Adaptive Borrowing as an alternative to Randomized Clinical Trials.

Randomized Clinical Trials can be a challenge in vulnerable populations including rare disease settings. Alternative approaches including Bayesian modelling and machine learning methods are effective methods that enable borrowing external data based on certain criteria. There are challenges including guidances and standardizations from regulatory agencies and data privacy issues. Some future areas of exploration also include consideration of multiple endpoints (e.g. both efficacy and safety).