Patients are playing an increasingly influential role in their own health. Biopharma knows it needs to better understand how patients live with their conditions and support their healthcare decision making. As reported in a recent survey of patients across five markets, patients want to be meaningfully engaged, empowered with the right information and services, have their input taken into consideration, and have a greater role in product creation. They also want trials to be easier to take part in and to align with the outcomes that matter to them.
Advances in technology are providing capabilities RWE teams can leverage to become more patient-centric, but deployment must go hand in hand with representative, privacy-safe studies that return value to participants. Used appropriately, technology can lift evidence from within corporate walls and scale the number of patients and physicians who benefit from it, improving their ability to make optimal healthcare treatment decisions.
- Understand the everyday lives of patients: Generate more robust evidence leveraging person-generated health data
Understanding individuals before and after they engage with the healthcare system has never been more important, yet most evidence is drawn from ‘traditional’ real-world data sources such as EHRs (electronic health records) and insurance claims. These are episodic; they only represent times a patient interacted with the healthcare system – providing a partial, fragmented picture of their overall health. Leveraging person-generated health data (PGHD) from apps, sensors and other devices (e.g. activity, heart rate, sleep patterns, weight change, or contextual data like weather or pollution levels), provides a window into individuals’ everyday life. These data can be used to understand the outcomes that really matter to people and to generate more robust evidence about disease and patient health.
- Improve patient experience during studies: Create a strategy for leveraging de-centralized research
Traditional study approaches are being replaced with direct virtual connections with study participants at scale, who take part in research from the comfort of their own homes. Virtual sites may consist of many millions of individuals, who can opt-in and provide informed consent via their own mobile phones or other devices. This decentralized approach enables broader representation and higher engagement in research by reaching patients where they are with minimal participation burden. Immediate connection to hundreds or thousands of study participants enables rapid recruitment and time to insight.
- Develop longitudinal patient relationships: Engage continuously with a population
The probability of change in patient health increases with time. Access to, and connection with, a population over the long term establishes a sustained relationship with a cohort of individuals and enables a succession of retrospective and prospective studies over time, unlocking more insights and enabling more efficient research. Although this can be achieved within one condition, benefits increase when establishing a cross-condition, enterprise-wide program. Deploying supporting technology enables RWE teams to quickly share insights and evidence across therapeutic areas, breaking down the silos of fragmented evidence generation and thereby enhancing understanding of disease and patient health.
- Ensure research and trials are accessible to all: Anchor healthcare research and clinical trials in representative data
Traditional RWE data sources such as EHRs and insurance claims data are heavily slanted toward people with access to the healthcare system. An unacceptable gap exists when research does not account for the vastly uneven access to healthcare in the U.S. As a result of not being able to seek care at the same frequency and standard, the disease symptoms and characteristics of progression of the un- or under-insured may be missed from analysis. In addition, as the American Journal of Therapeutics notes, clinical trials for approval of new medicines do not reflect the proportion of racial/ethnic groups in the U.S. Basing research on unrepresentative data limits generalizability and risks excluding large sections of society from equal contribution to evidence creation that drives decision making across the healthcare industry. Decentralized research approaches can improve representation through widening access to trials via virtual participation and user-centric digital approaches.
- Put the patient first: Conduct privacy-safe studies and return value to study participants
Research programs must be built in a privacy-safe, consent-based manner that is low burden for study participants. Transparency, data control and ethical considerations are paramount. Additionally, participants must see value returned to them through increased understanding of their own health and opportunities to help answer questions of importance to patients like themselves. Use of behavioral economics principles can inform such approaches to ensure appropriate value is offered, particularly when participants are expected to engage in study activities over long time periods.
Historically the Biopharma industry has been a step or two removed from patients. Technology has made closer connections with patients possible, but engaging ethically in value-based relationships with individuals who are willing to contribute their time and effort to healthcare research is both an opportunity and a responsibility.