The MRCT Center and Medable convened a multi-stakeholder task force to address ethical and regulatory opportunities and challenges related to Decentralized Clinical Trials (DCTs) and presented the work at a recent webinar, “Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best Practices.”
Dr. Barbara Bierer, MRCT Center Faculty Director, will be speaking on “Improving the Performance of Clinical Trial for Global Directives” at the Global Clinical Research Summit in Seoul on September 7th. Learn more
Description: We are delighted to announce a collaboration with Clinical Data Interchange Standards Consortium (CDISC) on the MRCT Center Clinical Research Glossary. This marks an important first step in making plain language a global clinical research standard. The MRCT Center Clinical Research Glossary was piloted in 2020 to test the process of creating a plain language glossary of commonly used clinical research terms that is freely available to everyone.
Please join us on April 5 from 11 AM – 12 PM ET for a joint webinar with the MRCT Center and CDISC. Learn about MRCT Center’s robust process of developing the plain language glossary, the CDISC public review, and how this collaboration will empower patients and participants with the necessary tools and information to make informed research decisions.
Description: Drs. Barbara Bierer, Luke Gelinas, Nora Hutchinson, and Deborah Zarin deployed a modified Delphi process to establish consensus on 35 recommendations across five domains related to the role of scientific review and landscape analysis in preventing uninformative trials. Their article, “How to limit uninformative trials: Results from a Delphi working group,” was recently published in Med.
Description: This case study describes how an IRB navigated returning results of a new COVID-19 assay from a non-CLIA-certified lab during a public health emergency.