As I reflect upon the dawn of a new decade and the fundamental changes to the health care data environment that have occurred, I’m excited to begin the next phase of my career by joining the team at Verana Health as Chief Medical Officer to contribute to the mission and strategy of this innovative company.
I have spent the last 20 years in clinical practice as a cardiologist in the Duke University Health System and as a clinical investigator at the Duke Clinical Research Institute. During that time, I had tremendous opportunities to collaborate with and lead cross-functional teams that have provided care for patients with cardiovascular disease, conducted clinical trials and observational registries, and trained the next generation of clinical researchers. Most notably, I’ve been inspired and uplifted by my experiences co-leading the ADAPTABLE clinical trial over the past five years. This innovative study — conducted across U.S. health systems connected through a standardized electronic health record (EHR) data platform — showed me what is possible with patient-centered, EHR-enabled clinical research embedded within routine clinical practice. Through this project, we have learned how to optimally engage with patients about their perceptions and ideas related to clinical research. Furthermore, the partnerships forged with patient investigators who have been involved in and contributing to all aspects of study design and execution, have been one of the most rewarding experiences that I have had in my career.
Consequently, I’ve become increasingly motivated to help develop innovative, collaborative solutions that can successfully overcome the barriers that constrain clinical care delivery and restrict clinical research.
Over the last several years, there has been a rapid expansion in the accrual of electronic health data from EHRs, administrative claims processing, digital health applications, biosensors, and other sources. Meanwhile, the widespread implementation of EHRs in the U.S. has been focused primarily on capturing data for the purposes of maximizing reimbursement rather than for improving long-term clinical care delivery or facilitating clinical research. Furthermore, the administrative and technical interoperability of the platforms utilized to capture and process these myriad sources of electronic data have been inadequate. Consequently, electronic health data, while proliferating, continue to exist in silos. This limits the utility and impact of real-world data (RWD) in health care and clinical research.
Clinicians are seeking better tools and support to adopt evidence into practice. Concurrently, patients are striving for better access to beneficial treatments and knowledge about their medical conditions and also opportunities to be more broadly involved in all phases of clinical research. In this light, several recent developments related to RWD are pointing towards a brighter and more rewarding future. First, medical professional societies have been expanding and evolving observational registries which they sponsor to directly incorporate EHR data for the purposes of practice-level quality improvement and research insights. Second, federal legislation has propelled the development of a national, interconnected, patient-centered research network enabled by EHR data used to support both observational and prospective clinical research studies. Third, regulatory authorities have committed to delineating the “fitness for use” of RWD captured in routine practice for medical product research and development and the Food and Drug Administration plans to issue real-world evidence (RWE) guidance by the end of 2021. Finally, patients are increasingly gaining direct access to their electronic health data within and across systems and are being empowered to share their data with their clinicians and with clinical researchers.
Based upon these developments and through my own experiences, I’ve come to realize that disruptive approaches are needed to improve clinical care delivery and overcome the inefficiencies and cost barriers that have stifled clinical research and limited the generation of high-quality evidence that will change clinical practice.
I’m convinced that RWD harnessed for purpose can catalyze transformation in the health care and clinical research environments.
As the data partner for the EHR-derived, observational registries operated by several professional societies, Verana Health is focused on providing value to clinicians and patients. Through these partnerships with professional societies, we enable routine insights into clinical care delivery patterns to facilitate quality improvement and clinical research. By leveraging unique data curation and analytic approaches, we are developing a learning data system that is evolving to be a “fit for purpose” evidence generation platform. Our platform is designed to inform practice guideline updates/revisions, accelerate medical product development, and spearhead the conduct of innovative, pragmatic clinical trials. Within this context, we seek to partner with all stakeholders – patients, patient advocacy groups, clinicians, researchers, medical professional societies, regulatory agencies, companies that develop medical products, and like-minded data and technology companies – to develop the most effective data solutions that will improve the health and quality of life of patients across diverse medical conditions.
We have a motivated, enthusiastic, talented, and principled team at Verana Health that is making tremendous contributions to realize our vision and mission. I’m thrilled to join this team and to contribute to its ongoing and future success. Meanwhile, I’m looking forward to reviewing our scientific objectives, highlighting our innovative data and technology solutions, and delineating our commitment to thoughtful data stewardship in future posts.