Life Science Compliance Update

February 03, 2016

ICMEJ Proposes Data Socialism – Data Utopianism Has its Cracks - Comments Due April 18

The International Committee of Medical Journal Editors (ICMJE) recently put forth a proposed set of new requirements for sharing data that was generated by interventional clinical trials. The ICJME believes there is an ethical obligation to responsibly share such data because the participants in the trials put themselves at risk.

Essentially the ICMJE is proposing that as a condition of consideration for publication of a clinical trial report in their member journals, the authors must share with others the deidentified individual patient data (IPD) that is underlying the results presented in the article, including any tables, figures, appendices, and other supplementary material, no later than six months after publication. This proposed requirement will include all data underlying the results of the article's findings, as well as any necessary metadata.

As you can imagine, there are strong opinions on both sides of this proposal. Those who are arguing for it, claim, "many funders around the world – foundations, government agencies, and industry – now mandate data sharing." You know, that whole, "everyone else is doing it, we should too," mentality that our parents warned us about when we were younger.

Those who are against it have a multitude of opinions and reasons for being against it. Some go so far as to refer to those who support data sharing as "data parasites," since they latch onto research that has already been painstakingly performed and utilize it for their own purposes.

Analysis

This new proposed rule may sound like a nice idea, having the ability to reexamine high-quality information for the possibility of new information being found, potentially resulting in higher patient satisfaction and longevity. However, as just about anyone who has ever managed clinical studies, performed data collection and analysis, or curated data sets knows, there are a litany of concerns over such a proposal. Dan L. Longo, M.D., and Jeffrey M. Drazen, M.D., penned an editorial laying out some of their concerns from that perspective.

One such concern is that someone who is not involved in the generation and the collection of the data will not understand the choices the researchers made in defining the parameters. Some specific questions raised by Longo and Drazen included, "How heterogeneous were the study populations? Were the eligibility criteria the same? Can it be assumed that the differences in study populations, data collection and analysis, and treatments, both protocol-specified and unspecified, can be ignored?"

A second, very valid, concern, is that an entirely new class of research person will emerge – someone who had nothing to do with the design and the execution of the study, but use another group's hard-earned data for their own ends. These "stealers of data" can then use the data to steal research productivity planned by the data gatherers, or even use the stolen data to disprove the original researchers analysis.

Data sharing may not be all bad, depending on how it is performed and what requirements are in place. Longo and Drazen posit, for example, that if data sharing were to work symbiotically, with collaborators whose collected data might be useful in assessing your hypothesis, it might be beneficial for all parties involved, including patients. Throughout the symbiotic relationship, the two (or more) teams of researchers work together to test a hypothesis and report new findings with coauthorship, acknowledging the group that proposed the new idea and the investigative group that pursued the data and allowed it to be tested.

It is interesting to note that four days after jointly submitting an editorial piece with Dan Longo, M.D., Jeffrey Drazen, M.D., walked back part of it. He clarified that the New England Journal of Medicine, the forum for the initial editorial, is "committed to data sharing in the setting of clinical trials." He went on to comment that he believes "there is a moral obligation to the people who volunteer to participate in these trials to ensure that their data are widely and responsibly used" and that "researchers who analyze data collected by others can substantially improve human health."

In the walk back, he concludes by once again bringing up data sharing through collaboration, signaling that such form of data sharing may be palatable to more than just the "data socialists" who want to take your hard-researched data a mere six months after the publication of your findings.

Saurabh Jha, a radiologist in Philadelphia, summed it up nicely,

It takes a lot of effort to generate data in biomedical sciences. To expect researchers to surrender the data for the greater good is fuzzy, and lamentably boring, adolescent naivety. If we do not recognize the self-interest of researchers, data socialism, like other forms of socialism, is condemned to failure.

If you would like to provide feedback on the ICMJE proposal, you may submit your comments and concerns to the International Committee of Medical Journal Editors by April 18, 2016.

For More Background on This Controversy David Shaywitz, MD at Forbes has a great series:

Data Scientists = Research Parasites?

Biden Cancer Project: An Opportunity To Implement Data Sharing Incentives    

Do We Really Want To Separate Clinical Data Gathering And Data Analysis?

        

 

 

 

October 13, 2014

Clinical Trial Transparency: Starting Jan. 1, 2015, European Medicines Agency Will Publish Clinical Reports For New Drugs; Individual Patient Data Next

Clincal Trail Transparency 2

On October 2, 2014, the European Medicines Agency (EMA) unanimously voted to publish the clinical reports “that underpin the decision-making on medicines.” EMA will publish data submitted as part of marketing applications starting January 1, 2015. Beginning July 1, 2015, the agency will provide access to reports relating to applications for line extensions of indications for existing medicines. The policy does not apply retroactively, so EMA will only publish new data.  

EMA is the “first entity in the world” to introduce such rules, EMA Executive Director Guido Rasi noted. “This unprecedented level of access to clinical reports will benefit patients, healthcare professionals, academia and industry.”

According to EMA’s press statement, “the publication of clinical reports will also help to avoid duplication of clinical trials, foster innovation and encourage development of new medicines.”  

Under the policy (available here), users who want general information about the data can search and browse on-screen after a simple registration process. Users who want the information for academic and non-commercial research purposes will need to provide more detailed information to the agency, including their affiliations and positions within their organisations. Any information that is considered "commercially confidential" will be redacted from the documents.

EMA notes that the data “will only start to become accessible once the final decision on a given procedure has been reached by the European Commission, which implies a timeframe of about 18 months.”

Further down the line, EMA will consult with various stakeholders to “endeavor to find the most appropriate way to make individual patient data available, in compliance with privacy and data protection laws.”

Controversy

The AllTrials campaign, comprised of the BMJ, the Cochrane Collaboration, and others, has been leading the charge for more clinical transparency. Earlier this year, they criticized EMA’s trial policy because the agency was only going to allow users to view trial data in an on-screen-only option. We wrote about that controversy earlier this year.

In the latest policy, EMA removed the on-screen-only restriction and adopted a more “user-friendly” approach which will allow users to download the information. “Now, the public can either browse or search the data on screen, or download, print and save the information,” EMA states.

While the searchability of the data seemed like the big issue a few months ago, EMA has fronted additional criticism. In addition to the push for transparency, the agency must reconcile pharmaceutical companies' rights to commercially confidential information (CCI).  

According to EMA's statement, “[t]he reports cannot be used for commercial purposes...Information that, in limited instances, may be considered commercially confidential will be redacted. The redaction will be made in accordance with principles outlined in the policy’s annexes. The decision on such redactions lies with the Agency.” Many argue that the definition of CCI is very unclear. 

EMA stresses how infrequently a CCI determination will actually limit what users will be able to see. In their policy, EMA states that certain aspects of reports "MAY contain CCI and, therefore, MAY be redacted. It should be noted that NOT ALL the information in the sections...will be redacted but only the SUBSET of the text considered being CCI" (capitalization included in the report).  View the appendix describing what EMA designates commercially confidential information on page 8 of the document

AllTrials, however, believes this gives too much power to the companies. The policy puts primary responsibility for redacting information into the hands of companies, AllTrials states, meaning they get to suggest which information submitted to the EMA should be kept hidden. Furthermore, the campaign notes that the "Terms of Use" that companies and independent researchers must sign allows trial sponsors to take direct legal action against researchers for possible violation of the Terms. They are concerned that trial sponsors can sue independent researchers, which they argue "puts a chill on independent research.” Outsourcing Pharma notes this may mean higher legal costs for contract research organizations (CROs).

The Agency is also involved in a separate process to make summaries of the results of clinical trials publicly available through the EU Clinical Trials Register.

August 13, 2014

European Medicines Agency Inching Towards Clinical Trial Transparency

The European Medicines Agency (EMA) Management Board has been inching towards a policy on clinical trial transparency. Striking a compromise between opposing stakeholders, however, has proved challenging. The European Union's pharmaceutical regulator has been moving towards a policy since at least December 2010, when EMA promised to disclose on-demand clinical trial data for drugs it had review. The final draft was pushed back from January 2014 to July 2014, and now EMA has stated that they will postpone the formal adoption of their policy until October.

EMA's road to a trial transparency policy has been rocky. On the one hand, they faced intense pressure from the pharma industry to curtail the release of the data. Companies have expressed concern that data will be misinterpreted by non-experts, casting unnecessary doubt on the safety or efficacy of their products. Journalists can occasionally latch onto very rudimentary analyses of complicated issues—especially where healthcare is concerned—and make a mountain out of a mole in a sense. This could block potentially beneficial medicines from development.

Also at issue is the use of data by competitors. Companies worry that their data could be used to find and patent new uses for drugs before the originating company is able to study the data, or that companies in markets outside the European Union may use the data to obtain their own approvals from local regulators. This could disincentive expensive R&D. Last year, AbbVie and InterMune sued EMA to block the release of data. Abbvie sought to protect their "confidential and commercially sensitive information," they noted at the time. While the company noted that it supports transparency of clinical research and safety information "for the benefit of patients and healthcare professionals," it opposes the publication of information "that does not meaningfully contribute to the scientific review or evaluation of our products." (Bloomberg).

On the other hand, pro-transparency groups have hounded the EMA to expand access to clinical study reports. EMA was criticized for "flip-flopping" on its promise for greater transparency when they held a stakeholder meeting about their draft policy in May. AllTrials.net (slogan, "Medicine is Broken, We Need Your Help To Fix It"), seems to be the watchdog of clinical trial transparency. They wrote that the EMA proposal, "to the shock of participants," seemed to be watered down from previous versions.

Namely, AllTrials argued that since EMA backpedaled on its policy, now: (1) clinical study reports would only be available for on-screen viewing and could not be saved, downloaded, printed or shared, (2) substantial parts of the reports could be redacted (hidden), and (3) trial sponsors could redact their own clinical study reports. Most of the press took issue with the trial data being view-only.

This draft policy came on the heels of Abbvie and InterMune dropping their case against the EMA, and EMA stating that they had reached an agreement with the companies on a policy. AllTrials seized upon what they deemed a weak transparency policy and wrote an article entitled, "Has the EMA made a backroom deal with pharma over transparency?"

New Policy for Clinical Trial Data

Seemingly in response to the criticism of their draft, EMA released a statement in June to clarify their stance on clinical trial transparency. They also note that they are being careful to ensure the policy will not prejudice citizens' rights:

The European Medicines Agency Management Board on 12 June 2014 agreed the policy on publication of clinical trial data, together with more user-friendly amendments proposed by EMA Executive Director Guido Rasi, that will not only allow the Agency to proactively publish clinical trial data that are submitted as part of marketing authorisation applications, but also give the possibility to download, save and print the trial data for academic and non-commercial research purposes. (emphasis added)

EMA noted that the "wording of the policy, including practical arrangements for academic and non-commercial research users, will now be finalized with a view to its adoption by the Board through written procedure by mid-July 2014, and will be effective from 1 October 2014."

The Agency is also involved in a separate process to make summaries of the results of clinical trials publicly available through the EU Clinical Trials Register

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