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Trials Methodology
Our Trials Methodology Research programme focuses on improving how clinical trials are designed, conducted, analysed, and reported, with the aim of making trials more efficient, inclusive, sustainable, and impactful for patients, practitioners, and health systems.
We work across the full lifecycle of clinical trials, embedding methodological research within real-world studies and collaborating closely with trial teams, patients, and international research networks.
Study Design
Study design defines how a clinical trial is structured to answer its research question, ensuring that the results are scientifically valid, ethically sound, and feasible to deliver in real-world settings.
To better align your intention with your design and outcomes, early engagement, is best.
We can support you with:
Design of Randomised Controlled Trials (RCTs)
Supporting the selection of appropriate trial designs, including parallel-group, cluster randomised, stepped-wedge, adaptive etc. Or ensuring your trial design meets your trial intention, e.g., designing a trial with a pragmatic intention, or a trial with an explanatory intention.
Why this matters:
Choosing the right trial design helps ensure that treatments are compared fairly and that the results are reliable and meaningful for patient care.
Protocol Development
Leading and supporting the development of clear, robust trial protocols that integrate scientific, methodological, and practical considerations, and that meet funder, regulatory, and ethics requirements while remaining feasible for participants and trial teams.
Why this matters:
A clear protocol helps ensure trials are run safely, consistently, and fairly, so participants know what to expect and results can be trusted.
Complex & Innovative Trial Designs
Advising on multi-arm, multi-stage (MAMS) designs, platform trials, and adaptive approaches to maximise efficiency and reduce research waste.
Why this matters:
Choosing the appropriate design can answer important questions faster, involve fewer participants unnecessarily, and make better use of limited research resources. Staying up to date with new trial designs is important to us so we can work with you on choosing the appropriate design for your study.
Feasibility & Pilot Studies
Designing feasibility studies that generate meaningful information to inform progression decisions, including recruitment capability, intervention delivery, and outcome measurement.
Why this matters:
Testing whether a trial can work in practice helps avoid studies that are unlikely to succeed and protects participants’ time and effort as well as reducing research waste.
Statistical Considerations, including Sample Size & Power Calculations
Working with statisticians to ensure assumptions are realistic and justified.
Why this matters:
Getting the numbers right ensures your trial can answer your research question. It also helps avoid trials that are too small to be useful, thus a waste of time and money, or larger than necessary thus putting additional burden on participants and using unnecessary resources and money.
Outcome Selection & Measurement
Supporting the identification of relevant, patient-centred outcomes, including the use of core outcome sets, and validated measurement instruments where appropriate.
Why this matters:
The success of your trial hinges on an appropriate outcome to answer your research question. Also, measuring outcomes that matter to patients ensures that trial results are relevant to real-life health decisions.
Embedded Methodology (SWATs)
Incorporating Studies Within A Trial (SWATs) at the design stage to formally evaluate alternative trial processes, e.g., recruitment, consent, and retention strategies or alternative modes of communicating trial results.
Why this matters:
SWATs help build evidence on how clinical trials should be run, so that future studies are more efficient, trustworthy, and respectful of everyone who takes part.
Trials Methodology Research
Trials Methodology Research focuses on how health and clinical research is conducted, rather than on testing specific drugs, devices, or interventions. It examines and improves the tools, processes, and practices used in clinical trials, with the aim of strengthening research quality, efficiency, and relevance.
This type of research is conducted by researchers often referred to as methodologists, who develop and evaluate methods across the full trial lifecycle, including trial design, recruitment, consent, data collection, analysis, reporting, and dissemination. Unlike interventional research, which studies the effects of treatments on patients, trials methodology research studies the research process itself.
Although it does not involve testing treatments, trials methodology research is still rigorous research. It addresses clearly defined research questions, is delivered through structured study designs (often embedded within active trials), and requires robust protocols, governance approvals, and appropriate ethical oversight. Importantly, this work benefits from patient and public perspectives, external input, and a strong grounding in real-world trial delivery.
Our programme embeds trials methodology research at the grant development phase, and within trials, enabling methodological questions to be tested in realistic settings and ensuring that findings are directly relevant to trial teams, funders, and health systems.
Core Areas of Activity:
Recruitment, Retention, & Participation Methods
Developing and evaluating approaches to improve participant recruitment, informed consent, retention, and follow-up across diverse trial settings.
Why this matters:
Ineffective recruitment and poor retention are major causes of trial delay, inefficiency, and failure; improving these processes strengthens trial delivery and value.
Inclusive Trial Methods
Designing and testing methods that address barriers to participation for under-served and under-represented groups.
Why this matters:
Inclusive trial methods improve the generalisability of findings and help address inequities in health research participation.
Trial Conduct & Operational Delivery
Evaluating processes related to trial set-up, site performance, protocol adherence, data quality, and coordination in multi-centre trials.
Why this matters:
High-quality trial conduct is essential for data integrity, regulatory compliance, and confidence in trial results.
Sustainability in Clinical Trials
Researching methods to reduce unnecessary burden, waste, and environmental impact in trial design and delivery, while maintaining scientific quality, ethical standards, and regulatory compliance.
Why this matters:
Sustainable trial methods reduce research waste, lower costs, and support environmentally responsible research systems.
Patient and Public Involvement and Engagement (PPIE)
Developing, implementing, and evaluating approaches to meaningfully involve patients and members of the public in the design, conduct, interpretation, and dissemination of trials methodology research.
Why this matters:
Effective PPIE improves the relevance, acceptability, and credibility of research and helps ensure that methodological innovation is grounded in real-world perspectives.
Embedded Methodology Research (SWATs)
Designing and implementing Studies Within A Trial (SWATs) to formally evaluate alternative trial processes and contribute to a cumulative evidence base for best practice.
Why this matters:
SWATs generate generalisable evidence on how trials should be conducted, supporting continuous improvement across the research ecosystem.
Evidence Synthesis & Meta-research
Synthesising methodological evidence through systematic reviews and meta-research to inform guidance and decision-making.
Why this matters:
Evidence synthesis helps ensure trial methods are based on what is known to work, reducing duplication and ineffective practice.
Translation & Capacity Building
Transforming methodological evidence into practical guidance, tools, and training for trialists and researchers.
Why this matters:
Building methodological capacity supports consistent application of best practice and strengthens the overall quality of clinical trials.
