Clinical Trials 101 - Why They Are Important and What You Should Know
Summary: This presentation discusses what a clinical trial is, why they are necessary, the phases of a clinical research trials, how they are reviewed to ensure patient safety, the process involved in participating in a clinical trial, and where one can go to receive further information about clinical trials. Presenter: Caitlin Guzowski MBA, MHA, CCRC Northside Hospital Cancer Institute https://www.northside.com/about/news-... As presented at the 2025 Survivorship Symposium, May 3-9 Many thanks to Sanofi and Bristol Myers Squibb whose support, in part, helped make this workshop possible. Presentation is 38 minutes with 11 minutes of Q & A To read the transcript, go to: https://bmtinfonet.org/video/clinical... Highlights: (03:19): The National Institute of Health defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions. (05:31): New interventions must be researched first before they can be approved by the Food and Drug Administration (FDA), for commercial availability. (09:22): Phase 1 clinical focus on tolerability and the most effective dose of the treatment for patients. (11:57): Phase 2 clinical trials collect data from more patients and focus on the drug’s effectiveness. (13:26): Phase 3 clinical trials test whether a new treatment is better than what's already on the market, or the FDA approved standard of care. (15:25): Before enrolling you in a clinical trial, your physician will explain why he or she believes you would be a good candidate for the study. They will go through how the drug is supposed to work and when you will receive it. The research team will follow up with an informed consent document that provides more details on what you will need to do while on the study, and your right to withdraw from the study at any time. (30:49): Clinical trials may be stopped early for several reasons, such as the side effects of the new treatment outweigh the benefits, or because the results with the new drug are so good that it’s better to fast-track the drug for FDA-approval. (36:52): If you are considering participating in a clinical trial, here are some useful questions to ask your clinical team, your physician, your nurse aide, and your coordinators. Key Points: Clinical trials are an integral part of developing and establishing new treatments and standards of care. Those participating in a clinical trial have a unique opportunity to receive the latest treatments being developed. Participants can expect more frequent appointments, evaluations, and tests compared to those receiving the standard medical treatment, and can assume they will be observed and monitored for side effects for a longer period of time. Safety is top priority, and participants undergo an extensive process to ensure they are a good candidate for a clinical trial. The clinical trial is also constantly evaluated for its safety and effectiveness, and participants are free to remove themselves from a clinical trial at any time. VISIT US ON SOCIAL MEDIA: / bmtinfonet / bonemarrowstemcelltransplantclub / bmtinfonet https://x.com/BMTInfoNet / bmt-infonet https://bsky.app/profile/bmtinfonet.b...
