Guidance for good randomised trials (The Good Clinical Trials Collaborative)

The Good Clinical Trials Collaborative (GCTC) is a global initiative that has brought together a wide range of stakeholders from academia, industry, government, regulators, research organisations, clinicians, trial participants, patient groups, and civil society to address persistent shortcomings in the design, conduct, and reporting of randomized controlled trials (RCTs). The resulting guidance establishes the key principles of good RCTs and translates this broad consensus into practical, principles-based direction to support reliably informative, ethical, and efficient trials in any context.

Five core principle areasare covered in this guidance document, each broken down into sub-topics that cover design, conduct, oversight, and reporting. Practical explanatory notes and examples are woven through the text, and it is available both as a downloadable PDF and as an interactive web-based resource.

1. Scientific rigour – appropriate trial population, robust randomisation, adequate sample size, unbiased outcome assessment, reliable data capture, appropriate statistical analysis, assessment of benefits and harms, and appropriate safety monitoring.
2. Participant rights and well-being – safeguarding participants’ rights, informed consent and communication processes, ongoing information and changes in consent, and proportionate approaches to safety management.
3. Collaboration and transparency – partnership with patients, communities, and collaborating organisations; appropriate governance and roles; public trial registration; timely and transparent reporting of methods and results.
4. Feasibility and context-appropriateness – designing trials that are practicable in their setting, making best use of existing data and health system infrastructure, and ensuring that procedures are proportionate to the importance and risks of the trial.
5. Quality management – competent leadership and oversight, proportionate governance, risk-based quality management and monitoring, and processes that focus on what most affects participant safety and the reliability of trial results.

An evaluation tool can be downloaded from the website (.docx version) to assess application of the five key principles of good RCTs prospectively, concurrently or retrospectively. The tool supports high-level reflection on and evaluation of the degree to which key elements of those principles have been considered and embedded in the design, delivery, analysis and reporting of an RCT (planned, underway or completed). It can be used by a diverse set of stakeholders: research teams and sponsors, funders, regulators, reviewers and journal edictors, patients, participants and communities, students to follow the progress on the principles and subprinciples of RCTs.

The guidance is meant for everyone involved in randomized trials of health interventions, in any role and any context. It covers all randomized designs (e.g. parallel, cluster, crossover; blinded or not), all types of health interventions (from drugs, devices, and surgery to behavioural, digital, and public health approaches), and all purposes (regulatory, safety and efficacy evaluation, health technology assessment, and public health decision-making). It applies in any setting worldwide, including hospital, primary care, community, and direct‑to‑participant trials, and is relevant to researchers, clinicians, patients and the public, regulators, ethics committees, funders, sponsors, industry, and providers.