How Connected Data will Power the Next Generation of Patient-Centric Clinical Research

MaryAnne Rizk is a Chief Strategy Officer at Medable.

SVP, DCT Solutions, Oncology at Medable

Tal Rosenberg leads the Partnerships organization at Datavant. Tal is a twenty-year veteran at creating new value ecosystems and markets.

Save the Date!

Until recently, the only way for a patient to gain access to a clinical trial offering potentially life-saving therapy was to appear in person at a clinic. At least one study found that cancer patients had to travel at least 25 miles each way to participate in a clinical trial and over 100 miles to participate in an NIH study.1 Decentralized Clinical Trials (DCTs) arose out of the need to reach patients where they lived. The COVID-19 pandemic accelerated DCT adoption, enabling trials to continue even when patients could not visit a site. They reduce patient burden and offer rich real-time insights. The shift towards DCTs is increasing access to trials for more patients, improving study enrollment and completion rates for trial sponsors. A study by The Tufts Center for the Study of Drug Development found that DCTs can provide a net benefit of up to 5x the upfront investment in phase II studies, and up to 14x greater in phase III.2

Understanding the patient perspective

Olga N., a stage III melanoma patient, never considered joining a clinical trial before. She was already struggling to maintain a daily routine for herself and her family and traveling to a clinical trial site was more than she could handle. Olga’s doctor informed her about the benefits of participating in a DCT. Her doctor explained how it would significantly simplify and ease her participation with virtual clinic visits, medication deliveries, home health services and data gathered through wearable devices. Olga was able to get access to a new therapy through the study without shouldering more burden. Moreover, the study enabled her to potentially have access to leading-edge therapies at little to no cost while contributing important knowledge about the disease that could benefit not just her, but future melanoma patients. 

Beyond the trial: Completing the picture of patient health

Patients interact with a multitude of organizations across the healthcare ecosystem throughout their lives. They visit primary care clinics, specialists, get lab tests, MRIs, pick up medication at their pharmacy and may use health apps and medical devices. That information is retained in siloed databases across disparate organizations. The problem of data fragmentation prevents investigators and sponsors from fully understanding the patients in their study. As a result, they are often left with unanswered questions and missing data and facts about their new intervention.

The power of partnerships

Medable’s decentralized and remote trial platform is helping Olga and thousands of other patients join clinical trials without having to disrupt their lives. For example, in one Medable study, deploying eConsent, reduced the patient enrollment period by 50%, reduced site need by 75% and decreased the total cost of the trial by $20m3. Medable’s flexible eCOA and eConsent solutions enable improved patient engagement and retention, yielding high-quality endpoint collection. 

Through Medable’s Partner Network, Medable leverages a spectrum of partners to provide complete solutions to sponsors and sites. One example is Medable’s partnership with Datavant. Medable partners with Datavant to connect patient trial data to a vast array of real-world data. Real-world data can enable sponsors to quickly recruit and retain larger, more diverse patient populations, significantly simplify patients’ and caregivers’ experience, and enrich the evidence collected during a clinical trial. This innovative partnership is changing the clinical research paradigm. Patient Access, Engagement & Retention is enhanced with a modern HIPAA compliant eConsent platform that delivers an engaging user experience for patients. Connecting real-world data further augments and extends a trial without requiring more effort from the patient.

Connecting trial data to real-world data will become a standard practice in research

Trial data, though rich, is a very narrow data set, representing just a sliver of the entire patient’s health profile from a highly controlled environment. Therefore trials come with inherent limitations including 1) their short duration; 2) incomplete data to explain adverse events and non-responders; 3) a lack of social determinants and other exogenous factors that can influence a patients’ response to therapy; and 4) the absence of cost burden data.

Connecting real-world data to clinical trials adds depth, breadth and dimensionality to trials. Linking electronic health record data and labs, for example, will add clinical depth to the patient’s trial data. This additional clinical data may a) help explain adverse events; b) add information that could serve as a surrogate endpoint for effectiveness; or c) support sub-population analysis that explains differential response between subgroups. Linking mortality data can add breadth to the trial by extending the observation of survival rate by months and years.

Linking social determinants of health, genetic sequencing or device data adds data dimensionality that may explain a patient's disease progression and response to therapy. Race, income, and employment may all be associated with a patient's health outcomes. Genetic mutations and their correlations to outcomes may improve the precision of identifying the right population for therapy. Device data from blood glucose to cardiac monitors, activity trackers, diet and sleep may correlate with intervention effectiveness and safety. Linking claims for the time period before, during, and after the trial adds the dimension of cost and can help establish baseline healthcare utilization and measure whether therapy affects disease burden during and after the trial officially ends. 

Connecting real-world data is the next step in patient-centricity because it a) adds data that represents the whole patient journey and all of the factors influencing their health;  b) alleviates the burden of additional clinic visits by collecting data directly from other health care organizations; and c) supports privacy compliance, enabling patients to consent to medical record retrieval or enabling data linkage through de-identified record linking. By connecting real-world data we can understand factors about Olga’s life, health, and behavior that help us understand whether a new therapy is working for her and define a group of patients like her who will benefit similarly. We accomplish this while alleviating the burden of her traveling to the clinic, taking tests and completing additional surveys.

Datavant the trusted, neutral ubiquitous solution for health data connectivity

Datavant’s mission is to connect the world’s health data to improve patient outcomes. The Datavant Switchboard is an end-to-end privacy-compliant platform that connects the nation’s largest health data ecosystem of more than 500 real-world data partners. Switchboard enables trial sites and sponsors to connect health data while retaining control over data access and complying with privacy regulations.

Medable’s agnostic sensor connectivity 

Medable further supports data connectivity with its agnostic capability to connect any type of device, sensor, or other wearable technology. These best-in-class and patient-preferred (vetted by Medable’s Patient Success and Patient Caregiver Network) connected sensors inform real-time patient safety monitoring decisions and provide the clinician with oversight that drives better clinical decisions and patient outcomes.

The pandemic stalled clinical research, creating a catalyst for providers and sponsors alike to adopt virtual and remote technology solutions. The result was a system-wide transformation that led to important new insights on how to improve and speed clinical trials. FDA and other regulatory authorities have accelerated the adoption of these methods with guidelines that enable decentralized clinical trials and the use of connected real-world data to support regulatory decisions.4, 5

These advances are improving patients’ clinical trial experiences and generating enriched evidence that combines the rigor of data collected in a trial with the breadth and depth of data that represents real-world patient experience.  We are transforming the experience of patients like Olga while gathering more evidence about new interventions that will speed the approval of life-saving therapies.

References

  1. At What Cost to Clinical Trial Enrollment? A Retrospective Study of Patient Travel Burden in Cancer Clinical Trials
  2. Tufts Center for Drug Discovery
  3. Medable Case Study: Age-related macular degeneration - patient screening and eConsent. 
  4. Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
  5. Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products