One way to improve clinical trial reporting: a Yelp-style rating system

This piece originally appeared in the Timmerman Report.

STAT recently published an in-depth report about the many research centers that don’t bother to publicly disclose the results of their clinical trials, even though they are required to do so. This follows on a New England Journal of Medicine article back in March that had a similar analysis of the lack of reporting and publication of clinical trial data to clinicaltrials.gov.

Most observers of biomedical research would agree that getting clinical trial data out about what happened in a trial is pretty important, whether the trial succeeded or failed. After all, biomedical translational research is most meaningful when done on human subjects and negative information can be quite informative and useful. Animal models are nice, but translation of results from animals to humans is a spotty proposition at best. We need to know what’s working, and what’s not, to know how to best allocate our research resources and how to treat patients.

The lack of reporting is an embarrassment for research. It’s also understandable, because so far the FDA hasn’t used its authority to punish anyone for delayed reporting. Nobody appears to have lost any research funding because they failed to post trial results in a timely manner. Universities told STAT their researchers were “too busy,” given other constraints on their time, to report their results. So what really seems to be going on is that reporting is prioritized below most other activities in clinical research.

It was interesting and eye-opening that industry fared better than academia in both the STAT story and the NEJM article with respect to how many studies have been reported. Having seen the industry process first-hand, I’d speculate that (at least for positive trials) there’s a much stronger incentive to get data out in public. Successful trial results can create buzz among clinicians and patients, revving up trial enrollment which can then help get a new drug on the market faster, and convince people to use it when it’s available. It may be that in academia the effort of getting trial results in the required format for clinicaltrials.gov is perceived as too much work, relative to the rewards. Academics are naturally going to spend more energy on directly rewarded activities like writing grant proposals and writing peer-reviewed scientific publications that help them win even more grants, promotions, and other accolades. Well okay. If this is the case, then figuring out new incentives may be key.

So what would work? Anyone who participates in a clinical trial is providing time, may be subject to risks and often is asked to provide samples that are biobanked to support future exploratory and translational research. It’s like when people donate to food banks. I’m pretty sure they mean that food to be eaten and not to sit on a shelf. These participants in clinical trials deserve to have their volunteerism rewarded.

This got me thinking about how to empower patients to get more of what they want. Patient-centered research is a buzzword these days, and for good reason. Patients have at times been an afterthought in the biomedical research enterprise. I thought of services like Yelp and Uber and Angie’s List and other peer-to-peer systems that allow users to get information, provide feedback and give ratings to specific providers. And I wondered: could this be a way to apply pressure to clinical trial researchers to improve their reporting? Continue reading

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An Open Standard for APIs Could Lead us to Better Health

There’s a parable about the elephant and the rider that’s been used by Chip and Dan Heath, and that originated with Jonathan Haidt, to describe how humans make decisions. A person’s mind can be thought of as consisting of a rider, representing the rational part of human thinking, and the elephant she’s riding, representing emotion. Both of these play a role in how a person decides things, and many of us believe the rider–the rational part–is in charge. The rider taps the elephant with her guide stick, and the elephant obediently moves in that general direction or does a specific task, like carrying lumber from place to place.

Except that’s not how a lot of decisions actually get made. Instead, the elephant sees a bunch of bananas, or a herd of other elephants, or a nice cool river to bathe in, and goes that way instead. And the rider…well, the rider can’t do much about it except, after the fact, rationalize how she always wanted to go in that direction to begin with. Yeah, it was time for a bath, sure

This framing has stuck in my mind for years and it’s a really helpful way of looking at many of the odd things that people do or say, ranging from climate change denial, to believing genetically modified organisms are inherently evil, to smoking despite everything we know about the harms that result, to even saying that Paul Blart, Mall Cop II is really, you know, not that bad–really. And it also speaks to one of the more vexing problems we have in human health. Why do people keep doing things they really probably shouldn’t, and know they shouldn’t, if they want to stay healthy?

I’ve touched before on how the power of digital tools can help make it easier for us to make good decisions. OPower is doing this for power consumption and conservation, and with the advent of tools like Apple’s Healthkit and the proliferation of activity trackers, the time is right to do this for health. Continue reading

Making Change

And now for something completely different! Short fiction in honor of the recent unveiling of the Apple iWatch and Healthkit.

“I wouldn’t eat that if I were you.”

Sylvia paused, bacon cheeseburger halfway to her mouth, and peered at the neon green band wrapped around her wrist. The wraparound touchscreen was currently showing a cat emoji. It had a frowny face, expression halfway between puzzlement and alarm.

“What did you say?”

“I’m just saying,” said her Best Buddy wristband, “that when we met a few weeks ago, you mentioned wanting to keep your weight in a specific range.” The emoji shrugged. “Little friendly reminder. You know?”

Sylvia carefully put the burger back down and resisted the urge to lick grease off her fingers. She fumbled for her napkin, her fingers leaving translucent streaks on the thin, white paper.

“I–well, yeah. But, I mean, you’ve never said anything like this before like when–” She broke off, remembering the milkshake, the onion rings, the King-size Choconut bar…

“Well it’s not the first thing you do, is it? When you meet someone and you’re just getting to know them?” The cat had morphed into a light pink, animated mouse, standing on its hind legs, bashfully kicking one leg. “But now, we’re friends!” Continue reading