The patient-centered trial
By: Marie Lux, MS, CCRA | May 20, 2016
How collaborating with patient advocacy groups drives patient awareness of clinical trials and helps sponsors develop more patient-friendly protocols.
There is a lot of talk these days about how the biopharma industry is becoming increasingly patient-centric, and how important it is to include the patient’s voice in key decisions. Regulators are looking for patient reported outcomes in label claims and patient-focused drug development that aims to more systematically incorporate the patient perspectives into decision making.
However, it has been challenging to translate that patient perspective to the clinical development process. Drug developers want to understand what drives patients to participate in trials, and what gets them excited about these opportunities, but few avenues exist for them to effectively capture this information, which is forcing them to make assumptions about what patients want, which may not be accurate.
One of the best ways drug developers can overcome this barrier is by collaborating with Patient Advocacy Groups. When sponsors and patient groups work together, it opens lines of communication through which patients can learn more about clinical trials and sponsors can adapt their trials to better accommodate patients’ needs. As we celebrate International Clinical Trials Day, I’d like to acknowledge our work with patient advocacy groups to highlight some of the benefits of clinical trial participation and to share their concerns with the broader clinical research community.
You want me to call where?
From the patient’s perspective, we’ve found that education is critical to improving trial awareness and participation. We have heard over-and-over that many patient populations are simply unaware of clinical trials, that their doctor’s never mention them, and that even if they do hear about an opportunity they view participating in a clinical trial as risky and only a last resort when all other treatment options have failed.
We try to dispel these myths by helping advocacy groups develop educational materials for their members, as well as hosting panel discussions and participating in live events where investigators and patients who’ve participated in trials answer questions and share their stories with the broader patient community. These events can be very powerful because they are hearing firsthand accounts from their peers about what the trial was like, and what fears they had going in.
We’ve also found that one-on-one conversations between investigators and potential patients can have a powerful impact on their decision to participate in a trial. While group events do a great job of raising awareness about clinical trials, talking individually to patients creates a personal connection, which can help them feel more engaged with the trial and the important role patients play in bringing new treatments to market.
In exchange, sponsors gain meaningful insight into the patient’s experience with the disease, and their biggest worries about the trial process. That insight, which can’t be captured through electronic health records or physician interviews, helps them design better trials and communication strategies that directly address their needs. In many cases these engagements can lead to small changes that have a significant impact on whether people agree to participate.
Some concerns are predictable like transportation issues, fears about missing work, or worry that they will lose a connection with their primary physician. But others are unexpected. For example, in a recent panel discussion with members from the Crohn's & Colitis Foundation of America (CCFA) and Lupus Foundation of America (LFA) - North Carolina, a CCFA leader shared the story of a patient who almost dropped out of a clinical trial because they asked him to call a number in Europe. It made him wonder if the trial was legitimate, and to worry that he was getting involved with something that wasn’t approved in the US. It was a small factor for the trial, but a big issue for him that could have caused him to drop out of a trial that ultimately changed his life in a positive way.
Gathering feedback from patients isn’t just a ‘nice to have’ feature for a clinical trial. These insights help sponsors make small changes, like choosing a local phone number or compensating participants for their travel; expenses that can have a big impact on their ability to recruit and retain patients. It also ensures they are tracking patient outcomes that will increase the value of the treatment for the patients, and help them meet increasing pressure for patient-centered data as a component of the regulatory approval process. It takes a little extra time and effort, but the benefits for sponsors and the patients they serve is worth it.