Talk NERDY completed its Fall Training: Clinical Trial Design Deep Dive into Pragmatic vs. Explanatory Trials. The training included 38 Talk NERDY alumni with lived expertise in Alzheimer’s disease, age-related macular degeneration, atrial fibrillation, chronic pain, and heart valve disease. The training was taught by Dr. Douglas Landsittel, Professor and Chair of Indiana University School of Public Health-Bloomington’s Department of Epidemiology and Biostatistics, and Alliance-related staff Beth Mathews-Bradshaw and Sara Collina. Learning goals included aspects of clinical trials that make them more or less pragmatic, learning the purpose and value of the PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary) tool and applying it to research, and learning about the challenges of implementing and evaluating pragmatic trials. For homework, participants reviewed one entertaining video on basic statistics, two videos about the Precis-2 tool, read three research articles, and watched an interview of Dr. Landsittel discussing pragmatic vs. explanatory trials. During the training, participants worked in breakout groups to map and score the three articles to the Precis-2 tool and brainstormed research questions conducive to pragmatic trials.
The Spring Training Session focused on additional education for Talk NERDY alumni with new courses. On May 16 and 18, 2023 Talk NERDY held its first Clinical Trials Take 2 course for two hours over two days on Safety and Randomization and Blinding. Topics included:
• The different types of clinical research;
• Phases of clinical trials;
• Blinding and randomization within clinical trials;
• Safety considerations, including: Data and Safety Monitoring Plans and Boards (What are they? How do they work?) and adverse events (AEs) and serious adverse events (SAEs) (What are they? How are they classified? How do they influence the outcome of a trial?);
• Background on Institutional Review Boards and how they work; and
• The informed consent process, to include: Assent/consent, cultural considerations, and special considerations for the aging population.
A Selection of Training Materials:
Clinical Research Overview
Interview with Dr. Cary Reid