3 Ways to improve the patient experience in clinical trials

The patient experience in healthcare is often the focal point of interaction between patients and their clinicians. It is frequently based on a relationship built over time and thus comes with some level of trust.

Clinical trials take a person out of that trusted environment, often in highly stressful health situations where a patient is already anxious and potentially confused or concerned. To get the best possible health and research outcomes, it is critical to prioritise the participant experience during clinical trials along with research outcomes.

While a person’s experience can influence outcomes in either setting, we see differences in what “experience” means in each and how organisations approach it.

Healthcare – the patient experience: In a speech to Harvard medical students in 1926, Francis Peabody, a physician teacher at Harvard Medical School, stated: “One of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”

Clinicians often engage with their patients on a consistent basis and establish a level of trust because of those engagements. When clinicians treat a specific acute illness or condition in the healthcare setting, there is an overall recognition that there needs to be a focus on humanity and compassion for the person, as those situations are often very stressful and uncomfortable. During these acute situations, because the interaction occurs in a healthcare setting with an innate level of authority, this often comes with a level of trust and dependency due to the patient’s perceived risk and need for the clinician’s expertise.

Clinical trials - the participant experience: Clinical trials thrust the patient into a new, often unknown healthcare setting where they are seen as a participant. Clinical trials primarily focus on the outcomes, rather than participants’ experiences during the trial. Finally, because clinical trials are research, they also must be executed with a level of rigour and control that may seem foreign compared to the typical patient experience in a healthcare setting and thus not fully understood by the participant.

Research shows that the “foreignness” of clinical trials can be mitigated and that taking specific actions can improve the participant experience during the trial. Research also shows that participants in clinical trials want to know more about the trial’s design and outcomes, which would also improve the overall experience.

In the clinical trial space, the goals are different, and therefore experiences will be different. However, there are ways clinical trials can be more participant-centric to build trust. Three recommendations include:

1. Make it convenient for participants to enrol, engage, and report results

Using technology in trial design is essential to alleviate the burden on participants and researchers. Creative and thoughtful design helps develop flexible, dynamic studies that relieve burdens without disturbing research continuity. Patients are more used to technology in their day-to-day lives, and thus solutions that engage them as participants and mimic that “everyday experience” are effective.

In a study run by an Australian CRO, the team was able to execute an entirely virtual trial that enabled them to connect with participants, collect data in real-time, improve overall participant retention, and deliver a timely outcome for the study.

Though entirely virtual trials are rare, the hybridisation of studies to include technology that enables participants and providers to connect and engage beyond in-person visits drives improved outcomes and addresses challenges associated with travel.

These kinds of hybrid studies:

• Incorporate immediacy, when needed, for reporting information.
• Educate the participants on why the trial can’t be 100% telehealth while leveraging digital solutions where possible and relevant.
• Enable clinical research to be controlled and as close to real life as possible, mimicking the experience of technology in day-to-day life within the confines of the clinical trial.

2. Use plain and easy-to-understand language

In the last 10 to 20 years, a significant movement in clinical trials indicated that participants may not understand the trial and expectations. Participants need to build trust in the clinicians explaining the trial details, which puts extra pressure on the clinician to establish trust with participants. Not all people enrolling participants have a medical background, nor can they translate the clinical trial protocol into what a real-world experience would be for the participant.

Improve language with these recommendations:

• Return to simple “kitchen table” language instead of long documents.
• Use videos, photos, and other visual tools, where relevant, to help participants comprehend the information. Meet them where they are at.
• Explain in detail why, how, and what to expect when participants take a test or record information. Follow up and share updates, including the results and how the trial is proceeding.
• Follow up after the trial and share the outcomes in a way they can understand. Do more than refer a participant to the published research.

Setting expectations with participants in the trial is vital to a positive participant experience, so that people understand why specific details are in place. This step can also eradicate uncertainty about what will happen during the trial.

For example, not all trials are set up for telehealth based on the timing of specific tasks, such as blood draws or other reporting requirements. This scenario provides an opportunity to cite how this research setting differs from a telehealth visit with a primary care physician. This explanation provides participants with information and interaction they can relate to, appreciate, and desire.

3. Reassure participants on data security throughout the trial

To combat perceived risk from participation, participants must be told that there are regulatory requirements for clinical trial platforms to protect personally identifiable information (PII) and personal health information (PHI). This means their data is secure and would only be used as the consent process outlines. Don’t assume that is understood.

It may help participants to understand more details about how their data is tracked, used, and shared.

• Help them understand that clinical trial data is de-identified – meaning it cannot be traced back to a named individual without key information housed separately from the clinical results data.

This is important for participants to understand, as they often believe the information they provide during the consent process is connected to and “identifiable” to their clinical data. This can cause unnecessary concern if not fully explained.

Given the perceived sensitivity of health data, participants must understand that they would not be identified by name, location, or other highly personal data. Data privacy in a clinical trial construct means the stored data would not be traced back to them as individuals. The only exception is if the participant consents to allow their trial data to be merged with their other health data as part of a real-world dataset.

• e-Consent data includes date of birth and medical history. This may confuse participants, so it’s important to note that their identifiable information, with limited PII/PHI, is encrypted and separated.

It’s vital to help participants understand that the data structure de-identifies clinical data and that their consent data is firewalled and maintained throughout the trial's life.

• For trials where the sponsor uses a bring-your-own-device (BYOD) model, this does add complexity to data security. However, meeting regulatory requirements still applies. Companies must think through all the constructs to ensure they are correctly applied by the technology provider(s).

To help participants understand the BYOD approach, the trial team can reassure participants about its use by explaining these points:

• The app and website don’t store the data on the device, and the data is protected in transit between the app/website and the clinical trial system.
• The data is secure, with minimal data retention and separation of data types in any third-party systems that are not a known source for the trial. However, these systems are compliant with data security standards.
• Some apps allow offline data collection. These apps temporarily store data on their devices when not connected to the internet and automatically upload it when they establish an internet connection and the data syncs. This reduces the risk of lost data, but does not reduce data retention and security standards.
• eConsent is in a different area of the system and safely stores their personally identifiable data with a firewall structure that separates it from the clinical trial data, thus maintaining the deidentification of their data.

An increased willingness to participate in clinical trials often happens when clinicians and trial teams keep these points in mind and educate participants on data security and privacy.

The next frontier - diversity and inclusion in clinical trials

As reflected in the recent efforts by regulators to define expectations for and reporting of inclusion and diversity in research, there is a continued need to make sure that research represents the diversity of the patients who would be treated. The industry acknowledges that change is overdue and that clinical trials must include more women and people of colour to ensure treatments and solutions work for all humans. This inclusive approach to clinical trials helps everyone better understand the scientific implications of different treatment options, whether therapeutics or devices, and improves overall health outcomes.

Increasing diversity and inclusion in clinical trials requires an improved focus on participant experience. Sponsors, sites, and contract research organisations can improve the participant-centric design of a clinical trial by discussing diversity and inclusion with participants, including the science and specific trial needs. They should also strive to retain participants, optimise their experiences, and help participants understand and better advocate for research.

Better integration, better experiences

Technology can help bring together patient experiences in healthcare with participant experiences in clinical trials. As one 2024 study suggests, “Digital platforms will likely evolve into singular, unified platforms that integrate external modules to generate a fully customisable system.”

The industry is already making progress integrating health record data, though work is still needed to address the larger challenges hindering broad-scale adoptability of health record-clinical trial data reusability. The more clinical trials leverage health record data sources to reduce data collection burden while leveraging new technology sources that mimic real-world technology experiences, the greater the opportunity for an improved participant experience.

Though we have seen significant progress, there is still room to go to improve overall participant experience and, with that, increase interest in participating in and contributing to clinical research. The opportunities to improve go beyond technology, though technology will play a pivotal role in driving engagement and improving participant experience.