The patient experience is a valuable source of information that can influence and guide the development of treatments, interventions, and healthcare policies. To gain representative and holistic patient insights, data, and trial engagement, it’s essential to understand and address the barriers those with a lived experience face and play to the motivators for engagement in clinical research and data sharing.

Patient organizations serve as advocates for patients’ needs and preferences, ensuring that these factors are considered in decision making processes. These organizations play an essential role in supporting patients throughout their care journey and serve as a crucial bridge between the patient community and other stakeholders, such as researchers, healthcare providers, and policymakers. They are best positioned to act as the trusted relationship stewards and subject matter experts for their patient communities. Their insights and expertise contribute to the development of patient-centered care models, improved treatment outcomes, and the overall advancement of the clinical industry. By collaborating with patient organizations to understand the lived experience of a disease or disorder, the acceleration of meaningful, patient-centered therapeutic advancements can be achieved for patients.

Barriers to patient and caregiver engagement

Common barriers to engagement in clinical research

One of the numerous barriers to patient engagement that is commonly expressed is geographical accessibility to clinical trial sites. Oftentimes, clinical trial sites are located far from where the patient population resides, meaning the patient and their support network are forced to travel long distances if they want to participate. In addition to the distance barrier, the time and energy it takes to manage their disease can stretch resources unmanageably thin. It takes considerable time to keep up with routine clinical visits, complete lab work, receive necessary medicine, and deal with insurance providers to get basic care covered. If the patient is able to maintain employment or is a primary caregiver at home, there is the added difficulty of building travel time into their day — along with weighing the costs and benefits of participating. These burdens extend beyond the patients themselves to their caregivers, partners, and families as well.

Another issue that may impede a patient’s ability to participate is that some trials have inclusion criteria that require patients to stop their regular treatment for several weeks before they can start a trial. Depending on the disease symptoms, this would require several weeks away from work and assistance in managing basic daily activities, which isn’t feasible for many patients. This reality means that some people will never have the option to participate in a trial which leads to a misrepresentation of study findings and can pose a significant amount of emotional and physical distress on the patients and their caregivers.

In contrast, some patients may not know they are eligible for a clinical trial. This may be due to a lack of communication from their clinical care team about their options or the clinician’s lack of awareness about the available resources. Unfortunately, in some instances trial options might not be discussed because it could require a patient go elsewhere for care. Therefore, even if a patient is eager to participate, they may not be getting the information or guidance to do so. For patients who can get into a clinical trial, they may face several potential barriers. For example, there are instances when the trial is discontinued before the study’s conclusion or delayed for indefinite periods. This can be especially difficult for patients with a limited number of years to live with the disease if they do not get into a trial, so waiting two-plus years to see if the trial will get rescheduled is a significant burden. Another example is if a patient can successfully participate in a trial, there is no standardized process for reporting findings to the patient once data analysis is complete. This leaves patients unsure about the value of their participation, what the outcomes were, and may decrease their desire to engage in future trials due to lack of clarity and not feeling fulfilled by their time donated.

Lastly, patients are often burdened by having to duplicate their efforts when providing their data and insights to multiple, disparate stakeholders, including healthcare providers, researchers, and patient registries. This repetitive task consumes a significant amount of time and effort, adding to the already complex and challenging journey of managing their health. Patients often find themselves having to navigate various systems and platforms, manually entering their information, which can be frustrating and time-consuming.

Cultural and educational barriers for patients

Cultural, educational, and technology literacy pose their own unique barriers to clinical trial participation and clinical care. Understanding the technical details of the clinical research process can be challenging for the majority of patients, especially when it comes to navigating the intricacies of technology. It is important to make a dedicated effort to translate clinical research information into a language that people without medical education can understand, while also addressing the technological aspects involved. In addition to the inherent complexities of clinical research, patients may face challenges related to technology literacy. Many clinical trials and care delivery rely on digital platforms, electronic health records, and telemedicine services, which can be unfamiliar territory for some patients. Lack of familiarity with and or access to technology and the internet can hinder their ability to access and participate in clinical trials or receive care effectively. Organizations should recognize this barrier by providing additional support and resources to help patients overcome technology-related challenges.

Furthermore, language barriers can exacerbate the issue. It is crucial to ensure that educational materials and information about clinical trials and care navigation are available in the patient’s native language and presented at a reading and comprehension level that meets their needs. Organizations should strive to bridge the language gap and ensure that all individuals, regardless of their language and reading proficiency, have access to vital information about their clinical care. Additional cultural barriers, such as the comfort level discussing personal medical information, prior or perceived potential mistreatment by the healthcare system, and socio-economic status, also play a significant role in hindering clinical trial participation.

Some patients may have concerns about how participating in a clinical trial and how genetic test results are leveraged and could impact their future healthcare coverage, employment opportunities, and other unknown factors. The coverage and protections available can vary based on the country and region in which the patient resides, further complicating the decision to participate.

Moreover, socio-economic status can act as a barrier to clinical trial participation and care options, particularly in cases where preventative procedures for heritable diseases are involved. Patients may face obstacles in obtaining access to these procedures due to clinicians’ assumptions about their health status and the general lack of urgency and prejudice surrounding patient employment and income status. The cost associated with preventative care for inherited genes can be prohibitively high, and instead of helping patients find the necessary resources to cover expenses, some clinicians advise patients to delay testing and subsequent treatments until they are financially stable. This directive can result in an indefinite postponement of preventative care and diagnosis, ultimately leading to poor health outcomes.

Motivators for engaging in research and sharing data and insights

Patients want to contribute to the understanding of their disease to help the broader community

There are numerous motivating factors to take into consideration that encourage those with a lived experience to participate in research and patient data initiatives. For example, patients want to contribute to the understanding and knowledge of their disease to help enable research developments and improve clinical care options. Another is that many people with rare and chronic diseases know others who have suffered and died from the same disease. Therefore, patients hope that by donating their data or participating in research, current and future generations of people with the disease will not have to go through similar experiences.

Focus on patient resilience and not just negative conditions

When it comes to sharing data, reducing burden on patients and caregivers and minimizing duplicative efforts is paramount. Providing an enjoyable experience and showing the value of donated data back to the contributor are table stakes when addressing motivations. There are times when researchers have specific goals for the information they want to gather from patients. However, one of the factors that may cause patients to be hesitant to share data is that the researchers’ requests often focus solely on negative experiences instead of their resilience. Not only do patients rarely have knowledge of research processes to ensure they provide a full, holistic picture of their experience, these siloed efforts can lead to administrative redundancy when only a small portion of data is requested, and it doesn’t tap into the entire lived experience journey or coordinate with broader data collection efforts for a condition or disease.

Build value and trust with patients by sharing impact and results

Another key consideration for engagement is that after a patient participates in a clinical trial, they are often left in the dark regarding the trial’s status. They may not know the trial’s results or how their contribution helped improve patient outcomes, which can lead them to feeling their efforts were fruitless. Understanding the impact and benefits of their participation is a strong motivator for patients, making it important to follow up with patients and caregivers and keep an open line of communication. When patients understand their impact and continue to see the value of their involvement, they are motivated to maintain engagement.

Conclusion

By gaining a deep understanding of patient and caregiver perspectives within the framework of their individual experiences, organizations can assume a pivotal role in advocating for and effectively conveying the significance of incorporating patient voices to other community stakeholders, including the industry and research community. This approach will not only foster patient and caregiver engagement by providing ongoing received value and ensuring their continued involvement with the organization but also drive patient-centered treatment developments.

For more information on how IQVIA works with patient advocacy organizations, please visit https://www.iqvia.com/locations/united-states/solutions/healthcare-solutions/patient-advocacy-organizations.

And you might also be interested in this white paper that delves into the topic a bit deeper: https://www.iqvia.com/locations/united-states/library/white-papers/meeting-your-patient-advocacy-mission.