The Open Data Revolution in Clinical Research

Where Is All the Clinical Trial Data?

Only about half of clinical trials make their way into medical journals, and even when studies are published the raw, patient-level data is rarely made available. Where is the missing data? Most of it is tucked away deep in the data vaults of pharma and medical device companies, never to see the light of day. For decades, research sponsors have participated in an industry-wide custom of publishing favorable research results and withholding negative ones. This was the main issue behind the 2012 landmark lawsuit against GlaxoSmithKline (GSK) in which the pharma giant was ultimately found guilty of withholding safety data on the diabetes drug Avandia.

After numerous scandals in which concealment of clinical trial data caused harm to thousands of patients, end users of clinical research – patients, doctors, and policymakers – are demanding transparency. Their efforts have not been in vain; more and more companies are opening their storehouses of data to the public, and it’s not a passing trend.

Open Data Milestones

In light of mounting pressure, several of the largest pharma and biotech companies have started to share their data to varying degrees. GSK led the way in 2012, followed by Roche and Medtronic in 2013, and Johnson & Johnson and Pfizer in 2014. As more companies follow suit, it is becoming clear that data sharing will soon become the norm.
In just the first few months of 2015, we witnessed three milestones in the open data movement:

  • The European Medicines Agency (EMA) put into force its landmark policy to publish all clinical reports for each new drug approved in the European Union.
  • The Institute of Medicine released a report with detailed recommendations to increase clinical trial data sharing. The Pharmaceutical Research and Manufacturers of America came out in support of the proposal.
  • Johnson & Johnson (J&J) announced that it would make its device and diagnostic data publicly available through collaboration with Yale University Open Data Access (YODA). (J&J made its drug data available last year). Through this partnership, YODA will act as an intermediary in what J&J says is “the first time any company has collaborated with a completely independent third party to review and make decisions regarding every request for clinical data.”

What Does It Mean?

Clinical research is entering a new era of transparency. The industry is moving away from the traditional tendency to treat data as an asset that would lose value if exposed to public scrutiny. The mindset is now shifting to one that sees data sharing as a duty and the only way to ensure that physicians make informed, timely decisions when treating their patients.

Experts argue that an open data system will assist not only independent evaluators trying to determine whether a pharmaceutical actually works, but it will also help drug companies run more effective trials. Large open data sets will improve the design of future clinical trials. Broad data sharing will also let pharmaceutical makers avoid committing tens of millions of dollars to late-stage studies that others have already found to be money sinks.

What’s Next?

“The question is not whether but how these data should be broadly shared,”said Dr. Michelle Mello in the New England Journal of Medicine. However, the question of how to share clinical trial data is a challenging one. While several companies including GSK, Pfizer, and Roche have set up online portals to share their files with outsiders with few restrictions on access, other companies are hesitant to open their doors so wide.

Many industry experts are praising YODA’s innovative third party data sharing model as the solution to this open data dilemma. In this model, YODA acts as a third party that reviews and approves requests for data independently of the companies it partners with. This way, manufacturers are shielded to some degree from unqualified parties who could misuse or misinterpret the data. The Scientific American went so far as to state that “such early signs of success might serve as the basis for devising a national system that replicates a YODA-like model for all U.S. drug trials, perhaps backed up by FDA-enforced penalties for companies that refuse to comply.”

Conclusion

It’s still uncertain which data-sharing model will become standard in the U.S., but it’s apparent that the clinical research industry has begun to think about data in a new way—as a shared resource. At Medrio, we’re excited about the ways this new outlook will help scientists devise novel ways to help patients.

Sources and Further Reading:

  1. Ross, J et al. “Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis”. The British Medical Journal (2012).
    doi:10.1136/bmj.d7292.
  2. Krumholz, H. “Give the Data to the People”. The New York Times (2014).
    http://www.nytimes.com/2014/02/03/opinion/give-the-data-to-the-people.html?_r=0
  3. Johnson & Johnson Press Release. “Johnson & Johnson Announces Clinical Trial Data Sharing Agreement with Yale School of Medicine”. 2015.
    http://www.jnj.com/news/all/johnson-and-johnson-announces-clinical-trial-data-sharing-agreement-with-yale-school-of-medicine
  4. “Secret Clinical Trial Data to Go Public”. The Scientific American (2014).
    http://www.scientificamerican.com/article/secret-clinical-trial-data-to-go-public/
  5. Mello, M et al. “Preparing for Responsible Sharing of Clinical Trial Data”. The New England Journal of Medicine (2013).
    http://www.nejm.org/doi/pdf/10.1056/NEJMhle1309073