This document discusses good practices for reporting clinical trials. It recommends following standardized reporting guidelines from organizations like EQUATOR to improve transparency and reproducibility. Key points covered include prospectively registering trials, writing protocols according to SPIRIT guidance, and addressing reviewer feedback to strengthen manuscripts. Adhering to reporting standards helps make research more organized and prevents good studies from being undermined by poor reporting.

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

3. 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

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

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

6. •CONSORT (RCT)
•STROBE (observational)
•STARD (Diagnosis)
•PRISMA (SR)

7. Checklists

8. 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%20Statem
ent%202000.pdf
• Manuscripts reporting results of evaluations of diagnostic
tests require a STARD flow diagram and checklist :
http://www.stard-statement.org/

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

10. Issued May 2005

11. 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/

12. http://clinicaltrials.gov/

13. www.who.int/ict
rp/en/

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

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

16. 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

17. 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.

18. 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

19. 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)

20. 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

21. 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

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

29. Don’t give up