FDA Commissioner Scott Gottlieb, MD

FDA’s Gottlieb Challenges Investigators to Help Boost Trial Participation by Women

To mark National Women’s Health Week, Food and Drug Commissioner Scott Gottlieb reaffirmed the “importance of making sure women are appropriately represented in clinical trials.” He applauded the U.S. Food and Drug Administration’s (FDA’s) Office of Women’s Health (OWH) and its work in providing more than $40 million for 371 projects to “inform the FDA’s […]

ACRP-PM

ACRP Announces Clinical Research Project Management Subspecialty Designation

In response to growing demand for validation of clinical research-specific project management competency, the Association of Clinical Research Professionals (ACRP) today announces a new subspecialty designation program, ACRP Project Manager, or ACRP-PM. “Project management is a growing subspecialty in clinical research, and is a skillset required of a wide variety of professionals involved in clinical […]

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FDA Approval Times Best Those of Comparable International Agencies

Maybe it’s time to show the U.S. Food and Drug Administration (FDA) a little love. “In 2017, FDA was the agency with the shortest median approval time (243 days), which is likely due to the wide use of facilitated regulatory pathways (FRPs) that year, where 40% of [new active substance (NAS)] approvals were designated as […]

Change Management in Clinical Trial Operations: Putting People Before Process

Clinical Researcher—May 2018 (Volume 32, Issue 5) SPECIAL FEATURE Matthew Harrington [DOI: 10.14524/CR-18-4027]   Imagine if a career staff member of your local hospital was told by management to prioritize high-risk patients and check on others later—or not at all. For many clinical research professionals, this is an unsettling yet familiar scenario. They face a […]

Expectations of Cell Therapy: An Evaluation of the Cardiovascular Cell Therapy Research Network PACE Trial

Clinical Researcher—May 2018 (Volume 32, Issue 5) PEER REVIEWED Shelly L. Sayre, MPH; Judy Bettencourt, MPH; Michelle Cohen, MPH; Rachel W. Vojvodic, MPH; Emerson C. Perin, MD, PhD; Phillip C. Yang, MD; Michael P. Murphy, MD; Doris A. Taylor, PhD; Patricia G’Sell, RN; Eileen Handberg, PhD; Lem Moyé, MD, PhD [DOI: 10.14524/CR-17-0041] [Editor’s Note: Tables […]