Centrale coördinatie van een multicenter studie als alternatief voor betaling per patient: de ervaring bij de HEALTH-trial

ABSTRACT Objective: Multicenter clinical trials can be organized in different ways. Multiple centers participated in the HEALTH trial (Hip Fracture Evaluation with ALternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty). For the Dutch sites most study tasks are managed by a central trial coordinator, whereas Canadian and US sites use local study coordinators. The aim of this study was to analyze how these strategies affected trial performance. Design: Prospective observational study. Method: Data related to ethics approval, trial start-up time, inclusion rate and percentage of completed follow-ups were collected for each hospital and compared. Data from pre-trial screening were compared with actual inclusion rates. Results: The median start-up time of the trial after obtaining ethics approval was shorter in the Netherlands than in Canada and the US (4.6 versus 11.6 weeks). The inclusion rate was similar in both groups (0.62 versus 0.64/month). The median percentage of enrolled patients in the Netherlands was 27.3% versus 17.0% in Canada/US. The actual inclusion rates were lower than expected from pre-trial screening. The percentage of effectuated follow-up visits was >90% in both groups. Conclusion: In this study, central trial coordination contributed to faster trial start-up and higher inclusion rates, but had no effect on the effectuated follow-up visits. Central coordination is therefore a suitable alternative for appointing these tasks to local research assistants and per patient payment. Central coordination enables non-academic hospitals to participate in clinical trials. Limiting conditions for central coordina

Multistudy Research Operations in the ICU: An Interprofessional Pandemic-Informed Approach

OBJECTIVES:. Proliferation of COVID-19 research underscored the need for improved awareness among investigators, research staff and bedside clinicians of the operational details of clinical studies. The objective was to describe the genesis, goals, participation, procedures, and outcomes of two research operations committees in an academic ICU during the COVID-19 pandemic. DESIGN:. Two-phase, single-center multistudy cohort. SETTING:. University-affiliated ICU in Hamilton, ON, Canada. PATIENTS:. Adult patients in the ICU, medical stepdown unit, or COVID-19 ward. INTERVENTIONS:. None. MEASUREMENTS AND MAIN RESULTS:. An interprofessional COVID Collaborative was convened at the pandemic onset within our department, to proactively coordinate studies, help navigate multiple authentic consent encounters by different research staff, and determine which studies would be suitable for coenrollment. From March 2020 to May 2021, five non-COVID trials continued, two were paused then restarted, and five were launched. Over 15 months, 161 patients were involved in 215 trial enrollments, 110 (51.1%) of which were into a COVID treatment trial. The overall informed consent rate (proportion agreed of those eligible and approached including a priori and deferred consent models) was 83% (215/259). The informed consent rate was lower for COVID-19 trials (110/142, 77.5%) than other trials (105/117, 89.7%; p = 0.01). Patients with COVID-19 were significantly more likely to be coenrolled in two or more studies (29/77, 37.7%) compared with other patients (13/84, 15.5%; p = 0.002). Review items for each new study were collated, refined, and evolved into a modifiable checklist template to set up each study for success. The COVID Collaborative expanded to a more formal Department of Critical Care Research Operations Committee in June 2021, supporting sustainable research operations during and beyond the pandemic. CONCLUSIONS:. Structured coordination and increased communication about research operations among diverse research stakeholders cultivated a sense of shared purpose and enhanced the integrity of clinical research operations