Partnering with Patients and Caregivers in Clinical Research

A version of this article was previously published in the Journal of mHealth

One definition of patient-centricity is “Putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family” (Yeoman et al. 2017). That is, patients should be involved in all decisions related to their health, including in clinical trials. To achieve true patient-centricity, the authors highlighted the need to understand the patients’ needs and experiences, listen and respond to patients’ feedback with respect and humility, partner with patients to innovate and measure impact and outcomes that are important to them, and provide easy-to-understand and convenient information.

At the clinical trial level, directly engaging patients and caregivers in protocol development, study design, recruitment, manuscript or plain language summary writing, and data dissemination is key to conducting a truly patient-centric study. In theory, this approach is promising for improving clinical decision-making and, ultimately, patient outcomes. However, as Sheridan et al. (2017) reported, many researchers, patients, and other stakeholders lack clarity about when and how to engage as partners within the clinical research process.

In addition, Hemphill et al. (2020) reported that, while engaging patients and other stakeholders in research partnerships shows promise for strengthening clinical trial evidence, this requires substantial resources and effort. There are several potential challenges associated with building relationships and communicating with patient and caregiver partners, including ensuring that they feel heard and valued, as well as managing expectations about the project progress or their roles. 

In this article, we will dive into the role of digital technologies and virtual tools for partnering with patients and caregivers during all stages of the clinical trial journey.

Virtual & decentralized trials

Caregiver helping elderly patient with mobile health technology

The COVID-19 pandemic has accelerated the interest in, and uptake of, decentralized and virtual trial designs. These benefit patients by removing or reducing the need to travel to a centralized study site. Digital technologies such as virtual patient diaries, eConsent, telehealth, wearables, and mobile apps have undoubtedly improved the clinical trial experience for patients. They should not, however, be the end all be all. Now is the perfect time to rethink how you involve patients in your trials and assess where there is room for improvement.

Patient and caregiver needs assessment

Understanding the lived experiences, needs, and wants of patient and caregiver research partners, particularly their motivations and perceptions of how engaging affects their lives, can help inform strategies for developing and sustaining mutually beneficial research partnerships (Hemphill et al. 2020). There are many ways to do this, and the rise of budget-friendly virtual collaboration and communication platforms has made it easier than ever to engage patients and caregivers in a compliant, convenient manner. Virtual communication also allows normally hard-to-reach populations, such as those living in rural, remote communities or belonging to ethnic minorities, to be engaged more easily. This is crucial since diversity is notably lacking in many clinical trials.

Online advisory boards or small focus groups are ideal for needs assessments, whether with patients, caregivers, or other stakeholders. To ensure an engaging, productive two-way conversation, look beyond basic surveys and phone calls and towards comprehensive, cost-efficient virtual solutions that host a wide range of communication and collaboration tools in a single place.

Protocol co-development

Involving patients and caregivers in protocol development, study design decisions, and recruitment can help optimize the clinical trial experience for participants. Patient partners can help determine which study questions to focus on and which endpoints to include. They can ensure that the logistics around the trial are not going to add an unnecessary burden on the patients or caregivers and hinder participation. They can also help directly with recruitment and raising awareness of the trial among other patients or caregivers in their networks. If done right, this patient-centric, holistic approach can lead to more effective recruitment, higher satisfaction, better adherence, and lower drop-out rates.

All of these discussions and co-creation sessions can be held virtually, either synchronously (in real-time) or asynchronously (over-time, anytime), using innovative online tools such as interactive annotation, ranking, rating, and mapping tools. Benefits of virtual collaboration include that patients and caregivers can remain anonymous, and visibility to their responses can be customized so that some questions are only seen by the study investigators/sponsors, while others are open for all patient and caregiver participants to view. In addition, virtual collaboration removes the need to travel to attend meetings and helps overcome time zone differences, things that have traditionally limited patient and caregiver participation in protocol co-development. If the online platform offers translation and/or interpretation services, potential language barriers can also be effectively removed.

Data dissemination

Another area where investigators and sponsors should partner with patients and caregivers is manuscript writing. In some cases, patients are included as study authors; in others, they might serve in more of a consultant role and simply give input on the manuscript. They can also be engaged in creating plain language summaries, either independently or together with the investigators or a medical writer. Again, leveraging virtual collaboration solutions minimizes potential barriers for patients and allows everyone to have an equal voice in these discussions.

When it comes to sharing the trial results with a greater audience outside of the journal readership, working with patient associations to disseminate the data can be an impactful strategy. However, many patients and caregivers are unlikely to read the full study, and even the plain language summary may fail to catch their attention. In today’s digital world, alternative formats such as educational webinars, podcasts, videos, and social media posts should be considered. These can feature patients, caregivers, researchers, or health care providers directly involved in the care of the patients.

Benefits for patients and caregivers 

Caregiver (parent) and patient at a doctor's appointment as part of a clinical trialIt is not just the clinical trial investigators that stand to benefit from these partnerships. Patients and caregivers benefit directly in many different ways. Being actively involved in clinical research empowers patients and caregivers to better advocate for themselves and make better health decisions. It also allows partners to feel as if their contributions are making a difference in other patients’ lives, especially for underserved or underrepresented populations. Some feel that their contributions give them a voice and may impact clinical decision-making in the future. It may also help build new or stronger relationships with investigators and other patients in the disease community, as well as lead to better understanding and knowledge of the research and data dissemination processes (Hemphill et al. 2020).

The concept of patient-centric clinical trials is not new. However, it is unfortunately not yet standard practice to embed the patient and caregiver perspective into the decision-making and study design process. To change the research paradigm from seeing patients merely as study subjects to partners, sponsors and investigators need to think outside the box and work closely with the people impacted by their research.

About Impetus Digital

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