1. Guidelines for Clinical Trial Registration.

2. Background. In 2005 the International Committee of Medical Journal Editors (ICMJE) announced that in order for clinical trial results to be considered for publication in journals that adhere to ICMJE standards, all clinical trials must be registered on a public registry

3. Why register a trial? ‘ to promote the public good by ensuring that everyone can find key information about every clinical trial whose principal aim is to shape medical decision-making" and to foster conditions in which decisions about care "rest on all of the evidence, not just the trials that authors decided to report and that journal editors decided to publish “’ Facilitates the dissemination of information Open access searchable databases of all trials Reassures participants that their altruism becomes part of public record Increases trust in medical science

4. 2005 ICMJE requirements’ ‘any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome’ …. More typical RCT’s, not phase I or preliminary trials and ‘medical intervention.

5. 2007 ICMJE requirements ‘ Any research study the prospectively assigns human participants or groups of humans to one or more health-related intervention to evaluate effects on health outcomes’ Now includes phase I and also a broader definition of interventions

6. What is a health intervention? drugs, surgical procedures, devices, behavioral treatments, dietary interventions, process-of-care changes

7. What does not need registration? Observational studies in which the assignment of the medical intervention is not at the discretion of the investigator … if in doubt, register!

8. How do I register? A Company/PPP Another clear funder but they cannot register your trial Not sure – the programme? They register (and pay!) and supply you with the ISRCTN Wellcome Trust register for you on their register and give you a ISRCTN – free! A University with a Clinical Research office? A University with a Clinical Research office? You will need to register (and pay) for your trial yourself www.controlled- trials.com/isrctn/submission/ You will need to register (and pay) for your trial yourself www.controlled- trials.com/isrctn/submission/ Who is your trial sponsor?

9. Summary Trial registration is broadly a good thing! ….. Apart from the form filling The Wellcome Trust will register the majority of our trials for us Whoever is funding your research should pay and be the ‘sponsor’ - this might have wider implications and these should be discussed with them. The new definition come into force on 1 st July 2008 Trials must be registered before the first subject is enrolled and you do not need to wait for ERC approval. If in doubt - register