Next step in Iranian Clinical Trial Registration movement Masoud Solaymani-Dodaran MD MPH PhD CCT FFPH.

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Presentation transcript:

Next step in Iranian Clinical Trial Registration movement Masoud Solaymani-Dodaran MD MPH PhD CCT FFPH

In this presentation The international movement How it started and where it is The Iranian movement How it started and where it is International visibility IRCT performance Prospective versus retrospective Is there any room for improvement?

ICMJE initiative International Committee of Medical Journal Editors ICMJE September 2004: first statement simultaneously published in eleven ICMJE member medical journal The ICMJE member journals will not consider a trial for publication unless it has already been registered in a public trials registry. Trials must register at or before the onset of patient enrollment. October 2004, Health ministers in WHO endorse the idea WHO tasked with creation of Primary Registry Network

What is a WHO primary registry? They are publicly accessible clinical trial registries which have been approved by WHO WHO Primary Registries meet specific criteria for content, quality and validity, accessibility, unique identification, technical capacity and administration Not for profit, digitally searchable, accessible all the time, any responsible registrant can register, information recorded in English, at least 20 items are recorded from each trial, etc

Iranian Registry of Clinical Trials We are the 9 th Registry in WHO Primary Registry Network 4 th of December 2008 (IRCT became a primary register) 7 th of April 2009 (IRCT became a data provider to ICTRP 3200 application to IRCT until Autumn trials has been approved 1 st of Day 1388 (Dec 2009) as the deadline for prospective registration of all trials in Iran, otherwise it won’t be published in Iranian journals Signing a Research contract for a trial using public funding is subject to registration in IRCT

IRCT performance

What is next for IRCT? Trial start date RetrospectiveProspective Definition of Retrospective

Is there any room for improvement? Trial end date RetrospectiveProspective Definition of Retrospective

How much?

How can this happen Lets get the message out for prospective registration The registration process should become faster Regulation? Penalty? Lets not forget how far we have come but there is still a long way to go