In recent years, there has been a growing emphasis on the concept of “patient-centered care” within the healthcare landscape.
The U.S. Food & Drug Administration (FDA) has recently issued guidance on diversity, equity, and inclusion (DEI) in clinical trials, underscoring a sustained commitment to advancing patient-centered care and taking progressive strides in enhancing its implementation.
While a substantial body of literature delves into the dynamics of patient-centered care within traditional healthcare settings such as hospitals, primary care, or specialty offices, it is crucial to recognize that these fundamental principles extend seamlessly into the realm of clinical trials. The holistic approach to patient engagement and satisfaction remains pivotal, transcending healthcare boundaries and permeating even the intricacies of clinical trial environments.
What Does a Patient-Centric Clinical Trial Look Like?
Patient-centered care has been a central theme for more than two decades. In a 2002 article titled “Patient-centeredness: a new approach,” Elizabeth B. Anderson identifies six necessary components for patient-centered care:
- Engaging in meaningful discussions with patients about the disease and its impact on daily life.
- Recognizing each patient as an individual with a unique cultural background and life experiences.
- Establishing common ground with patients to collaboratively manage the disease.
- Integrating preventive and wellness activities into the comprehensive treatment plan.
- Equipping patients with understandable and actionable health information.
- Nurturing an improved physician-patient relationship.
Over 20 years later, these six elements remain essential for patient-centered care. They remain relevant both to physicians and to clinical trial teams.
A patient-centric clinical trial begins with talking to people who live with the condition under investigation, says Director at Clinical Trials Consulting & Training in the UK, Simon Day. Yet this is a standard some clinical trials still fail to meet.
“Many companies do still try to develop new therapies without seeking out patient and caregiver feedback on the design of studies, choice of important endpoints, dosing, or even treatment packaging,” says Day. The regulatory consultant notes that few other consumer products would enter development without consulting the envisioned consumer — yet many therapies still do.
The result is a disconnect between how clinical trial teams think about the importance of patient-centered care and what clinical trial teams do in planning and executing trials. Fortunately, “toolsets, guidances, and methodologies for incorporating patient input during the clinical stage of development” exist, write Marquerita Algorri and fellow researchers in an April 2023 article in the Journal of Pharmaceutical Sciences. The right eClinical tools can help clinical trial teams turn their abstract understanding of the value of patient-centered trials into concrete steps to understand and integrate patients’ experiences and perspectives.
Setting Up Clinical Trials That Integrate Patient-Centric Care
The FDA’s DEI guidance on clinical trials provides some insight into setting up patient-centric trials. To create more inclusive trials, for example, the FDA recommends that planning teams:
- Aim to include a representative sample of the population for whom the therapy is being developed. Enroll participants so the study population constitutes a clinically relevant cross-section with regards to age, sex, race, and ethnicity. The FDA recommends paying special attention to recruiting female patients, members of racial and ethnic minorities, and children and teens where appropriate.
- Interrogate exclusion criteria: Does each criterion help protect the safety of participants or achieve study objectives? Criteria that fall under neither of these categories should be discarded or modified.
- Specifically define the population covered by the exclusion criteria. The FDA gives the example of a study that may pose unreasonable risks to patients with advanced heart failure but acceptable risks to those with milder heart failure. In this situation, the FDA recommends specifically defining the stages of heart failure at which a patient would be excluded from the study.
- Consider whether exclusion criteria from phase II studies can be eliminated or modified in phase III trials, given the differences in objectives between these two phases.
The FDA also provides guidance on patient-centered trial design and methodology approaches, such as adaptive clinical trial designs and the early development of a broader pediatric development program.
Building a more representative patient cohort requires clinical trial teams to understand the challenges patients face. Patients themselves offer the ideal source for such information.
Many patients, particularly those with rare diseases, are well-versed in available treatments and clinical trial options by the time they sign up for a trial, writes Neha Shankar Sharma in Perspectives in Clinical Research. By having early conversations with these patients, clinical trial teams can identify gaps in their knowledge, provide necessary information, and understand the barriers patients may face in trial participation.
Identifying barriers early prevents these factors from becoming de facto exclusionary criteria. As the FDA recommends, exclusion criteria that do not protect patient safety or meet study objectives should be eliminated. If “patient cannot obtain transportation to a study site” is neither safety- nor objective-related, it should not prevent an otherwise qualified patient from participating. To identify these de facto exclusions, clinical trial teams must communicate with patients early in the planning process.
Following Through: Patient-Centric Care in Clinical Trial Execution
Using the right eClinical tools can help clinical trial teams offer a patient-centric approach. However, the tools should not be confused with the end goal, write Ronald M. Epstein and Richard L. Street in the Annals of Family Medicine. Implementing a technological tool is not a patient-centered approach “unless it strengthens the patient-clinician relationship, promotes communication about things that matter, helps patients know more about their health, and facilitates their involvement in their own care,” write Epstein and Street.
Epstein and Street were concerned with the rise of electronic health records in the early 2010s. A decade later, their advice still applies to eClinical platforms.
These and other eHealth tools can enhance patient-centered care in clinical trials, write Frank J. Penedo et al. in The Lancet Oncology, but they cannot guarantee it on their own. These tools must be implemented not as an end, but as a means to achieve the goals of communicating with patients, informing them, and involving patients in their own care as the clinical trial proceeds.
One way to embed patient-centered care into eClinical platform use is to choose a platform that integrates easily with other, related technologies. In a 2018 study of patients who used digital health technology combined with regular doctor’s visits, Penelope Schofield, Tim Shaw, and Michaela Pascoe found that much of the technology they sought to study was fragmented — and this fragmentation led to suboptimal outcomes in achieving patient-centered care.
“A personalized, integrated health care model that is responsive to consumer needs requires not just a passive repository of medical information; it would require a team approach,” write Schofield, Shaw and Pascoe. Clinical trial staff can begin to build their own “team” by choosing eClinical tools that communicate seamlessly with an eTMF, Medical Affairs tools, and other related software.
Patient-centric care requires more than merely choosing new technologies or redecorating a waiting room. It demands an unwavering commitment to improving communication, empowering patients, and cultivating meaningful relationships. The strategic adoption of cutting-edge eClinical tools serves as a pivotal means to achieve these objectives by fostering enhanced data integration and offering robust support for patient-centered care support.
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