Ben Harris is a medical physicist from Indiana and an example of a patient conducting a Do It Yourself (DIY) study. Diagnosed in January of 2011 with ALS (amyotropic lateral sclerosis, also known as Lou Gehrig’s disease), Harris became both the clinical researcher and the single-patient subject in his search for effective treatment of the disease.
It was six months after his diagnosis that Harris took part in a sponsored clinical trial for a new experimental drug. The treatment gave him some relief from his ALS symptoms and hope that the progression of the disease could be inhibited. Other patients had similar results.
“Accounts similar to Ben’s began to emerge in the chat-rooms,” says Harris’ brother, who is making a video documentary of the events surrounding the ALS diagnosis and the pursuit of this new treatment. “There’s one small problem: the FDA’s process would take between 5 and 7 years before [this new drug] would be approved and made available. My brother could be dead by then.” In clinical research, time can mean everything, particularly to patients.
Harris began an intensive Internet search for information about the compound used in the trial. He eventually discovered the active ingredient in a patent application. No longer part of a trial protocol, Harris began doing his own studies on that ingredient and sharing the results with an online ALS community.
We don’t condone any unauthorized research on patented assets, as the “pharmaceutical industry must continue to advocate for policies that sustain and encourage innovation, such as intellectual property protection.” (from Lilly CEO Calls for a Health Care Policy Environment That Promotes Medical Innovation)
What we can appreciate is the patient’s desire for all available information that might be valuable to treat their disease. With the rise of the Internet and information sharing networks, patients and their families are learning and sharing information in break-through ways. What we’re seeing is the emergence of the “patient researcher”, where the patient has a vested personal interest in contributing information and experience to advance research that might lead to treatments for themselves and others.
We want to enable and contribute to informed patients and help build tools to facilitate the exchange of information.
How are we doing this?
Our vision of an Open Clinical Intelligence Network (OCIN) where people are able to access, collect, curate and share information to drive forward clinical research, includes individual patient researchers.
Patients and researchers both benefit from and contribute to knowledge-generation systems. Chat-rooms, question-and-answer forums, trial registries, drug labels, communities like PatientsLikeMe and other on-line sources can be vibrant crucibles of knowledge that can serve patients and inform clinical research.
We’re developing capabilities to follow relevant clinical research on the web, configured and tailored to what the individual wants to see. Ultimately, the knowledge harvested and generated can contribute to bringing new treatments forward for approval by regulators.
Clinical research is driven forward by many sources, and we see the value of these unique contributors working feverishly in the long-tail of science. Connecting patient-researchers with the rest of the engaged clinical crowd and open, webified data will not only benefit individual patients, but has the potential to amplify and accelerate clinical development for all.