Titusville, NJ — Helping modernize the clinical trials process by leaps and bounds, Janssen is undertaking new initiatives to empower research volunteers. Called the Global Trial Community, the initiative is expected to improve patient engagement and thereby enhance the trials process for volunteers and for sites. One key aspect of the program is the delivery of a patient’s own data to them—during the trial.
“We believe patients own their data, so why should we hide it from them? It’s all about creating more openness and trust,” says Janssen’s clinical innovation project leader Caroline Feys. In addition, Janssen is working to make such data-sharing an industry standard. It started an association of pharmaceutical companies called the Patient Data Access Initiative in order to determine ways for sponsors to share patients’ data with them compliantly. This will bring Janssen closer to its ultimate goal of connecting patients with one another during a trial. “We know patients are currently looking for each other on social media,” Feys said, “so our ultimate aim is to be able to facilitate that too.”
According to T.J. Sharpe, a cancer survivor and patient advocate, “The real-time feedback you get from patients is often just as valuable, if not more valuable, than what you get from your physician. There is a recognition now that anything that can help a patient is beneficial, but the industry as a whole is still having a hard time understanding how to do it.”
Sharpe, who explores an array of patient issues in a blog on Novartis.com, participated in a clinical trial through the Global Trial Community. “I got real-time information from other patients who were on the same trial as me; they told me about side-effects, they advised a good night’s sleep before a treatment,” he said. “That’s not information you normally get on a standard clinical trial, but it is so helpful. Patients connecting with each other should be the norm, and where there are exceptions they should be justified, and there should be a legitimate medical reason why the connections are not allowed.”
Why This Matters
“Many patients have great difficulty finding a suitable trial and are therefore denied life-saving treatment,” Sharpe said. “Information is often scattered across numerous different registries, exclusion/inclusion criteria is hard to understand, and there is so much complicated medical language.”
According to Feys, “The [Global Trial Community] helps us to stay in contact with our patients before, during and after the trial and enables investigators to build long-term relationships with patients. Before a trial, a lot of patients are not aware of what a clinical trial even is. We inform them, we educate them, and we ask for input into our trial design to build studies that suit them better. It is about taking them on the journey with us, empowering them.”