The Good Clinical Trials Collaborative has published new draft guidance for Randomized Controlled Trials (RCTs). The draft guidance is now available for public consultation between 4th August to 30th September.
The guidance has been developed with direct contributions of over 100 leading experts from across the clinical trials community and input and insights from many more. You can read more about the process of developing the guidance.
Our next objective, through the public consultation, is to maximise the scrutiny the draft guidance receives. This can help ensure the final guidance is inclusively developed and as fit-for-purpose as possible.
How to provide feedback
You can access the feedback form to provide comments on the guidance by clicking on the ‘feedback form’ button. In the feedback form, you will have the opportunity to provide general comments and more specific feedback on principles and sections of the guidance.
If you choose to complete all the sections, it may take around 20 minutes to complete the survey. However, you can move through the survey much quicker if you do not have the time or only want to complete certain sections.
If you are interested in contributing but may find it difficult to complete an online survey for any reason, please contact email@example.com to contribute alternatively.
What happens after the consultation process finishes?
Following the consultation process, the feedback provided will be carefully reviewed and considered by the GCTC Secretariat with input from relevant experts as appropriate. Amendments will be made to address any factual inaccuracies, key omissions, repetitive or contradictory statements. Any feedback that is specific to certain contextual factors (e.g. particular types of intervention, participant population, or healthcare setting) or which focuses on a particular detail will be reviewed to consider the implications for the wider, principle-based nature of these guidelines (all RCTs of any health intervention for any purpose in any setting).
Once we have reviewed the feedback and modified the guidance document accordingly, a new version will be published on the website, initially in 6 languages (Arabic, Chinese, English, French, Japanese and Spanish).
We have created an FAQ page which may cover any additional questions you have.