Patient Centricity in Clinical Trials:

In our latest blog about clinical trial management, Lionbridge experts offer perspectives on the challenges of executing multilingual and multi-regional clinical trials.  We cover topics such as language compliance requirements, improving patient outcomes with communications, and the latest innovative clinical study language support solutions.

With our life sciences expertise, scale, cutting-edge technology, and comprehensive suite of language support solutions, Lionbridge is ready to help you develop and deliver safe medicines and medical devices.

Patient Centricity as a Key Tenet of Clinical Research

The concept of patient centricity has become a core attribute of ethical clinical research involving human volunteers. Building on strategic regulatory initiatives and guidance documents (the FDA’s Patient-Focused Drug Development, EMA’s Regulatory Science to 2025, PMDA’s Guidance on Patient Participation, ICH’s Reflection Paper on Patient-Focused Drug Development), the Life Sciences industry has demonstrated strong commitment to incorporating the patient voice into pharmaceutical product development through various approaches.

On the list of award categories included in the 2022 Reuters Events™ Pharma Awards, there are various examples of successes that patient centricity can produce:

• Establishing patient centricity as an organizational mission and strategy
• Building strategic partnerships with patient communities
• Promoting the use of plain language
• And more…

The broad remit of patient centricity in clinical research may create concern about its true alignment with patients’ genuine needs and expectations. Clinical trial participants, including patients and caregivers, are at the heart of the trial’s success. Understanding caregiver and patient insight through all aspects of the clinical trial process is vital to understanding how to achieve that alignment. It’s also critical to preserving healthy, collaborative culture. This dynamic ensures that a patient-centric approach doesn’t become something researchers must do “to” patients; precisely the mindset it was developed to prevent!

Patient Centricity and Prioritizing Positive Patient Outcomes in Clinical Trials

Compared to the scientific and technological advancements the clinical research industry brings, participants’ expectations of their patient experiences (besides those directly connected with the therapeutic results) are simple and practical. Their expectations are grounded in the daily reality of their lives. These are five factors to consider for better patient centricity in clinical research.

#1 Trial awareness: The point when a patient considers participating in a clinical trial isn’t the start of their individual patient journey. Some patients may have been diagnosed with a condition with few, or no, available treatments. Some patients may be receiving treatment but aren’t satisfied with the results. Some patients may have exhausted their standard treatment options. For all patients, clinical trials often present a treatment opportunity. Unfortunately, lacking information about these opportunities may impede their clinical trial access.

The international Perceptions and Insights Study, conducted by the Centre for Information and Study on Clinical Research (CISCRP), indicates that this impediment is ongoing, despite abundant information about clinical trials. For example, out of 11,793 respondents, a quarter stated they were “not confident in their ability to find a clinical research study right for them.”

Lack of accessible information about clinical trial options is a significant barrier to clinical trial access. It also contributes to patients’ low confidence in clinical research, hampering patient engagement and leading to inadequate patient recruitment.

#2 Trial information: Informed consent is a foundational ethical and legal prerequisite in clinical research involving human volunteers. To enable informed decision-making (whether to participate, refuse, or withdraw consent to participate), the information provided to prospective and active participants must be sufficiently broad and detailed. Giving that information to patients isn’t always straightforward. Examples of this complicated process can be found in the research by Naidoo and colleagues. This research explored the burden experienced by patients through their participation in a randomized clinical trial. The findings showed that trial information’s volume, complexity, and format may present a genuine psychological burden for patients. Study volunteers reported feeling:

• Stressed and overwhelmed
• Intimidated
• Confused
• Embarrassed to admit not understanding trial information

Trial information that’s unclear or difficult for participants to understand may do more than complicate informed consent. This information may actually invalidate informed consent due to impact on the participant’s capacity to make an informed decision.

#3 Response burden: Patient responses to standardized study questionnaires can serve as evidence for the potential benefits and risks of an investigational therapy.

These questionnaires (also known as patient-reported outcome assessments or PROs) help ensure a trial is assessing outcomes that are meaningful and important to the target patient population. However, PROs may also present challenges and inconvenience to patients. The likelihood of this effect increases in patient populations with high disease burden. This is the issue identified by regulators as requiring trial sponsors’ attention. The FDA and EMA used guidance documents (including the Draft Guidance on Core Patient-Reported Outcomes in Cancer Clinical Trials and the Guideline on the Use of Patient-Reported Outcome Measures in Oncology Studies) to call for trial sponsors to explore methods that help lessen patient response burden.

Trial participants’ difficulties and burden of completing PROs may lead to missing or poor data. Difficulties and burden may also result in participants’ disengagement and dropout from trials.

#4 Trial logistics: Taking part in a clinical trial doesn’t occur in a vacuum. Trial participants still experience the challenges, complications, and responsibilities of their own day-to-day lives. Study visits require participants’ time and commitment. They also involve practical considerations (and concerns) for the participant, such as childcare arrangements, language barriers, or financial impact from the cost of travel or other associated expenses. Coupled with emotional and physical aspects of managing a medical condition, complex trial logistics often present a significant hurdle to patients’ trial participation.

Furthermore, a hurdle for some participants can be a solid barrier for others. Adopting individual, patient-centric solutions in a trial won’t necessarily deliver desired patient outcomes. Patient centricity must be considered holistically at the trial’s planning stage. For example, providing technology to patients to facilitate patient-reported data collection is insufficient. To lessen their burden, the training and technical assistance for this technology must be adequate.

Absence of patient-centric support infrastructure to facilitate participation in a clinical trial adversely affects trial experiences and retention.

#5 Trial results: Lay summaries (also called plain language summaries) provide a compact description of the individual clinical trial and its aggregate results. They’re intended for trial participants and the general public. From a scientific and research-oriented perspective, sharing trial results helps a trial sponsor fulfill ethical obligations, as well as regulatory and legal requirements. From a patient-centric perspective, sharing results:

• Showcases commitment to transparency and accountability
• Helps build a positive rapport with target patient populations
• Furthers awareness about clinical research

Failing to share trial results, or providing incomplete or confusing information, may signal a lack of respect and appreciation for trial participants.

The Perceptions and Insights Study (referred to earlier in this blog post) revealed a geographical divide in the likelihood of people receiving trial results. Individuals from Europe were more likely to receive a summary of the study results (50%) than individuals from South America (26%) or Africa (19%). Disappointingly, the absence of post-participation communication (“not hearing back from anyone”) was a common theme among many participants.

Lack of communication about trial results or inadequate communication can negatively psychologically impact trial participants. This lack may also deteriorate perception of the sponsor’s brand image, or create or deepen negative attitudes toward clinical research.

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