MRC Biostatistics UnitClinical trials are the gold standard when evaluating the potential of a novel treatment. A standard that should not be compromised during a pandemic. However undertaking clinical studies during a pandemic is challenging, as we need to understand how many people will be infected and where these infections will take place. The situation is made more complex by the fact that COVID-19 is a novel disease. There is limited understanding of the natural history of the disease, which makes it difficult to choose how effectiveness of a treatment should be assessed.
We are working closely with clinical experts, to utilise efficient (adaptive) trial designs to evaluate possible treatment options for COVID-19. Key to our work is having the opportunity to dismiss insufficiently promising treatments quickly, and at the same time, allow early decisions about positive effects to be made early as well. We are also exploring multiple treatments within one trial.
Publications
- Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19
- How achievable are COVID-19 clinical trial recruitment targets? A UK observational cohort study and trials registry analysis
- Lopinavir-ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.
- AGILE-ACCORD: A Randomized, Multicentre, Seamless, Adaptive Phase I/II Platform Study to Determine the Optimal Dose, Safety and Efficacy of Multiple Candidate Agents for the Treatment of COVID-19: A structured summary of a study protocol for a randomised platform trial.
- Dexamethasone in Hospitalized Patients with Covid-19 – Preliminary Report
- Endpoints for randomized controlled clinical trials for COVID-19 treatments.
- A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19
- Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial.
- Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial
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