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