Reporting of clinical trials: Why & how?

there are many clinical trials every day but good reporting of these trials is essential. This talk may help in this

1. Good Reporting of Clinical Trials Hesham Al- Inany , M.D, PhD BJOG Editor (since 2004) Prof , Obstetrics & Gynaecology Cairo University

2. Why to talk about Reporting? A coming mandatory era Help to make research in the world more organised Sometimes good research may be undermined by poor reporting

3. What about Good reporting? A Standarised way of reporting Approved by authorised bodies

4. Equator http://www.equator-network.org

5. CONSORT (RCT) STROBE (observational) STARD (Diagnosis) PRISMA (SR)

6. Checklists

7. Other checklists: Systematic review meta-analyses require a QUOROM (PRISMA) statement checklist : http://www.prisma-statement.org/ Reports of observational studies in epidemiology require STROBE: http://www.strobe-statement.org/ Meta-analysis of observational studies requires a MOOSE statement: http://www.consort-statement.org/mod_product/uploads/MOOSE%20Statement%202000.pdf Manuscripts reporting results of evaluations of diagnostic tests require a STARD flow diagram and checklist : http://www.stard-statement.org/

8. How To Start? Register ur trial The Answer is : Number

9. Issued May 2005

10. Clinical trial registries NIH - http://clinicaltrials.gov/ WHO - http://www.who.int/ictrp/en/ Meta-register of clinical trials: http://www.controlled-trials.com/mrct/

11. http://clinicaltrials.gov/

12. www.who.int/ictrp/en/

13. www.controlled-trials.com/mrct/

14. www.controlled-trials.com/mrct/

15. How To Start? For any clinical trial: A protocol should be written It is essential for study conduct, review and reporting The question is how to write a protocol The Answer is : SPIRIT

16. SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials ) is an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to be addressed in a protocol .

17.   STUDY PERIOD   Enrolment Allocation Post-allocation Close-out TIMEPOINT** -t 1 t 1 t 2 t 3 t 4 etc. t x ENROLMENT:                 Eligibility screen X               Informed consent X               [List other procedures] X               Allocation   X             INTERVENTIONS:                 [Intervention A]               [Intervention B]     X   X       [List other study groups]               ASSESSMENTS:                 [List baseline variables] X X             [List outcome variables]       X   X etc. X [List other data variables]     X X X X etc. X

18. BJOG requires: A flowchart/checklist A copy of the ethics approval (or an explanation as to why ethics approval was not received) A copy of the original protocol upon which the trial was based Proof of registration – after 1 st July 2005 this must have been prospective ( The trial registration number should be included at the end of the abstract )

19. What Are the Secrets of Reporting? Submission Talk the paper up a little in the covering letter Attention to details such as section numbers, equations, notation, etc. Put as much effort into the revision as the original submission

20. Revision Secrets Don’t ignore the reviewers or editor no matter how stupid they are Repeat the reviewer comments then respond to them Highlighten ur revision statements

21. Back to reporting Register your study (trial) prospectively Follow reporting guidelines (Equator) Clear concise manuscript

22. Don’t give up