As we stand at the threshold of a new health care era defined by precision medicine, clinicians — now more than ever — need access to personalized, genomic data on all patient populations. This brave new world of health care requires dedicated efforts so that traditionally underrepresented groups, including people of color and rural residents, can benefit from best practices and leading-edge therapies.

Unfortunately, a major barrier persists. These populations are poorly represented in clinical trials and genomic registries, putting them at risk of experiencing worse health care outcomes than other populations. In cancer care, that can make a life-or-death difference. Typically, their clinicians, absent genomic data, must make decisions with limited understanding of rare tumor variants and uncertainty about the most effective treatments to offer. New approaches in precision medicine are changing care dynamics.

Clinicogenomic databases (e.g. amassing data of conditions with genetic causes and linked clinical outcomes) are reaching population scale and include real-world data from electronic medical records. That data is being used to train artificial intelligence to create synthetic controls and other robust clinical trial tools. Our imperative is to identify effective ways of engaging underserved communities in clinical trials so all populations can contribute to genomic databases, ensure inclusivity when training AI models, and get optimal care for all.

We encourage the creation of genomic registries powered by innovative technologies. But how do we engage underserved populations and what would the ideal clinicogenomic registry look like? We studied these questions and sought to answer them using oncology and tumor registries as an example. With patient trust as our north star, we found that:

• Patients are more likely to take part in trials and registries when they are asked by a trusted health care provider. A key barrier is the place where sign-ups happen — generally at academic medical centers where sometimes patients have no longstanding relationship with the provider. Research has shown these patients are more likely to respond to longtime family doctor or some other trusted provider.

• Transparency is essential when recruiting clinical trial participants. Participant compensation trends have added complications to clinical trial enrollment. This barrier can be mitigated by focusing instead on the degree to which patients can control their own data and shape policy in a way that addresses the tradeoffs between societal benefits and participants’ benefits. We believe the ideal clinicogenomic registry embraces transparency and a participant-centric framework for permitted data uses. The patients must trust that they have some control over how their data is used.

• True informed consent is crucial. Efforts should be encouraged to provide the patient with a more practical means to expand or revoke broader, forward-looking informed consent. Authorization processes can be designed to make consent more voluntary and use-case specific, with an eye toward future research. Ideally, the participant would have opportunities to discuss each subsequent use of their data or specimen and ask questions along the way. With high complexity, literacy challenges, or language barriers, the consent process could be video-recorded for the patient’s future reference.

• Health care professionals need to be trained in providing culturally sensitive care. The All of Us research program, a national effort to accelerate health research by exploring the relationship between lifestyle, environment, and genetics, acts as a learning laboratory for optimizing many tools and strategies for gathering informed consent in populations with low health literacy.

• Ideally, a clinicogenomic registry would allow participants in placebo or control arms to directly benefit from their participation. This would help overcome a major impediment to clinical trial enrollment.

• The ideal registry would meet a quality standard allowing for the creation of simulation cohorts and drug registration trial cohorts and the use of the data in regulatory dossiers.

• Trusted channels of digital governance and exchange between stakeholders and users is imperative. As it is now, interoperability, security, privacy, and proprietary challenges contribute to the boundary problem that limits the mobility of the health data necessary to successfully link genomics with public health outcomes.

• Data collection needs to be standardized. The Total Cancer Care Protocol aims to standardize data collection across tumor types and address data interoperability.

• An ideal clinicogenomic registry provides a window into the interplay of socioeconomic factors, genetics, and the natural history of disease. Using digital tools and virtual clinical research practices to engage cancer patients holds much promise to capture nuance and address health disparities.

• Technology that serves patient and provider interests empowers collaboration. Cloud computing, mobile computing, digital ledger technologies, tokenization, and artificial intelligence technologies are powerful tools that could enhance engagement along the data lifecycle. A robust, private, permissioned blockchain platform for collecting health data can add a virtual and longitudinal dimension to clinical research. A database that gives providers and patients visibility and agency into data promotes collaboration and health information exchanges.

*Silva P, Vollmer Dahlke D, Smith ML, Charles W, Gomez J, Ory MG, Ramos, KS. “An Idealized Clinicogenomic Registry to Engage Underrepresented Populations Using Innovative Technology.” J. Pers. Med. 2022; 12 (5): 713. https://doi.org/10.3390/jpm12050713