Challenge

With regulators advocating for increased diversity in clinical trials to ensure that new treatments are accurately assessed across varied demographics, trial design is under the spotlight. Traditional clinical trials are often time-consuming, expensive, and burdensome for participants, with conservative study designs frequently excluding those who could benefit from a new medicine due to safety concerns. Real world evidence studies are growing in acceptance with regulators and payers, and since the Lord O'Shaughnessy Review highlighted the urgent need for more decentralisation, the need for technical solutions has never been greater.