Open Access News

News from the open access movement

Saturday, January 26, 2008

More on the need for open data in medical research

Andrew Vickers, Cancer Data? Sorry, Can’t Have It, New York Times, January 22, 2008.  (Thanks to LISNews.)  Excerpt:

Not long ago, I asked a respected cancer researcher if he could send me raw data from a trial he had recently published. He refused. Sharing data would make the study team members “uncomfortable,” he said, as I might use this to “cast doubt” on their results.

I’d heard this before: as a statistician who designs and analyzes cancer studies, I regularly ask other researchers to provide additional information or raw data. Sometimes I want to use the data to test out a new idea or method of statistical analysis. And knowing exactly what happened in past studies can help me design better research for the future. Occasionally, however, there are statistical analyses I could run that might make an immediate and important impact on the lives of cancer patients.

A few years back, a study was published showing that a certain drug could prevent one type of cancer. The problem was that the drug didn’t work very well and had some side effects, so almost no one used it. At the same time, a colleague showed that a protein found in the blood could predict which patients were at high risk for cancer. We put two and two together and realized that we could use the protein test to work out which patients would benefit from the drug.

To make things even easier for us, it turned out that the researchers who had conducted the trial had actually measured this protein in all their patients. So we wrote to them and asked whether they would share their data. They refused on the grounds that they might consider a similar analysis at some point in the future. But years have passed, no such analyses have been forthcoming and few patients are benefiting from what could be a very effective drug.

Given the enormous physical, emotional and financial toll of cancer, one might expect researchers to promote the free and open exchange of information. The patients who volunteer for cancer trials often suffer through painful procedures and harsh experimental treatments in the hope of hastening a cure. The data they provide ought to belong to all of us. Yet cancer researchers typically treat it as their personal property.

I’m sometimes told that sharing data would violate patient privacy — though changing names to codes is easy enough. Other requests are killed by red tape....

Most refusals are more blunt. “I am not prepared to release the data at this point,” one researcher wrote me, even though he was a government employee and his trial, which had been published several years earlier, was federally financed.

Dr John Kirwan, a rheumatologist from the University of Bristol in England, has studied researchers’ attitudes on sharing data from clinical trials. He found that three-quarters of researchers he surveyed, as well as a major industry group, opposed making original trial data available....

Dr. Kirwan went on to ask his subjects why. Their reasons were entirely trivial: one cited the difficult of putting together a data set (wouldn’t this have to be done anyway in order to publish a paper?); another was concerned that the data might be analyzed using invalid methods (surely a judgment for the scientific community as a whole). This is something of a clue that the real issue here has more to do with status and career than with any loftier considerations. Scientists don’t want to be scooped by their own data, or have someone else challenge their conclusions with a new analysis.

Yet this is exactly what cancer patients need. They want new results to be published as quickly as possible and to encourage a robust debate on the merits of key research findings....

With the rise of the Internet, sharing data has become a simple matter. Geneticists, for example, publish their raw data on a central Web site. The data from medical trials are given freely by patients. They should insist that these belong to science as a whole.

Update.  For the record, Eli Lilly denies that it ever suppressed results of negative clinical trials.  In the course of reporting this for Outsourcing-Pharma, Kirsty Barnes unearthed a few other nuggets:

...The American Psychiatric Association (APA) and the American Academy of Child and Adolescent Psychiatry (AACAP) renewed their call for a mandatory public registry for clinical trials.
APA president Carolyn Robinowitz said: "Open access to all clinical trial data is necessary to better understand the risks and benefits of treatments"....

As of December 2007 an FDA Amendments Act (FDAAA) requires trial sponsors of all clinical trials, except those in Phase I trials and small feasibility studies of devices, to register specific information on, the world's largest clinical trials registry.

Previously, the FDA Modernization Act (FDAMA) of 1997, which established the, only mandated the registration of FDA-regulated efficacy drug trials for serious or life-threatening diseases or conditions.

The new law not only widens the net to require that the majority of trials are registered, but also...requires the eventual inclusion of trials results, and imposes penalties for non-compliance.
The idea behind this was to create a "public database of clinical trial data with mandatory disclosure requirements...."