TY - JOUR T1 - Use of connected digital products in clinical research following the COVID-19 pandemic: a comprehensive analysis of clinical trials JF - BMJ Open JO - BMJ Open DO - 10.1136/bmjopen-2020-047341 VL - 11 IS - 6 SP - e047341 AU - Caroline Marra AU - William J Gordon AU - Ariel Dora Stern Y1 - 2021/06/01 UR - http://bmjopen.bmj.com/content/11/6/e047341.abstract N2 - Objectives In an effort to mitigate COVID-19 related challenges for clinical research, the US Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of connected digital products (CDPs), tools that enable remote patient monitoring and telehealth consultation, in clinical trials both before and after the onset of the pandemic.Design We applied a comprehensive text search algorithm to clinical trial registry data to identify trials that use CDPs for remote monitoring or telehealth. We compared CDP use in the months before and after the issuance of FDA guidance facilitating virtual clinical trials.Setting All trials registered on ClinicalTrials.gov with start dates from May 2019 through February 2021.Outcome measures The primary outcome measure was the overall percentage of CDP use in clinical trials started in the 10 months prior to the pandemic onset (May 2019–February 2020) compared with the 10 months following (May 2020–February 2021). Secondary outcome measures included CDP usage by trial type (interventional, observational), funder type (industry, non-industry) and diagnoses (COVID-19 or non-COVID-19 participants).Results CDP usage in clinical trials increased by only 1.65 percentage points, from 14.19% (n=23 473) of all trials initiated in the 10 months prior to the pandemic onset to 15.84% (n=26 009) of those started in the 10 months following (p<0.01). The increase occurred primarily in observational studies and non-industry funded trials and was driven entirely by CDP usage in trials for COVID-19.Conclusions These findings suggest that in the short-term, new options created by regulatory guidance to stimulate telehealth and remote monitoring were not widely incorporated into clinical research. In the months immediately following the pandemic onset, CDP adoption increased primarily in observational and non-industry funded studies where virtual protocols are likely medically necessary due to the participants’ COVID-19 diagnosis.Data are available in a public, open access repository. At the time of publication, the authors will share data from the study on the public GitHub repository https://github.com/arieldora/Covid19digitaltrials. ER -