Earlier this month, we ran across this tweet from Stephanie Fischer (@SDFatPhRMA):
Though the comment may be referring mostly to prohibitive eligibility criteria found in some trial designs, there are many additional factors that make trials “hard to get into,” according to feedback from patients. Inconvenient locations, overly-demanding reporting requirements, and too-frequent lab test appointments are just are few. As technologies that allow data collection and at-home lab tests improve and become more widespread, the rise of online clinical trials may provide more opportunities for researchers to conduct more inclusive studies, and to help patients overcome some of these common barriers to participation.
This work, “Open Health” is a deriviative of “Open Health: stethoscope” by Maria Boehling for opensource.com, used under CC-BY-2.0.
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.
The NIH’s National Heart, Lung and Blood Institute (NHLBI), with help from WisdomTools and the New England Research Institutes, has created a role playing video game (RPG) called The Paper Kingdom. The game was developed to help ease the fears of kids and their parents and to help them learn more about clinical trials before making a decision about whether to participate in one. You can download the game for Windows or Mac computers from the Children and Clinical Studies section of the NHLBI’s website.
The game starts out like a picture book; a few slides set the scene. You are sent to remind your brother to take his medicine, but you find that he’s not in his room. Suddenly, you are transported into a book titled, The Paper Kingdom, that you find laying on your brother’s floor. His fears about joining a clinical trial have come to life within the book. You must rescue him from them by educating him about clinical trials.