The Future of Health Data: Real World Data is only Real when it includes the patient

Clinical trials have been transforming at a rapid pace to adapt to a drastically changed world as a result of the pandemic. Just like during any major event in history, there are those who readily seek new technologies and methodologies and emerge as winners. Those reluctant to adapt to their environment are left in the dust. To illustrate this reality, only 10.4% of Fortune 500 companies have survived since 1955. Blockbuster Video was late to realize the importance of online video-streaming technology, passed up on the opportunity to acquire Netflix, and became part of history after only a few years. Meanwhile, many clinical trial sponsors and CROs are beginning to realize that the traditional way of conducting clinical trials is becoming quickly antiquated. In addition to the need for new technology that enables remote and hybrid trials, there is a need for better quality data coming directly from the patient.

What is Real World Data for the patient, study sponsor, or for the researcher? We can first start with what Real World Data is not. Real World Data is not the bulk purchase of de-identified data sets. It is not static data, a snapshot of someone’s health at one point in time. For it to be Real World Data, then, it must be real-time and longitudinal. It also must account for all people including people in under-served communities who are especially vulnerable and have suffered disproportionately during the pandemic. In other words, Real World Data needs to capture how and where people live, ease of access to healthcare, as well as other important social determinants of health. 

Patients, as well as their family and caregivers, need seamless access to their longitudinal health timeline. Improved access to key health history of study participants can greatly improve the effectiveness and efficiency of clinical trials, while lowering their cost. For study sponsors, access to high quality, multidimensional Real World Data is extremely valuable for running analytics, machine learning, and AI to gain important insights for drug development. Researchers would like to measure the safety, efficacy, and quality of drugs. Most importantly, patients need to be engaged with their health data to ensure retention in the trial. Patients who had a great experience are more likely to return for future trials for which they qualify.

To keep up with the rapidly changing environment and to emerge as a winner, CROs, Pharmaceutical companies, and life science enterprises need to embrace Real World Data that is patient-centric, longitudinal, multidimensional, and real-time. This will lead to more meaningful insights and Real World Evidence as well as better, faster, and cheaper clinical trials. Study participants will enjoy a better experience, and researchers will have access to better quality outcomes data, all feeding into the positive feedback loop leading to improved future trials. 

Real World Data has tremendous value not just for Pharma but across the entire healthcare spectrum. Healthcare providers, especially those specializing in oncology or rare diseases, need the patient’s health history, often across multiple providers scattered across the country, to quickly onboard the patient, accurately diagnose the disease, and provide effective intervention as well as long-term follow-up care. Having a longitudinal health record not only saves time, it can save lives. Patient records are often offered in paper or CDs and typically take a minimum of 4-6 weeks to obtain with patient consent. The result is often a thick binder of health data that is not standardized, not intuitive, and cannot be readily utilized. 

Providers and payers are now subject to the Interoperability and Patient Access final rule. On April 30, 2021, the requirements for hospitals with certain EHR capabilities to send admission, discharge and transfer notifications to other providers went into effect. On July 1, 2021, CMS began to enforce requirements for certain payers to support Patient Access and Provider Directory APIs. 

Healthcare insurers are also adopting a patient-centric mindset as a result of the legislation. To truly adopt a patient-centric mindset is to anticipate the needs of the patient and provide them a comprehensive view of their health on-demand. With this, patients will be better able to identify actions that lower certain health risks. In addition, payers will be able better engage their patients and their caregivers, leading to an improved care journey. Payers will be able to capitalize on improved risk adjustments from access to real-time data. Patients could then benefit from a healthy lifestyle through lower insurance premiums.

Real World Data is only real when the patient is in complete control of aggregating and sharing their EHR, genomics (DNA), wearables and medical devices. Pharma, payers and providers all obtain tremendous value from Real World Data. It is time they realize what is real and what is not.