The health care industry has traditionally moved at a snail’s pace when adopting innovation, but there is growing evidence that Silicon Valley’s ways are rubbing off on the sector. Recently, we have seen coders, scientists, and doctors team up to convene medical hackathons, the NIH has begun classes on lean start-up methods, and health care start-up incubators like Rock Health are flourishing. Even the FDA is developing expedited pathways to bring innovations to the market.
Most physicians appreciate the cross-pollination between the medical and tech sectors and welcome any change that brings progress to our patients faster. But when people long for a future health care system that changes with the pace of technology, I am skeptical. I support the concept of quickly bringing advances to patients, but there is one area that should continue to act as the rate-limiting step in health care innovation: clinical trails.
Nothing has reinforced this belief more than the experience of conducting my first clinical trial on a medical device. I recently began investigating a device that allows parents to turn their iPhone into an otoscope to inspect their child’s ears. The device is promising and could help patients while saving time and health care dollars, but like any medical device, it needs to be fully studied. But even for a low-risk device in a well-trodden field, clinical trials take time. I am well into my research and have yet to touch a single patient. While frustrating, the slow pace of clinical trials isn’t solely a negative.
Why clinical trials take so much time
I previously worked at a venture capital firm, and it pains me to recognize that in the time it has taken me to design my experiment and slog through the necessary paperwork, a tech start-up could have created a product, validated it, and attained thousands of users. I wish I could “move fast and break things” (the famous Facebook motto), but medicine is different. In other industries, the research stage involves observing how consumers respond to a ‘minimum viable product;’ in health care, the question is more complicated.
For medical research, even the process of formulating the test question takes time. Researchers need to develop a safe method to not only evaluate whether the innovation is useful, but also whether there are any bizarre ways that the device could possibly hurt a patient. To add layers of safety onto the protocol design, a scientific review committee and an institutional review board read, criticize, and change the study plan to promote patient safety. Only after traversing this regulatory swamp, can a researcher begin actually recruiting patients, conducting the study, and analyzing the data. Even after the data has been acquired and analyzed, the results must be submitted to a journal and assessed by a panel of peers before the conclusions can be published.
All of this takes months of time and incredible patience. But the layers of third-party assessment at each stage are important. In tech, breaking things is exciting and innovative, but in medicine, we go to great extremes to not “break” our patients. Even my relatively simple study on a familiar device took months to prepare, so you can imagine how much time it would take to start trialing a new heart valve.
Safely accelerating clinical trials
I am not saying we shouldn’t optimize aspects of clinical trials that are redundant. In fact, companies, like gobalto are creating software to help automate and accelerate many of the administrative aspects of a clinical trial. Likewise, IBM and the Mayo Clinic are using big data and the supercomputer Watson to more efficiently find patients for trials and speed up recruitment. And the FDA has proposed using national registries to evaluate medical devices, which could allow for better post-approval surveillance to potentially de-risk shorter trials.
In spite of all these improvements, clinical trials will never be fast
While we can optimize elements of administration and experimental design, there is an important benefit to evaluating new products with patients over an extended period of time — it gives us a better chance of catching unexpected side effects. Indeed, in a recent interview, the CMO of Eli Lilly mentioned that when it comes to clinical trials, they are actually going to “slow down in order to speed up” and spend more time on phase II studies. It speaks volumes when big pharma, with all the pressures of stock prices and waning patent terms, concludes that there’s value in clinical trials taking more time.
When I worked with entrepreneurs and investors, I came to appreciate how uncertain study lengths directly affected companies’ financial well-being. Still, we encouraged entrepreneurs to utilize the clinical study time to prepare for the other Sisyphean tasks, like GMP and 510K paperwork (which will also take months), that lie ahead. As an investor, despite the upfront cost, I learned that a robust clinical trial to fully evaluate a drug or device can avoid further misguided investment. But more importantly, the bottom line of a clinical trial is not finances or the sexiness of fast technology adoption; it is one of patient safety. This is the juxtaposition between tech and health care and why medical innovation will always take more time.
While I understand the anxiety of the inventors patiently awaiting the results of trials, the extra time invested may actually help them. During the scientific review stage of my study, the statistician pointed out a potential bias in my design: my original setup evaluated whether the device was as good as a traditional otoscope, but what if it is actually better? I guess it could be. I will edit the study and resubmit, but it will take another week.
While the drawn-out clinical trial process can be painful, it leads to the best compromise to allow companies to obtain honest data on their device and for physicians to ensure that the innovation actually helps their patients.
Note: The author has no financial ties or relationships to any of the companies mentioned in this post or the device he is studying.
Manan Shah is a physician who blogs at Manan M.D.
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