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Study Design require careful alignment between the research question, intervention, comparator, outcomes, recruitment strategy, operational plan, and statistical analysis.
The Methods Clinic supports clinicians, investigators, and research teams in designing investigator-initiated, pragmatic, explanatory, and context-appropriate clinical trials.
We work directly with your clinical question and research setting to develop a design that is methodologically rigorous while remaining practical for the teams, participants, institutions, and healthcare systems involved.
Our support begins early, before key decisions are finalised, helping reduce avoidable design weaknesses and improve the overall credibility of the trial.
Design decisions made at the beginning of a study influence every stage that follows.
Weak alignment between the research question, study population, outcomes, data collection, and analysis can lead to avoidable bias, unclear findings, operational difficulties, and challenges during peer review.
The Methods Clinic helps identify these risks early and develops a coherent study framework that supports credible interpretation and meaningful clinical conclusions.
We help refine the clinical problem into clear primary and secondary objectives.
We identify the most suitable trial design based on the intervention, comparator, population, setting, and intended conclusion.
We support the selection of outcomes that are meaningful to patients, clinicians, funders, and decision-makers.
We consider recruitment, site capacity, timelines, intervention delivery, follow-up, and available resources.
Methodological guidance across every critical trial decision, helping you develop trials that are rigorous, feasible, transparent, and clinically meaningful.
Refining the clinical question into clear trial objectives, hypotheses, and decision-relevant outcomes.
Choosing between parallel-group, cluster-randomised, crossover, factorial, adaptive, pragmatic, or other appropriate trial designs.
Designing cohort, case-control, cross-sectional, registry, and other observational studies with methods aligned to clinically relevant research questions.
Defining the intervention, control condition, standard-of-care comparator, treatment strategy, and protocol adherence expectations.
Developing inclusion and exclusion criteria that support scientific validity while maintaining practical recruitment.
Providing guidance on randomisation methods, allocation concealment, stratification, blocking, and cluster assignment where applicable.
Assessing whether participant, clinician, assessor, or analyst blinding is feasible and necessary.
Defining primary, secondary, safety, exploratory, patient-reported, and health-system outcomes.
Clarifying the treatment effect of interest, target population, endpoint, intercurrent events, and summary measure.
Supporting assumptions related to effect size, event rates, variability, power, precision, attrition, clustering, and feasibility.
Defining assessment time points, duration of follow-up, outcome windows, and retention strategies.
Ensuring the analysis plan matches the trial question, design, estimand, outcome structure, and missing-data strategy.
Identifying risks related to selection, performance, detection, attrition, contamination, protocol deviations, and generalisability.
Determining whether a pilot or feasibility phase is needed before a definitive trial.
Critical review of protocols, concept notes, statistical analysis plans, grant applications, and near-final trial documents.
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Developing a clinical study, preparing a grant application, planning an analysis, or refining a manuscript?
