Glossary website.
Adding Real-World Evidence to a Totality of Evidence Approach for Evaluating Marketed Product Effectiveness
Publication
Presented on: December 19, 2019
Published in: Duke Margolis Center for Health Policy
10-Year Update on Study Results Submitted to ClinicalTrials.gov
Publication
Published on: November 14, 2019
Published in: The New England Journal of Medicine
Understanding the Need for Non-Interventional Studies Using Secondary Data to Generate Real-World Evidence for Regulatory Decision Making, and Demonstrating Their Credibility
Publication
Published on: November 2019
Published in: Duke Margolis Center for Health Policy
Evolving science in clinical trials in special populations
Presentation
Presented on: October 29, 2019
Presented at: The Annual Meeting of the International Coalition of Medicines Regulatory Authorities (ICMRA) Summit in Rome, Italy.
The Culture of Trial Results Reporting at Academic Medical Centers
Publication
Published on: October 28, 2019
Published in: JAMA Internal Medicine
Efficiencies in Clinical Research: A USA perspective
Presentation
Presented on: October 8, 2019
Presented at: Translational Research Institute (TRI) Australia