Intended for healthcare professionals


Clinical trial transparency in the Americas: the need to coordinate regulatory spheres

BMJ 2018; 362 doi: (Published 09 August 2018) Cite this as: BMJ 2018;362:k3479

The paper (BMJ 2018;362:k2493, doi:10.1136/bmj.k2493) was published with a number of reference errors. The full list of originally published references can be found in the data supplement available alongside this correction. The corrected reference list is reflected in the current version of the article at 10.1136/bmj.k2493.

In addition, the following paragraph was missing from the originally published version of this article:

From ‘Argentina’

Argentina enacted the Good Clinical Practice Regime in Pharmacology Research (Disposition 6677/10-ANMAT), applicable to research aimed at obtaining data for regulatory approval and product registration. Local jurisdictions can also impose additional requirements. ANMAT guidelines mention the Declaration of Helsinki (DOH, 1964 and current versions) and the Council for International Organizations of Medical Sciences (CIOMS, 2002 version) as references for its application, incorporating DOH and the CIOMS 2002 version as part of Good Clinical Practices (GCP). Given that both sponsors and researchers must respect these international guidelines, reference to different guidelines and different versions in overlapping governance regimes—not unique to Argentina—may raise compatibility and consistency issues. More detailed, current ethical obligations regarding transparency of health-related research prescribed in CIOMS 2016 version are not yet part of Argentina’s GCP.

The above paragraph has been reinstated and these changes are reflected in the current version of the article available at 10.1136/bmj.k2493.

The originally published article, omitting the above paragraph and updated references is available in full as a data supplement accompanying this correction notice.

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