Implementation of platform trials in the COVID-19 pandemic: A rapid review.

MOTIVATION: Platform designs - master protocols that allow for new treatment arms to be added over time - have gained considerable attention in recent years. Between 2001 and 2019, 16 platform trials were initiated globally. The COVID-19 pandemic seems to have provided a new motivation for these designs. We conducted a rapid review to quantify and describe platform trials used in COVID-19. METHODS: We cross-referenced PubMed, ClinicalTrials.gov, and the Cytel COVID-19 Clinical Trials Tracker to identify platform trials, defined by their stated ability to add future arms. RESULTS: We identified 58 COVID-19 platform trials globally registered between January 2020 and May 2021. According to trial registries, 16 trials have added new therapies (median 3, IQR 4) and 11 have dropped arms (median 3, IQR 2.5). About 50% of trials publicly share their protocol, and 31 trials (53%) intend to share trial data. Forty-nine trials (84%) explicitly report adaptive features, and 21 trials (36%) state Bayesian methods. CONCLUSIONS: During the pandemic, there has been a surge in the number of platform trials compared to historical use. While transparency in statistical methods and clarity of data sharing policies needs improvement, platform trials appear particularly well-suited for rapid evidence generation. Trials secured funding quickly and many succeeded in adding new therapies in a short time period, thus demonstrating the potential for these trial designs to be implemented beyond the pandemic. The evidence gathered here may provide ample insight to further inform operational, statistical, and regulatory aspects of future platform trial conduct.

The Retail Outlet Health Kiosk Hypertension Trial (ROKHYT): Pilot Results.

BACKGROUND: Blood pressure (BP) control was only 43.7% in the National Health and Nutrition Survey (NHANES) survey in 2017-2018. Scalable, nonclinic-based strategies to control BP are needed. We therefore conducted a pilot trial of a text-messaging intervention in a national network of retail outlet health kiosks with BP devices. All study procedures were conducted remotely. METHODS: Eligible individuals (N = 140), based on average BP greater than or equal to 140/90 mm Hg at kiosks during the prior year, were randomized to intervention vs. usual care. Intervention consisted of tailored text messages providing educational information with embedded links to educational videos on topics related to BP control. BP measurements were obtained at kiosks at 3, 6, and 12 months following randomization; control was defined as BP < 140/90 mm Hg. Follow-up at 12 months was curtailed due to SARS-CoV-2. We therefore combined 12-month (N = 62) or carried forward 6-month (N = 61) data as the primary end point. RESULTS: Participants were 51.4% male, 70.7% white/Caucasian, had mean age of 52.1 years, and mean baseline BP 145.5/91.8 mm Hg. At the end point, 37.7% intervention vs. 27.4% usual care subjects achieved BP control (difference, 10.3%, 95% confidence interval -6.2%, 26.8%). In an intention-to-treat analysis with multiple imputation of missing data, 12-month BP control was 29.0% vs. 19.8% favoring intervention (difference, 9.2%. 95% confidence interval -7.3%, 25.7%); intervention vs. control differences in adjusted mean BP levels were systolic BP: -5.4 mm Hg (95% confidence interval: -13.5, 2.7) and diastolic BP: +0.6 mm Hg (95% confidence interval: -4.2, 5.4). CONCLUSIONS: These pilot results support the potential for a highly scalable text-messaging intervention to improve BP. CLINICAL TRIALS REGISTRATION: Trial Number NCT03515681.