Background The Covid pandemic has illustrated a substantial need for good Randomized Controlled Trials (RCTs) to better understand the benefits and hazards of medical interventions. The Good Clinical Trials Collaborative (GCTC) has created new guidance to promote and enable high-quality, ethical RCTs.

Methods In 2020, the Collaborative convened two workshops with a diverse, global, multi-disciplinary, multi-stakeholder group of 84 members to design the guidance. Draft content was reviewed at workshops, exploring scientific and ethical considerations, clinical contexts and quality management. After public consultation, the Guidance was finalized and published on www.goodtrials.org in 2022.

Results The agreed Five Principles of Good RCTs are that they are designed to produce scientifically sound answers to relevant questions, respect the rights and well-being of participants, are collaborative and transparent, are appropriate for their context, manage quality effectively and efficiently. The Guidance is underpinned by considerations that help a trial to fulfil its ethical responsibilities regarding participants, future and current patients. It is designed to support all RCTs in all settings to be relevant, informative, and provide sound answers to clear questions, thereby driving the development of better interventions and the delivery of future care. For professionals, the Guidance can be a tool to prompt and justify tailored applications of the principles in a particular setting. However, the Guidance can also aid community engagement by improving understanding of what a good RCT looks like – and why – for non-professional audiences.

Conclusion We hope that this Guidance can be a foundation of common understanding that good healthcare is informed by good evidence from good trials – and that it can help improve the standards of clinical trials and the way we collectively learn from and utilize their results.