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?

        

 

 

 

December 12, 2014

NIH Launches "ClinRegs" Website Aggregating Country-By-Country Clinical Research Regulation

 

ClinRegs


The National Institutes of Health's (NIH) National Institute for Allergy and Infectious Diseases (NIAID) has launched an online database of country-specific clinical research regulatory information “designed to save time and effort in planning and implementing clinical research.” The website, ClinRegs, provides users with useful comparison capabilities between thirteen countries. 

“By providing well-documented, up-to-date regulatory information for multiple countries in a single place, ClinRegs is intended to serve as a central resource and time-saver for persons involved in planning and implementing international clinical research,” the website states.

ClinRegs provides an overview of country-specific regulations in the following topic areas.

  • Competent Authority Oversight
  • Ethics Committee Oversight
  • Clinical Trial Lifecycle
  • Sponsorship
  • Informed Consent
  • Investigational Products
  • Specimens

The website currently asks for feedback from users, and NIAID notes that additional topics may be added based on that feedback. 

As an example, the Clinical Authority Oversight section for India states, in part:

In India, the Drugs Controller General of India (DCGI), head of the Central Drugs Standard Control Organization (CDSCO), is the competent authority responsible for clinical trial oversight, approval and inspections. The DCGI grants permission for clinical trials to be conducted in India in accordance with the provisions of the DCA, 1940/DCR, 1945 and Schedule Y. The DCGI is also commonly referred to as the Licensing Authority in the Indian regulations.

CDSCO is India’s central regulatory body for pharmaceuticals and medical devices. The DCGI, who directs CDSCO, handles the drug and device regulatory process; he/she is also responsible for registering all imported drugs and new drugs and for overseeing clinical trials. CDSCO functions under the Directorate of General Health Services (DGHS) which is part of the Ministry of Health and Family Welfare (MOHFW).

NIAID has aggregated information from Brazil, China, India, Kenya, Liberia, Malawi, Peru, South Africa, Tanzania, Thailand, Uganda, the United Kingdom, and the United States. Mali, Mexico, Haiti, and Vietnam will be possible additions to the programs, according to NIAID.  

The comparator tool provides side-by-side comparisons with countries on your chosen topic. For example, this shows a look at the "informed consent" requirements of both the United Kingdom and the United States. 

ClinRegs


Given the fact that large pharmaceutical companies operate internationally and must navigate a wide variety of complex clinical regulation, this website is very helpful. Having one master resource such as this can serve to both clarify a company's obligations, and expedite their understanding of responsibility in one country verses another. 

 

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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