Sharing Diverse Patient Data to Support Clinical Trials: Can We Afford Not To?
By Monica Matta
Monica Matta is head of operations and GM of provider business at COTA of Boston, MA.
Flatly, we cannot.
Clinical trials are the foundation of innovation in the fight against hard-to-treat diseases, including cancers. For the millions of people living with cancer, and the millions more who will be newly diagnosed this year, clinical trials are critically important for opening up new treatment options and paving the way for improved outcomes.
Cancer may affect everyone, but not everyone has equal access to the resources and research projects designed to combat this complex group of diseases. Certain racial and ethnic groups are systematically excluded and chronically disenfranchised when it comes to screening, testing, and clinical care. These groups, including individuals affected by the socioeconomic and environmental determinants of health, often experience worse health outcomes and mortality at higher rates.
Black patients, for example, are significantly more likely than members of any other group to die from many cancers, including prostate cancer, breast cancer, and multiple myeloma. While black patients account for anywhere from 15-20% of the national incidence of these diseases, they only comprise 3-5% of clinical trial representation. This is a huge problem.
Clinical trials for new therapies are often not truly representative of the populations the therapies will be treating. Lower participation rates not only leave patients without access to potentially ground-breaking therapies, but also leave investigators with worrisome gaps in knowledge about the efficacy and safety of these treatments in the wider, real-world population.
The ethics are clear. There are also financial arguments supporting the need for increased diversity in clinical trials. If manufacturers and payers cannot verify that new therapies are going to achieve the desired result across all potential populations, why should they invest time and resources in distributing these agents to patients?
We simply cannot afford, both morally and more tangibly, not to focus on architecting more representative and inclusive clinical trials.
We can begin to meet the needs of underserved and underrepresented populations by encouraging more individuals to participate in clinical trials and prioritizing the evaluation of real-world outcomes with an emphasis on privacy and ensuring equitable access to the results. In order to do so, investigators must have access to rich, curated, diverse real-world data that accurately capture the experience and outcome of patients from all backgrounds.
Healthcare providers, including cancer centers, oncologists, and other specialists, remain a critical conduit for facilitating education about the benefits of data sharing and connecting patients with clinical trial opportunities. We must continue to build strong relationships between patients, providers, and clinical trial sponsors to gain the trust and input of diverse populations.
As we look to the future, however, there is much potential in leveraging technology and portals to clinical research marketplaces that allow individuals to grant access to their personal data assets for specific, well-defined use cases. These marketplaces will likely include some type of data dividends as compensation for participation. Patients can then become the direct purveyors and benefactors of their data, creating an entirely new model which reengages the right stakeholders in the conversation once more.
As we develop these ideas and tackle the myriad issues around the creation of such a system, we will need to keep informed, empowered patients at the center of all we do. Privacy, security, and equity must remain paramount to ensure our efforts are transparent, sustainable, and effective.
Whatever the next generation of data sharing will look like, we have opportunities right now to meet our obligations to patients. By pairing technical innovations with clinical expertise, we can lay the foundations for more expansive use of real-world data from traditionally underrepresented populations. We can continue to prioritize de-identification and patient privacy as we grow our data-sharing networks to encourage contribution and participation. We can proactively connect with representatives from underserved groups to provide education about clinical trials. We can keep working across the healthcare enterprise to refine our research approaches, expand access to breakthrough therapies, and support patients throughout their healthcare journey.
This is a moral imperative. For the sake of our neighbors, friends, families, and colleagues, we cannot afford not to be inclusive when it comes to clinical trials for cancer and the real-world evaluation of new protocols. The choices we make now will directly impact the lives of millions as we look to a future where sharing patient data with researchers is empowering and rewarding for all.