Bill leads product strategy and innovation at CRF Health. He has worked in the Pharmaceutical industry for over 25 years and is the author of over 70 publications and an industry textbook on ePRO. His recent scientific work includes the use of wearable technology and BYOD eCOA in clinical trials.
Bill is Vice Director of the C-PATH ePRO Consortium and a member of the DIA Study Endpoints Community.
Title of Session: Using Mobile Sensors in Clinical Trials to Support Labelling Claims
Description of Session:
In this session we review the work of the Study Endpoints Community wearables working group. This working group comprises over 40 participants from biopharmaceutical companies, CROs, eClinical technology solution providers, regulatory bodies and academia. The role of the group is to build on recent work published by the Critical Path Institute’s electronic patient-reported outcome (ePRO) consortium and the Clinical Trial Transformation Initiative (CTTI) in helping to address knowledge gaps in the use of mobile sensors (including wearables) to generate clinical endpoints to support labelling claims for new drug applications.
The session will present findings and recommendations from three workstreams considered by the working group. Taking parallels with the patient-reported outcome (PRO) evidence dossier associated with supporting the use of specific PROMs in regulatory drug submissions, we present our work in defining the structure and content of an evidence dossier to support the use of a mobile sensor to collect clinical endpoint data to support labelling claims for future new drug applications.
Second, we report recommendations and considerations related to the implementation standards required to advance the use of mobile sensor technology for data capture in clinical trials, and consider a sub-set of these standards and considerations for broad use.
Finally, we explore guiding principles to those designing clinical trials on determining the optimal strategy for positioning endpoints based on mobile sensor data relative to other assessments (such as clinician-reported outcomes and patient-reported outcomes) to increase the likelihood of trial success.
The session will include interactive discussion around the recommendations and considerations presented, and will aim to elicit additional feedback from practitioners to guide future working group activities.
Identify the format and content of an evidence dossier to support clinical endpoints derived from wearable devices in regulatory drug submissions
Outline key considerations in the practical implementation of wearables to measure intervention effects in clinical trials
Discuss endpoint hierarchy considerations when including new objective sensor-based clinical endpoints.