“This is a battle that ultimately has to be won and will be won because we’re building a system here that is fundamentally better for patients, and they will vote with their feet.”
– Marty Tenenbaum
“We’re setting up a place where someone who has questions can post them, and hopefully someone else will either have the answer or will want to try to run the experiment.”
– Marty Tenenbaum
A community of advanced cancer patients, diagnosticians, scientists, researchers, bioinformaticians, molecular biologists, modelers, and clinicians has come together to help with advanced cancer patient testing and treatment decisions. To increase the value of the community to patients and other participants, we are defining and building a bundle of precision oncology services and a platform to continuously learn from patients using those services – The Advanced Cancer Navigator.
The purpose of this meeting and these notes is to get feedback on this venture. Please contact us with your thoughts.
Here is a summary of the key arguments and services in our pitch deck:
Navigating the cancer maze is a nightmare for patients with metastatic disease. (Why/The problem we are addressing)
No one knows the optimal way to treat advanced cancer because every patient’s tumor is unique and must be treated with an individualized combination of therapies in cocktails or over time. There are far more rational regimens than can be tested in clinical trials.
Precision oncology can help inform treatment decisions, but requires frequent clinic visits for blood draws, imaging, and biopsies, and careful management of scarce tumor tissue. Picking the right tests can be hard, and interpreting test results is often challenging,not to mention Integrating results across tests and time to provide a comprehensive view.
Every patient taking every drug is an experiment that could provide insight on which tests and therapies work and which don’t. However, only the patient experiences that are being captured and reviewed are those in clinical trials, about 5% of the total.
The bureaucracy of academic medicine and misaligned incentives impede the free flow of data, specimens, and information. This adversely affects clinical decisions. Patients pay the price.
The Advanced Cancer Navigator solves these problems by providing four essential services absent in the current system. (What/Our solution to the problem)
- A One-Stop-Shop for patients seeking services beyond the standard of care. A services guide identifies vetted “best of breed” providers for services such as molecular profiling and ex vivo drug screens that reduce guesswork and increase confidence in treatment decisions. Navigation, trial matching, and virtual tumor board services help patients and physicians make more informed decisions. Agreements with preferred providers and specimen management partners streamline access to their services and provide for return of raw data to facilitate integration of services into workflows, as well as research collaborations.
- A transformative platform for clinical oncology that tightly integrates research and care to continually learn from every patient. The platform aggregates medical records in real time and transforms them into structured,regulatory-grade, real world data. The data is used to recommend treatment and trial options to patients and physicians, and to run decentralized trials and exploratory signal seeking studies for under $1000 per patient, with no startup costs or delays. Studies that show signals can be rapidly replicated, seamlessly scaling from an n-of-1 case study to a case series, and ultimately to an open label trial with synthetic controls. This approach encourages continuous refinement of multi-therapy regimens before locking down the protocol for inexpensive pivotal trials.
- A global data commons where patients consent to share their data with each other and the research community. The data is routinely mined for clinical insights that could benefit both participating and future patients. It is also used to evaluate the comparative effectiveness of new tests and treatments and accelerate their development by steering patients to the stuff that works.
- Educational forums where leading researchers, bioinformaticians and clinicians are invited to pitch their latest precision oncology services and therapy options. Patients and physicians evaluate these innovations in n-of-1 studies on our platform. If successful, they are incorporated into the services catalog and our standard workflows. Patient forums enable patients with similar conditions to learn from each other’s experiences.
Ideas for implementing these services came out of our discussion:
We must build a testing and treatment system that will provide the best, personalized approach for each patient and continuously learn from every patient. (How/Architecture)
Every advanced cancer patient’s disease has evolved through many mutations that make it unique. Their cancer must therefore be treated with an equally unique personalized combination of therapies, administered in a strategic sequence, with personalized dosing. To answer the treatment decision, we should first have a database where we can bring all the patient cases together and try to find a good match for this patient. But the uniqueness of each personalized treatment means there may be no detailed data or evidence to support the decision in advance. The opportunity then is to run each treatment decision as a prospective experiment and see the outcome. We must create a platform to manage the flow of data.
These services represent a disruptive shift in healthcare. (Implementation/Call to action)
This venture will accelerate the disruptive shift from the batch standard of care to personalized treatments, from evidenced-based (randomized clinical trials) to evidence-informed (real world evidence), and from power in large, legacy institutions to patients. It will unfold like other grassroots social movements, such as the Homebrew Computer Club, which was a small group of hobbyists and hackers that came together in the 1970s and led to Apple Computer, or the advocates who drove the FDA to accelerate adoption of new HIV/AIDS drugs. We will grow with an empowered patient here, a doctor there, and a researcher there. It won’t happen in a day. This is a change that will happen because we’re building a system which is fundamentally better for patients, and they will vote with their feet.