Cancer clinical trials: Unleashing the power of collaboration to break the 5% participation barrier once and for all.
Biden Cancer Initiative Announces the Oncology Clinical Trial Information Commons. New shared infrastructure will make it possible for cancer patients to know their clinical trial options.
9 organizations join forces to make clinical trial information available, paving the way for improved trial matching technology and services. Founding members are BreastCancerTrials.org, Cancer Commons, Ciitizen, EmergingMed, GenomOncology, Genospace/Sarah Cannon, IBM Watson Health, Massive Bio, and Syapse.
In 1960, the airline industry formed Sabre as a data platform with all the information that would be needed to schedule flight reservations. It was the single source of truth for the airline industry, making it possible for travel agents and Internet booking systems to efficiently match passengers to flights.
Today, the Biden Cancer Initiative is pleased to announce that 10 healthcare innovators are joining forces a Sabre-like system for clinical trials: TheOncology Clinical Trial Information Commons (OCTIC), a shared platform where all information about clinical trials can be stored and accessed for patient matching and other data mining. The system will employ a single set of terms and rules, plus a user-friendly interface for biopharma companies to readily enter and update their trials.
The information will include patient selection criteria, trial locations, and patient participation requirements, all in a consistent, machine-readable format. To address the issue of proprietary selection criteria, OCTIC will provide a mechanism for clinical trial sponsors and investigators to mark certain selection parameters for private disclosure, available for patient-matching, but not to be publicly viewed. Governance rules and mechanisms will be established to ensure appropriate access and use of the clinical trial information.
The 9 founding members have agreed to work cooperatively to create a first release of OCTIC tools before the American Society of Clinical Oncology (ASCO) Annual Meeting in 2020. They will meet to share their current technologies and approaches, and work together to design a “best of all” solution that encompasses their collective understanding of the technical requirements. They will each decide which technologies to contribute to the combined solution, and they’ll develop a plan on how to assemble it. They’ll work together to make the platform and run pilot programs to test it.
The program is intended to be compatible with all parts of the clinical trials ecosystem. It can be the single point of data entry for clinical trial sponsors and investigators. Government registry programs can read directly from it, making them better. Patient advocacy organizations, health institutions, and technology developers can connect to it in order to power their services. OCTIC won’t compete with anyone; rather it will make many parts of the oncology clinical trial ecosystem more efficient.
Why this matters to patients
I meet patients all the time who struggle to find a clinical trial. Some of them are successful in finding one, and sometimes that treatment prolongs their lives.
Melissa Crouse was diagnosed with lung cancer in 2005, and it has been metastatic since 2008. Surviving more than three to five years is unusual. Thanks to clinical trials, she is still alive today. Melissa is a walking history book of lung cancer treatment innovations, having participated in SIX clinical trials in the course of her cancer care. Not all of them worked for her, but at each step she contributed to our scientific understanding, and then she was able to find her next move. Her medical team has supported her throughout her journey, even creating a trial for just her when none were available. Today, she is active in a trial for a new drug that targets rare mutations in the RET gene, and her cancer is under control.
Clinical trials allowed Melissa to be at three children’s weddings and the birth of her six grandchildren. She was able to continue her profession as a middle school chorus and orchestra teacher. Plus, through her experience, she has become an advocate and role model for other patients and part of a loving community that needs her.
Melissa found me on social media. She wanted to thank me and the Biden Cancer Initiative, where I serve as Program Lead for Clinical Trials Acceleration, for prioritizing access to trials. Until recently, clinical trials were seen as a treatment of last resort. Fortunately, that has changed, and in fact the American Society of Clinical Oncology (ASCO) has publicly taken a stance that all trials, including phase 1 studies, are not just a way for patients to contribute to scientific knowledge; they say that trials are a therapeutic option to be considered in the context of the patient’s condition at all steps of their care, not just when all “standard of care” options are exhausted.[i]
Relevant clinical trials are often invisible
Most patients are unable to find the clinical trial options that would be relevant for them. That means that important options in their care, which could keep them alive like Melissa, are invisible to them, and they are invisible to those trials. While up to 25% of patients could qualify for participation in a clinical trial, less than 5% actually do. We can do better.
Clinical trial information inaccessible
I use words wrong all the time (maybe I just did!). Recently, speaking with friends about a person with cancer, I said that “he progressed while on the trial.” Someone, rightly, corrected me to say that his cancerprogressed while on the trial. Slight lapses of syntax in the way we talk with one another generally have no real consequence. In cancer treatment, however, technical syntax inaccuracy can literally be a matter of life and death. Today’s public system for clinical trial information, a registry called ClinicalTrials.gov, is an open-text database, meaning there is no defined structure or syntax for things like disease names, drug names, biomarkers, and patient qualification criteria. As a result, the publicly available information about clinical trials is not readily searchable.
Available information is incomplete and opaque
There’s another complicating factor. Not only is the syntax haphazard, but the information is incomplete. Some clinical trial information is held closely by the companies that are developing new therapies. Disclosing it publicly would reveal too much of their scientific interests to their competitors.
Incomplete disclosure results in poor trial matching in two ways. One is false hope — a patient thinks that they match to a trial, only to be knocked out by some selection factor that wasn’t apparent to them. Second and even worse, patients might never see a trial that could be perfect for them, because the criterium they technically match to isn’t made known, so they don’t seek it out. The only reliable information about clinical trial selection criteria is the protocols themselves, which are confidential documents between drug companies and clinical researchers.
Clinicaltrials.gov was built as a repository for clinical trial information for researchers and the public, and in some ways, it serves that purpose. However, now that patients and health care providers are relying on that information to find trials as a care option, its limited searchability and incomplete information have become serious weaknesses that are affecting patient care.
Existing efforts are fragmented and unsustainable
I’ve spoken with many healthcare institutions, technology companies, and patient advocacy organizations, and all of them wrestle with the same problem. They do not have access to complete, accurate, machine-readable information about clinical trials that would make it possible to readily match patients to suitable trial options. So, what do they do? They make their own databases. They read the trial listings on ClinicalTrials.gov and try to decipher them, and then they enter that information into their databases. They also request clinical trial protocols from sponsors and investigators to get complete information.
Every single one of these innovators does the same activities, at great expense. I’ve spoken with two companies that spend over 70% of their operating budget on clinical trial database development and management. That means that $7 of every $10 they raise from investors goes into activity that is not their business — money is spent “on the way” to being able to do what they want to do: provide value to patients, hospitals, and drug companies with applications and services. Raising this money is incredibly difficult — investors don’t want to pay for databasing — and it’s dilutive to the founders’ financial stake in their companies and to their mission of improving patient care.
Let’s play this movie to its natural conclusion. Even if all these innovators make a functioning clinical trial database, the result is industry fragmentation. And because there is no single place for drug makers to enter complete and structured information, the work of managing each database will be a never-ending process. This is a path to perpetual frustration and less than adequate patient care. This destructive cycle needs to be broken.
Making clinical trial options accessible
The Biden Cancer Initiative will work closely with the OCTIC members to help enable its success. We’ll facilitate meetings, help grow the partners, foster pilot programs and help to communicate progress and success of the endeavor. We’re proud to be aligned with passionate and innovative organizations who are willing to work together and contribute their capabilities toward collective impact for patients.
When the Cancer Moonshot was launched in 2016, I wrote a post in Medium entitled: “The Best Weapon to Fight Cancer: Collaboration”. I still believe that is true. Imagine if every patient had access to trials the way that Melissa Crouse did. Together, through information transparency and availability, we will make it happen.
[i]Weber, Levit, et al. “Reaffirming and Clarifying the American Society of Clinical Oncology’s Policy Statement on the Critical Role of Phase I Trials in Cancer Research and Treatment”. Journal of Clinical Oncology, Volume 35, Number 2. January 10, 2017.
