Genomics data scientist Harsha Rajasimha, Ph.D., Founder and Executive Chairman of IndoUSrare, highlights the risks of developing AI/ML algorithms based on biased data, as well as efforts underway to improve global collaboration on the collection and sharing of health data that may help us realize the potential of AI in diagnoses and treatment of rare diseases.
The FDA is requesting feedback on three new draft guidances related to clinical trials, including how they should be applied to increasingly diverse trial types and data sources.
The draft guidance covers DCT design, informed consent, the use of remote clinical trial visits, safety monitoring and software used in conducting DCTs for drugs, biological products, and devices. The comment period is open until August 1, 2023.
Randomized clinical trials are the gold standard for conducting clinical research. They are, however, fraught with issues and come with burdens to the patient, site and sponsor. Decentralized trials (DCTs) allow for a novel, agile and more cost-effective approach to an industry standard and traditional methodology. Here’s how to determine if a full or hybrid DCT is a good option for your clinical trial.