Sharing trial data has been a controversial topic for quite a while. Recently the editors of major medical journals decided to take a stand. They will make access to trial source data a requirement, as a condition of publication, arguing that patients and the scientific community have a right to this information.[1]
The Clinicaltrials.gov website provides much useful information on development projects not easily available from other sources. Unfortunately, it is not being maintained; the results sections are often blank even after studies have long been completed. One can only speculate about the reasons for this; obviously corrective action is necessary. FDA recently complained about this state of affairs and announced plans to clean up and penalize any non-compliant stragglers.
Renowned institutions as well as pharma companies made the list of delinquents which reads like the Who is Who in drug development when the compliance status of Clinicaltrials.gov was reviewed in a recent publication.[2] An article in the NEJM last year was an eye-opener: the results of only 17% of studies were made available in Clinicaltrials.gov within a year of completion, as required.[3] And after 5 years, still only 50% had the results section updated as required by law (see Figure from the NEJM article). Mind you, we are not talking about study publications here, just a short description of results in the database! This is an embarrassing state of affairs not only for industry but for NIH studies as well.
A few companies have seen the writing on the wall and made some major concessions. In 2012, GSK CEO Andrew Witty agreed to make clinical trial data accessible to researchers upon request, with an independent panel of experts as gatekeepers. This was an industry first, and a major shift in philosophy and behavior for a Big Pharma company. Others have followed, and in 2014 J&J entered into an agreement with Yale’s YODA (Open Data Access) Project to do the same.[4] But not all have embraced transparency. Roche initially resisted all efforts of independent researchers to gain access to the oseltamivir / Tamiflu clinical trial data sets. They relented eventually and opened their books but only so after an epic battle with BMJ investigators who literally had to fight for full access.[5]
Then there is the issue of publications being delayed or of data not being published at all because results were equivocal, not favorable enough, unfavorable, contradictory to prior results, or a combination of these reasons. Pretty much all these delays are by design: a change of internal priorities. Hey, wake up: it’s all about marketing and making a buck! We are treated to the frenzy of Late Breakers and First Results and Breaking News when data ‘good for marketing’ are to be disseminated. Not so much for the other categories. Publishers and KOLs are complicit in this game of publishing selectively.
Here some suggestion for the main stakeholders:
PATIENTS
Demand transparency as a condition of study participation, ie, publication of results in a reasonable timeframe after study completion
JOURNALS
Demand that full datasets be made public at the time of publication, not afterwards
INVESTIGATORS
Demand control over the publication process, insist on timely publication, and expect to be held accountable for non-compliance
COMPANIES / SPONSORS
Publish on time and engage neutral experts to review both the data, the data analysis and the publication; overcome your fears that the competition may gain from open access. Remember, you will gain from it as well.
FDA / EMA / HAs
Demand compliance with Clinicaltrials.gov requirements at times of submission and approval.
It has been too long that the “Medical Information” department was run by marketing folks in companies. Many “Medical Affairs” teams are still in a direct reporting line to the VP of Marketing. No wonder that publications are prioritized based on commercialization goals.
The game is afoot. There is change underway. As Gorbachev famously said to Honecker in 1989: “life punishes those who come too late.” Half a year later the Berlin Wall came down…
FYI: There is a petition drive underway by AllTrials. You can sign up at their site if you support the push for greater data transparency.[6]
References:
[1] J Drazen. NEJM January 25, 2016 – DOI: 10.1056/NEJMe1601087
[2] J Miller. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012. BMJ Open 2015;5: e009758. doi:10.1136/bmjopen-2015-009758
[3] M Anderson. Compliance with Results Reporting at ClinicalTrials.gov. N Engl J Med 2015;372:1031-9
[4] http://news.yale.edu/2014/01/30/yale-program-s-agreement-johnson-johnson-allows-broad-access-clinical-trial-data
[5] http://www.bmj.com/tamiflu
[6] http://www.alltrials.net/
