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Trial registration & IRCT progress

Trial registration & IRCT progress. Masoud Solaymani-Dodaran. Financial interests creates reporting BIAS. It is regrettably true that many trial results irrespective of their scientific importance will remain unpublished if they put the financial interests of the sponsor at risk.

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Trial registration & IRCT progress

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  1. Trial registration &IRCT progress Masoud Solaymani-Dodaran

  2. Financial interests creates reporting BIAS • It is regrettably true that many trial results irrespective of their scientific importance will remain unpublished if they put the financial interests of the sponsor at risk.

  3. Selective reporting results in distortion of evidence • Trial results may be reported selectively i.e. not reporting the results regarded as unfavorable. This has the potential of distorting the existing body of evidence on any particular issue. • We also know that the researchers tend to report positive findings more than the rest and the Journal editors for their part are also looking for trials with positive findings either a large effect of a new treatment or equivalence of two approaches to treatment (non-inferiority trials).

  4. Time for action • September 2004 simultaneous editorials (ICMJE initiative) • October 2004, Health ministers WHO • Primary Registry Network • October 2008 (item 19 declaration of Helsinki)

  5. What is a clinical trial? (WHO) • A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. • Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc http://www.who.int/ictrp/en/

  6. Which trials should be registered? (ICMJE) • a trial must have at least one prospectively assigned concurrent control or comparison group in order to trigger the requirement for registration • Among the trials that meet this definition, ICMJE wants to ensure public access to all “clinically directive” trials — trials that test a clinical hypothesis about health outcomes Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 2004;351(12):1250-1

  7. 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

  8. Requirements of a primary register 1 • Accept prospective registration of interventional clinical trials submitted by Responsible Registrants. • Participate in the development of Guidelines for Clinical Trial Registers. All registers will have documented Standard Operating Procedures (SOP). • Be able to collect and display the WHO Trial Registration Data Set • Flag trials that do not provide the complete WHO Trial Registration Data Set at the time of initial registration. • Submit the WHO Trial Registration Data Set, in English, to the Central Repository. • Endeavour to keep registered information up-to-date.

  9. Requirements of a primary register 2 • Endeavour to maintain a publicly accessible audit trail so changes made to the WHO Trial Registration Data Set can be tracked. • Never remove a trial once it has been registered. • Be searchable over the Internet at no charge. • Publicly disclose ownership, governance structure and not/for-profit status. • Be managed by a not-for-profit agency • Be open to all prospective registrants • Should a register cease to function the register agrees that at least the WHO Trial Registration Data Set (original and updated) for all trial records will be transferred to a Primary Register or appropriate alternative.

  10. Primary Registry Network

  11. Key dates • 4th of December 2008 (IRCT became a primary register) • 7th of April 2009 (IRCT became a data provider to ICTRP

  12. Aims and Spin offs from IRCT • Aims • Honest public reporting of trials • Showcasing achievements of Iranian Researchers • Complying with international norms on clinical trial registration • Public Education of Clinical Trials and their importance • Spin offs • Raising clinical trial profile • Improving standards of conduct

  13. Where are we? • 1200 application to IRCT until summer • 179 trials has been approved • 6 workshop on trial registration; More in the pipeline • Honorable Dr Lankarani’s approval to put 1st of Day 1388 as the deadline for prospective registration of all trials in Iran, otherwise it won’t be published in Iranian journals • http://commission.hbi.ir/link%20files/Picture1.jpg

  14. Where we want to go? • We want all prospective trials to get registered in IRCT • We want all previously conducted trials to get registered in IRCT as far as possible (positive points will be awarded for each retrospectively registered trial in the annual evaluation of the research activity)

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