Project 418604

The overall goal of this 2-year project is to build capacity for sex/gender uptake and patient engagement in clinical trials. A clinical trial is a research study used to compare a new drug to a harmless pill, or placebo. In Canada, we are changing our approach to clinical trial research. We now believe that patients (men and women) should be partners in deciding on the importance of research, designing studies, and sharing study results. However, investigators do not know how to work with patients, and patients do not know how to work with investigators. Our work will refine and test two decision aids to build capacity for sex/gender uptake and patient engagement in clinical trials. Decision aids can assist patients and investigators weigh their own potential benefits/risks of engaging patients as partners in clinical trial research. We have completed Phase 1 (CIHR-funded) of this project. We partnered with Clinical Trials Ontario and collaborated with patients, investigators, health care providers, and health charity and patient organizations to design two decision aids: one for patients and one for investigators. We are now seeking further funding to refine, translate (English to French), and test the decision aids through: 1) alpha (usability) testing (Phase 2), and 2) beta (field) testing (Phase 3). These methods follow International Patient Decision Aid Standards. In Phase 2, we will conduct testing cycles of five patients (men and women) and five investigators (men and women) per testing cycle. After each cycle we will make changes and continue testing cycles until no further comments are received. In Phase 3, we will test each decision aid with English- and French-speaking patients and investigators to ensure they are: 1) clear, 2) acceptable, and 3) easy to use. We have a strong project team that includes patient partners, investigators, and Clinical Trials Ontario who will make the decision aids freely available on their website.