The need for integrating patient engagement strategies early in the medicine development process has sparked widespread discussion in the pharmaceutical industry and beyond. This shift toward patient-centric, patient-empowered healthcare and decision-making has highlighted gaps in the current process, where patients are the lowest in the chain of command during drug development. Now, experts are turning to patient input earlier in the process, gaining an understanding of their journeys and experiences in the pursuit of more effective care and reduced inefficiencies.
Increased complexity in clinical trials coupled with immense volumes of research data has commanded a re-evaluation of how this information is collected and what it is used for. Traditionally, patient perspectives have been consolidated into unstructured data sets, including hand-written, paper-based assessments. Not only does this approach present a huge manual burden for the patient, but it also runs the risk of improper or illegible data input and subsequent access delays for sponsors.
Additionally, poor patient recruitment in the early phases creates substantial bottlenecks and delays in more than 80% of clinical trials. This presents an opportunity to overhaul the recruitment process to determine suitability for targeted trials, ultimately ensuring valuable, productive patient input.
Key Challenges with the Current State
Three key challenges exist with the current state of patient input.
- Early Patient Engagement in Healthcare
When interest in early patient involvement is gauged, many respondents' express enthusiasm and willingness to participate in early drug development. However, they need to be invited early on in the process, which is impeded by regulatory challenges and organizational hesitations toward direct patient interactions. Furthermore, there are concerns about patients’ capacity for mitigating bias based on their individual experience and their ability to participate in a complex drug development process.
- Regulatory Concerns
Without a structured framework regulating patient-generated data and real-world evidence, organizations are reluctant to implement early patient involvement. This is further compounded by a lack of regulatory requirements and, subsequently, tangible evidence to sway clinical leaders in favor of incorporating patient perspectives at this stage.
- Logistical and Cost Restraints
As a direct result of the previous factors, there are methodological challenges, such as a lack of scientifically rigorous methods, concerns about “unblinding” studies, and conflicts arising between research specialists, clinicians, regulators, and the patients themselves. Furthermore, the existing framework of validating patient reported outcomes (PROs) is a tedious and expensive process.
Areas of Opportunity
Four key opportunities exist to improve patient input.
- Evolving Regulatory Frameworks
Several regulatory frameworks are adapting to incorporate the patient voice while addressing the aforementioned concerns. The EMA is developing robust scientific methodologies with the aim of ensuring that patient voices are considered more systematically in the benefit-risk evaluation. Additionally, the FDA has been receptive to calls for more patient-centric approaches in several research initiatives. They recently announced the development of patient-focused development guidance (PFDD) documents to accommodate the collection of patient input in accordance with existing regulations.
- Patient Software (eCOA))
Digital technologies have been transformative in capturing large volumes of data with expanding clinical research initiatives. The incorporation of electronic clinical outcomes assessment (eCOA) wearables has been instrumental in addressing the question of balancing early patient involvement with logistical concerns. Leveraging sensors and wearable devices facilitates the collection of patient information, generating 1,000 data points per second or 33 million readings per patient annually. Furthermore, these vast amounts of information can be collected while reducing on-site visits and direct patient consults, lessening the administrative burden on patients and providers alike. Furthermore, the use of eCOA over paper-based approaches enhances data quality through guided responses, medication reminders, and content libraries, which aid patient comprehension and adherence.
- Improved Quality of Care
In the current state, the patient perspective is often filtered through the lens of the provider or regulator, eliminating vital data points that can drastically impact how patients respond to the therapeutic. It’s time to view the patient as more than the conceptual “end-user” and seek their real-world input at each stage in the development process. Not only does this provide potentially influential information on long-term drug efficacy, but it also empowers patient groups with an understanding that their individual experience is valued in tandem with lab data, leading to elevated standards of care and increased adherence to treatment.
- Multilingual Communication
Language barriers are a huge roadblock to incorporating the patient voice into drug development. Recruiting and engaging patients into the early stages of the process requires effective communication from the get-go. One way to drive this change is by offering robust, holistic language services to ensure you are capturing a broader recruitment pool that is not limited to one language group.
The benefits of including diverse sociolinguistic groups include increased scope of input and better understanding the challenges and concerns unique to their specific communities. In turn, this facilitates transparency between patients and provider. Long term, it enables drug development teams to consider how addressing diverse patient input can impact drug adherence and treatment efficacy and identify the gaps that need to be filled.
Prioritizing Patient Engagement and Input Seamlessly
Despite the benefits, there are many obstacles in the pursuit of patient engagement in the early stages of drug R&D. Although it is widely acknowledged that patients are central to development programs and regulatory decision-making, integrating the patient voice is still a challenge. A key way to tackle this is by rethinking product development through patient engagement strategies and perspective. In doing so, the goal of improving patients’ health and well-being can be better achieved, and patients can begin to understand and see the value of their input in developing effective therapeutics.
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