Sanofi, Novartis, NCI, Ranbaxy top missing data list as Shire most transparent

Sanofi sign

A new, automated system coming out of the U.K.’s University of Oxford has named and shamed the worst culprits when it comes to not publishing trial data, with Big Pharma topping the list.

The so-called TrialsTracker system found that, overall, 45.2% of trials conducted by major sponsors during the last decade are missing results. The biggest single culprits of this lack of reporting are:

  • Sanofi: failed to report on 65.5% of the trials it sponsored--285 trials missing out of 435
  • Novartis: failed to report on 37.6% of the trials it sponsored--201 trials missing out of 534
  • NCI: failed to report on 34.8% of the trials it sponsored--194 trials missing out of 558
  • Hôpitaux de Paris: failed to report on 63.7% of the trials it sponsored--186 trials missing out of 292
  • GSK: failed to report on 22.6% of the trials it sponsored--183 trials missing out of 809

Glaxo ($GSK), rounding off the top five, is perhaps the most ironic and galling, given that a few years back it signed up to the U.K.-based AllTrials clinical trial transparency register, pledging it to release all data from its trials.

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There’s also a special mention for India’s Ranbaxy, which has published no results at all for any of the 35 trials it has run in the last 10 years.

But with the bad comes the good, and Ireland-based Shire was found to have published results for all of the 96 trials it has run over the past decade.

Among biopharma companies, the top five most transparent, measured by the percentage of trials missing, after Shire were Colgate Palmolive, Bristol-Myers Squibb ($BMY), Eli Lilly ($LLY), and Johnson & Johnson ($JNJ).

The TrialsTracker works by identifying studies on the world’s largest clinical trial register, ClinicalTrials.gov, that haven’t published results two years after the end of the trial.

Since January 2006, major trial sponsors completed 25,927 eligible trials, but this new program found they haven't published results for 11,714 of them.

Síle Lane, director of campaigns at Sense about Science, which runs the AllTrials campaign, said: “We should all be outraged that in the last 10 years 8.7 million patients have taken part in trials that haven't published results. These people volunteered for a clinical trial trusting that whatever was found out in the trial would be shared with doctors and researchers and used to make life better for patients like them. When results from trials are never shared and never used, that’s an enormous betrayal of their trust.

“I hope this new tracker will focus trial sponsors’ minds on the information they haven’t shared. The situation is urgent. When researchers retire, when computers break, when notebooks get lost we lose more knowledge about our medicines. Every day that passes means more information is lost forever. Trial funders need to ensure that missing results are shared, now, before it’s too late.”

In a statement to FierceBiotech, Novartis said: “We are aware of the TrialsTracker initiative and are reviewing against our own records. Initial analysis suggests the data presented is misleading as it focuses on PubMed and clinicaltrials.gov records, but doesn’t include other publication outlets including our own clinical trials results website www.novartisclinicaltrials.com.

“Novartis is committed to clinical data transparency and has been registering clinical trials on clinicaltrials.gov since 1999. In May 2005, Novartis became one of the first companies to publish interventional clinical trial results within one year of trial completion, regardless of outcome, on a public website. This pre-dates any country regulatory requirement to make trial results public.  In 2014 Novartis extended its leadership in clinical data transparency by providing access to its trial data to external researchers through www.clinicalstudydatarequest.com.”

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