RCTs play a central role in generating the evidence needed to inform the development and implementation of interventions to improve health. In promoting the unique benefits of randomization, this guidance is promoting methodology that – when implemented effectively – answers questions reliably.
Investing in and adhering to the principles of this guidance will strengthen the scientific and ethical quality of any RCT. This guidance recognizes that the application of these principles will look different from trial to trial. However, the essential goals remain the same and a good trial will apply all the principles wisely. By supporting the key messages with explanations of their importance, the guidance can act as a tool to both prompt and justify the tailored application of the principles in a particular trial or setting.
It is important to recognize and challenge barriers to implementing the principles of this guidance. Clinical trials need robust systems and administrative functions to succeed but these same systems and administrative functions can fail to facilitate – or even deter – pursuit of the principles of good RCTs to the detriment of individual and public health and well-being.
If this guidance helps the clinical trials community to develop, fund, participate in, run, regulate and utilize good trials more effectively, it will have been successful. However, the authors welcome recommendations for modification or refinement based on experience of use.
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