Introduction Pragmatic surgical RCTs are needed but it is unclear how to design studies with evolving innovative interventions. The aim of this paper was to describe how a pilot RCT comparing two standard techniques incorporated an additional randomised group with a nested IDEAL (Idea, Development, Evaluation, Assessment and Long-term evaluation of innovative surgery) Phase 2b evaluation of an ...

When global clinical trials are carried out, it is important to consider the influence of racial and ethnic differences on the outcome. From this viewpoint, global clinical trials in East Asia, where racial differences are estimated to be small, are now attracting close attention. Under such circumstances, we conducted a survey using the data registered with ClinicalTrial.gov to investigate the...

In clinical trials, subjects are usually entered one at a time, and their responses to treatment monitored sequentially. Regular monitoring of trial progress in the early stages is crucial for accurate reporting of the final results. This paper discusses in detail the principles of quality data management in clinical trials, with specific reference to three clinical data management systems name...

Economic endpoints are increasingly common in randomized clinical trials. As a relatively new addition to the field, methods of measuring and analyzing cost data are still evolving. These developments will be stimulated by the demands of the public for efficient and effective medical care, which will be based on the findings of clinical trials.

OBJECTIVE We aimed to provide recommendations for addressing comorbidity in clinical trial design and conduct in multiple sclerosis (MS). METHODS We held an international workshop, informed by a systematic review of the incidence and prevalence of comorbidity in MS and an international survey about research priorities for studying comorbidity including their relation to clinical trials in MS....

OBJECTIVE Acupuncture is often used and frequently advocated for the symptomatic treatment of fibromyalgia. A systematic review has previously demonstrated encouraging findings. As it is now outdated, we wanted to update it. METHODS We searched seven electronic databases for relevant randomized clinical trials (RCTs). The data were extracted and validated independently by both authors. As no ...

Background Decisions by leading journals to require trial registration and to make protocols of phase III randomized clinical trials (RCTs) publicly accessible were landmark events in clinical trial reporting. Materials and Methods We identified phase III cancer RCTs published between 2013 and 2015 in New England Journal of Medicine (NEJM), The Lancet, The lancet Oncology, JAMA and Journal of...

Subgroup analyses of major randomized clinical trials in heart failure are published frequently, but their impact on medical knowledge and practice guidelines has not been previously reported. In a novel analysis, we determined number of citations, impact factors, number of authors, and citations in guidelines of both parent trials and sub-studies; we also qualitatively assessed whether the ana...