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The planning, development, progression and output of platform trials - a systematic survey
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Description: This mixed methods systematic survey is planned to be conducted at Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, over a period of 2 year (01.2021 to 01.2023). The aim of this study is to follow up on all platform trials since their inception and determine their characteristics, progression, development and output over time. Objective A Performing a systematic survey including all registered and/or published platform trials to date. Describe the different definitions of platform trials classified by authors of the trial and define a working definition. Objective B Determine the prevalence of platform trials over the last 10 years (in absolute numbers and as a proportion of all registered RCTs. Objective C Based on working definition, determine overall baseline characteristics (population, intervention, control, indication, blinding, randomization, adaptive design elements) and the status of the platform trials (in planning, ongoing, terminated, concluded) including descriptive statistics. Objective D Determining the progression and development of platform trials (completion/ graduation or termination of treatment comparisons, update of the control arm, fulfillment and reporting of recruitment miles stones as well as determine the prevalence of discontinued trials. Objective E Determining the output of platform trials based on publications, results and uptake in in guidelines (e.g. output of trial). Objective F Evaluating the transparency of platform trials based on the availability of protocols, amendments and registration of trials in trial registries.