Positioning the Patient in Drug Trials

One of the biggest challenges that the clinical research industry consistently faces is to fulfill clinical trial enrollment goals as initially projected. Meeting each individual study enrollment goal on time is a crucial step toward the potential submission and approval of new therapies for patients. It is paramount that all stakeholders involved in the clinical research industry understand what patients genuinely want and need from clinical trials, and that these wants and needs are addressed with a fit-for-purpose approach. All elements of studies should be designed and executed in a site- and patient-centric manner, allowing our industry to take the studies to the patient in a way that reduces the patient burden.

Some of the patient-focused activities PPD Clinical Research Services has established as customary practice for patients in studies include implementing decentralized methods (such as home trial services and remote digitally facilitated visits supplemented with supporting activities, such as patient travel, patient expense reimbursement, patient concierge services)and connecting them to patient advocacy groups. Additionally, we provide support directly to participating sites by training them in the core elements of clinical trial practice. In this article, we will address some of the patient- and site-focused offerings currently being implemented. The goal of these offerings is to address patient and site needs, with the ultimate objective of eliminating unnecessary burden and accelerating the completion of enrollment in clinical trials.

It is important to evaluate each trial individually to develop indication-specific solutions that allow us to reach more patients. Sponsors, contract research organizations (CROs), project teams, and a variety of external organizations need to work together to identify patient channels suitable for each trial. These organizations may include academic medical centers, site networks, academic research organizations, patient advocacy groups and communities, professional organizations, commercial pharmacies, and specialized patient recruitment vendors.

In building comprehensive patient recruitment and retention strategies, it is also important to eliminate known recruitment barriers, including lack of awareness, access deficiencies, lack of trust, study visit inconvenience, and various socio-economic challenges. As such, the focus must be on how to make clinical trials more accessible to all patients and to deliver a customized, diverse, and inclusive patient recruitment and retention strategy for each study.

We continuously evaluate recruitment and retention progress against the study projections, analyzing activities for performance of both high- and low-performing sites; site feedback on recruitment methods used; the number of referrals from each patient channel being used; any patient feedback received; and real-time review of patient demographic data. This information should be used to adjust patient recruitment strategies to ensure maximum value and effectiveness. Recruitment channels that are not performing well should be eliminated in favor of investing in the channels that are working. Taking feedback and best practices from high-performing sites can be used to support other less successful sites.

Patient advocacy groups enable us to apply the patient’s voice related to their specific disease, into our trial designs. There are thousands of patient advocacy groups globally, including many that are country-focused or region-focused for specific diseases in multiple therapeutic areas. By working with project teams and clients, these relationships can be maintained not only when there are active studies needing participants but in between trials to keep the relationships active. Patient feedback is invaluable to ensure the materials we have created and the solutions we have deployed (i.e., home health care or transportation services) are of real benefit to patients.

Patient concierge services also can ease the patient burden by serving as a personal assistant to patients by providing study visit reminders, check-ins, and protocol compliance reminders, which increase engagement in the study. Patient concierge services support the site staff by taking on certain logistical activities, such as scheduling patient transportation and following up on reimbursements for patients. There are various third-party sources that can book transportation and arrange reimbursements. Working through a patient concierge service gives the site and patient one point of contact.

Decentralization has provided components that enable much needed flexibility and options to clinical trials so they can better adapt and lower the impact on patients’ lives. These trials use solutions, such as electronic informed consent forms (eConsent), electronic clinical outcome assessments (eCOA), telemedicine visits, wearable devices and sensors, home trial services, mobile sites, and virtual sites. These technologies enable certain clinical trial procedures to be done at locations other than a site, such as the patient’s home or place of work, resulting in a reduced patient burden of trial participation. In addition to making the clinical trial procedures more accessible and convenient for patients, the reduction in on-site time for the patient helps relieve some of the study site’s workload.

Home trial visits have been valuable in supporting the end-to-end clinical trial process. Nothing gives patients more control of their research journey than meeting them in the comfort of their home. Patients can interact with the protocol design and implications for them using their own device, as part of the eConsent process. Additionally, patients can fit in trial procedures around their lifestyle, accommodating work, school, and family life commitments. We are all familiar with the loss to follow up, especially where patients are required to commit to the trial over several years. Home trial visits not only accommodate travel to holiday destinations, but also allow patients to remain in the study even when they’ve moved further away from the site, as seen in long-term studies.

Today, there is significant focus on diversity and inclusion in clinical trials, with regulatory authorities requiring greater awareness and access to clinical trials for underserved people. In response, the industry is seeking ways to invest in innovative clinical trial design and execution to focus on ways to engage, recruit, and retain specific populations, and use virtual and digitally enabled technology to make trial participation easier. One action that can be taken to help increase the diversity of clinical trial populations is to implement programs that focus on training research-naïve physicians how to become a fully operational study site. That, in turn, will help make clinical trials more accessible to the patients who could benefit the most. By adding new research sites and enabling them to be successful in clinical trials, we will broaden the pool of patients potentially eligible for trials. These types of training programs are designed to address the industry challenge of site and patient access for pharmaceutical and biotech companies that are developing promising new therapies, as well supplying a more convenient option for patients to access more care options closer to home.

Through the various approaches and options, it is critical to map out the patient journey. Start with their first disease symptoms and diagnosis, then to awareness of the trial and agreement to take part, followed by the trial itself, and ensuring the support put in place fits the patient’s disease and lifestyle. Reducing the burden on patients and caregivers is what will make a difference in encouraging and enabling them to enter and take part in studies. The clinical research industry must continue to be open to integrate feedback from patients and sites to promote these existing strategies in patient engagement, and to become aware of when novel issues or needs arise. By tailoring the clinical trial process around the patients, we greatly improve our chances of improving human health.

About the Authors

Lisa Dyment (top) is Senior Director, Patient Services; Eve Kamau (middle) is Director, Decentralized Strategy and Innovation; and Jenna McDonnell (bottom) is Director, Decentralized Clinical Trials Strategy, all at PPD Clinical Research Services, Thermo Fisher Scientific.