COVID-19- Why Solidarity and Discovery Trials MAY Fail to Bring Informative and Timely Results?
Liang S1, Qiu T2, Wang Y3, Han R4, Dabbous O1, Toumi M3
1Aix-Marseille University, Paris, 75, France, 2Aix-Marseille University, Marseille, France, 3Aix-Marseille University, Paris, France, 4Aix-Marseille University, Luxembourg, Luxembourg
OBJECTIVES : The SOLIDARITY and DisCoVeRy trials were launched by the World Health Organization (WHO) and France to accelerate the evaluations of efficacy and safety of several potential treatments against COVID-19. This study aims to review the study designs and implementation both trials. METHODS : Study design of the SOLIDARITY trial and the DisCoVeRy trials were identified from the European Clinical trial registry, the U.S. National Library of Medicine Clinical Trials.gov, WHO International Clinical Trials Registry Platform (ICTRP) on May 10th, 2020. Study objective, timelines, interventions, population and endpoints were extracted and assessed to address the issue of implementation of two trials. RESULTS : The SOLIDARITY trial and the DisCoVeRy trial mostly shared the same characteristics, such as study objective (to assess the efficacy and safety of potential interventions against the standard of care in hospitalized COVID-19 patients), interventions (remdesivir, lopinavir-ritonavir, lopinavir-ritonavir-interferon beta, and hydroxychloroquine), and population selection (hospitalized adult patients with laboratory-confirmed COVID-19, and with or without respiratory failure). Initially launched on April 3rd and March 22nd, 2020, the SOLIDARITY trial and the DisCoVeRy trial targeted 50,000 patients and 3,100 patients, respectively. The primary endpoint is all-cause mortality in the SOLIDARITY trial and severity rating on a 7-point ordinal scale at day 15 in the DisCoVeRy trial with an extensive data collection for secondary end points representing more than 100 variables. This design made the data collection inapplicable in a pandemic. However, the SOLIDARITY trial allowed customization for country-specific studies, sample size, endpoints contributing to significant deviation from the original protocol. CONCLUSIONS : From the logistic perspective, both trials lacked the resources to secure aligned and high-quality implementation. This review called for a pandemic task force with operational experts from the front-line of COVID-19 treatment to inform policymakers to make pragmatic and effective decisions when launching joined effort for trials.
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy
Clinical Outcomes, Epidemiology & Public Health, Health Service Delivery & Process of Care
Comparative Effectiveness or Efficacy, Disease Management, Hospital and Clinical Practices, Public Health