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Tag: academic research

Can Rah-Rah, Blah-Blah and Meh Accelerate Digital Health Innovation?

By MICHAEL MILLENSON

Can combining health tech “rah-rah,” health policy “blah-blah” and the “meh” of academic research accelerate the uptake of digital health innovation?

AcademyHealth, the health services research policy group, is co-locating its Health Datapalooza meeting, rooted in cheerleading for “Data Liberación,” with the National Health Policy Conference, rooted in endless debate about policy detail.

Sharing a hotel room, however, does not a marriage make. In order to get better digital health interventions to market faster, we need what I’m calling a Partnership for Innovators, Policymakers and Evidence-generators (PIPE). As someone who functions variously in the policy, tech and academic worlds, I believe PIPE needn’t be a dream.

The potential of digital health is obvious. Venture funding of digital health companies soared to $8.1 billion in 2018, up 40 percent from 2017, according to Rock Health, with another $4.2 billion invested during the first half of this year. Meanwhile, MedCityNews proclaimed 2019 “the year of the digital health IPO,” such as HealthCatalyst and Livongo.

Separately, Congress has sought to speed digital health innovation through bipartisan efforts such as the 21stCentury Cures Act and the formation last year of the Bipartisan Health Care Innovation Caucus. The Department of Health and Human Services (HHS) is also pursuing innovator and advocacy group input on regulatory relief.

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What I Would Do If My Foot Caught Fire

flying cadeuciiI know it seems like the obvious choice, but I would not run a randomized clinical trial.

I have recently lamented the pernicious influence, within my domain of public health practice, of hyperbolic headlines proclaiming “this,” followed unfailingly by equally and oppositely hyperbolic headlines reactively proclaiming “that.”

But we are obligated to acknowledge that there are, generally, research studies underlying the headlines, however extreme the pop culture distortions of the actual findings. So to some extent, the problem originates before ever the headlines are a gleam in an editor’s eye, with our expectant anticipation of the next clinical trial, and the next, and the next.

By all means, bring on the clinical trials! They serve us well. They advance the human condition. I run a clinical research lab — my career is devoted to just such trials.

But still, I wouldn’t conduct one if my foot caught fire.

Of course, there is a very good case for running such a study, as many vitally important questions about the right response to a foot on fire are at present unanswered. What, for instance, would be the ideal volume of water? Should it be hard water, or soft? Fluoridated, or not? A controlled trial is very tempting to address each of these.

The vessel is even more vexing. What would be the best kind of bucket? What size should it be? What color should the bucket be, what composition, and what’s the ideal kind of handle? I think the variations here are the basis for an entire research career.

Perhaps the notion of running randomized, double-blind, controlled intervention trials to determine the right response to a foot on fire seems silly to you. But if so, you must be suggesting that science does not preclude sense.

That’s rather radical thinking in some quarters.

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Fast Science: The Uncertainty Paradox

Reading Barbara Ehrenreich’s “Bright-Sided” has been liberating in that is has given me permission to let my pessimistic nature out of the closet.

Well, it’s not exactly that I am pessimistic, but certainly I am not given over to brightness and cheer all the time. My poison is worry. Yes, I am a worrier, in case you had not noticed. So, imagine how satisfying it is for me to find new things to worry about. As if climate change were not enough, lately I started to worry about science.

No, my anxiety about how we do clinical science overall is not new; this blog is overrun with it. However, the new branch of that anxiety relates to something I have termed “fast science.” Like fast food it fills us up, but the calories are at best empty and at worst detrimental. What I mean is that science is a process more than it is a result, and this process cannot and should not be microwaved. Don’t believe me? Let me give you a couple of instances where slow science may be the answer to our woes.

1. Lies and damned lies

Remember this story in the Atlantic that rattled us with its incendiary message? Researcher John Ioannidis has been making headlines with his assertion that most, if not all, of what we know in medicine is in doubt, given how we do and publish research. And how we do and publish research has everything to do with the speed of “progress.” Academic careers are made with positive results, to sell news the media demand positive results, and to respond to this demand academic journals prefer only to publish positive results (this last phenomenon is referred to as “publication bias,” and is something Ben Goldacre rails against at length). A further manifestation of this fast science is that “no replicators need apply.” I am, of course, referring to an extension of the publications bias, whereby journals are not interested in publishing even a positive study that replicates a previous finding — this is simply not sexy. Thus, results have to be quick and positive to grab a share of our attention and sell academic prestige, journals and news.Continue reading…

Mission Critical: How Translation-Focused Disease Foundations May Save Medical Research

Patients waiting expectantly for medical research to produce important new cures are finding bad news almost everywhere they turn.

Pharmaceutical companies are suffering from a much-discussed innovation crisis, as old drugs lose patent protection without new drugs to replace them; meanwhile, the small biotechs that could potentially bail big pharma out struggle to raise capital .

University scientists, for their part, are beset by an unseemly credibility crisis, as the intrinsic fragility of medical research is now vividly apparent from the soaring number of high-profile retractions, and the well-documented difficulty of reproducing many published findings outside the originator’s lab.

At the heart of this crisis is the misalignment of two very different cultures.

Academic scientists tend to focus on publishing papers, and usually assume that the results will eventually be useful. They place a high value on novelty, and relatively less value on whether the data are robust, easily reproducible by others, or truly relevant to human disease. Captivating data from putative laboratory models of disease generate publications, even if the model is not very predictive of human disease – and unfortunately, most models aren’t.

Conversely, big companies traditionally focus on generating efficiencies through scale, and on developing reproducible processes. This works very well for manufacturing, reasonably well for large late-stage clinical trials, and essentially not at all for early-stage (discovery) research.

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