Heidmann discusses the difficulties of enrolling patients in clinical trials and the ways these issues can be dealt with.
Kimberlee Heidmann serves as Executive Vice President of Patient Experience and Customer Success as well as the Global Head of Quality and Regulatory Affairs at Scout Clinical. She spoke with Pharmaceutical Executive about Scout Clinical’s participation with Meeting Protocol Worldwide and their work to improve patient enrollment in clinical trials.
Pharmaceutical Executive: What are the modern difficulties with enrolling patients in clinical trials?
Kimberlee Heidmann: There are many barriers to patient participation in clinical trials, resulting in less than 5% of eligible patients participating in clinical research. Many individuals are not aware of ongoing clinical trials that they may qualify for, and they lack an understanding of the clinical investigation process and the potential benefits to current or future patients with their diagnosis if they do enroll. The patient identification process may also be challenging. CROs and sponsors must ensure that patients meet very stringent inclusion and exclusion criteria and are potentially willing to make lifestyle changes required by the clinical trial protocol. Some protocols require participants to make significant changes in their lives for a months-long period, and these factors may deter enrollment. These significant barriers cause up to 20% of clinical trials to terminate early due to enrollment targets remaining unmet.
These challenges in patient recruitment have existed for decades. However, what is different today is that the patient’s voice has been significantly amplified. Patients can make their concerns known through advocacy groups, conversations on social media, webinars, and focus groups. There is a community outcry for more equitable healthcare. This is not just a conversation that’s happening between clinicians and participants. The global community is advocating for less expensive and more accessible forms of healthcare, and clinical research is part of this conversation. In recent years, the industry is focusing on learning more about the correlation between recruitment and retention issues and the experience of the patient and their care circle.
Underlying all these issues is the complexity of the logistics of moving many people across state and country borders. Transporting patients for clinical trials is not as simple as securing a car and driver. There are many accessibility concerns that must be addressed. Many rare disease clinical trial patients are children who must travel with their families and caregivers. A patient might need to be transported with specialized medical equipment that standard transportation services are not equipped to handle. Movement across international borders requires consideration of each country’s unique requirements and regulations. These complexities must be considered and adequately addressed to ensure patients can remain in clinical trials.
PE: Why are trials so often located so far away from patients?
Heidmann: While there are a limited number of participating clinical research sites for a given clinical trial, patients are everywhere. For 70% of potential trial participants, the nearest clinical trial site is over two hours away. Certain clinical trials can only be conducted at major academic medical centers and hospitals, placing them out of reach of patients in rural communities. In rare disease clinical trials especially, we often have patients who do not reside in the country the study is taking place. Even in instances where a patient is geographically close to a trial site, transportation may still be difficult to secure due to accessibility needs. Our mission is to make clinical trials available to more populations and increase access to underserved communities across the globe.
Even if patients are eligible to participate in a nearby clinical trial site, they may be unaware of the study at all. An important factor to consider is physician education. Patients are likely to join clinical trials suggested by their primary physician. This won’t occur if clinical trial information is not available to local family doctors. Educational programs, patient advocacy groups, and other initiatives can serve to bridge this gap in awareness and make even more patients aware of their potential eligibility in a clinical trial.
It's not necessarily a matter of where the trial is being conducted, but a limitation on the number of clinical trial sites, transportation barriers, and lack of awareness about clinical trials among patients and physicians. Our goal as part of this industry is to bring that research to many, many more patients in our entire society.
PE: What sort of innovative approaches do you take to fill clinical trials?
Heidmann: At Scout Clinical, what we want is to be a collaborative partner to the sponsors by helping to pull together multiple perspectives, industry experience, and innovative tools–all the aspects that may potentially address barriers to patient participation. We particularly integrate patient and caregiver education via appropriate and accessible materials to help the patients and their families understand what services are available to them and how they may receive the support needed to keep their participation cost neutral and fill their day-to-day practical needs.
We collaborate with our sponsors at the study design phase by partnering with subject matter experts and advocacy groups to investigate what kinds of support we may offer to patients. We consider specific logistical barriers, cost neutrality, emotional and mental support, corollary services, and milestone reporting. We represent the patient voice to support the sponsor in determining the schedule of assessments, the requirements of patients, and lifestyle changes. All these factors may be addressed at the outset of study design even before the patient enrollment period begins.
For instance, if a patient will have to go on a specific diet associated with the study, we will determine how to help them mitigate the financial burden and impact on their personal life. We may suggest setting up an account for them to purchase groceries from a particular store. In the case where a site visit may take an exceptionally long time, we will provide overnight accommodation for the patient and their caregiver near the hospital or clinic. These solutions can be presented to patients and their care circles at the enrollment phase, which supports recruitment as well as retention.
Scout Clinical’s innovative approach considers the personal aspects of the patient, their family unit, and their care circle. We integrate these aspects of patient experience with the expertise of thought leaders from research and clinical perspectives.We assemble a toolbox for a clinical trial experience that meets the needs of the patients, study protocol, and the overarching goals of the CRO or trial sponsor. We then offer a collaborative approach to the sponsors to conceptualize the study design relative to the patient experience. Patients are the most important aspect of clinical trials, and we help sponsors to consider the impact of these variables of retention on the prospects of timely delivery and solid data in any given study.
PE: What are the benefits of custom-building studies for each sponsor?
Heidmann: Successful studies are measured not only by their outcomes, but by their efficiency and timeliness. There are specific timelines that studies must maintain, and delays to onboarding and enrollment slow down the entire process. Sponsors who prioritize engaging the sites in discussions on trial design can gain insights into what is impactful and efficient. This allows sponsors to move away from processes that perhaps worked in the past or in another therapeutic area or patient population, and to expand access to different groups and create diversity in research that is better suited for the current study.
Additionally, the reduction in site burden via streamlining of various tools and technologies reduces the number of vendors and systems that sites must interact with. We regularly get feedback from sites that they are overburdened with multiple systems, technologies, and devices they need to keep track of and train their staff to use.
Custom building services for studies allows us to provide a streamlined system and a comprehensive toolbox in a simple, user-friendly environment. In addition to participant logistics, we can also provide site training and education, caregiver education, and site collaboration tools. We didn't decide to build a box of services and say to our sponsors, “Now you have to fit inside our box of services.” Rather, we want to build a better toolbox that fits the needs of each patient, individual sponsor, and clinical trial.