Trend in Clinical Trial Participation During COVID-19: A Secondary Analysis of the I-SPY COVID Clinical Trial.

ABSTRACT: To analyze the temporal trend in enrollment rates in a COVID-19 platform trial during the first three waves of the pandemic in the United States.

Design

Secondary analysis of data from the I-SPY COVID randomized controlled trial (RCT).

Setting

Thirty-one hospitals throughout the United States.

Patients

Patients who were approached, either directly or via a legally authorized representative, for consent and enrollment into the I-SPY COVID RCT.

Interventions

None.

Measurements and main results

Among 1,338 patients approached for the I-SPY COVID trial from July 30, 2020, to February 17, 2022, the number of patients who enrolled (n = 1,063) versus declined participation (n = 275) was used to calculate monthly enrollment rates. Overall, demograph

SUBMITTER: Yang P 

PROVIDER: S-EPMC10281328 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature