The five principles for good clinical trials

Nick Medhurst

Manager, Good Clinical Trials Collaborative

An abundance of tools is widely available to researchers today that can empower clinical trials to be more adaptive, connected, efficient, flexible, resilient and transparent.

The use of new tools in clinical trials can help bridge the gap between research in higher- and lower-income countries. But their potential can be wasted when used without thinking about the fundamental scientific and ethical components of a good trial.

The Good Clinical Trials Collaborative worked with a global consortium of experts, organisations and communities to develop five principles of a good randomised clinical trial.

1) Answer the question

Conclusive results – not just positive ones – protect lives and ensure there is an end result for the time and resources invested in a trial. It starts with trial design: making sure a trial is set up to succeed is half the battle. Randomisation is the most powerful tool we have to make reliable comparisons.

2) Deliver for participants and the public

Beyond consent, a good trial will ensure patients are empowered with relevant, understandable information, and their rights and wellbeing are respected and protected. Ensure important information is made available to the public too.

3) Think collaboratively

Cooperation, fairness and transparency help make better use of resources but also build greater trust and confidence in clinical trials. This is not just for the organisations and individuals involved but for everyone, including the general public, who may be affected by the results.

4) Make sure the trial can work

If design is half the battle, making a trial happen is the other. A good trial should act in harmony with where it is taking place, understanding the context, setting and communities involved. Trials that do not are frequently wasteful, duplicative and likely to fail.

5) Keep an eye on what matters

Understanding what might go wrong and being ready to avoid or remedy important errors are indicators of a well-planned trial. Fine tuning the systems and processes that will track, highlight and address key challenges makes for a well-run trial too.