The Spark Global
atient engagement can come in different forms and serve different purposes. The COVID-19 pandemic has highlighted just how important it is to bring patients into the medicines development lifecycle, not only as clinical trial participants but as active collaborators in how the lifecycle is shaped. While many factors for effective engagement are common both during normal times and during a pandemic, the pandemic has brought to light some specifics. This article offers practical advice and tips from the perspective of patients as to how stakeholders involved in clinical research, specifically the pharmaceutical industry, academic institutions, and public bodies, like the National Institute for Health Research (NIHR) in the United Kingdom, can continue to embed the patient voice in the medicines development lifecycle despite the challenges posed by the pandemic.
- Collaboration and Consideration
- Organizational Culture and Standard Operating Procedures (SOPs)
- Value
- Innovation
- Diversity and Inclusion
1. Collaboration and Consideration
Once patients are being engaged, we need to be considerate to needs specifically around the pandemic but also in the aftermath:
- Ask patients how to make the engagement work for them, from travel to information to support.
- What feels comfortable for one person might not be so for another, regardless of what the official guidelines are at the time.
- Open dialogue is important, regardless of pandemic circumstances; however, it is more important now than ever before.
- Transparency is key. Offer as much information as possible so patients are able to make an informed decision about the engagement and be open with them about what might be practically possible and reasons why something might not be.
- Be empathetic. Every patient is an individual who has different needs and is approaching the pandemic in their own way. Do not judge their decisions, and never assume what one patient does will be what another will choose to do too.
2. Organizational Culture and SOPs
In my experience, the most effective and efficient patient engagement takes place in organizations where everyone understands the importance of the patient voice, regardless of their function area or the level at which they sit in the company. When everyone is on board, patient engagement tends to run more smoothly. Multifunction collaboration is key. During the pandemic, it is particularly important to involve legal or compliance teams as early as possible. The pandemic has posed new legal/compliance challenges due to changes in the way patients are being engaged. For example, it has not necessarily been possible to directly transfer in-person engagements to virtual ones in a compliant way. An advisory board meeting that in-person could have lasted a whole day and involve a large number of people might now have to be split into a series of shorter meetings with fewer people in order to remain compliant with pandemic restrictions. Considering these types of challenges early on, with collaboration from the right support staff, is crucial.
Processes should also be flexible, and SOPs need to be patient- and pandemic-friendly. Can contracts and invoicing be done electronically to ensure a patient does not need to venture out to a post office? Many people have been financially affected by the pandemic, so are payment terms short, and is the payment process reliable and easy to navigate? Is there flexibility in the contract terms to allow for last-minute changes in case the pandemic worsens or abates during the project? Processes that are too rigid will only make patient engagement less efficient and could even deter patients from becoming involved.
3. Value
4. Innovation
5. Diversity and Inclusion
What do we mean by diverse?
The pandemic has placed particular focus on race (or ethnicity) and age. While these are certainly important, there are other factors to consider regarding patient engagement, including:
- gender,
- disability (physical and mental, both hidden and visible),
- sexuality,
- location (rural or urban),
- socioeconomic status,
- work status,
- education,
- health and digital literacy, and
- geographic diversity.
How do we make patient engagement opportunities more accessible?
Increasing patient collaboration is one way of reducing barriers to clinical research and healthcare for diverse populations. By doing this, the life sciences industry can start to understand how the challenges specific to diverse groups can be addressed. Therefore, we need to create opportunities for a greater variety of people to be involved and included. Ways to achieve this may encompass the following:
- Involving a diverse set of high-level patient advocates to help develop patient engagement opportunities from the outset, for example as part of a patient advisory council.
- Developing relationships with patient organizations and patient leaders with unique perspectives, such as BME Against Cancer, Asian MS, Tigerlily Foundation, and Mind Out. Sometimes extensive research will be required to find such individuals and groups. Although many are local and small, they typically are highly engaged with the communities they are trying to reach. So, establishing a connection with these groups can be very valuable.
- Further utilizing virtual and hybrid environments to make opportunities more accessible, bearing in mind that digital tools might not suit everyone.
- Creating opportunities around what best suits the participants … and remembering it may not be your typical workday that offers this.
- Considering cultural and language barriers. This could include providing translation or interpretation services, for example if you’re conducting interviews, advisory panels, or focus groups; producing materials that are culturally sensitive and use inclusive language so that patients feel supported and included in the engagement; or offering anonymity to someone who might not have disclosed their condition to the wider community.
While it is important that the way in which patients are engaged during a clinical trial as participants is improved, this is not the only area of patient engagement that the industry should be looking at as we move through and out of the pandemic. Patient-centeredness within the life sciences industry has come a long way in recent years, but there is a need to ensure that the pandemic is used as a catalyst for making patient collaboration an indispensable and sustainable part at every step along the medicines development continuum. We can use the pandemic experience to create a truly patient-focused future for the healthcare and clinical research ecosystem.