[HTML][HTML] The evolution of master protocol clinical trial designs: a systematic literature review
EL Meyer, P Mesenbrink, C Dunger-Baldauf… - Clinical Therapeutics, 2020 - Elsevier
Purpose Recent years have seen a change in the way that clinical trials are being
conducted. There has been a rise of designs more flexible than traditional adaptive and …
conducted. There has been a rise of designs more flexible than traditional adaptive and …
Practical considerations and recommendations for master protocol framework: basket, umbrella and platform trials
C Lu, X Li, K Broglio, P Bycott, Q Jiang, X Li… - … Innovation & Regulatory …, 2021 - Springer
Master protocol, categorized as basket trial, umbrella trial or platform trial, is an innovative
clinical trial framework that aims to expedite clinical drug development, enhance trial …
clinical trial framework that aims to expedite clinical drug development, enhance trial …
[HTML][HTML] Master protocol trials in oncology: review and new trial designs
A Hirakawa, J Asano, H Sato, S Teramukai - Contemporary clinical trials …, 2018 - Elsevier
In oncology, next generation sequencing and comprehensive genomic profiling have
enabled the detailed classification of tumors using molecular biology. However, it is …
enabled the detailed classification of tumors using molecular biology. However, it is …
A tutorial on pilot studies: the what, why and how
Pilot studies for phase III trials-which are comparative randomized trials designed to provide
preliminary evidence on the clinical efficacy of a drug or intervention-are routinely performed …
preliminary evidence on the clinical efficacy of a drug or intervention-are routinely performed …
A guide to the reporting of protocols of pilot and feasibility trials
L Thabane, G Lancaster - Pilot and Feasibility Studies, 2019 - Springer
Publishing protocols of trials including protocols of pilot and feasibility trials—designed to
inform the designs of main trials—has been advocated as an important strategy towards …
inform the designs of main trials—has been advocated as an important strategy towards …
This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols
F Schiavone, R Bathia, K Letchemanan, L Masters… - Trials, 2019 - Springer
Background There are limited research and literature on the trial management challenges
encountered in running adaptive platform trials. This trial design allows both (1) the …
encountered in running adaptive platform trials. This trial design allows both (1) the …
Guidelines for randomized clinical trial protocol content: a systematic review
Background All randomized clinical trials (RCTs) require a protocol; however, numerous
studies have highlighted protocol deficiencies. Reporting guidelines may improve the …
studies have highlighted protocol deficiencies. Reporting guidelines may improve the …
Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies
Objectives Designing studies with an internal pilot phase may optimise the use of pilot work
to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed …
to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed …
An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database
SAM Billingham, AL Whitehead, SA Julious - BMC medical research …, 2013 - Springer
Background There is little published guidance as to the sample size required for a pilot or
feasibility trial despite the fact that a sample size justification is a key element in the design …
feasibility trial despite the fact that a sample size justification is a key element in the design …
Questions asked and answered in pilot and feasibility randomized controlled trials
M Shanyinde, RM Pickering, M Weatherall - BMC medical research …, 2011 - Springer
Background In the last decade several authors have reviewed the features of pilot and
feasibility studies and advised on the issues that should be addressed within them. We …
feasibility studies and advised on the issues that should be addressed within them. We …