Use of connected digital products in clinical research following the COVID-19 pandemic: a comprehensive analysis of clinical trials

Abstract

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.

Keywords: COVID-19; clinical trials; general medicine (see internal medicine); health economics; information technology; telemedicine.

Figure 1

Proportion of clinical trials started monthly that use connected digital products for telehealth delivery or remote monitoring. The preperiod and postperiod analysis windows include the 10 months before and after the COVID-19 pandemic onset. Percentages on the left and right represent the average percentage of trials using connected digital products during the preperiod and postperiod, respectively. *Statistical significance in the mean difference between the preperiods and postperiods using two-sided proportion tests. Source: authors’ analysis of ClinicalTrials.gov data.

Figure 2

Proportion of clinical trials started that use connected digital products for telehealth delivery or remote monitoring, by study type and funder type. ‘Preperiod’ and ‘postperiod’ refer to the 10 months immediately before and after COVID-19 onset in the USA. March and April 2020 are excluded because policy changes and guidance documents were issued during that time. Trials started in the postperiod are divided into ‘COVID-19’ trials and ‘non-COVID’ trials based on their diagnoses in the ClinicalTrials.gov conditions label. *Statistical significance in the mean difference between the preperiods and postperiods using two-sided proportion tests. Source: authors’ analysis of ClinicalTrials.gov data.