Medical innovation over the past few decades has significantly raised the bar for the quality of treatment that life sciences companies and the healthcare industry can provide to patients. In tandem, the communication barriers between patients, clinicians and life sciences companies are breaking down rapidly. We have entered an era where patients are empowered to do their own research and advocate for the best treatment to suit their needs. Furthermore, the ubiquitous rise of digital devices and channels offers more outlets for patient-reported outcomes (PROs) than ever before. Consequently, researchers must directly be involved with the evolving metrics for success in patient-centered medical care and extend their analytic methodologies to encompass this new data stream.
In traditional pharmacoepidemiological studies, treatment has been viewed through a healthcare team and pharmaceutical lens, where success is characterized by how well a treatment plan worked in preventing or solving a medical challenge in the patient. Now, there is an imperative for researchers to shift toward greater patient centricity to achieve a deeper understanding of the patient experience in the real world. Doing this effectively demands that researchers seek out information beyond the realm of the traditional healthcare setting to form a more complete picture of patient lives and personal health.
Uncovering patient-centric insights
The emerging need for more patient-centric insights in epidemiological studies is coinciding perfectly with the unprecedented quantity of patient-generated health data (PGHD) being generated. The very same channels and technologies that have contributed to an influx of PROs and other important information from people can equip researchers with a rich mine of evidence that populates in real time. This can improve researchers’ understanding of the current health of patient populations as well as the gaps where medical innovation is most needed.
PGHD can include patients’ interactions, outcomes and side effects with existing treatments. It can also incorporate contextual information, such as demography, behaviors, environmental conditions and general health. These data points span from actively reported patient information, such as those collected in surveys, to passively collected data from connected medical technology (Internet of Things) such as wearable devices, implantables and smartphones. It can also include information that may have been recorded by patients for reasons unrelated to healthcare, such as fitness monitors, or shopping lists that provide data on dietary habits.
The global pandemic has been a major driver for actively collected PGHD, with the emergence of COVID-19 health registries playing an important role in supplementing other research information to uncover the pandemic’s impact. One such data resource is the US/UK community-based COVID-19 registry known as CARE1 Additionally, as technology evolves, a huge number of objective data points can be gleaned passively from devices to paint a more complete picture of patient experience.
Key considerations for researchers
Although its potential to enrich research is great, PGHD remains a relatively nascent tool in epidemiological studies, particularly in an era where rules, regulations and public perception around data sharing are in flux. Evolving challenges loom in the ethical and compliant use of these types of data. With concerns around cybersecurity and data privacy, researchers must stay current and transparent on how they obtain and use this data and with what permissions. Other barriers to the use of PGHD include data standardization, the rapid pace of device development and the sheer volumes of data. These challenges are being met with robust methodologies and technical innovations including machine learning.
In the context of real-world epidemiological studies, PGHD can offer rich context that might otherwise have gone unexplored. Extending data collection outside a traditional healthcare setting not only enables greater frequency, continuity and diversification of data, but it also creates the opportunity for datasets influenced less by biases or misreporting, and with reduced missing data especially in the area of medication adherence.
As a result, epidemiologists can mitigate the chance of false conclusions that could undermine the validity of their findings. The holistic picture of real-world outcomes that PGHD enables allows researchers to explore aspects of population health that they may have otherwise not known to be relevant. It simultaneously widens and deepens the pool of understanding around how medicine and patient care can be improved through a lens of patient eccentricity.
Through strategic and ethical implementation, leveraging PGHD to achieve patient centricity holds the promise to fundamentally evolve the way life sciences defines success. The fruit of this effort will be more thoughtful and personalized patient care that elicits better outcomes both in terms of the treatment plan itself and the patient receiving it. Coming full circle, the context gleaned from available treatments can be shared with drug developers to inform their product pipelines based on what treatments are needed by patients. Furthermore, it can help to improve both the safety and quality of medicines.
Through this process, researchers can be the catalyst that closes the communication gap between the life sciences industry and the patients it serves, enabling those patients to access the best treatment possible for their own needs.
1. COVID-19 Active Research Experience. CARE Project. https://www.helpstopcovid19.com. Published 2020. Accessed February 19, 2021
About the author
A professional with nearly 40 years’ experience in medical data collection and research, Alison Bourke is an industry thought leader in pharmacoepidemiological data science, study design and analysis. In addition to her role as scientific director at the Center for Advanced Evidence Generation within the Real-World Solutions of IQVIA, Alison is deputy chair of PRIMM (Prescribing and Research in Medicines Management – UK and Ireland, a multi-disciplinary organization devoted to the study of medicine use in society) and served as president of the International Society for Pharmacoepidemiology (ISPE) from August 2018 to August 2019. In April 2019, Alison joined the GetReal Initiative Think Tank as a core member.