Clinical trials often are a patient’s best hope, particularly for patients with cancers that have a poor prognosis. But too often patients and their oncologists are unaware of trials that may be a match for a patient, and trials suffer from under-enrollment. Racial and ethnic minorities in particular are underrepresented in trials. There are multiple factors involved in successful clinical trial recruitment, but access to data that can more accurately detect whether a patient is eligible for a trial can make a difference. Widespread adoption of EHRs, in theory, has made more data available for clinical trial matching - but for cancer patients, the relevant data needed for trial matching is often spread across multiple providers and not readily available. Ciitizen is revolutionizing healthcare data access by leveraging the patient’s HIPAA right of access to collect all of their medical records across all of their providers, including lab results, medications, diagnosis, genetic tests, pathology reports, and radiology images, into a single location, controlled by and free to the patient. For patients interested in clinical trial possibilities, Ciitizen’s advanced machine-learning platform creates a research-grade, ‘digital twin’ enabling matching to clinical trial criteria. Patients can also contribute a de-identified copy of this “digital twin” to power research. By putting the patient first and creating useful data, Ciitizen is building a new healthcare data infrastructure that has the potential to revolutionize clinical trials and power personalized medicine.
Ciitizen started by focusing on those patients most in need - those with stage 3 and 4 breast cancer and cholangiocarcinoma - and more recently has expanded to include patients with blood cancers. Ciitizen enrolls patients by working with trusted patient advocacy groups. Patients typically learn about clinical trials through their oncologist, but not even doctors know about all available trials (even trials enrolling at the physician’s practice site). This results in patients and doctors being unaware of trials that could have extended the patient’s life - and contributes to trial under-enrollment. To accurately “match” a patient requires detailed information on the patient’s illness and on available clinical trials for that cancer. Ciitizen’s ML-platform extracts relevant data from the patient’s medical records across all sites of care and translates this medical information into clinical trial selection terminology. Ciitizen takes information about trials from clinicaltrials.gov and maps the patient characteristics to the available trial criteria to produce a potential match report. This trial match report can be segmented geographically to focus on matching trials within travel distance. Patients are encouraged to discuss the matches with their oncologists. Soon, Ciitizen will make this tool available for oncologists to use to find available trials for their patients. To date, Ciitizen has successfully used its platform to help cancer patients find potential clinical trials. But this technology can also be used to help trial sponsors recruit patients and yield data about which of the exclusion criteria is resulting in the highest rejection of otherwise eligible patients.
Ciitizen’s unique core technology of patient record aggregation and structuring has the potential to serve all patients, from any background, at any location, and in any healthcare setting. In the United States, Ciitizen leverages HIPAA’s right of access to enable patients to receive all of their health data across all their sites of care (not just the superficial data accessible through FHIR APIs). Ciitizen also is leveraging the information blocking rules to obtain patient data from new sources, such as HIEs. Internationally, patients must upload their records currently, but the process will soon be automated. The company’s ML-based technology platform quickly automates information extraction and research-grade notations from those records, creating a single, standardized medical history from all points of care. This has the potential to dramatically change how patients find potentially life-saving or life-extending clinical trials. Armed with their own healthcare data, patients can now be 100% matched to a trial without ever setting foot in a clinic, something Ciitizen has accomplished for several patients. And this can be done in a matter of minutes, not months as is standard today. Because Ciitizen’s technology produces research-grade data, the technology is also being used to power a number of cancer studies, including one examining the efficacy of COVID-19 vaccination for persons with blood cancers. Patients consent to share their de-identified, extracted and standardized Ciitizen profile with researchers.
Compiling a comprehensive history of a patient’s data and records is Ciitizen’s success bar. These rich datasets are drawing the notice of pharmaceutical companies as Ciitizen has signed several large deals in the last six months with the largest pharma firms in the world. However, Ciitizen’s perceives its deep and lasting relationships with advocacy groups and patients as its most valued success. Ciitizen has built long-term relationships with various foundations, advocacy groups, and research organizations including BreastCancer.org, The Cholangiocarcinoma Foundation, the Leukemia and Lymphoma Society, Touch (the Black Breast Cancer Alliance, the Male Breast Cancer Coalition, and more. These partnerships enable Ciitizen to work together with trusted patient allies to help patients find the best possible treatments and to advance research into more effective cancer therapies. To highlight just one of our partnerships: recently, Ciitizen partnered with the Leukemia and Lymphoma Society (LLS) to facilitate the largest COVID vaccine study as blood cancer patients are at a much higher risk of dying from COVID-19. In nine weeks, they have had over 2500 patients register and participate – the largest COVID antibody study for cancer patients to date. While Ciitizen’s emphasis is serving patients, it also could yield benefits for sponsors and investigators. Every hour saved inpatient screening by study staff saves 6 person-months of preparation in a 1000-person trial, assuming a 1:1 Accept: Reject ratio. Trials could begin more quickly, and at lower cost, without compromising their rigorous, science-driven patient selection requirements.
By leveraging existing laws granting patients the right to their data and EHRs adoption by providers nationwide, Ciitizen places patients at the center, giving them agency over their data and removing common barriers to health data access that prevent patients and their oncologists from finding potentially life-saving or life-extending trials.