In 1803, President Thomas Jefferson funded the Lewis and Clark expedition. Two months after the expedition ended, Jefferson gave the first report of their findings.
More than 200 years later, the distance Lewis and Clark covered in that two-year odyssey takes just a couple of hours; communications with people "in the field," anywhere in the world, is instantaneous.
Obamacare is Obama’s healthcare legacy and it looks likely to survive under the new Trump administration — with substantial changes. The less publicized ‘Cancer Moonshot', an effort to accelerate cancer research for a cure, could have been even more monumental if Biden’s final report to Obama in October didn’t show that the research world hasn’t progressed much from the days of Lewis and Clark.
The processes used to engage participants, run studies and report results are unacceptably slow and problematic. This means our capacity to implement treatments that we know work to improve health outcomes is highly inefficient. While there has been some progress, like recent regulations by HHS to improve the accessibility of research, the fact remains: our research processes are completely antiquated.
We won’t cure cancer, or make substantial improvements in other areas of personal and societal health without real innovation in the tools and techniques we use to plan and run research studies.
Most of us believe research is important. While we follow celebrities on Twitter and join political advocacy campaigns on Facebook by the millions, few of us join studies because we don't know where to find them. While we get TV ratings, movie box office receipts, and poll results within hours, it can take years before major health research results are available — if they are released at all.
The Department of Health and Human Services announced new rules recently to improve study accessibility. The goals of these regulations are sound.
Recruitment is a significant issue in studies. So, require researchers to register planned studies so participants know about them.
Study results help us make better decisions and develop clinical interventions. So, require those results to be released in a timely fashion.
Makes sense.
But these regulations are only going to make a small dent in helping solve the issues affecting the world of research, especially when it's the lack of innovation in research processes that needs to be addressed. Another rule only adds to an already burdensome regulatory environment.
According to the Tufts Center for Drug Development, most research studies don't end on time or budget. It can take a year, or more, to design a typical research study. Layers of inconsistently applied regulation, and disconnected systems make completing a study successfully nearly impossible.
The individuals who run research studies, particularly those in academia, have multiple other professional responsibilities. Many see patients, mentor students and teach classes, which makes it difficult for them to devote adequate time to the complex management requirements of a research study. They run studies in some of the most bureaucratic organizations in the world (academia and healthcare) and under layers of different inconsistently applied regulations.
Researchers keep these varied jobs because of a difficult financial reality. Increased competition for grant funding means that NIH award rates have dropped by almost half since 2008. They have to piece together responsibilities, each with their own funding streams, to keep their jobs.
Other industries have made substantial investments in process innovation and efficiency to reduce costs and improve customer satisfaction. Look at banking, another highly regulated industry. Online tools, new products, unique branch designs, telephone support and ATMs alone have completely redefined the banking experience.
In the halls of academic research, processes and tools have changed little in 40 years. The experience is so poor that shows like "The Unbreakable Kimmy Schmidt" makes fun of the terrible experiences participants have in research studies.
The impact of these problems on our lives are significant. The complexity and cost of studies are so high, few are even attempted. According to the the Institutes of Medicine, 50% or more of all treatments conducted in the US have insufficient evidence to suggest they work. Outside the medical world, there is even less evidence. What prevents illness and disease? What social policy programs are most effective? What diet works? How do I optimize my health?
The research studies aren't being done. So, we make some of the most important decisions of our lives, not based on "what works," but based on anecdote, habit, and whoever speaks the loudest.
The ‘Cancer Moonshoot’ brought some much needed energy to one research topic. The recent reporting regulations from HHS are useful.
But, to see real impacts in our personal and societal health, we need to address the systematic inefficiency and operational issues within the research world. The sector needs to aggressively explore and invest in operational and technical approaches inspired by other regulated sectors, like banking.
Ultimately the investments could produce some of the most meaningful returns possible: a better, healthier world.
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Matthew Amsden is CEO of ProofPilot, an online platform that makes it as easy to design, launch and participate in randomized controlled trials as it is to manage a blog.