Contemporary clinical trials · 2026
Lessons learned and recommendations from the Canadian adaptive platform trial of treatments for COVID in community settings (CanTreatCOVID).
Adaptive Clinical TrialКлиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Hosseini Banafshe, Condon Amanda, da Costa Bruno R, Daley Peter, Greiver Michelle, Jüni Peter, Lee Todd C, McBrien Kerry, McDonald Emily G, Murthy Srinivas, Selby Peter, Pinto Andrew D
Аннотация
BACKGROUND: The Canadian Adaptive Platform Trial of Treatments for COVID in Community Settings (CanTreatCOVID) is a multi-provincial adaptive platform trial (APT) evaluating outpatient therapeutics for individuals with mild to moderate SARS-CoV-2 infection at high risk of severe outcomes. Conducted across six Canadian provinces from January 2023 to March 2025, this paper describes its implementation and lessons for future APTs.
METHODS: We conducted a structured reflection on trial implementation across six domains: governance, stakeholder engagement, recruitment strategies, consent and enrollment processes, operational challenges, and cross-trial collaboration. Insights were derived from documentation of trial operations, governance records, protocol amendments, monitoring reports, and discussions among trial leadership and committee members. Lessons were synthesized across domains and translated into recommendations to support future APT implementation.
RESULTS: CanTreatCOVID highlighted the need for a centralized governance model. While the Steering Committee and Data Safety Monitoring Committee provided strategic oversight and safety monitoring, complementary committees for statistical methods, therapeutic selection, and recruitment addressed trial-specific needs. Regular stakeholder engagement supported trial design and implementation. Proactive communication with ethics boards facilitated regulatory approvals. Pre-negotiated agreements and national ethics review pathways were critical enablers accelerating site activation. Recruitment required multi-faceted strategies that adapted to evolving standards of care, supported by flexible, remote consent and online screening processes that reduced participant burden. Finally, aligning eligibility criteria, outcomes, and analytic approaches with international APTs enabled pooled analyses and strengthened evidence generation.
CONCLUSION: CanTreatCOVID demonstrates feasibility of decentralized APTs in community settings. These lessons and recommendations provide a framework to optimize future APTs.
TRIAL REGISTRATION: ClinicalTrials.gov (NCT05614349).
METHODS: We conducted a structured reflection on trial implementation across six domains: governance, stakeholder engagement, recruitment strategies, consent and enrollment processes, operational challenges, and cross-trial collaboration. Insights were derived from documentation of trial operations, governance records, protocol amendments, monitoring reports, and discussions among trial leadership and committee members. Lessons were synthesized across domains and translated into recommendations to support future APT implementation.
RESULTS: CanTreatCOVID highlighted the need for a centralized governance model. While the Steering Committee and Data Safety Monitoring Committee provided strategic oversight and safety monitoring, complementary committees for statistical methods, therapeutic selection, and recruitment addressed trial-specific needs. Regular stakeholder engagement supported trial design and implementation. Proactive communication with ethics boards facilitated regulatory approvals. Pre-negotiated agreements and national ethics review pathways were critical enablers accelerating site activation. Recruitment required multi-faceted strategies that adapted to evolving standards of care, supported by flexible, remote consent and online screening processes that reduced participant burden. Finally, aligning eligibility criteria, outcomes, and analytic approaches with international APTs enabled pooled analyses and strengthened evidence generation.
CONCLUSION: CanTreatCOVID demonstrates feasibility of decentralized APTs in community settings. These lessons and recommendations provide a framework to optimize future APTs.
TRIAL REGISTRATION: ClinicalTrials.gov (NCT05614349).