Many sponsors, CROs, and sites are working to become more patient-centric. They may write recruitment materials in layperson’s terms, meet with nonprofits, and hold forums to understand participant perspectives.

Unfortunately, participants often feel their clinical trial experience needs to meet their initial expectations. To change this, it is essential to consider how the trials are conducted.

Patient-Centered Design

In patient-centered care, an individual’s health needs and desired outcomes drive healthcare decisions and quality measurement. Patient-centered care requires all individuals to be treated as full partners with their healthcare providers.

It is achieved by creating a relationship based on open and honest communication, respectful and compassionate care, and emphasizing the whole person (physical, emotional, mental, spiritual, social, and financial).

Clinical trials and studies with patient-centered design must consider each participant’s circumstances. Sponsors and CROs can customize the experience to fit what they know will be most beneficial to participants by surveying participants to determine their needs. It includes allowing for flexible trial durations, reimbursing travel expenses, and arranging site visits that fit into busy schedules.

The goal is to create a trial that is as convenient as possible for the person being studied while providing accurate information about the treatment. A recent study found that trials incorporating patient input took four months to recruit 100 people, compared to seven months without that same patient involvement.

Getting to this point, however, requires that all stakeholders – from parking valets to C-suite executives – work together to understand the needs of patients and how they can be met. And it’s essential to carry this patient-centric approach into post-trial communications.

Patient-Centered Recruitment

Many clinical trials are designed without the patient in mind. It can result in cumbersome trial protocols that add unnecessary burdens to participants already struggling with their condition, unsatisfactory participant experiences, and low customer perception scores for sponsor companies.

Clinical research teams can start by listening to patients. Feedback from patient advocacy groups and individual patient forums can help researchers understand how patients talk about their medical conditions and the treatments they’re considering and then craft recruitment materials in their language.

Patient-centric recruiting also means thinking about ways to make participation more convenient for patients. For example, reimbursing expenses like childcare or hotel stays for participants and their families can be an effective way to help people feel more comfortable about participating in a trial.

Another important aspect of patient-centered recruitment is providing ongoing support to participants throughout the trial. It can include resolving pre-trial operational issues, answering questions about the study, and even sending participants reminders to arrive at their appointments on time. Ongoing engagement can keep the clinical trial in mind for patients and increase satisfaction and retention rates.

Patient-Centered Care

Patient-centered care focuses on partnerships between patients and their healthcare professionals. It respects patients’ values, preferences, and expressed needs. It provides clear, understandable information about their health status and treatment.

It personalizes care to preserve a patient’s routine as much as possible. It involves patients and their family members in decision-making and acknowledges the importance of patients’ social support networks.

Patient-centered care is one of six aims – safety, effectiveness, efficiency, patient-centeredness, and equity – recognized as necessary for the quality of medical practice. However, the measures are not yet up to the challenge of ensuring that it occurs, and most healthcare organizations still treat patients more like subjects than as full partners in research.

Fortunately, many sites and sponsors are working to improve the patient experience. A recent study found that 80% of respondents said they were trying to make their trials more patient-centric. It includes designing trials to make participation as easy and convenient for patients as possible, e.g., through remote or wearable technology, and involving patients in trial design to ensure that trial outcomes are relevant to them.

In addition, patient-centric trials move through recruitment more quickly. For example, a recent analysis showed that drugs developed using patient-centric designs for neurology and oncology trials recruit 100 participants in about half the time of traditional trials, and they are more likely to be added to the drug formulary.

Patient-Centered Outcomes

Whether it’s about reducing the time needed for accrual, improving the selection and refinement of outcomes through active solicitation of patient views, or speeding the implementation of research results, patient-centeredness is vital for clinical trial success. But it’s also about delivering a meaningful experience to participants throughout the study, creating greater satisfaction, retention, loyalty, and trust for the trial sponsor.

For many patients, the patient-centricity of a clinical trial begins with accessible information, services, and support that meet their needs. By delivering straightforward, concise, and easy-to-understand content, researchers can make participants feel understood and supported, which increases the likelihood they’ll participate again in another trial.

While many trials can be adapted to fit the needs of low-income patients, some require long-distance travel or overnight stays. For this reason, reimbursing patients for expenses such as childcare, family hotel stays, and transportation can be an essential way to get the most out of a patient-centered trial and ensure that participants aren’t hindered by the barriers they may face.

That is equally important to find ways to reduce the time a participant spends at the clinic and offer flexible scheduling for those who work or have young children. It will increase the number of patients who can participate in a clinical trial and speed up the development of new treatments.

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