Life Science Compliance Update

April 14, 2016

NEJM: What Do I Need to Learn Today – The Evolution of CME

Graham McMahon, MD, MMSc, the President and CEO of the Accreditation Council for Continuing Medical Education, has written an article for the New England Journal of Medicine about the evolution of continuing medical education (CME). The article, "What Do I Need to Learn Today? – The Evolution of CME," asks for clinicians, educators, healthcare institutions, and regulators to contribute to the continuing transformation of CME.  He also suggests that CME be included as a significant asset for regulatory efforts such as MOC and the Merit-Based Incentive Payments System.

Dr. McMahon stated that such a continued transformation will serve to "expand the opportunities for educational innovation that improves physician practice and ultimately benefits patient care and the health of our country." To help the transformation, Dr. McMahon recommends that clinicians become more aware of their individual strengths and weaknesses and choose CME activities that can help them grow and become better clinicians.

In order to meet the learning needs of clinicians in today's healthcare environment, it is imperative for educators to design CME activities that focus on the learners, rather than the teachers, and incorporate opportunities for interaction and reflection. Interprofessional continuing education (IPCE) gives physicians the opportunity to build the competencies needed for team-based practice. Patients should be active in their care and should be viewed as part of the healthcare team; including patients as CME speakers can work to engage physicians' hearts as well as their minds.

Part of the problem today, as outlined in the article by Dr. McMahon, is that information is "ubiquitous," meaning that the simple exchange of information has little value, and that in order to truly learn and understand something, shared wisdom and the opportunity to engage in practice-relevant problem solving is crucial. Dr. McMahon realizes that once physicians see and understand that they are actively (and actually!) learning, they embrace future activities that allow them that same learning opportunity.

As stated by Dr. McMahon,

Education that's inadequate, inefficient, or ineffective, particularly when participation is driven by mandates, irritates physicians who are forced to revert to "box-checking" behavior that's antithetical to durable, useful learning.

It is important that going forward, regulators begin to focus on educational outcomes, not the process, and work to create other conditions that maximize flexibility and innovation in CME. The ACCME's collaboration with the American Board of Internal Medicine (ABIM) to simplify the integration of Maintenance of Certification (MOC) and CME, is an example of regulatory authorities working together to reduce the burden placed on physicians, helping to promote lifelong learning.

Dr. McMahon also points out that "If more regulatory authorities recognize the value of education in driving clinical practice and quality improvement and allow educational activities to count for multiple requirements, they can reduce the burden on physicians and promote lifelong learning. For example, participation in CME could be designated as a method for meeting the clinical practice improvement expectations of Medicare’s new Merit-Based Incentive Payment System."

Each year, the accredited CME community collectively provides nearly 150,000 activities. Accredited CME activities are required to be evidence-based and free of any commercial bias or influence. The more involved healthcare leaders, educators, and learners, become in the process, the more CME can do to promote performance, quality improvement, collegiality, and public health.

April 12, 2016

JAMA: Research Parasites Wanted

As reported, earlier this year, a top medical journal ignited a backlash by referring to "research parasites", also known as people who did not personally run a clinical trial or collect data but "use another group's data for their own ends, possibly stealing from the research productivity planned by the data gatherers." The New England Journal of Medicine quickly backtracked, as we noted, and clarified its support of data sharing.

Four days after jointly submitting the editorial piece with Dan Longo, M.D., Jeffrey Drazen, M.D., stated the Journal's support and noted it 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 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.

Now, research published in the Journal of the American Medical Association (JAMA) suggests there are not enough of these so-called data parasites. The study found that although more than 3000 trials are available to investigators through open data platforms, only 15.5% had been requested by a limited number of researchers. Most proposals focused on nonprespecified subgroups or predictors of response rather than validation of study results. The reasons speculated for underutilization of clinical trials data include lack of knowledge about these resources, possibly due to lack of publication of results from proposals, or lack of funding to support analyses.

In an accompanying editorial, the editors of JAMA argue that sharing data has two principle purposes: to verify the original analysis and hypothesis generation. "It has the potential to advance scientific discovery, improve clinical care, and increase knowledge gained from data collected in these trials. As such, data sharing has become an ethical and scientific imperative," they wrote.

They also outline that researchers intentionally or inadvertently do not always report important findings from their investigations, citing a report involving clinical data. However, offering all possible data available for reexamination and replication of analyses can help ensure that the publications have fidelity to the trial plan. Perhaps more important, they write, are the study participants. The article cites the International Committee of Medical Journal Editor's position that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk.

Increasing, data sharing is actually being mandated by trial sponsors and has been supported by numerous groups like the Institute of Medicine/National Academy of Medicine, European Medicines Agency, and ICMJE. Journals and funders, they write, must find common ground to ensure data sharing occurs, but note it is easier to call for data sharing than to actually create a system that protects the privacy of patients and is also efficient, effective, and fair to the investigators who collected the data.

The editorial explains that three issues must be addressed for such a system to be successful. First, the shared data must be deidentified for the protection of individual study participants. Second, a system of sharing data must be efficient. Finally, the system must be fair and respect the investment and contributions of the trial investigators.

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?

        

 

 

 

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