ood randomized controlled trials (RCTs) play a central role in generating the evidence needed to inform the development and implementation of health interventions. However, useful evidence from good RCTs is often lacking. This can be because the RCTs were never done, because those that were done failed to produce scientifically robust and clinically relevant answers, or because the results were never published.
The Good Clinical Trials Collaborative (GCTC) has developed a new guidance to promote and enable good RCTs. The inclusive and broad-based guidance, which is available in five languages, will help researchers make RCTs smarter and better inform healthcare strategies. The collaborative is currently seeking input to shape the guidance through a public consultation until September 30. We invite you to get involved and share this opportunity with any organizations or individuals with an interest in RCTs.
Need for New Guidance
But it is implausible that a single set of operational rules and checklists will suit all purposes. Rather, what is needed is new guidelines which are based on the underpinning scientific and ethical principles of randomized controlled trials. We need guidelines that genuinely guide – guidelines that allow flexibility to meet the needs of specific trials in specific circumstances and enable innovation so that the trials of tomorrow are better than the trials of today.
The Good Clinical Trials Collaborative
The GCTC has brought together a wide range of individuals and organizations with an interest in and role to play in the design, delivery, analysis, and reporting of RCTs, and in implementing the results. This includes those who fund, regulate, design, deliver, or are responsible for RCTs, those who provide audits and quality-assurance functions, research organizations, ethicists, clinicians, participants, and lay health advocates. It includes those from a wide variety of sectors (industry, academia, government, charitable, nongovernmental organizations, participant and public groups) and settings (including higher and lower income countries around the world).
The new guidance has been developed to be:
- Based on key scientific principles and ethical principles that really matter when it comes to designing, conducting, and regulating a RCT. The guidance is designed to enable those involved in RCTs to work out for themselves how to design and deliver their RCT in their setting.
- Clear, concise, consistent, and proportionate to the context and setting in which RCTs are conducted, recognizing that there are risks associated with both usual clinical practice and a lack of reliable evidence on the effects of an intervention.
- Forward looking, fostering innovation in health interventions and trial methods, including the appropriate use of routine healthcare data, technologies, and designs.
- Flexible, widely applicable, usable, and durable across disease areas, intervention types, development phases, trial designs, geographies, and time.
The guidance aims to contribute toward a regulatory system that enables critical and rational thinking, in which trials are structured to meet standards of scientific and ethical excellence. The guidance focuses on what matters when designing, conducting, and regulating a RCT.
Get Involved
Through this guidance we hope to shape a future in which improvements in patient care and public health are driven by robust evidence from high-quality randomized controlled trials.