Digital health technologies offer the potential to improve the conduct of clinical trials. If harnessed correctly, they can reduce patient burden, streamline operations, and optimize data collection. The key to unlocking these benefits is to ensure that patient and site perspectives are considered during the planning process. CTTI has released a new manuscript in Contemporary Clinical Trials Communications that features the first evidence-based set of recommendations for incorporating patient and site perspectives in digital health trials.
CTTI’s comprehensive recommendations for planning trials using digital health technologies offer advice across several research study topics, including:
Engaging patients and sites in planning clinical trials using digital health technology
Maximizing value and minimizing burden for study participants
Addressing challenges for investigative sites
This comprehensive set of recommendations was developed by first conducting a survey of 193 potential research participants regarding their willingness to use digital health technology in clinical trials as well as their preferences and concerns. Site experiences and preferences were captured through qualitative interviews with 12 different investigators. CTTI then collated this information and conducted an expert meeting over two days. Attendees, including patients, investigators, regulators, sponsors, and technology experts, presented key findings and discussed strategies and implications.
Because patients and site personnel offer important perspectives on how best to incorporate digital health technology into a trial, CTTI recommends their input be taken into account early and often. Ensuring their engagement helps stakeholders incorporate digital health technologies in the most efficient way possible, which can help to advance clinical trials and accelerate the development of new treatment options.