Integrating PHD (personal health data) in medical R&D
Monday, November 17, 2014
3:55 PM - 4:50 PM
GH - Empire Ballroom I
Eric Green, Director, National Human Genome Research Institute, National Institutes of Health
Anna McCollister-Slipp, Co-Founder, Galileo Analytics
Tom Parsons, Co-Founder, HealthXL
Eric Schadt, Director of the Icahn Institute for Genomics and Multiscale Biology, Chair of the Department of Genetics and Genomics Sciences, and the Jean C. and James W. Crystal Professor of Genomics at the Icahn School of Medicine, Mount Sinai
Ravi Seshadri, Vice President, Technology, NantHealth
Todd Sherer, CEO, The Michael J. Fox Foundation for Parkinson's Research
Lifestyle applications and devices have become increasingly common, making it easy to track and access personal health data. The question now is how new technology and the resulting data will fit into the healthcare ecosystem. At a recent Partnering for Cures panel, "Integrating PHD (personal health data) in medical R&D," thought leaders examined the impending collaboration of personal genomics, medical research, and patient care in the context of current and upcoming technology.
Moderator Todd Sherer of The Michael J. Fox Foundation for Parkinson's Research kicked off the panel by stating that today we have the capacity to track a patient 24 hours a day, and unlocking these phenotypic data along with genomic data has the potential to solve every disease that has afflicted mankind. Sherer asked the panel how we can get from where we are today to that endpoint and what challenges and obstacles may be encountered along the way.
Tom Parsons of HealthXL said that innovators will be the leaders in the next wave of data collection. He pointed out that 99.9 percent of the data gathered by personal technology are from a time period when the patients are not in a clinical setting and, therefore, these data are crucial to improving the clinical trial process. However, it is unclear how exactly the data will be used in clinical trials, so it is important to clarify their use upfront in order to help create and better format the technology so that it is more aligned and suited for clinical trials.
Eric Green of the National Human Genome Research Institute at the National Institutes of Health shared that the necessary technologies exist, and research studies can be set to integrate data and gain insights into complex diseases that are multifactorial. Anna McCollister-Slipp of Galileo Analytics agreed that the technology necessary to incorporate personal health data into the medical research system is available, but companies need to open up direct access to their application programming interfaces (APIs) so that data can be pulled as needed for clinical or personal use, which would make it possible to integrate multiple data streams. McCollister-Slipp further explained that we need to start designing research studies around the needs of individuals rather than the needs of the pharmaceutical companies or the researchers. Eric Schadt of Mount Sinai also emphasized the need for the integration of multiple data streams and stated that it is necessary to interpret that integrated information through predictive models in order to inform decision-making at all levels.
As the conversation shifted toward engaging patients in clinical trials, Ravi Seshadri of NantHealth said that we need to go in the direction of having "adaptive trials rather than having the traditional trials." McCollister-Slipp suggested that "We need to share the data with patients so they know what they're contributing. Patients are a lot smarter than they're given credit. Give them the raw data – they'll understand some of the larger endpoints." Schadt added that patients need to realize the benefits of engaging with their information, and "it all has to be in real time – integrating and evaluating the data without having to seek regulatory approval on all those models. We need to get comfortable where the models are dynamic, and the outcomes will help assess effectiveness."
In terms of engaging patients in clinical trials, Green stated that patients will gravitate toward the trials they believe are well designed and suited for their lifestyle. He insisted that the technology is already available, and that currently we're facing an "intellectual block more than a technological block."
After briefly touching upon the issues of consent – and agreeing upon the need to harmonize patient consent around the world – the panel deliberated the role of the physician within this evolution. Seshadri stated that technology is a game-changer, and physicians need to educate themselves along with patients: "Physicians need to buy in for this all to be successful." Schadt agreed, stating that we need a model for physicians so that they can readily find the useful information and patterns that only their highly trained minds can seek.
The audience raised questions about the changes in the institutional review board (IRB) process to accommodate this new era of big data. The panelists agreed that there is a lot of momentum to solve IRB issues, and there needs to be appropriate regulation and legislation to address liability.
Throughout the panel, Green cautioned that, while we have positioned ourselves technologically and analytically to dissect the genomic and environmental basis of many diseases over the next 5 to 10 years, this doesn't necessarily promise a cure. All of the data being collected are research-grade data, not intervention or treatment data. He concluded the discussion by predicting that clinical studies are going to be bigger and wilder than we can anticipate in the next five years, and the scale of the data analyzed will be mind-numbing ,which could help us learn how complicated some diseases are and result in amazing progress.