Thirty years ago, patient recruitment was a challenge for pharma companies. Today the patient participation rate in trials still hovers around five percent and is not expected to improve anytime soon. Maura Snyder, director of Clinical Insights and Experience at Janssen, shares some of her thoughts on the recruitment challenge and what pharma must do to overcome it.
This is part two of a three-part series that will look at how the industry is changing its perspective on patient recruitment.
Ed Miseta: You have a commercial marketing background in pharma. Is there anything we can learn from the large service-based corporations that can be applied to the issues this industry faces with patient recruitment?
Maura Snyder: I don’t believe patients evaluate their medical care or treatment in a clinical trial any differently than their experiences with other service providers. Their experience will always come down to good customer service.
We live in a customer-service oriented world where consumers are used to instant gratification. In some regions, you can order something on Amazon and have it in two hours. The Disney Philosophy is it wasn’t our fault, but it is our problem. That’s the philosophy we all need to have.
With that in mind, one of the things Janssen is focused on is getting the patient perspective as early as possible. Most companies will build a lot of assumptions into their trial about what they think patients need and want. But we need to hear those concerns from the patients even prior to protocol design.
At Janssen we have conducted clinical trial simulations in a safe environment. We run through the trial to see how the patients react to it. We want to learn their concerns and figure out what we can do to mitigate them. This helps us to learn what is important to patients. We might not be able to change everything about the trial, but there are always things that we can and should change. For the things we can’t change, we can figure out how to better communicate those to patients.
Miseta: Is this still a learning experience for a lot of people?
Snyder: It definitely is. When I came over to the clinical side of the business three years ago, one of my first questions was, “What did the patients say?” The typical reaction was, “Well, we can’t talk to patients.” My feeling was that we could talk to patients, we just had to do it compliantly and come up with acceptable methodologies and ways to do it.
Miseta: Are you making progress?
Snyder: We have come a long way. There is no short answer to that question. I can tell you that we are now getting actual patient perspectives and not using proxies to make assumptions. We have also found that getting the patient perspective on topics related to trials can be eye-opening.
For example, we asked patients and investigators about their experience in a clinical trial. Investigators shared with us that they had up to 10 people invested in the patient’s care, along with other individuals who were also interacting with them. It sounds like they had an entire care system focused on the patient and saw this as a benefit.
When we spoke to a patient group and discussed the topic of the care system, patients saw this very differently. They responded that they did not always know who to talk to because there were so many people interacting with them. They felt they were answering the same question two or three times, depending on when they were contacted and who they spoke to. This was frustrating and confusing for these patients.
We must view these scenarios from the patient perspective and understand the situation they are dealing with. Better communication is a vital first step.
Miseta: Recruitment used to involve finding a site and then recruiting patients. Today, sponsors seem to be finding patients first and then connecting them with a site. Is this a growing trend?
Snyder: I think so, especially in the rare disease space. Some patients are raising their hands to be part of communities where they are opting in to receive information, including information about clinical trials. By partnering with these communities, we are able to proactively share clinical trial opportunities that might be right for them and direct them on next steps they can take. There are also new tools that are being used to help identify patients and sites. For example, one of the things we are trying is taking data that exists, such as claims data as an example, and using it to determine where the disease hot spots might be and where we might find potential sites.
Of course, another issue is physicians not referring patients to trials because they fear they might lose their patients. But, when we ask patients how they expect to learn about trials, the number one answer is from their physician, because that’s the person who best understands their condition and their medical history. If a trial is appropriate for them, patients expect that conversation will take place.
Miseta: What are we doing to keep patients engaged in trials?
Snyder: That’s a good question. We have trials that require seven or eight years of follow-up. Patients may not even be on the drug anymore, but the long-term follow-up is still required. I think the key is making sure you get the patient perspective. We have spoken to thousands of patients to better understand their needs. What we’re hearing is not rocket science.
Patients want you to make their lives easier. They prefer to Skype or make a phone call as opposed to coming into the clinic. They want to get paid for their time. They want to be provided with transportation to not be a burden on their caregiver. If they need to stay overnight, they want someone to pay for their room. If they must endure an eight-hour infusion, they want to be provided with WiFi.
These seem like little things, but they make patients feel valued. And feeling valued is what will keep patients enrolled in a study. And don’t forget about the sites. We must arm sites with what they need to make trials easier on the patients. Patients have told us they don’t care who the sponsor company is. Their relationship is with the site.