Note: This tool is in its pre-publication stage

Explore the beta version

The Good Clinical Trials Collaborative has recently released the Evaluation Tool.

It was developed to accompany the Collaborative’s Guidance for Good Randomized Clinical Trials (RCTs), which sets out five principles of good RCTs. Good RCTs are defined as being informative, ethical and efficient.

The Evaluation Tool is designed to be a quick, user-friendly reference guide.

At any stage of a trial, it helps users reflect on whether the principles of good trials have been considered and embedded.

For more detail on the principles of good RCTs, refer to the Guidance.

We want this tool to be helpful to a range of audiences who can use it alongside the Guidance, to support their reflection and evaluation on key aspects of RCTs.

 Example roles are listed here:

• Research teams and sponsors – to help review and optimise planned or ongoing trials.
• Funders – to support funding prioritization decisions and constructive feedback to applicants.
• Regulators – to help set expectations of best practice and support holistic review of a trial’s attributes.
• Reviewers and journal editors – to support review of and commentary on trial manuscripts and reports.
• Patients, participants and communities – to help review trial’s quality and identify opportunities for improvement.
• Students – to develop skills in design and critical appraisal of clinical trials and their results.

Any combination of the above can use the Evaluation Tool to support dialogue about purpose, priorities and expectations.

This tool can be used at multiple points during the planning, conduct, and evaluation of a trial, as below:

• Prospectively: to assess plans and prompt improvements in trial design and delivery.
• Concurrently: to consider changes to protocols and plans in the light of experience and new information e.g. enrolment, event rates, participant experience, new data from other trials.
• Retrospectively: to support evaluation of the trial’s conduct and results – and to prompt lessons that can be applied to future trials

Download the beta version of the Evaluation Tool here

This tool is still in its pre-publication stage. If you have any comments or questions, reach out to us at [email protected]