In case you missed it, the cause of Clinical Trial Abundance just received a high–profile boost in the New York Times, in the form of a compelling article from our co-blogger Ruxandra Teslo. Along with the New York Times article, Ruxandra and I have also published a companion piece for the Institute for Progress describing what we can learn from Australia’s approach to clinical trial regulation, and how we could reform our own system to address the issues Ruxandra raises in her article.
Readers of this blog are probably already familiar with the stakes of clinical trial reform, which Ruxandra starkly lays out in her New York Times article: Advances in AI and biology could help unlock new treatments and cures - but only if we can run clinical trials faster and more cheaply. Today, however, the opposite is happening: a steady rise in clinical trial costs is preventing new treatments from being developed. Clinicians, patients, and researchers face far too many unnecessary barriers to testing new drugs. And nowhere are these barriers more keenly felt than in the crucial first-in-human trials that help validate our biological hypotheses.
In the article, Ruxandra frames this challenge with powerful testimony from patients, clinicians and researchers; all of whom are stymied by a system that too often puts safety theater above the concrete needs of patients. As Dr Eric Hong, one of her interviewees describes it, “We often forget that the most toxic thing for the patient is the cancer itself.”
But the article isn’t just about patients’ individual stories: Ruxandra identifies a set of systemic problems that prevent patients from getting the treatments they need. Most notably, she points to a web of regulations that have made running trials far too difficult, driven by “a medical framework that treats any potential risk, however negligible, as something that must be mitigated and a reason to delay while drastically underweighing the cost of delay itself.” After laying out the shortcomings of our own system, she notes that there is a better model: clinical research in Australia proceeds without many of our own regulatory and bureaucratic barriers while retaining protections for study participants.
It’s a galvanizing piece. As I read it, I couldn’t help feeling, in turn, angry, hopeful, and grateful to have the opportunity to work on a topic that could make such a difference in patients’ lives. I hope it will inspire many others to do the same.
And if, like me, you feel inspired after reading Ruxandra’s piece, then your next stop should be our new IFP white paper. Here, Ruxandra and I take a much closer look at how Australia has succeeded in building a more efficient clinical trials system - one that has attracted an increasing amount of attention and investment from US pharmaceutical companies. We walk through the process of setting up a phase I trial, and how Australia does it better at each stage. We then describe what we can take away from their experience and bring to the United States - including specific policy reforms that can be taken up in Congress. If Ruxandra’s New York Times piece serves as a call to action, then our IFP piece serves as a practical guide for reformers and policymakers. We hope that together they can serve as both an introduction and a roadmap to those who would like to see clinical trial abundance move forward.