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Reporting of clinical trials: Why & how?


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

Published in: Health & Medicine, Business

Reporting of clinical trials: Why & how?

  1. 1. Good Reporting of Clinical Trials Hesham Al-Inany, M.D, PhD BJOG Editor (since 2004) Prof , Obstetrics & Gynaecology Cairo University
  2. 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. 3. What about Good reporting? • A Standarised way of reporting • Approved by authorised bodies
  4. 4. Equator
  5. 5. •CONSORT (RCT) •STROBE (observational) •STARD (Diagnosis) •PRISMA (SR)
  6. 6. Checklists
  7. 7. Other checklists: • Systematic review meta-analyses require a QUOROM (PRISMA) statement checklist : • Reports of observational studies in epidemiology require STROBE: • Meta-analysis of observational studies requires a MOOSE statement: http://www.consort- ent%202000.pdf • Manuscripts reporting results of evaluations of diagnostic tests require a STARD flow diagram and checklist :
  8. 8. How To Start? • Register ur trial • The Answer is : Number
  9. 9. Issued May 2005
  10. 10. Clinical trial registries • NIH - • WHO - • Meta-register of clinical trials:
  11. 11.
  12. 12. rp/en/
  13. 13.
  14. 14.
  15. 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. 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. 17. STUDY PERIOD Enrolment Allocation Post-allocation Close-out TIMEPOINT** -t1 0 t1 t2 t3 t4 etc. tx 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. 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 1st July 2005 this must have been prospective (The trial registration number should be included at the end of the abstract)
  19. 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. 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. 21. Back to reporting • Register your study (trial) prospectively • Follow reporting guidelines (Equator) • Clear concise manuscript
  22. 22. Don’t give up