We’ve been talking to a wide variety of stakeholders who agree that the clinical trials system needs to get better. There might be different answers on how it needs to get better, but the consensus is that there is something wrong that needs to be fixed. When asked for a solution though, it’s clear that no one has come up with systems-level recommendations that are implementable. “I’ve been thinking about your question for a while and have no answers.” Those were the words of Curt Meinert, who we’ve heard referred to as a legend in the clinical trials world, and has dedicated his life to this topic.
So who has society has entrusted to think about solutions to these grand problems? The obvious answer is government, but we know that every part of the government has specific mandates they need to fulfill. Each stakeholder has their own goals, their own interests, and their own ideas.
MIT collaborative has turned to academics in this and previous projects as well. It makes sense, academia has long been the place where society has expected the neutral ideas and solutions to emerge. But the academic world has it’s own problems.
Like other groups, academia is moving towards a model of consistent, positive results. There are metrics for innovation, impact, and even connections. With these metrics, the value of research has taken on a new tone, and the large-scale, systems-level problems have a low value. For academic researchers to work on large-scale problems, they have to forego publication for long periods of times, sometimes years. Producing PhDs is very difficult when the scale of the problems you are working on can fit multiple academic careers. Finally, working on one project, especially in engineering, is very risky in the current academic climate. Multiple projects that leverage each other, produce consistent papers, and can be used for future funding is the way to go. It doesn’t matter how smart and hardworking you are, in a system that doesn’t allow you to think broadly and deeply at the same time will not let you tackle problems that no one else wants to think about.
In many ways, it mirrors the clinical trials system. The drive for consistent, positive results has lead to a lot of new discoveries, but a lot of waste as well. We are trying to produce solutions and products before we have even defined the problem. In many cases, the problem is big, and requires thought instead of quick action such as the example from stroke. Multiple trials for the same molecule happen at the same time, hoping one of them will succeed. We blindly do research hoping for that one great discovery that will drive our profits. Finally, clinical trials have also been criticized for lacking implementation and translation research. We produce drugs, but no one regulates how they fit into the current population. Academics are often panned for producing research that has no relevance.
We have heard that academics need to step up if the clinical trial system is to be improved. But it’s unfair to ask them of such a tall task without providing incentives in a system that discourages such thought. So what keeps our team going? I am reminded of the example Dean Ed Schlesinger of the Johns Hopkins Whiting School of Engineering provided: “Abel Wolman was a professor who standardized the chlorination of water to kill certain bacteria and microbes that prevented the spread of many diseases. His research has saved thousands of lives. And you know what, no one even cares what his h-index is.”