CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, writer Karyn Korieth spoke with Marie Emms, head of Patient Engagement at Syneos Health, who has 20 years’ experience in global patient recruitment and retention strategies for clinical trials.
Q: Many clinical trial protocols for broad disease states are difficult to recruit because they require very specific patient populations. What strategies could the industry use to address this challenge?
A: Finding patients that meet specific criteria within broad disease states requires a shift in thinking. Instead of treating this type of trial as we would any broad disease trial, we should think about it as we would a trial in rare disease. The patients exist, but there are only a handful of them within a broad disease state. For example, in a breast cancer clinical trial, you may be looking for patients with a specific BRCA mutation. With that level of detail, it’s not that you are looking for a patient with breast cancer, but rather, you are looking for a patient with a very, very specific type of breast cancer. We have to think differently about how we are going to approach these studies.
Finding those patients comes back to identifying the right sites. We need to make sure that the sites we choose are not just broad, general sites that see multiple patients every week with the condition, but that they are the sites seeing the very specific patient population that is needed. Perhaps they might only be seeing a couple of these patients every quarter or even one or two a year. The condition could be that rare. But we need to make sure that we are going to the centers of excellence where those specific patients are referred. From there, we need to work with each site and develop a very site-specific, tailored plan to help them think about this as a rare disease and how to find those patients.
Q: What are some of the practices used in rare disease studies that could be adapted to a broad disease protocol with narrow inclusion/exclusion criteria?
A: There are a number of lessons that can be taken from rare disease states and utilized in broader protocols. One example is acknowledging that the patients might not be close to the site we choose. In rare disease states, it’s very common for patients to travel for long distances, even to different countries, to the site for the clinical trial. After we identify the sites that have the experience with the specific patient population, we need to think about how best we can support those sites and give them the tools to ensure that their wider referral networks are aware that they are participating in this clinical trial. If they don’t have networks set up, we can help them think through how a typical patient would get to their site, how long that would take and how to disrupt that journey to make sure that the patient is able to find the site quicker.
From a practical patient recruitment perspective, we need a strategy in place to make patients aware that the study is enrolling whether you are recruiting for a rare or broad disease. Some of the typical approaches used in patient recruitment around paid media and social media or with geo-targeting, where we only target patients within a certain radius of a site, get blown out the window with rare disease. It’s a much broader campaign. We may use an earned-media approach in which we work with the sites to develop their thought-leader development skills. We set them up with interviews, broaden their reach and raise their profile within the disease community as the place that might potentially be able to help those patients. The patients are motivated to find that site and want to participate because they know, in a lot of cases that is their only option.
Advocacy groups are often knowledgeable in sharing with us where the patients are, who they think are the specialists in the field and what we can do to best reach those patients and tell them about the study.
Q: Are there any additional specialists that are important to consult when you are enrolling these types of studies where you’re looking to find a patient fitting a specific profile?
A: When looking for rare patients within a broad disease state, we need to recognize that they probably feel quite alienated because they are not part of a large community where they have treatment options. It’s also, therefore, a lot harder to find these potentially eligible patients, which brings us to the important role that the feasibility team plays.
When we are talking to sites during the feasibility period and asking about the number of patients that they see, we also need to find out how they talk to patients about clinical trial participation and whether there is a dedicated person at that site who has those conversations.
Enrollment starts with identifying those sites who are best placed to support the sponsor in meeting study objectives. Where we see the greater success is where feasibility is working in tandem with the patient engagement team to review the data, identify the gaps and ensure the sites that are chosen are given the support they need.
It is this approach that we can take to those broad state studies to ensure we are setting all sites up for success.