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This program is available also as a video in YouTube: https://youtu.be/j_j7x_Itefw
Joyce Graff and Robin Martinez speak with Dr. David Gerber, Professor of Internal Medicine in the Hematology Oncology Department of the University of Texas Southwestern Medical Center in Dallas.
Dr. Gerber has a particular focus on lung cancer, and leads or collaborates on many clinical trials involving advances in treatment for lung cancer. His research has generated over 130 publications that he has authored or co-authored, including articles, abstracts, book chapters, books reviews and invited manuscripts. His studies have contributed to invitations to lecture both nationally and internationally.
Our conversation focuses on the challenges of maintaining clinical trials during the COVID emergency. The U.S. Food and Drug Administration has issued guidance to clinical trial leaders, suggesting ways that the normal protocols might be modified to work within the restrictions imposed by COVID. Staff must always protect the patient from harm, and also has an obligation to keep the data collected in the trial as consistent as possible so that the trial results will be meaningful.
FDA Guidance document, as updated July 2020
These changes involve reduction in the number of visits to the hospital, virtual meetings with staff, and increasing the convenience of the patient whenever possible — changes that have in fact been welcomed both by patients and by staff. There is active consideration of continuing some of these changes even after the emergency subsides.
See also this article by Dr. Gerber in the Dallas News: Finally an Improvement in Clinical Trials
Dr. Gerber has an article “in press” which will be listed here as soon as it has been released. It has been accepted for publication but is not yet public.