All Trials Registered-All Results Reported. European Medicines Agency wrote about the benefits from increased access to clinical trial data

[Myrddin]

This week, the heads of the European Medicines Agency wrote

nejm.org/doi/full/10.1056/N...

Yesterday the pharmaceutical company LEO Pharma announced its commitment to publish results of its clinical trials dating back to 1990. They are also going to provide access to anonymised patient-level data dating back to 2000 on request.

GSK joined the campaign to publish clinical trial data back in february

gsk.com/media/press-release...

They have been sharing their approach with LEO Pharma and with other companies who are having these discussions. These companies are moving further and further away from the obfuscating attitude of the some of the industry trade bodies who seem to want to keep secrecy as the norm.

Thes changes have come about because of the campaign for publication of clinical trial reults. see alltrials.net

[Kwenda]

For more on this subject see also previous posts.

healthunlocked.com/cllsuppo...

Dick

[Mikey47]

The e-mail I received from the Alltrials campaign also asked us to write to our health Ministers and you can find a sample letter (depending on your country) at the following link: alltrials.net/2013/write-a-...

I have just written to Jeremy Hunt Sec of State for Health in the UK. If you are on a clinical trial yourself you should add that.

[Kwenda]

The movement towards the release of ALL trials data is gaining momentum from an article in the important British Medical Journal.

The Unpublished Studies October 30, 2013

About 30 percent of large clinical trials registered withClinicalTrials.gov go unpublished, report Christopher Jones from Cooper Medical School of Rowan University in New Jersey and his colleagues in the British Medical Journal.

They sorted through trials involving more than 500 participants that were prospectively included in the database and that were completed by January 2009. Of the 585 trials they homed in on, the results from 171 had not been published by November 2012.

Part of the social contract of clinical trials, Jones and his colleagues write, is that although participants themselves may not benefit from the study, society will when the results are made known. "The non-publication of trial data … violates an ethical obligation that investigators have towards study participants," Jones et al. say. "When trial data remain unpublished, the societal benefit that may have motivated someone to enroll in a study remains unrealized."

Of those 171 unpublished trials, 133 had no data in ClinicalTrials.gov itself. In addition, Jones and his colleagues found that the lack of publication was more common in industry-sponsored trials — 32 percent — than non-industry sponsored ones —18 percent.

"There's no excuse for not publishing results but a huge public health benefit to having a complete picture of what was found in trials conducted on treatments currently available to patients," Síle Lane from the UK group Sense about Sciencetells the Guardian.

eurekalert.org/pub_releases...

theguardian.com/science/201...

Dick