Evaluation Tool

A tool to support application of the key principles of good RCTs

Explore the Evaluation Tool

The Good Clinical Trials Collaborative has developed the Evaluation Tool to accompany the Collaborative’s Guidance for Good Randomized Clinical Trials (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.

Who can use this tool?

This tool will 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.

When to use this tool

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 a trial’s conduct and results – and to prompt lessons that can be applied to future trials

Explore the Evaluation Tool