12 Result(s)
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Article
Open AccessA methodological review of randomised n-of-1 trials
n-of-1 trials are a type of crossover trial designed to optimise the evaluation of health technologies in individual patients. This trial design may be considered for the evaluation of health technologies in r...
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Open AccessWhat is the purpose of clinical trial monitoring?
The sources of information on clinical trial monitoring do not give information in an accessible language and do not give detailed guidance. In order to enable communication and to build clinical trial monitor...
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Open AccessCorrection: Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups—practical guidance to support better practice
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Open AccessTrial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups—practical guidance to support better practice
Randomised trials, especially those intended to directly inform clinical practice and policy, should be designed to reflect all those who could benefit from the intervention under test should it prove effectiv...
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Open AccessPractical guidance for planning resources required to support publicly-funded adaptive clinical trials
Adaptive designs are a class of methods for improving efficiency and patient benefit of clinical trials. Although their use has increased in recent years, research suggests they are not used in many situations...
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Open AccessCosts and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project
Adaptive designs offer great promise in improving the efficiency and patient-benefit of clinical trials. An important barrier to further increased use is a lack of understanding about which additional resource...
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Open AccessUtilising benefit-risk assessments within clinical trials—a protocol for the BRAINS project
Depending on the treatment to be investigated, a clinical trial could be designed to assess objectives of superiority, equivalence or non-inferiority. The design of the study is affected by many different elem...
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Open AccessThe adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. ...
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Open AccessChallenges in the design, planning and implementation of trials evaluating group interventions
Group interventions are interventions delivered to groups of people rather than to individuals and are used in healthcare for mental health recovery, behaviour change, peer support, self-management and/or heal...
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Open AccessDesign, planning and implementation lessons learnt from a surgical multi-centre randomised controlled trial
Increasingly, pragmatic randomised controlled trials are being used to evaluate surgical interventions, although they present particular difficulties in regards to recruitment and retention.
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Article
Open AccessDevelopment process of a consensus-driven CONSORT extension for randomised trials using an adaptive design
Adequate reporting of adaptive designs (ADs) maximises their potential benefits in the conduct of clinical trials. Transparent reporting can help address some obstacles and concerns relating to the use of ADs....
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Open AccessUse of home visits increases data completion and retention in studies involving family members
