Virtual Clinical Trial of Digital Therapy App in Depression
Sponsored by: eClinicalHealth Ltd
- Clinical Trial
- Digital Therapy
Date: 11 September
Time: 3PM London/10AM New York
Clinpal platform supports Meru Health digital therapy app
Average per-patient costs of face-to-face investigator site visits have increased to an average of $3,000 - $4,000. (Deloitte Insights, Digital R&D, Transforming the future of clinical development, 2018) In the US, patients must travel an average of about 50 miles to attend a site visit, with a disproportionate number being relatively well-off, white, urban/suburban patients. The typical investigator enrols only three patients, with 48% of them missing enrolment targets and 49% of their patients dropping out of the trial. With only about 5% of patients participating in clinical research, biopharmas are seeking more successful and less expensive ways to increase recruitment across a more geographically, socioeconomically, and ethnically diverse patient population, while increasing patient engagement and reducing the number of non-compliant patients and drop-outs.
Technologies available today enable patients to attend remote video teleconference visits with investigators, study coordinators, and mental health professionals, both those associated with traditional investigator sites and those attached to virtual, central sites - and for a fraction of the cost of a traditional site visit. Visiting nurses and phlebotomists located close to where patients live can efficiently and inexpensively record observations and collect samples for laboratory analysis during visits to patients' homes or places of employment. A number of medical devices may be shipped to patients' homes, with online video instruction in how to use, and remote video teleconference support from site staff or central, digital concierges who assist and observe patients remotely to ensure correct use of medical devices. A number of these devices transmit data immediately through an embedded SIM, allowing immediate tabular and graphical display of data for the traditional or virtual site investigator's review and approval.
Meru Health has launched their online medical clinic treating depression and burn-out as a service now offered by large employers to their staff. Meru Health delivers their service via an online, smartphone app supported by licensed mental health professionals. With one-fifth of university students having symptoms of depression and anxiety and diagnoses of depression increasing by 50% over the last ten years at the Finnish Student Health Service (FSHS), Meru Health has joined forces with the FSHS and eClinicalHealth Ltd in launching a project to study the efficacy and feasibility of a digital therapeutic intervention for depression in a randomized-controlled clinical trial. Recruitment is underway for 120 students with depression at FSHS locations across Finland. Meru Health's digital therapeutic service will be delivered to participants via their smartphone. Clinpal, the remote, direct-to-patient, virtual clinical trial platform developed by eClinicalHealth Ltd will collect and analyze the data.
This webinar will describe the two technologies powering this trial - from Meru Health and from eClinicalHealth. Webinar participants will learn about both the technical and mental health benefits offered by this remote therapeutic treatment program in depression. Participants will also gain an understanding of how the Clinpal platform, built on a single database for patient recruitment & engagement, screening, eLearning, eConsent, ePRO, EDC, and data reporting, allows for rapid study development and deployment across smartphones, tablets, PCs, and Macs, improving the results of clinical trials by introducing virtual clinical trial elements.
Meru Health engaged eClinicalHealth early in the design of the protocol and operational execution of this fully mobile-based CNS trial, allowing eClinicalHealth to provide them with the most value using the Clinpal rapid development and deployment technology and services package.
Co-founder, COO, Meru Health
Riku Lindholm (MSc) is a Digital Health entrepreneur. Currently, he serves as the Co-Founder & COO at Meru Health, an online medical clinic treating depression and burnout.
VP, US Operations, eClinicalHealth Ltd
Mark Paul has served in clinical development for over 25 years in a series of progressively responsible positions including data management, clinical operations, project management, and sales and marketing. Mark serves as head of project management at eClinicalHealth.
Key Learning Objectives
- Learn how to introduce elements of virtual clinical trials to study designs.
- Understand how to implement a BYOD study that includes a therapeutic app plus an eClinical app.
- Evaluate key considerations when selecting a technology platform to support direct-to-patient remote trials.
- Conceptualize â€œwhatâ€™s on the horizonâ€ for virtual and direct-to-patient clinical trial design.
- Head of Clinical Operations
- Head of Innovation
- C Levels
- Project Managers
- Project Directors
- Head of Information Technology IT
- Head of Real World Evidence
- Head of Patient Centricity
- Head of Patient Innovation
- Head of Medical Affairs
- Head of Patient Recruitment
- Clinical Trial Leader
- Head of Observational Research
- Chief Technology Officer
- Chief Information Officer
- Head of Regulatory
- Head of Data Management
- Head of Data Collection
- Medical Director