Reporting of clinical trials: Why & how?
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Transcript of Reporting of clinical trials: Why & how?
Good Reporting of Clinical Trials
Hesham Al-Inany, M.D, PhD
BJOG Editor (since 2004)Prof , Obstetrics & GynaecologyCairo University
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
What about Good reporting?
• A Standarised way of reporting• Approved by authorised bodies
Equator
http://www.equator-network.org
•CONSORT (RCT)•STROBE (observational)•STARD (Diagnosis)•PRISMA (SR)
Checklists
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/
How To Start?• Register ur trial
• The Answer is : Number
Issued May 2005
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/
http://clinicaltrials.gov/
www.who.int/ictrp/en/
www.controlled-trials.com/mrct/
www.controlled-trials.com/mrct/
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
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.
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
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)
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
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
Back to reporting
• Register your study (trial) prospectively• Follow reporting guidelines (Equator)• Clear concise manuscript
Don’t give up