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Bulletin of the World Health Organization

Print version ISSN 0042-9686

Bull World Health Organ vol.84 n.6 Genebra Jun. 2006

http://dx.doi.org/10.1590/S0042-96862006000600007 

NEWS

 

How will the platform work?

 

 

The planned International Clinical Trials Registry Platform will not be a register itself, but rather will provide a set of standards for registers to follow to be internationally acceptable.

The project has set down 20 aspects about a planned trial that should be reported prior to recruiting participants in order to register that trial. These 20 items must all be publicly disclosed upon registration.

The platform is also developing a global trial identification system that will assign to every qualified trial a unique reference number to crossreference duplicate records across registers and information systems worldwide.

The platform will create an internet search portal where scientists, patients, doctors, donors and anyone else who is interested can search among participating registers for information about clinical trials taking place throughout the world.

Visitors will not be able to enrol in a trial directly through the site, but they will find contact information for the person who can assist them with enrolment or any other queries.

The 20 items to be submitted when registering a clinical trial are as follows:

1. Name of primary register, and unique ID number assigned by the primary register to this trial.

2. Date of registration in primary register.

3. Secondary ID: other identifying numbers and issuing authorities.

4. Source(s) of monetary or material support.

5. Primary sponsor: individual, organization, group or other legal person responsible for the trial.

6. Secondary sponsor(s).

7. Contact for public queries.

8. Contact for scientific queries.

9. Public title: intended for lay public in easily understood language.

10. Scientific title of the study, as it appears in the protocol.

11. Countries of recruitment.

12. Health condition(s) or problem(s) studied.

13. Intervention(s).

14. Key inclusion and exclusion criteria for participant selection, including age and sex.

15. Study type: for example, single arm or randomized trial.

16. Date of enrolment of first participant, anticipated or actual.

17. Target sample size: number of participants that trial plans to enrol.

18. Recruitment status of this trial. Pending: participants are not yet being recruited or enrolled at any site. Active: participants are currently being recruited and enrolled Temporary halt: there is a temporary halt in recruitment and enrolment. Closed: participants are no longer being recruited or enrolled.

19. Primary outcome(s).

20. Key secondary outcomes.

For full details please see: http://www.who.int/ictrp/data_set/en/index.html