The Future: Every Eligible Patient Gets the Trial They Need, Wherever They Are
Doubling progress in clinical research by doubling patient participation
(Part 3 of a 3-part series)
In my last two posts, I described the consequences of inefficient cancer trial matching, and the practical reasons why the system has not improved for decades.
The first post described the challenges that patients and their care teams encounter in finding trials for new cancer therapies. Information about clinical trials is opaque, unsearchable, and incomplete. Searching for trials is a laborious and frustrating process; the key ingredients for finding a trial is time and perseverance. That’s a tall order for patients, their stressed family members, and their overworked physicians. Furthermore, those trials are generally not available at the place where patients are getting their care. As a result, many patients outside the elite academic medical centers succumb to their disease without even knowing if there was a trial that may have offered hope for them. This inefficiency is a silent killer in cancer.
The second post described a widespread effort by technology entrepreneurs to overcome this problem. I was one of them, and I have met many more. I’ve learned that we all work to overcome the same issues around the structure and accuracy of publicly available clinical trial information. We then realize that there are deeper problems regarding access to accurate and complete selection criteria, and then availability of trials where the patients are located. It is a system of many moving parts, and most of them don’t work.
“If you just focus on the smallest details, you never get the big picture right.” This quote from Lee Hood, one of the great luminaries of systems biology and precision medicine, describes why we have not moved the participation rate for cancer clinical trials despite widespread effort over the last 20 years.
The Biden Cancer Initiative is dedicated to overcoming this inertia. Our mandate is to foster a flexible, adaptable framework that makes it feasible for patients anywhere to participate in clinical research for the newest therapies, giving them more options for their treatment and helping to get effective treatments to more patients sooner.
Just like Lee Hood does in systems biology, we’ll be taking a big-picture approach, but then working with those who execute on ground-level– with patients — to make things work. So how will we do that? Three productive themes emerge, which together comprise an action plan.
Theme 1: Identify, assess, and communicate
Our first task is to find what does work. There are tremendous innovations happening all around us. I’ve already met with several of the people behind these, and I want to find more. Some of these new ideas are already achieving some validation in health care settings, but others are just trying to get a foothold. We want every effective approach and technology to see the light of day and to have a chance at helping patients and trials connect. For this, we’ll serve as a sensor and amplifier, for instance by providing presentation opportunities and publishing case studies as we go.
As we find innovations, we’ll work to provide opportunities to showcase and validate improved capabilities, through cross-sector pilot programs.
Theme 2: Foster innovation efficiency
We cannot have every entrepreneur and every local hospital IT department working on solutions, especially if they all have to deal with the same building-block issues before they can even get started. It is frustrating to see so many talented people working on the same foundational elements, like structuring clinical trial requirement databases. We need to move past this. When you think about it, every industry has a supply chain that provides the inputs for production. Clinical trial matching should be no different.
As I have spoken with innovators, they would be happy to pool their expertise for a simplified template for trial information, such as selection requirements and trial sites. Perhaps with a neutral facilitator like BCI we can drive this to completion. Several innovators have already volunteered to team up on this issue. I believe we can conquer it, and that the whole field will have the opportunity to move forward.
Meanwhile, perhaps there are ways we can upgrade the infrastructure itself. Transcelerate, a non-profit consortium sponsored by the biopharmaceutical industry, has a cancer clinical trial “registry of the future”, with significant improvements over clinicaltrials.gov for including additional data important to patients and improved usability. Something like that, paired with a common data structure, could have the potential to achieve trial transparency.
Theme 3: Drive distribution and adoption
All this will have limited impact without participation by drug developers and uptake by hospitals. So we’ll work closely with both, figure out their pain points and incentives, and align with them.
Our goal for pharma is that they make their selection criterial available for patient-matching, including the criteria that they hold private — because we can’t build a better system to serve patients without it. Furthermore, we’ll ask them to commit to making more of their trials available in community hospital settings, so that any patient can access them.
Meanwhile, we want to make it possible for any hospital to benefit from an improved clinical trial ecosystem. This may require supporting local efforts in creative, distributed ways.
Join the conversation!
In his recent comments in New York City, Vice President Joe Biden commented that he has two unique abilities, which he confers onto the Biden Cancer Initiative. One is the ability to convene people — to bring people to the table to solve important problems. The other is the ability to bring people together to commit and collaborate — to set a high bar and encourage everyone live up to it. Those are the unique qualities that will make this initiative successful.
We have already assembled a working group on clinical trial matching — individuals who bring a wide range of expertise and perspectives that will make this effort successful. However, it goes beyond us. If we want to make the ecosystem better, we need to work with everyone in it.
Do you know of an entrepreneur working at this problem?
Do you know of a community-based private practice, hospital or health system that matches patients to trials consistently? Perhaps their expertise can be translated to other settings to help even more patients.
What patient group has served you or a loved one well in providing information about available clinical trials? We want to work with them to share their practices and reach more patients.
Do you know of a patient who benefited from effective clinical trial searching? Let’s make sure their story gets heard. It might motivate more patients and it might reveal novel ways to find trials.
An open invitation for collaboration
Are you interested in working with us to create, validate, and deploy new strategies for patient enrollment in cancer clinical trials?
We want to hear from you. Please send your inputs and inquiries to clinicaltrials@bidencancer.org.
I began this three-part series with a story of a cancer patient who was let down by the system. Unfortunately, Norman’s story is all too real and all too common, across the US. It is time to apply the “urgency of now” to make sure every patient gets the trial they need, where they are.
