At Lilly COI we spend plenty of time exploring the future of clinical trials. We continue to explore clinical trial matching, Internet-based studies, mobile health in trials, and other possibilities. Though we are excited by these possibilities, we also know that it will take some time for possibilities to fully morph into practicalities. Technologies need to improve, regulatory questions need to be answered, and clinical trial models need to evolve. Meanwhile, patients are in great need of an improved clinical trial experience today. We can’t ask patients to wait on a convergence of ideal conditions, especially when there are feasible improvements that we can make now.
“Nobody really cares about me, I’m not Beyonce.”
This quote was attributed to Deborah Peel, founder of Patient Privacy Rights, in a Bloomberg article about data mining of online patient conversations. Peel’s point is that though people generally understand the public nature of their online conversations, they may not realize the extent to which their conversations are being monitored, packaged for consumption, and sold. As data-enabled Internet business models continue to emerge, so too will new questions, ethical and otherwise.
Evolving Business Models
Treato, which is the focus of the Bloomberg article, is a big data company evolving one of these new business models. The company’s software scrapes tens of thousands of online patient discussions daily, aggregates that data, and then analyzes it for customers. The final product is insight into trends about how drugs are used and what problems consumers experience with them. Until recently, Treato’s customers were primarily healthcare and especially pharma. One pharma client, for example, uses Treato to understand the patient journey, particularly patient concerns as they move from diagnosis to treatment.
Now Treato is pursuing a new customer: Wall Street. Treato sends fund managers regular reports summarizing online chatter about drug side effects or prescribing trends. Wall Street interest in this area is certainly not new. Treato’s predecessors built businesses by putting investors in touch with health professionals and researchers. But the data-enabled Internet-centric approach to gathering this insight is relatively new. By using software to pluck data directly from patient conversations, Treato has access to both more and different data than has been previously available.
Last week, our friends at PACE Network USA were kind enough to invite me to write a guest blog for their site about open data initiatives and their potential impact on clinical trials. In the post, we mention OpenFDA as an example of the kinds of open data that could be a boon for health-related app developers and patients alike:
Simply put, open data initiatives like openFDA create new opportunities for collaboration, discovery and insight, and could greatly improve clinical trials by increasing researchers’ ability to learn from earlier studies and real-life occurrences. Projects like the American Society of Clinical Oncology’s CancerLinQ and Project Data Sphere (PDS) have already begun to change how oncologists share information with other oncologists. OpenFDA expands on these initiatives by allowing researchers from private companies and research institutions to easily access the wealth of information stored in the FDA’s archives. For patients, this can potentially accelerate access to lifesaving innovation. (from The FDA on Open Data)
Some developer teams have already taken on the task of developing web applications from the available FDA data. Social Health Insights, for example, created what is believed to be the first app based on OpenFDA data within hours of its release.
Recently, NPR featured a story about an experimental program called OpenNotes, which gives people access to the notes doctors write about them. Though there was some trepidation on the part of doctors, the program turned out to be tremendously successful. For example, 80 percent of patients reported having a better understanding of their health, and two-thirds said they were more disciplined about taking their prescribed medications.
Advocates like ePatient Dave, Regina Holliday and many others have been leading the charge to demand patient access to their personal health information across all medical specialities and organizations. Healthcare is not a one-size-fits-all proposition. Assuring patients have access to their information is fundamental to support making the best, most-informed, personal healthcare choices. The success of OpenNotes makes us feel encouraged about the possibility that making it easier for patients to access their medical information will also make it easier for them to connect to clinical research studies. And, there’s also a lot of promise in initiatives like Blue Button, which allows people to access and download their health records online.