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Randomization within the context of a platform trial can either be a one- or a two-step strategy. The traditional mode of randomization (the one-step strategy) requires greater screening when directed at a master protocol trial. The two-step strategy for ISAs can raise challenges about informed consent.
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cover the rest of the master protocol design scenarios when they are not strictly covered by basket trials or umbrella tri-als. Under this denition, platform trials may be conducted in a perpetual manner, where multiple drugs and/or multiple disease populations can be added to the platform trial for investigation at dierent times.

As its first priority, GCAR is sponsoring GBM AGILE, an adaptive platform trial for patients with GBM – the most common and deadliest of malignant primary brain tumors. Key strategic partners for the GBM AGILE study effort include the National Brain Tumor Society, National Foundation for Cancer Research, and Asian Fund for Cancer Research.
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  • There has been a rise of designs more flexible than traditional adaptive and group sequential trials which allow the investigation of multiple substudies with possibly different objectives, interventions, and subgroups conducted within an overall trial structure, summarized by the term master protocol. This review aims to identify existing ...
  • Motivation. Native applications often register themselves as protocol handlers to increase discoverability and usage. While websites currently have this ability to register to handle schemes via registerProtocolHandler (), it is desirable to have web apps be first-class citizens and be launched directly when a custom-scheme link is invoked.
  • COVID-NMA is an international research initiative supported by the WHO and Cochrane. We provide a living mapping of COVID-19 trials. We are also conducting living evidence synthesis on preventive interventions, treatments and vaccines for COVID-19 to assist decision makers. See the description of our model here and our living review protocol here.
  • Conclusion. The terms ‘master protocol’, ‘basket trial’, ‘umbrella trial’, and ‘platform trial’ are inconsistently described. Careful treatment of these terms and adherence to the definitions set forth by the FDA will facilitate better understanding of these trial designs and allow them to be used broadly and to their full potential in clinical research.
  • The ACTIV-1 master protocol will test promising immune modulator compounds, a class of drugs that help minimize the deleterious effects of an overactive immune response to SARS-CoV-2 infection. This Phase 3 trial will enroll hospitalized adults with moderate to severe COVID-19 disease. It will evaluate the safety and efficacy of at least three immune modulators when given as an add-on therapy ...