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Common goals

Data disclosure programmes are improving standards globally

A football in the back of a netThe topic of data disclosure and increasing transparency is not new. In the US, the initial federal mandate to register clinical trials dates back to 1997, though more attention has focused on the expansion via the Food and Drug Administration Amendments Act (FDAAA) programme mandated in 2007 and still being phased in.

This expansion has made more clinical trial data publicly accessible. Interpretation and assessment of the implications of the 2007 mandate have caused much debate but, three years on, have not diluted the multi-stakeholder responsibility for timely and accurate reporting of clinical research data in the form of primary peer-reviewed publications.

Timeframe
Timeframe requirements for data disclosure of a phase II to IV trial for an approved product on ClinicalTrials.gov have driven parallel efforts to publish primary publications more quickly. Further, as data are reported in ClinicalTrials.gov without the contextualisation or critique that are crucial to practitioner interpretation, the discussion portions of a primary paper and the peer-review process continue to distinguish the value of a medical publication to a researcher or healthcare professional. 

Significant influences
FDAAA is an important cornerstone, but there have been other significant influences on publication professionals. Of note are the International Committee of Medical Journal Editors (ICMJE) guidelines that dictated prospective trial registration as a condition of publication, and ongoing attention given by politicians and the lay press to the potential for sponsor bias in the reporting of clinical trials in publications. The platform for the profession has been raised and publication professionals have met the challenge. As part of this, a group of publication professionals authored Good publication practice for communicating company sponsored medical research: the GPP2 guidelines on behalf of the International Society for Medical Publication Professionals (ISMPP).

There are numerous examples of industry-wide professional bodies and guidance endeavouring to stay ahead of regulation or set the bar higher. Further, companies or sponsors often set internal standard operating procedures or best practices above the level required by common industry guidance and regulation. In the publication arena, FDAAA, ICMJE and GPP2 all contribute to our motivation and ability to raise standards for medical publications as advocates in our own professional settings.

There have been parallel initiatives to FDAAA, led by the World Health Organisation, regulators in Europe and individual countries worldwide. In Europe, contemplating the publication-related implications of mandated clinical trial reporting requirements is timely as the European Medicines Agency is moving closer to implementing clinical trial posting and reporting requirements for the European Union Drug Regulatory Authorities Clinical Trial (EudraCT) database, which was established in 2004.

Past consternation
With FDAAA there was consternation over the incremental resources and work required, and debate over interpretation and translation to sponsor company standard operating procedures. EudraCT may fare better, however, as many companies have already had to think through the implications of FDAAA, including in global publication team settings.

One difference between ClinicalTrials.gov and EudraCT is that EudraCT will cover all interventional trials. Dealing with clinical studies for both unapproved and approved products, the need for a clear plan and to use processes that support timely publication of the results of a clinical trial (excluding phase 1) will arguably be greater considerations than are faced with ClinicalTrials.gov.

Harmonisation
There is also a need for harmonisation. Will reporting requirements for EudraCT (or any clinical trials reporting repository) get ahead of other databases (or vice versa) and, for publications, will the posting details ever constitute prior publication, as was an early fear with FDAAA? This debate was settled by ICMJE, but there were some US cases previously where publishers assessed FDAAA-related results disclosure as a reason to reject a manuscript. As results are populated in different databases, consistency between databases and the source primary publication will need to be reviewed to ensure optimal patient safety.

In a few years, European requirements for data disclosure will have made another step towards increased transparency. No doubt there will be problems to overcome, but the emphasis on timely publication in line with best practices will remain.

The Author
Julia Ralston is president and CEO, MedErgy HealthGroup - Philadelphia and London

To comment on this article, email pme@pmlive.com

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15th March 2010

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