The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
Cytel’s COVID-19 Trial Tracker continues to provide real time updates to the status of COVID-19 clinical trials worldwide. Funded by the Gates Foundation, the COVID-19 Trial Tracker uses machine learning technology to ensure that registries across the world feed into the Trial Tracker.
In April 2020, Cytel launched an open-access global COVID-19 Clinical Trial Tracker to help facilitate greater collaboration between researchers, policymakers, clinicians, journalists, philanthropists, and other critical stakeholders. Funded in part by The Bill and Melinda Gates Foundation, a leader in global health solutions, this live dashboard offers an overview of all the clinical trials taking place in the international effort to tackle the pandemic.
We have been posting regular updates on the clinical development of COVID-19 therapy and vaccines, on Cytel’s Blog page. The following details are based on an updated data search accessed on January 11.
Single arm trials are emerging as an accepted way of assessing a new treatment intervention. They establish clinical benefit by demonstrating the positive effects of a new therapy or treatment, without the need to use placebo or standard of care as a control. Instead, alternative approaches of establishing the comparison are used; these have become known as external controls or synthetic control arms (SCA) and include approaches leveraging real world data from various sources or evaluations of historical clinical trial data.
Is your Trial a Candidate for a Synthetic Control Arm? Continue reading this blog to learn more.
A number of trials recently disrupted by the COVID-19 pandemic are now in the process of re-assessing recruitment timelines, and establishing new recruitment targets. Recruitment projections, though, are only as good as the starting assumptions with which a forecast is made and the models subsequently used to calculate timelines.
Overly simplistic assumptions, even familiar ones like, “All patients will arrive and enroll in a strictly linear fashion,” have strong drawbacks. In order to maximize the potential to achieve recruitment milestones and to avoid misleading trial projections, planning must take careful precautions even when conditions are not this uncertain.