July 20, 2018: Developing Technology-Derived Novel Endpoints for Use in Clinical Trials: Recommendations and Case Examples from the Clinical Trials Transformation Initiative (Will Herrington, MA, MBBS, MD, MRCP, Rob DiCicco, PharmD, Jen Goldsack, MA, MBA, OLY)

Speakers

Will Herrington, MA, MBBS, MD, MRCP
MRC-Kidney Research UK Professor and
David Kerr Clinician Scientist
Nuffield Department of Population Health, University of Oxford

Rob DiCicco, PharmD
Principal Consultant
TransCelerate BioPharma Inc.

Jen Goldsack, MChem, MA, MBA, OLY
Senior Project Manager
Clinical Trials Transformation Initiative

Topic

Developing Technology-Derived Novel Endpoints for Use in Clinical Trials: Recommendations and Case Examples from the Clinical Trials Transformation Initiative

Keywords

Clinical Trials Transformation Initiative; Mobile technology; Clinical trials; Endpoints; Patient centricity

Key Points

  • The Clinical Trials Transformation Initiative (CTTI) is committed to driving the adoption of technology-derived novel endpoints in clinical trials.
  • CTTI developed a 6-step process to help develop novel endpoints. The process includes identifying an aspect of health affected by the disease that the patient cares about, selecting suitable mobile devices for capture, and describing the study population for whom the endpoint will be targeted.
  • There is a need for sophisticated analytical methods in determining how mobile technology can best be used to generate novel endpoints.

Discussion Themes

There are a variety of benefits of using mobile technology in clinical trials. Patient centricity, efficacy, and efficiency are the primary areas of potential advantage.

CTTI developed a Mobile Clinical Trials (MCT) program to identify and address the challenges related to planning for and conducting clinical trials that use mobile technologies. Four areas of focus include decentralized clinical trials, novel endpoints, stakeholder perceptions, and mobile technologies.

 

Tags

@Collaboratory1, @CTTI_Trials, #mobiletech, #ClinicalTrials, #pctGR