“An approximate answer to the right problem is worth a good deal more than an exact answer to an approximate problem.” – John Tukey
Biopharma, governments, and the healthcare industry as a whole are grappling with what really provides healthcare value, and how to evaluate and measure it. Though not a new problem, it’s one that is now front-and-center as established models for healthcare research and evaluation are proving too slow, costly, and restrictive for today’s needs.
At the same time, easy-to-use mobile computing is everywhere in our day-to-day lives, providing the pipeline to ever more comprehensive and accessible data about our world.
How are these two things related? The relative lack of mobile technology in health research illuminates the limitations of research designs and data gathering methods from the 1970s that are still relied on today.
In field after field for the past 30 years, Internet technology has shown it can radically democratize and commoditize information, through automation and scaling with low-to-zero marginal costs. There’s a fancy term for this: disintermediation. Many in the healthcare and clinical research fields are looking toward general-purpose consumer mobile technology to disintermediate themselves from the data they seek. Direct engagement with patients using a mobile-centric, real-time approach is a big part of the way forward. This disintermediation aims for greater efficiency and improved accuracy in research. In some cases, entirely new ways of looking at problems may result from the ability to passively collect continuous data streams – the Parkinson’s mPower study is a great early example.
There’s no question population health and observational research are being transformed by the ability to use mobile technology on a wide scale: A flood of low cost wireless sensors coming to market opens possibilities for ubiquitous, passive data collection. We have an unprecedented ability to engage and capture near-real time, in some cases, continuous data at a very low burden to the participant. Online communities are empowering patients by bringing together people who share a common disease burden and providing them with the chance to interact, share knowledge, and compare experiences like never before. This often includes raising the visibility of research participation opportunities.
The needs of interventional research are changing too. An increased emphasis by payers and providers on effectiveness requires understanding how patients and therapies work in the real world. With the ubiquity of smartphones, we can collect patient-reported measures in a far more meaningful and timely way than with paper diaries or dedicated hand-held devices, allowing us to develop the evidence needed for a value-based market. Even in pivotal randomized registration trials, we can introduce changes to help better engage and retain patients, shorten timelines with adaptive designs that rely on real-time data, and do so in a way that improves these studies’ ability to demonstrate safety and efficacy.
We’re still in the early days of this patient-centric era. Most mHealth and virtual trial systems are bespoke platforms with purpose-built apps. These custom built solutions can be coded exactly to the needs of a given project. But building custom solutions sacrifices reusability and inhibits the ability to start the next project fast with out-of-the box, proven technology.
At OpenClinica, we are working to achieve both. We aim to combine the rigor and exactness of RCTs with a big data/population based approach that yields richer answers about how the real world works. The best way to do that is with a platform that creates a unified experience based on reusable, but customizable components. Our nearly 10 years of work in electronic data capture has taught us a lot about how to ensure data integrity and enable our customers to implement research protocols without writing code. At the same time, we’ve built a user experience for study participants that from the ground up is designed around simplicity, mobile-friendliness, and, ease-of-use. We’ve focused on components that solve problems in a generalizable way and just work, while also providing the means to tailor the user experience and features to meet the unique needs of each study.
Every day is an exciting challenge as we and our customers learn more about the patients we both serve. Just a few months after the launch of OpenClinica Participate, we have started, or will soon begin, connecting patients in a daily diary study on nutrition, a behavioral health risk screening study, a hospital safety outcomes project, a long-term maternal & child health cohort, and two surgical device studies, including one involving photos captured directly from mobile devices. We’re rapidly making refinements to their user experience and adding features that help improve the speed, convenience, and quality of the research. With these new approaches comes changes at every level: research design; privacy, ethics, and consent; data validity; regulatory compliance; and analytical models. But the potential payoff is great – we now have new abilities to ask big, important research questions that have been impossible to answer in the past.