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