Regulatory bodies are increasingly emphasizing patient centricity in clinical trials, reshaping their design to prioritize patient needs and experiences. John Clarke, Associate Director of Patient Recruitment at Indero, leverages his extensive experience in clinical research and patient recruitment to navigate this evolving landscape. This discussion explores how new guidelines are enhancing patient involvement, ensuring diverse representation, and improving the overall quality of clinical research.
Regulatory expectations
1. 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. The approaches taken to achieve this can vary depending on the indicationâdermatology versus rheumatology, for exampleâbut we must take a holistic approach and consider every aspect of the research process that can impact the patientâs experience. One key element is the choice of sites from where sponsors and CROs recruit. This can be significantly impacted by the characteristics of the sites selected to participate in a clinical trial. 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. and this will ultimately benefit both the sponsor and future patients.
2. 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 underutilized in the past, for example, for socioeconomic or geographic reason. 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
3. 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 on forums and 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 is precisely because they are well informed about their condition that they add value to the protocol development process. I also believe we need to clearly communicate who is most likely to benefit from clinical trials to our target populations. Patients might not 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.
4. 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. One important example 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 is 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 transportâas 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
5. 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, their unique journeys and finding ways to reduce the burden of participating in research. The opportunity for patients to review a protocolâand the earlier in the process they do itâthe 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 patientsâ expectations as well as their capabilities. Incorporating the patientâs perspective is vital here, as it helps us to distinguish between essential and desirable endpoints.
6. What tools or technologies are available to ensure trial designs remain patient-centered and adaptable?
The more we move towards decentralized trials, the 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 toâor know how to useâcompeting 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 are having these conversations means we are working towards making clinical trials even more patient centric, which is obviously the ultimate goal.
Future trends
7. 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 ânice to haveâ to essential. Overall, bringing patient involvement to the forefront will ensure it remains a central focus over the next decade.
8. What impact do you think increasing patient involvement will have on clinical trial timelines and costs?
I am excited about the opportunities that increasing patient involvement holds because, ultimately, clinical trials are performed to help patients. It is 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 is work needed to get to that point. We will need to try new approaches and learn from patientsâimplementing lessons learned along the wayâwhich 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 have done ourselves, and the community we support, a real service.
The shift towards patient-centric clinical trials is transforming the industry. By prioritizing patient needs and diversity, sponsors can improve trial outcomes and compliance. This evolution promises more effective and accessible healthcare solutions, benefiting both sponsors and patients.
About the Interviewee
John Clarke, Associate Director Patient Recruitment at Indero, holds a MSc in Clinical Exercise Physiology. John has more than 15 yearsâ experience in clinical research, including 10 years heavily involved in patient recruitment. He also has several yearsâ experience in website development and social media campaign management. Johnâs expertise spans problem-solving, data analysis, qualitative research, statistics, critical thinking, and customer relations.
His leadership style is rooted in hard work, respect for individuals, and commitment to bringing out the best in everyone. Johnâs approach, combined with his extensive experience and skills, make him an exceptional figure in the field of patient recruitment.
