Improving Patient Care: 6 Strategies for Research Sites

Improving patient care at clinical research sites is essential to the overall success of clinical trials. Not only does this serve the immediate well-being of participants, but it also lays the groundwork for successfully advancing therapeutic development. When you as a research site work to improve patient care during a clinical trial, you are able to cultivate widespread trust in medical research, accelerate the process of turning research findings into real-world medical solutions, and enhance patient outcomes.

But, how to improve patient care in clinical trials?

When you commit to better patient care at research sites, you support the integrity and success of clinical trials. The end result: You contribute to better healthcare for the whole patient population. Here are 6 strategies sites can implement to improve patient care:

1. Democratize access to clinical trials for diverse patients;
2. Dedicate attention to patient education, preferences, and morale;
3. Follow up with patient referrals quickly upon receipt;
4. Implement electronic source data capture;
5. Provide pre-screening logs to the trial sponsor and prioritize routine communication;
6. Confirm site technology has proven data security and privacy.

Sites around the world (including Brazil) are already implementing these strategies in their daily workflows. Keep reading to see how.

(1) Democratize access to clinical trials for diverse patients

Improving patient care starts at the beginning of the clinical trial process: recruitment. It’s critical to ensure that patients have sufficient access points to trials, and to ensure that patients from all backgrounds have that access.

The A.C. Camargo Cancer Center in São Paulo, Brazil, democratizes access to clinical trials for diverse patients through internal and external channels, said Tatiany Barreto Aguiar de Souza, senior patient recruitment analyst. “We receive potentially eligible patients from other hospitals and clinics and also from the Brazilian Public Health System (Sistema Único de Saúde). Our aim is to offer innovative treatments to those who can benefit from these clinical studies. As for research participants who live in other states in Brazil, we have a finance department that only manages airline tickets and accommodation (approved in advance by the sponsors), in order to organize the visits and not burden the patients with travel costs.”

Additionally, the team routinely looks for innovations such as recruitment platforms and apps to boost access for health professionals and patients to their studies. “We always keep our institutional website up-to-date, and emphasize weekly with … our patient referral partners what studies are open for recruitment,” de Souza said. “In addition, we have a network of doctors who refer external patients to our research center. We also carry out active searches in our computerized health system.”

The team at São Lucas Clinical Research Center in São Paulo, Brazil takes a similar approach with internal and external resources. “We are located on the health campus, next to a university and a large university hospital, which guarantees access to outpatient, emergency, and inpatient care,” said Flávio Magaldi, new business coordinator. “Access to the hospital's database and physical facilities guarantees heterogeneous and diverse recruitment, and direct contact with the potential participant makes the process humanized and agile. For recruitment, we look for patients in specific medical outpatient clinics and use open recruitment campaigns on social networks, following the criteria established for each trial.”

(2) Dedicate attention to patient education, preferences, and morale

Patient centricity, or prioritizing patient well-being and experience, can increase patient engagement and retention.

At São Lucas Clinical Research Center, their patient-centric approach to trials includes a focus on the individuality and well-being of each patient. “We strive to maintain close and transparent contact, clarifying any doubts and continuously informing them about the progress of the trial and the evolution based on the collected analytics,” Magaldi said. “We strive to create a welcoming and safe environment where participants feel confident and well cared for. In addition, we respect participants' preferences, allocating their visits with their doctors of choice whenever possible. We ensure that they are fully involved in the trial process, informing them in advance of any specific visits or procedures. We provide test results whenever requested and make ourselves available as a reference for any clinical situations, offering consultations with nutritionists, psychiatrists, and cardiologists to meet all the participants' needs. This personalized and comprehensive approach aims to guarantee high-quality care and a positive experience for all trial participants.”

Additionally, the São Lucas Clinical Research Center team prioritizes ongoing patient education on topics including:

• the chances of allocation to different trial arms;
• how the trial will be conducted, including the frequency and duration of visits;
• the importance of remaining in the trial for follow-up examinations and disease progression;
• benefits and potential risks.

At A.C. Camargo Cancer Center, the research team has established a culture of integrating clinical research with the other areas of healthcare, including laboratory, imaging, nursing, hospitalization, and reception. This ensures that research patients can be easily identified and given the best guidance on the day of their visits, said de Souza. “We have created an internal identification in our internal system for patients included in clinical trials, in order to make it clear to all employees that that specific patient is part of a clinical study and needs specialized guidance.”

At Centro de Pesquisa Clínica São Francisco na Providência de Deus in São Paulo, Brazil, the team treats communication as a critical way to overcome the risk of insufficient patient adherence and lack of motivation. Specifically, that looks like “​maintaining good communication with the participant, explaining since the start of recruitment what the monitoring and assistance will be like, and how long the treatment is expected to last,” said Mariana Rodrigues Zanona, nurse and clinical research coordinator.

(3) Follow up with patient referrals quickly upon receipt

Timely communication with patients can keep patients motivated and reassured that they are sufficiently progressing through recruitment. This element of a positive patient experience can reduce chances of dropout and extra recruitment costs. As soon as you receive patient referrals in the system where you manage pre-screening, make sure staff can quickly review patient information and follow up with those referrals to finish any remaining pre-screening tasks. This ensures you connect with patients while their interest in trial participation is at its peak, setting the foundation for a stronger patient-to-site relationship for the duration of the enrollment and treatment phases.

(4) Provide digital pre-screening logs to the trial sponsor and prioritize routine communication

Without early insights into recruitment and enrollment progress, there’s very little sponsors can do to identify and address barriers to enrollment. Helpful insights include eligibility criteria that are disproportionately affecting patients or subsets of patients, as well as patterns in reasons patients decline to participate in a trial. You can quickly solve that gap in visibility by routinely sharing pre-screening logs with the trial sponsor. With that information, the sponsor can proactively address perceived patient burdens and reduce barriers to participation, which ultimately supports you in enrolling eligible patients faster and more efficiently. Not only does this improve the patient experience, but it eliminates unnecessary roadblocks in your workflow that delay enrollment.

For the team at A.C. Camargo Cancer Center, pre-screening and recruitment strategy can go hand-in-hand. “We are always open to participating in meetings with sponsors in order to discuss the best recruitment strategies for certain studies and actions to be implemented to reach our recruitment goal,” de Souza said. “We are also open to filling in pre-screening logs.”

The team at São Lucas Clinical Research Center implements pre-screening practices while also keeping up a regular cadence of communication with sponsors with an emphasis on ensuring patient safety. “Our team optimizes collaboration with sponsors through transparent, ethical, and effective communication,” Magaldi said. “We prioritize openness in all interactions, communicating any complications immediately and clearly. This approach allows all parties involved to be aware of day-to-day situations, ensuring mutual collaboration and trust. We ensure weekly communication about specific points that need attention and discuss critical points that could affect the safety of participants on a daily basis. We are committed to responding to sponsors' demands in the shortest possible time, always informing them of the deadline for resolution.”

(5) Implement electronic source data capture

With eSource, you can shorten patient visit times by 25 minutes while enabling more attentive interaction between site staff and patients during those visits. Not only does this save staff time, but shorter patient visit times can improve patient satisfaction by minimizing the disruption to their daily lives, and by lowering the burden of participation. When visits are efficient and well-organized, patients experience less waiting time and inconvenience, which can alleviate the stress and fatigue associated with frequent visits. This efficiency demonstrates respect for the patients' time, enhancing their overall experience and willingness to remain in the trial.  

(6) Confirm site technology has proven data security and privacy

Patients need to be able to rely on their site teams to handle their personal information with complete care and respect. This protection establishes trust between participants and researchers, an essential piece of successful trial recruitment and retention. Make sure your technology:

• Automatically de-identifies any patient information that transfers to sponsor dashboards;
• Includes secure access controls;
• Complies with applicable data protection regulations.

Additionally, make sure your patients are informed about how their data is used, stored, and protected.

With key tactics and technology, research sites can improve patient care easily and effectively.

Enhancing communication with sponsors and patients, implementing eSource and secure technology, simplifying access to trials, emphasizing patient education and morale support – these are just a few strategies your site team can lean into to benefit patients. Regardless of your approach, there are many metrics for improved patient care that you can track, including:

• Shorter visit times;
• Enhanced safety;
• Trial completion;
• Patient satisfaction and motivation;
• Faster enrollment timelines.

When you determine the best ways for how to improve patient care at your site, you can expect better patient outcomes and experiences. This all ladders up to greater trust in, and better data from, clinical trials overall.