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 …

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 …

In oncology, next generation sequencing and comprehensive genomic profiling have
enabled the detailed classification of tumors using molecular biology. However, it is …

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 …

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 …

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 …

Background All randomized clinical trials (RCTs) require a protocol; however, numerous
studies have highlighted protocol deficiencies. Reporting guidelines may improve the …

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 …

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 …

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 …