Scientific Approach To Clinical Trials
Clinical trials are investigations designed to assess the effects – wanted and unwanted – of healthcare interventions in people.Clinicians and patients need access to clinical trial results to make treatment decisions. Our policy would adopt the "All Trials" campaign proposals. All tests of treatments and medications on humans would be registered and recorded.
The "All Trials" proposals:
- Planned clinical trials should be registered, with a summary of the trial protocol, before the first participant is recruited. Past trials that were not registered should now be registered retrospectively. This is essential if the trial was on medicines or interventions that we currently use .
- A summary of results should be publicly available where the trial was registered, within one year of completion of the trial. Summary results from all past trials of medicines currently in use should be made publicly available on a register now.
- Summary results include information on the primary and any secondary outcomes measured and statistical analysis. This is part of the structured information that global registries should support.
- Trial sponsors or others who produce a full report for marketing authorisation or any other purpose should make this publicly available. The narrative reports of adverse events and individual patient data in a full report can be redacted and available on request to researchers, in the same way that reports of adverse incidents currently are, with a commitment that no reasonable request will be refused.