In a world where patients are asking more questions and expecting more from their healthcare, we need to design trials that are truly focused on both the care provider and the patient perspective if we want to make clinical research more accessible. However, what may seem obvious on first pass in the development of a patient and carer profile may be layered with multiple individual characteristics that speak to different needs. To achieve increased accessibility, we need to be more curious about the patient and their care providers and design trials in a way that seamlessly integrates into their daily lives.
Conversely, the operational realities of clinical research cannot allow for infinite variability and will always require a balance between patients’ optionality and trial feasibility. Planning a patient-centric clinical trial therefore requires a deeper understanding of the unique patient and care provider challenges and significant forethought into the trial’s virtual capacities to accurately determine the services, processes and workflows required within the trial’s ecosystem.
One of the goals of an effective modern trial design is to increase access by reducing participation barriers, and a second is to increase retention once the patient is enrolled. Infusing the patient and care provider perspective into trial design also brings the opportunity for more representative diversity and can ultimately improve the patient experience. For these reasons trial design must begin with an honest assessment of patient perspectives.
When designing a trial, we need to consider who the patients are: their demographics, disease cohorts, and geographies, and examine the challenges these patients face in relation to these categories and characteristics in the context of their existing experience with their trusted healthcare providers. Analysing patient surveys, organising focus groups, and engaging PAOs are tools that can help us to understand what is important to these patients and avoid the pitfalls of overgeneralisation or making assumptions that can lead to irrelevant solutions. Organizing and identifying common perspectives rather than creating profiles can better inform the design and help to fit elegance into common trial components to accommodate our diverse daily lives.
To challenge this assumption on a personal level, I recently conducted a qualitative research focus group to explore the dynamics that are in play for care providers and patients in a healthcare and clinical trial setting, and how we can leverage that insight to design trials that maximize the utility of simple virtual trial elements, minimise disruption, and ultimately build virtual capacity into clinical research. I asked individuals in my personal network, friends, family, neighbours, and colleagues about themselves, their healthcare experiences and where they felt there was room for improvement in the process. The anecdotal evidence collected from 20 persons aged 7-70 uncovered some unexpected variations that can inform approaches to patient centric design.
What did I find? The patient perspective is not a monolith, and some preconceptions around cohort similarities and their assumed needs may require closer inspection. For example, focus group participants, Sarah and Veronica’s profiles may look similar at first glance: both are full-time employed, 30-something females with similar background and family units. It would be easy to translate their commonality as representing similar barriers, needs and desires within a healthcare or clinical research environment. However, their health conditions, lifestyles, work, and social dynamics diverge, manifesting in different requirements and considerations for their trial experiences and needs from their healthcare team. What is important, engaging, or convenient for Sarah may not be so for Veronica and vice versa, so the solutions provided to them may differ.
Needs and feasibility assessment
After investigating the patient perspective, we must ask ourselves what solutions are available to us to support care providers in meeting patient needs throughout their clinical trial journey. Based on the interviews conducted with the sample patients, we can assess the kinds of tools, support, options, and resources that will improve accessibility and convenience for each patient, even though how they use them to bring value might differ.
To further highlight the differences between seemingly similar patients, let us look more closely at the needs of Sarah and Veronica:
- Sarah would likely benefit from more virtual options and flexible hours. As such, offering online booking and telehealth options, or providing assessments and resources virtually with timely transparent feedback would likely fit her fast-paced lifestyle.
- Veronica, on the other hand, would be more likely to appreciate open community and conversation. Patient virtual communities, proactive and direct-to-patient support would provide the human relationship and connection that is often important for patients with certain conditions such as chronic disease.
In summary, both might benefit from virtual community tools, but how they would use these services may differ significantly.
Determining what is important to patients and their care providers and the types of remote and virtual options that would help trials fit into their daily lives allows us to tailor their experience to a certain degree. However, there is a limit to the ability to personalise a trial experience; it cannot be endlessly customised. We need to identify what is common and then assemble a solution that enables unique applications of those common elements.
Assembling the solution
As the industry increasingly adopts modern clinical trial approaches, we have collectively generated a variety of digital and remote solutions to suit specific needs or enable certain trial elements and to empower sites and their patients. There are options to suit virtual capacity requirements and make space for patients, though the reality of operationalising the trial will require careful and creative considerations to assemble the best-fit solution.
To keep patients and care provider needs at the core, consider these four elements while planning virtual building blocks for your trial: flexibility, consistency, creativity, simplicity.
Identify the fundamental components that facilitate your trial’s virtual dimensions, then assess their flexibility to meet multiple requirements or serve several functions when used in a variety of combinations. For example, can the solution or method provide options for patients with unique needs or preferences? Do the solutions fit well together, flex to cover gaps and remain consistent in their delivery?
Once you have selected the building blocks, get creative. Explore novel ways to assemble these building blocks to identify options that you may not have considered previously, then simplify. Creative solutions only work if they are simple enough to be executed.
During planning, it is important to include cross-disciplinary teams to provide more comprehensive problem-solving and varied perspectives on what core components will have the highest impact on the patient experience in your modern trial.
Our modern clinical research approaches allow for a profound opportunity to improve patient centricity, leading to other benefits, improved efficiency and reduced burden for patients and sites, if operationalised in the right way. There is a plethora of potential solutions on the market that could provide patients and care providers with the options they require or desire, to increase their accessibility and engagement in clinical trials, resulting in improved retention rates and better data collection. However, as clinical trials continue to grow more complex and scale across countries, the feasibility of including these technologies must be assessed hand-in-hand with both patient centricity and simplicity. No two patients and no two trials are the same, therefore the effective modern strategies and best-fit digital solutions for each trial will vary depending on the needs and feasibility assessments.
By Madelaine MacKay, Senior Director, Product Management, ICON
The post Turning Clinical Research into Virtual Capacity appeared first on .