HJBR Sep/Oct 2020

20 SEP / OCT 2020 I  HEALTHCARE JOURNAL OF BATON ROUGE THE RIGHT TO TRY Can you please explain the difference between Right to Try and expanded access/compassionate use? Dr. Lauren Zatarain The United States Food and Drug Administration (FDA) has a pro- gram called expanded access, also known as compassionate use, which provides a pathway for patients to gain access to inves- tigational therapeutics prior to official FDA approval. Patients must have a serious or rare condition for which no current standard approved therapies are beneficial outside of clinical trials. Right to Try is a law signed by President Trump in May 2018 that allows terminally ill patients to utilize non-FDA approved therapeutics outside of a clinical trial. Right to Try does not require FDApermis- sion prior to use of the therapeutic, whereas expanded access programs do require FDA permission prior to drug company distribu- tion of therapeutics to the patient. The pa- tient’s physician initiates either pathway to successfully obtain the therapeutic from the drug manufacturer. Cyndi Knox Right to Try removes some of the regulatory barriers required in obtain- ing access to an investigational therapeutic Cyndi Knox, RN, BSN, MBA, OCN, CCRC received a nursing degree from Louisiana State University Health Science Center in New Orleans, and a Master of Business Administration from Louisiana State University in Baton Rouge. Knox is an oncology certified nurse by the Oncology Nursing Certification Corporation, and also holds a research certification from the Association of Clinical Research Professionals. She has worked in clinical research for the past 12 years at the Mary Bird Perkins Cancer Center in Baton Rouge, where she currently serves as director of the clinical research program. Knox is active in leading the Mary Bird Perkins Cancer Center component of the Gulf South Clinical Trials Network, and is also an active member of the nursing committee for the ECOG-ACRIN Research Base, as well as a liaison to the melanoma committee for ECOG- ACRIN. In addition, she serves on the Accrual Taskforce, and as a volunteer auditor for ECOG-ACRIN. Dr. Lauren Zatarain is a medical oncologist at Mary Bird Perkins – Our Lady of the Lake Cancer Center. She received undergraduate degrees in biological sciences and Spanish from Louisiana State University. She received a medical degree from Louisiana State University School of Medicine in New Orleans. She completed an internal medicine residency, and served as chief resident at Louisiana State University – Earl K. Long Hospital in Baton Rouge. Dr. Zatarain accepted a fellowship in hematology and oncology, and served as chief fellow at Vanderbilt University. She currently serves as a clinical assistant professor of medicine at Louisiana State University Health Sciences Center – Baton Rouge. Dr. Zatarain currently serves on the Breast, Colorectal, and Lung Multidisciplinary Care Team (MDC) at the Cancer Center. Lauren Zatarain, MD, and Cyndi Knox, clinical research director at Mary Bird Perkins - Our Lady of the Lake Cancer Center offered to share their thoughts about Right to Try with Heathcare Journal of Baton Rouge .