Clinical Trial Registration

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The registration of all clinical trials is

a scientific, ethical and moral responsibility

www.who.int/ictrp

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Trial registration• The World Medical Association (WMA)

Declaration of Helsinki states that “Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.”;

www.wma.net/en/30publications/10policies/b3

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Trial registrationThe International Committee of Medical

Journal Editors (ICMJE) considers clinical trials for publication only if registered in an appropriate registry .

www.icmje.org

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ICMJE Recommendations, 2015

• Clinical trials should be registered in a publicly accessible database before the first participant is recruited.

• Major scientific journals will no longer publish the findings of a clinical trial unless it was registered before the first participant was recruited in a registry that meets WHO criteria.

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Clinical Trial• The ICMJE defines a clinical trial as

any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome.

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Health-related interventions

• Health-related interventions are those used to modify a biomedical or health-related outcome; eg., drugs, surgical procedures, devices, behavioural treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes.

• Health outcomes are any biomedical or health related measures obtained in patients or participants, including pharmacokinetic measures and adverse events (ICMJE,2015).

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The purpose of clinical trial registration

The purpose of clinical trial registration is: • To prevent selective publication and selective reporting of

research outcomes, • To prevent unnecessary duplication of research effort,• To help patients and the public know what trials are

planned or ongoing into which they might want to enroll, • To help give ethics review boards considering approval of

new studies a view of similar work and data relevant to the research they are considering.

Retrospective registration, for example at the time of manuscript submission,

meets none of these purposes. (ICMJE,2015)

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Which trials registries are acceptable to the ICMJE?

The ICMJE accepts registration in any registry that is a primary register of the WHO International Clinical

Trials Registry Platform (ICTRP)

http://www.who.int/ictrp/

or in www.ClinicalTrials.gov which is a data provider to the WHO ICTRP.

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The WHO’s ICTRCP International Clinical Trials

Registry Platform (ICTRP)

The WHO Registry Network

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International Clinical Trials Registry Platform (ICTRP)

• The ICTRP is a global initiative. • It aims to make information about all clinical

trials in humans available to all.

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:// . . / / / / / .http www who int ictrp network primary en index html

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www.Clinical trials.gov

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• They are accessible to the public at no charge,• open to all prospective registrants,• managed by a not-for-profit organization,• have a mechanism to ensure the validity of

the registration data, • and are electronically searchable. • An acceptable registry must include the

minimum 20-item trial registration dataset

International Clinical Trials Registry Platform (ICTRP)

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WHO Registry Network

• Primary Registries in the WHO Registry Network meet specific criteria for content, quality and validity, accessibility, unique identification, technical capacity and administration.

• Primary Registries meet the requirements of the ICMJE.

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Registries ( WHO- ICTRP) The registries that currently meet these criteria are:1. Australian New Zealand Clinical Trials Registry (ANZCTR)

2. Brazilian Clinical Trials Registry (ReBec)

3. Chinese Clinical Trial Registry (ChiCTR)

4. Clinical Research Information Service (CRiS), Republic of Korea

5. Clinical Trials Registry - India (CTRI)

6. Cuban Public Registry of Clinical Trials(RPCEC)

7. EU Clinical Trials Register (EU-CTR)

8. German Clinical Trials Register (DRKS)

9. Iranian Registry of Clinical Trials (IRCT)

10. Japan Primary Registries Network (JPRN)

11. Thai Clinical Trials Registry (TCTR)

12. The Netherlands National Trial Register (NTR)

13. Pan African Clinical Trial Registry (PACTR)

14. Sri Lanka Clinical Trials Registry (SLCTR)

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Trial Registration Data Set

• The minimum amount of trial information that must appear in a register in order for a given trial to be considered fully registered. There are currently 20 items in the WHO Trial Registration Data Set (TRDS).

• http://www.who.int/ictrp/network/trds/en/

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Trial Registration Data Set

1. Primary Registry and Trial Identifying Number2. Date of Registration in Primary Registry3. Secondary Identifying Numbers4. Source(s) of Monetary or Material Support5. Primary Sponsor6. Secondary Sponsor(s)7. Contact for Public Queries8. Contact for Scientific Queries9. Public Title10. Scientific Title

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Trial Registration Data Set11. Countries of Recruitment12. Health Condition(s) or Problem(s) Studied13. Intervention(s)14. Key Inclusion and Exclusion Criteria15. Study Type16. Date of First Enrollment17. Target Sample Size18. Recruitment Status19. Primary Outcome(s)20. Key Secondary Outcomes

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For more information International

Standards for Clinical Trial Registries.

World Health Organization. November 2012.

available at :http://apps.who.int/iris/bitstream/10665/76705/1/9789241504294_eng.pdf?ua=1