Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04363268 |
Other study ID # |
Pro00041635 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 20, 2020 |
Est. completion date |
December 31, 2022 |
Study information
Verified date |
April 2020 |
Source |
Medable Inc. |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
ACCESS enables individuals to contribute to critical research, via an iOS and Android
smartphone mobile application. ACCESS combines patient reported outcomes, data from wearable
devices and real-world data (such as claims, EHRs, etc), with an opt-in to participate in
current and future studies for diagnostics, treatments and vaccines. The data that people
share can be quickly and anonymously matched to research studies, providing researchers with
a foundational framework for dynamic research at scale and participants a way to be
personally matched and prescreened for future research.
Description:
In the urgency of the COVID-19 outbreak, Medable will enable an observational study protocol
under which clinical trials can rapidly be conducted. The observational study protocol will
include the conduct of smartphone based research to capture an essential dataset to improve
our understanding of disease evolution, risk factors, and outcomes as well as enable
population-based monitoring to reduce the spread of disease. Under this protocol, sub-studies
and clinical trials can be conducted for interventions, including vaccine trials. The work
may include new tools such as surface environmental or personal swabs to test for presence or
absence of disease. Data collection efforts on behalf of rapidly evolving multiple study
designs and participant opt-in data sharing, will enable the compilation of critical
epidemiological and other data across the United States to accelerate the understanding for
effective mitigation and treatment of COVID-19.
ACCESS (American COVID-19 Collaborative Enabling Seamless Science), a novel COVID-19 digital
research infrastructure, provides a mobile app tool for participants to report specific data
and facilitate remote access to accelerate critical research and clinical treatment
development.
ACCESS leverages leading digital health technologies to facilitate at-home research, clinical
trials, and population-based long-term outcome studies and data de-identification measures
(data coding/tokenization). The infrastructure combines opt-in wearable sensors, patient
reported data and outcomes, opt-in data aggregation and additional opportunities for users to
participate in clinical trials and share their de-identified data based upon reported
information.
Prior to COVID-19, the FDA expressed an interest in expediting drug development through
developing trial designs that test multiple drugs and/or multiple subpopulations in parallel
under a single protocol, without a need to develop new protocols for every trial. This has
become even more important during the COVID-19 pandemic. This type of work will also be
enabled under the ACCESS system.