Regulatory Focus™ > News Articles > UK Organizations Band Together to Form New Clinical Trial Transparency Standards

UK Organizations Band Together to Form New Clinical Trial Transparency Standards

Posted 24 May 2012 | By

A number of prominent UK healthcare organizations have banded together to form a new set of principles meant to set a new voluntary standard for the reporting of clinical trial data, reports PMLiVE.

The coalition of groups, which includes the Association of the British Pharmaceutical Industry (ABPI), the General Medical Council, the Prescription Medicines Code of Practice Authority and The Academy of Medical Royal Colleges, is being called the Ethical Standards in Health and Life Science Group (ESHLSG).

Its new code of conduct for clinical trial transparency, the Clinical Trial Transparency Principles and Facts, was released at a joint conference sponsored by the British Medical Journal and ABPI.

Explains PMLiVE: "The guidelines include a 21 day limit for investigators to publish methods and plans for a clinical study on a publically accessible register once patient enrolment has begun, and that in commercial pharmaceutical trials, investigators should make available the methods and results of their trial within one year of the product gaining market authorization. In addition, if the product fails to gain market authorization, but the results are of significant medical importance, researchers should make those results available within a year of completion of the trial in a publicly accessible website or journal."


Read more:

PMLiVE - UK health groups publish clinical trial transparency standards

Pharma Times - ESHLSG publishes transparency principles for clinical trials


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