The importance of real-world data (RWD) and real-world evidence (RWE) in healthcare is undeniable, and from the conversations happening at events and conferences I recently attended, it’s not a question of ‘if’ but ‘when’ it will be fully utilized to drive decisions and actions.
This fall, I attended the Healthcare Leaders Conference in Dallas, TX, and the Future of Health Data Summit 2019 in Washington, DC. Both of these conferences provided an opportunity to connect with a diverse group of stakeholders and speak on the topic of RWE and the role it plays in improving patient care and drug development. In my conversations, a few key takeaways stood out around innovations related to the use of meaningful data.
Rather than attracting a single type of healthcare stakeholder, I was pleased to see a diverse group of attendees at both conferences. I believe this is a reflection of the cross-industry collaboration that is becoming more commonplace. There is growing consensus that the key to solving the most vexing problems in healthcare will be the partnership between healthcare organizations and technology companies. At these two events in particular, there was a great deal of discussion to determine how RWE can have the greatest impact today and acknowledgement that we need to work together to address the barriers to expanded use.
The FDA has signaled a greater degree of openness to advance the use of RWE in drug development than at any time in their history. Dr. Janet Woodcock of the FDA told the audience at the Future of Health Summit, that we’re not yet on the superhighway in regards to using RWE in regulatory decision making, but we’re nearing the on ramp. Two areas that must be addressed are the absence of data standards and areas of bias that exist in RWE, however, there is a growing sense across the industry of our collective responsibility to address these challenges.
Though we are living in an era of personalized medicine, some of the most critical patient information is locked away in the EHR. Physicians are spending inordinate amounts of time entering data, but it is basically unusable for population-level analysis or point-of-care decision support. When we unlock this data and organize it in a meaningful way, we enable physicians to apply the information and make decisions in a data driven way.
RWE is increasingly being used to accelerate the speed, monitor the safety, and ultimately reduce the cost of clinical trials. RWE shouldn’t completely replace most clinical trials, but it will create new opportunities to improve quality, outcomes, and economics in drug development.
My major takeaway from these events is the high speed at which we are moving to a data driven healthcare system. The use of data to improve care and reduce costs will fundamentally change the way patients are treated. This transformation will not come from technology solutions alone. Because of the dynamic, complex nature of today’s medical records, they can not be curated by NLP and machine learning alone. Expert human clinical judgement will be required to achieve the level of accuracy mandated by regulatory bodies. What will continue to evolve is the level at which these technologies can support the data curation process thus accelerating the speed. Additionally, the extent to which important data points are captured initially in analyzable formats will grow over time.
As we close out 2019 and move into 2020, I’m more confident than ever about COTA’s ability to transform cancer care by informing decisions in oncology. For patients and clinicians alike, RWE will have an exceptional impact as it is used to create efficiencies and improve quality in drug development and at the point of care.