Represent Nursing’s Voice in FDA’s Oncology Center of Excellence’s Pragmatic Clinical Trials
Nurse advocates have an incredible opportunity to represent patients and the profession in shaping the future of patient-centered pragmatic clinical trials. Through July 5, 2024, the U.S. Food and Drug Administration’s (FDA’s) Oncology Center of Excellence is crowdsourcing (https://shareyourvoice.ideascalegov.com/c/landing) clinically relevant trial questions for FDA-approved therapies in its innovative Project 5 in 5 initiative.
By collecting only the information necessary to answer research questions, pragmatic clinical trials streamline data collection and design. They focus on efficacy, using a straightforward clinical benefit endpoint such as overall survival, FDA explained (https://www.fda.gov/about-fda/oncology-center-excellence/project-5-5).
Pragmatic clinical trials are more reflective of routine clinical practice, often with fewer and broader eligibility criteria and flexibilities in trial delivery and outcome measurement. “Studies conducted in the real-world setting can reduce the burden of trial participation, with the hope to facilitate more diverse trial populations, more rapid enrollment, and reduced attrition. Pragmatic trials may have the potential to result in evidence that is more broadly representative of the general population affected by the clinical question,” FDA said (https://www.fda.gov/about-fda/oncology-center-excellence/project-5-5).
Using the crowdsourcing platform, nurses can submit questions and ideas or add comments and details to other previously submitted questions. An example (https://shareyourvoice.ideascalegov.com/c/landing) of the type of questions FDA is seeking is, “What is the median overall survival for patients with <specific type of cancer> treated with drug X versus drug Y?”
FDA said that it will share the submissions with government agencies, cooperative groups, and other parties who may be interested in implementing pragmatic clinical trials but that the Office of Oncology Excellence will not be involved in the implementation and conduct of the clinical trials. “This initiative is important to enhance patient-centric clinical trial innovation,” FDA said (https://shareyourvoice.ideascalegov.com/c/landing).
“Anyone can submit an idea!” FDA said (https://shareyourvoice.ideascalegov.com/c/landing). “We encourage oncology providers, researchers, patients, caregivers, and advocacy groups to participate.”
Oncology nurses have a unique perspective of using FDA-approved therapies in clinical practice as well as the patient experience with the agents. By sharing your real-world stories, you can help shape future clinical trials to better meet the ever-evolving oncology healthcare needs.