What constitutes full access to data in industry-funded trials? The Lancet

What constitutes full access to data in industry-funded trials? : The Lancet.

The Lancet, Volume 378, Issue 9808, Page 1976, 10 December 2011
Open any medical journal and you are likely to find significant results outnumbering those that are non-significant. Novel, positive findings evoke greater interest than do confirmatory or “negative” trials, although the latter are equally as important. Such publication bias at a journal level has long been judged problematic. But might selective data reporting at a study level be even more sinister? The answer is yes.
Take the case of GlaxoSmithKline’s Avandia (rosiglitazone) for type 2 diabetes. Regulatory approval was granted in 2000, but reanalysis of the raw data in 2007 showed a rise in myocardial infarctions and the drug was suspended in Europe in 2010. To avoid such problems recurring, regulatory agencies require protocols and results to be publicly posted online, and journals require authors to confirm that they had full access to all the data in the study.
Nonetheless, as a disturbing letter published in this issue shows, problems still arise with interpretation of what constitutes full access to data. Only 31 of 39 academic authors of industry-sponsored trials who were surveyed had full or partial access to patient case report forms in their studies and fewer than a third checked these forms against the study database (or used them for analysis). Investigators should have access to such information if they request it, but this seems not always to be the case. 20 (17%) of 112 US medical schools surveyed in 2005 had quarrelled with their industrial sponsors over control or access to study data.
Revelations with serious outcomes for patients (such as those surrounding rosiglitazone) will continue to be made unless investigators and clinicians have access to all the facts. Policy makers and clinicians rely on investigators to review raw data, and regulatory agencies, peer reviewers, and editors to vet the findings. When declaring “full access” to data, we remind authors to think carefully about what this means. Health-policy decisions must be driven by the most reliable data, and those data should be as transparent and truly accessible as possible.


Introduce tus datos o haz clic en un icono para iniciar sesión:

Logo de WordPress.com

Estás comentando usando tu cuenta de WordPress.com. Cerrar sesión /  Cambiar )

Google+ photo

Estás comentando usando tu cuenta de Google+. Cerrar sesión /  Cambiar )

Imagen de Twitter

Estás comentando usando tu cuenta de Twitter. Cerrar sesión /  Cambiar )

Foto de Facebook

Estás comentando usando tu cuenta de Facebook. Cerrar sesión /  Cambiar )


Conectando a %s

A %d blogueros les gusta esto: