NIH and FDA release clinical trials protocol template

  NIH and FDA develop and release a clinical trials protocol template.  NIH and FDA collaborated with the research community to develop a common Phase 2 and Phase 3 IND/IDE clinical trial protocol template. The goal is to support investigators and speed up FDA review of NIH clinical trials. The document is consistent with International Council for Harmonisation E6 (R2) Good Clinical Practice Guidance. At … Continue reading NIH and FDA release clinical trials protocol template

VCU joins the TriNetX Health Research Network

CAMBRIDGE, Mass., May 24, 2017 – Virginia Commonwealth University (VCU) has joined the TriNetX health research network, which is comprised of healthcare organizations representing over 84 million patients globally, biopharmaceutical companies and contract research organizations (CROs) who are working together to improve protocol design, site selection, patient recruitment, and collaborative research across a range of therapeutic areas and development stages.  As a member, VCU will … Continue reading VCU joins the TriNetX Health Research Network

International Clinical Trials Day!

The Wright Center for Clinical and Translational Research sponsored the International Clinical Trials Day event on May 19th at the VCU Gateway Building. Visitors, patients, and staff learned about the history of clinical trials, how to navigate StudyFinder-the central point for enrolling in clinical trials, and discovered how research is changing patients lives!  “I have seen so many patients being positively impacted by Clinical trials … Continue reading International Clinical Trials Day!

Wright CCTR and VCU Library Co-Host Seminar on Research Participant Strategies

The C. Kenneth and Dianne Wright Center for Clinical and Translational Research (Wright CCTR) partnered with the Tompkins-McCaw Library to host a seminar at the library titled, “Strategies and Tools for Research Participant Recruitment,” on Wednesday, June 15. Jonathan P. DeShazo, Ph.D., M.P.H., associate director for the Wright CCTR’s Enterprise Informatics and co-director of the Biomedical Informatics Core, and Megan Blumenthal, lab manager for the VCU School of … Continue reading Wright CCTR and VCU Library Co-Host Seminar on Research Participant Strategies

Clinical Trials Awareness Week May 2-6, 2016

Whether you’ve taken a medication today to manage a chronic disease or simply to keep a headache at bay, you know that medical innovations have the power to change lives. But these breakthroughs don’t just happen. Developing new medicines is a lengthy and complex process, relying heavily on volunteer participation to evaluate potential therapies for safety and effectiveness in clinical studies. Without the patients who … Continue reading Clinical Trials Awareness Week May 2-6, 2016