“Too much ownership of data and secrecy involved”

That’s what one author writes in a series of papers published in Circulation: Cardiovascular Quality and Outcomes this month addressing issues involving the integrity of research data.

Yale’s Harlan Krumholz writes: “Patients facing a decision deserve information that is based on all of the evidence.”  Further excerpt:

Every day, patients and their caregivers are faced with difficult decisions about treatment. They turn to physicians and other healthcare professionals to interpret the medical evidence and assist them in making individualized decisions.

Unfortunately, we are learning that what is published in the medical literature represents only a portion of the evidence that is relevant to the risks and benefits of available treatments. In a profession that seeks to rely on evidence, it is ironic that we tolerate a system that enables evidence to be outside of public view. Those who own data, usually scientists or industry, have the choice of what, where, and when to publish. As a result, our medical literature portrays only a partial picture of the evidence about clinical strategies, including drugs and devices. Experts have recently drawn attention to this issue, including contributions in this issue of our journal, but there is resistance to change.

The sharing of trial data, as of yet uncommon except through mechanisms by some funders such as the National Heart, Lung, and Blood Institute, could provide an opportunity to leverage the strength of the global community of investigators. Many trials yield only a fraction of the knowledge that could be produced with more resources and creativity.

Now is the time to bring data sharing and open science into the mainstream of clinical research, particularly with respect to trials that contain information about the risks and benefits of treatments in current use. This could be accomplished through the following steps:

  1. Post, in the public domain, the study protocol for each published trial. The protocol should be comprehensive and include policies and procedures relevant to actions taken in the trial.

  2. Develop mechanisms for those who own trial data to share their raw data and individual patient data.

  3. Encourage industry to commit to place all its clinical research data relevant to approved products in the public domain. This action would acknowledge that the privilege of selling products is accompanied by a responsibility to share all the clinical research data relevant to the products’ benefits and harms.

  4. Develop a culture within academics that values data sharing and open science. After a period in which the original investigators can complete their funded studies, the data should be de-identified and made available for investigators globally.

  5. Identify, within all systematic reviews, trials that are not published, using sources such as clinicaltrials.gov and regulatory postings to determine what is missing.

  6. Share data.

Dr. Peter C. Gøtzsche of the Nordic Cochrane Center writes:

“…despite the existence of hundreds of thousands of randomized trials and >4000 updated Cochrane reviews of these trials, physicians and governments cannot choose the best and most cost-effective treatments for the patients.

Selective reporting can have disastrous consequences for patients and for our national economies. One example is the rofecoxib (Vioxx) scandal. The drug maker Merck concealed, for many years, that its drug causes heart attacks, and the use of rofecoxib has probably caused ?10 000 unnecessary deaths in the United States alone.

Another example is the mild 2009 influenza epidemic.The drug maker Roche had omitted publishing most of its clinical trial data on oseltamivir (Tamiflu) and refused to share them with independent Cochrane researchers. We do not know whether oseltamivir decreases the risk of influenza complications, but it is not likely, because Roche would have published its studies if this was shown.”

A paper co-authored by Yale’s Dr. Joseph Ross concludes:

Only by making individual patient data available to the whole research community can we derive full benefit from the enormous resources devoted to human clinical trial research and maintain patient trust in the research process.

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Comments (6)

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Paul Scott

March 23, 2012 at 10:54 am

David Healy makes a great case in his new book Pharmageddon that until raw data is made available from clinical trials the medical literature is going to exaggerate effectiveness and minimize side effects. True science is the open examination of natural events. This is not possible in the way we now publish clinical trials, yet they fly under the banner of science. Clinical trials, even within public registries, offer us only summary tables that have been manipulated to provide a desired result.

suzanne hicks

March 26, 2012 at 4:45 pm

About two years ago at a National Breast Cancer Coalition Annual Advocacy Meeting I learned about the concept of Open Science. As a two-time cancer survivor(melanoma and breast) and psychotherapist I found the idea so logical, patient-based, and sound scientifically that I immediately had a paradigm shift in my own thinking about research. Since then I have queried researchers at every opportunity and have found most reacting as if I were speaking another language. Good people all, most don’t get it. Collaboration instead of competition? Sharing negative results? Putting the rights of the patient first? Universities and Industry valuing contributions to public health as much as publications or patents? There are many hurdles to open science, but as anyone who has had a life-threatening illness knows, it is the right way to go. Currently it appears to be developing bottom-up. Rightfully it could and should be top-down. It is the right thing to do. And soon, Please…..