Medical Researchers Want Up To Five Years Exclusivity For Clinical Trial Data Derived From Volunteers

from the papers-before-patients dept

A year ago, we wrote about how TPP’s requirement for “data exclusivity” risked undermining one of science’s fundamental principles: that facts cannot be owned. Data exclusivity is just the latest attempt by Big Pharma to extend its monopoly over drugs, whether using patents or other means. To a certain extent, you might expect that: after all, companies are designed to maximize profits, and if it means more people suffer or die along the way, well, that’s regrettable but sort of beside the point. However, it’s surprising to see a group of medical researchers writing in the prestigious New England Journal of Medicine (NEJM) calling for just the same kind of data exclusivity. The post is in response to an earlier NEJM article by the International Committee of Medical Journal Editors (ICMJE), entitled “Sharing Clinical Trial Data“:

As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the deidentified individual-patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication.

Reasonable enough, you might think. But in the new commentary from the International Consortium of Investigators for Fairness in Trial Data Sharing — which doesn’t seem to have any online presence currently — a group of “282 investigators in 33 countries” (pdf) beg to differ:

Although we believe there are potential benefits to sharing data (e.g., occasional new discoveries), we believe there are also risks (e.g., misleading or inaccurate analyses and analyses aimed at unfairly discrediting or undermining the original publication) and opportunity costs (e.g., the ICMJE proposal would have enormous direct costs and would probably divert resources, both financial and human, from the actual conduct of trials).

It’s rather telling that the new discoveries that arise from research are dismissed as “occasional,” while the rather weird concern about “discrediting or undermining the original publication” is put forward as if it were a major problem in the field. The International Consortium of Investigators for Fairness in Trial Data Sharing has a few suggestions for what should be done instead of the ICMJE proposal:

The timeline for providing deidentified individual patient data should allow a minimum of 2 years after the first publication of the results and an additional 6 months for every year required to complete the study, up to a maximum of 5 years.

Five years’ data exclusivity takes us into TPP territory. And then there’s this:

Persons who were not involved in an investigator-initiated trial but want access to the data should financially compensate the original investigators for their efforts and investments in the trial and the costs of making the data available.

You may have thought research was about winning new knowledge and willingly sharing it with your peers, but in fact it’s about money. Actually, what is most shocking about the International Consortium of Investigators for Fairness in Trial Data Sharing’s opinion piece is not what it says, but what it doesn’t say. The whole thrust of the piece is what a tough life researchers have:

To complete an RCT [randomized, controlled trial], investigators must develop a protocol, obtain funding, overcome regulatory and bureaucratic challenges, recruit and follow participants, undertake analyses, and publish the results. This process takes several years, and for large clinical trials it can sometimes take a decade or longer. Adequate incentives for researchers to invest the substantial time and effort required to conduct RCTs and to publish the results in a timely fashion are important.

But at least it’s a noble struggle, you might think, since this is all done for the patients’ benefit. Or maybe not:

A key motivation for investigators to conduct RCTs is the ability to publish not only the primary trial report, but also major secondary articles based on the trial data.

It’s all about those career-enhancing publications, apparently. But it’s not just the patients who are missing from the International Consortium of Investigators for Fairness in Trial Data Sharing’s worldview. They are also ignoring an absolutely indispensable aspect of clinical trials. It’s so important that the ICMJE’s article begins by acknowledging it in the first sentence:

The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk.

This is why the data that results from those clinical trials must be shared as soon as possible: because members of the public who volunteer to take part in them have literally risked their lives in order to benefit others. The idea that this data should be hoarded by the researchers for up to five years just so that they can squeeze out a few more articles that look good on their CV is profoundly insulting to the participants and their unsung selflessness.

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Comments on “Medical Researchers Want Up To Five Years Exclusivity For Clinical Trial Data Derived From Volunteers”

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Peter (profile) says:

A few years ago, a study found that for most articles in the Flagship-journal ‘Nature’, the original data did NOT support the conclusions made in the paper – bogus research, revealed only when data were made available for independent verification.

The reaction of the editors: “A condition of publication in a Nature journal is that authors are required to make materials, data, code, and associated protocols promptly available to readers without undue qualifications.”

As for the “adequate incentives for researchers are important”: indeed they are. However, “A key motivation for investigators to conduct RCTs” is not the ability to publish, but the availability of (tax-payer funded) grants to do the studies.

If the public pays for the work, it would seem reasonable that the public gets the results. All of them, and in a timely manner.

Anonmylous says:

Yes its about money.

Not about ethics.
Not about verifiable, testable results.
Not about sharing and benefiting the future patients.

No, its about money and only money. It doesn’t matter if they get false results from bad data, poor trial designs and trial administrators more concerned with their own paycheck and job security. It doesn’t matter how many people they kill later because no one could show these studies were flawed. It doesn’t matter the taxpayers money wasted on lawsuits against those companies that isn’t recovered when a settlement is reached for pennies on the dollar spent to prosecute.

You don’t matter. Just your money. Its anti-science.

Anonymous Coward says:

Re: Yes its about money.

At least they are hiding it behind “career-opportunity”-arguments.

That it is a problem to present raw data would seem to be a question of communication them in a responsible way as their argument confirms. The argument for withholding the data untill an article has provided a need for such evidence has some relevance in providing an advantage to the conductors of the experiments (an incentive to not only work in theory, but also design and conduct experiments).

But as much as I respect scientists:

Trusting in scientists to never make mistakes in data-treatment presented publically is like trusting in god. Completely unscientific!
– the coward

That the data provides others the opportunity to treat the data in another way seems irrelevant to the subject of the topic and providing exclusivity to scientific data is a rather troubling idea since it furthers the “IP on everything”-thinking that is so destructive to creativity and innovation!

That One Guy (profile) says:

Re: stop volinteering

Yeah, that was my thought upon reading the article too. If they’re going to use volunteers and then lock up the data just so they can personally benefit from exclusive use of it for years sounds like people need to stop volunteering to help greedy idiots like that.

They want people to help out in their studies they can go out and hire people willing to undergo the tests, and if the public doesn’t get access to the data in a reasonable time frame(several months would be acceptable, years not a chance) then clearly they don’t need public funding either, they can find someone else to bankroll them.

Annonymouse (profile) says:


Who are these people exactly. Lets have their names published and then people who bankroll them.
If they are as blatantly greedy as this then it is almost guranteed they have done something criminal somewhere that is worth extradition and a job making small rocks from big rocks.
Mind you the Nuremberg laws really should come into play.

Anonymous Anonymous Coward (profile) says:

All the data

“the ICMJE proposes to require authors to share with others the deidentified individual-patient data (IPD) underlying the results presented in the article”

I find it interesting that they want to limit the data to that which is presented in the article. The researchers should be required to present ALL of the data they collect along with an explanation of why certain data was excluded from the results presented in the article. A few deaths and/or otherwise non study related results (it didn’t help or hinder the disease but it caused hives in a certain percentage of trial participants, for example) should NOT be left out.

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