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How do trial teams plan for retention during the design stage of the trial? A sco** review
BackgroundRetention to trials is important to ensure the results of the trial are valid and reliable. The SPIRIT guidelines (18b) require “plans to...
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New clinical trial design in precision medicine: discovery, development and direction
In the era of precision medicine, it has been increasingly recognized that individuals with a certain disease are complex and different from each...
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Clinical research nurse predictions of trial failure, recruitment and retention: a case for their early inclusion in trial design
BackgroundClinical research nurses are a key part of the clinical trial team but typically get involved later in the trial, usually during...
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Value of Information for Clinical Trial Design: The Importance of Considering All Relevant Comparators
Value of Information (VOI) analyses calculate the economic value that could be generated by obtaining further information to reduce uncertainty in a...
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Looking ahead in early-phase trial design to improve the drug development process: examples in oncology
BackgroundClinical trial design must consider the specific resource constraints and overall goals of the drug development process (DDP); for example,...
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Patient-centred clinical trial design
Patient involvement in clinical trial design can facilitate the recruitment and retention of participants as well as potentially increase the uptake...
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The Trial within Cohorts (TwiCs) study design in oncology: experience and methodological reflections
A Trial within Cohorts (TwiCs) study design is a trial design that uses the infrastructure of an observational cohort study to initiate a randomized...
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Design of the STEPS trial: a phase II randomized controlled trial evaluating eHealth-supported motor-cognitive home training for Parkinson’s disease
BackgroundElectronic health (eHealth) technology offers the potential to support and motivate physical activity for symptom management in Parkinson’s...
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How do trial teams plan for retention during the design stage of the trial? A sco** review protocol
BackgroundRetention remains a major challenge for many clinical trials. The SPIRIT guidelines state the following information on retention should be...
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Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods
BackgroundPreventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not...
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A gated group sequential design for seamless Phase II/III trial with subpopulation selection
BackgroundDue to the high cost and high failure rate of Phase III trials where a classical group sequential design (GSD) is usually used, seamless...
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Whose knowledge counts? Involving communities in intervention and trial design using community conversations
BackgroundCurrent debates in Global Health call for expanding methodologies to allow typically silenced voices to contribute to processes of...
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Patient engagement in clinical trial design for rare neuromuscular disorders: impact on the DELIVER and ACHIEVE clinical trials
BackgroundEngaging individuals living with disease in drug development and regulatory processes leads to more thoughtful and sensitive trial designs,...
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Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting
BackgroundExternal randomised pilot trials aim to assess whether a future definitive Randomised Controlled Trial (RCT) is feasible. Prespecified...
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A prospective, open-label, randomized clinical trial to evaluate the efficacy and safety of remimazolam in patients undergoing EBUS-TBNA: REST trial design
BackgroundRemimazolam is safe and effective for moderate sedation during flexible bronchoscopy, but its safety and efficacy during endobronchial...
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Distributive randomization: a pragmatic fractional factorial design to screen or evaluate multiple simultaneous interventions in a clinical trial
BackgroundIn some medical indications, numerous interventions have a weak presumption of efficacy, but a good track record or presumption of safety....
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Commentary on 2022 guidelines on clinical trial design in cluster headache and further suggestions
BackgroundNew guidelines for cluster headache clinical trials were recently published. We welcome these new guidelines and raise additional...
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Optimal trial design selection: a comparative analysis between two-arm and three-arm trials incorporating network meta-analysis for evaluating a new treatment
BackgroundPlanning the design of a new trial comparing two treatments already in a network of trials with an a-priori plan to estimate the effect...
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Patient-Centered Clinical Trial Design for Heart Failure Devices via Bayesian Decision Analysis
BackgroundThe statistical significance of clinical trial outcomes is generally interpreted quantitatively according to the same threshold of 2.5% (in...
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Design and rationale of the Botswana Smoking Abstinence Reinforcement Trial: a protocol for a stepped-wedge cluster randomized trial
BackgroundWith expanded and sustained availability of HIV treatment resulting in substantial improvements in life expectancy, the need to address...
