We ran a Q&A with John Clarke, associate director in patient recruitment at Innovaderm on the changing landscape of patient centricity in terms of clinical trials and how the industry can navigate the evolving regulatory expectations around that.
Regulatory expectations
How are new regulatory guidelines shaping the way clinical trials are designed to prioritize patient needs?
Regulatory bodies worldwide are placing more importance on patient centricity. This involves not only increasing patient involvement in the design of clinical trial protocols, but also more closely acknowledging their journey throughout a study. How to achieve this can vary depending on the indication – dermatology versus rheumatology, for example – but what’s important is that we must take a holistic approach and consider every aspect of the research process that can impact the patient experience. One key element is the choice of sites from where sponsors and CROs recruit; the characteristics of the sites selected can have a significant impact. Regulatory bodies are also striving to ensure clinical trials include a diverse range of patients, ensuring study results are truly representative of the real-world population. This will ultimately benefit both the sponsor and future patients.
What challenges do sponsors face in aligning trial protocols with evolving diversity and inclusion expectations from regulatory bodies?
These new expectations are making CROs, and sponsors engage with populations that have potentially been under-utilized in the past – for example, for socioeconomic or geographic reasons – which will undoubtedly impact study timelines and budgets. This is especially true in industry research, which has at times been criticized for not prioritizing diversity. However, making trials more diverse and inclusive presents an opportunity to further improve the quality of our research, garnering more information to better understand potential drug biases between different patient cohorts.
Role of patient associations
How can patient associations effectively contribute to the development of patient-friendly study protocols and materials?
Patient advocacy groups are becoming increasingly prominent in clinical trials, and include not only national and regional organizations, but also people who share common struggles and engage with forums on social media platforms. They are highly desirable allies from a recruitment perspective, providing active and invested audiences who are knowledgeable about their condition and therapeutic options. It’s precisely because they are well informed about their condition that they add value to the protocol development process.
Accessibility and inclusion
What strategies can be implemented to make clinical trial reports accessible and understandable to non-specialist audiences?
Perhaps the main issue is that the language used in reporting is too technical; the industry needs to simplify communications to make trial information and results more accessible to the general population, which will also enhance the community’s perception of clinical research.
How does enhancing accessibility benefit both patients and the broader healthcare community?
Improving the accessibility of clinical trial information could help patients and the broader community to better understand the benefits of clinical research, recognize how it builds our knowledge of diseases and potential treatments, and encourage them to participate if they have the opportunity.
Diversity in trials
What measures are most effective in recruiting diverse patient populations for clinical trials?
I believe we need to clearly communicate who is most likely to benefit from clinical trials to our target populations. Patients might not initially benefit themselves but, by participating, we enhance therapeutic options, which will potentially help them or millions of others in the future. Being explicit about these facts can help to build trust and encourage more diverse patient populations to take part.
Could you share examples of successful strategies for improving representation of underserved communities in trials?
The best strategy for patient recruitment is to take a holistic approach. This includes selecting the right sites, as they know their patients better than any sponsor or CRO. They will know which methods have worked in the past and how they might reach patients to ensure diverse population representation, whether that’s approaching community centers or using digital marketing strategies. This is just the start, however, and we must also deliberately select sites that are already accessible to these populations – for example, that are open on weekends or can be reached by public transport – as well as ensure the protocol is amenable to patient needs. Essentially, we need to identify where to reach certain populations, remove barriers and provide opportunities to encourage them to participate.
Patient-centric trial design
How does patient involvement in protocol review enhance trial outcomes and compliance?
Patient input from the outset helps to improve clinical trial outcomes and overall compliance. This emphasizes the importance of understanding patient populations and their unique journeys and finding ways to reduce the burden of participating in research. The more opportunities patients must review a protocol – and the earlier in the process they do it – the more opportunities we have to incorporate their feedback. Ultimately, this leads to better outcomes and compliance in a trial. Sponsors understandably aim to maximize the data obtained from a trial, but we must remain mindful of patients’ expectations as well as their capabilities. Incorporating the patient’s perspective is vital here, as it helps us to distinguish between essential and desirable endpoints.
What tools or technologies are available to ensure trial designs remain patient-centered and adaptable?
As we move towards decentralized trials, more patients are completing study activities away from the clinic. This creates a double-edged sword as these patients often require the latest technologies, which many might not have access to – or know how to use – competing with our diversity and inclusion goals. In response, we are starting to design trials that include options to accommodate all patients while still maintaining data quality. There are a lot of competing priorities with this question, but the fact that we’re having these conversations means we are working towards making clinical trials even more patient centric, which is obviously the goal.
Future trends
How do you envision the role of patient centricity evolving over the next decade in clinical trials?
As I mentioned earlier, I think we will see a more holistic approach to research moving forward, which will be driven by enhancing patient engagement and getting their feedback earlier in the process. Involving the patient has always happened to a degree, but it is shifting from a ‘nice to have’ to essential. Overall, bringing patient involvement to the forefront will ensure it remains a central focus over the next decade.
What impact do you think increasing patient involvement will have on clinical trial timelines and costs?
I’m excited about the opportunities that increasing patient involvement holds because, ultimately, clinical trials are performed to help patients. It’s hard to say how this will impact timelines but, I would argue that eventually, having a better understanding of the journey and where to access patients will help us recruit faster. If we recruit faster, then we will save money, but there’s work needed to get to that point. We will need to try new approaches and learn from patients – implementing lessons learned along the way – which will take time and money in the process to optimize these new approaches. The benefits in the long term are certainly worth it; the time and money that is hopefully saved can be reinvested back into clinical trials, improving the quality of our research and the timelines to execute trials. Ultimately, increasing the number of drugs that enter the market, and improving our ability to help patients. If we can achieve this, then we’ve done ourselves, and the community we support, a real service.
