Importance of Seeking Patient Insights to Develop Effective Decentralized Clinical Trial Strategies
Patient-centered drug development is the name of the game. Technology solutions help to broaden opportunities for patients to participate in clinical studies, help sponsors and sites monitor the patients’ progress in real time and help maintain scientific rigor in the data collection process. The industry is aware that deep insights are required to develop patient-focused protocols, trial designs, enrollment, retention strategies and shared decision-making tools. How much do we really know about the burden of disease, how patients experience their diagnostic and treatment journey, and what factors influence their health behaviors and decision-making process? And where do we get that information?
Question: Why is it important to gain deep insights into the patient and caregiver journey?
YPrime: Traditionally we only scratch the surface. We have demographic, disease, and historical data, but that doesn’t tell us much about how the patient experiences the burden of their disease or condition. On the one hand, we can gather so much valuable data from clinical trials, on the other hand, participating in clinical trials can create additional burdens for the patient. It makes sense that if we want to collect this critical data, we will want to support patients’ participation in completing study requirements by easing the burden on both patients and their care partners. Gathering these insights and applying what we learn helps us achieve both goals.
Question: How do we proactively gain deeper insights into the complexities of a patient’s diagnostic and treatment journey?
YPrime: Gathering in-depth patient insights requires going beyond a person’s condition to getting a more holistic view of their daily lives and the ecosystem of influences surrounding their health behaviors and decisions. By engaging directly with patients, care partners, healthcare providers (HCPs), and patient advocacy groups (PAGs) we can uncover the thoughts, attitudes, emotions, and beliefs that influence each unique patient population.
Question: Where is a good place to start gaining these insights?
YPrime: Obtaining protocol feedback is critical to the success of every study. This can be done through several different methods such as surveys, advisory boards, in-depth interviews with key opinion leaders, and patient workshops. It’s also important to have one-on-one conversations with patients and care partners to build empathy with internal stakeholders and deliver more patient-centric protocols. Key endpoints are, for a patient dealing with a chronic disease or even an acute condition, likely quite different from those included in a clinical trial protocol. This insight helps sponsors identify any potential barriers as well as any motivators to participation and can help avoid common, potentially costly, amendments.
Question: What are other benefits of having patient insights during drug development?
YPrime: Speaking directly to patients and/or care partners allows us to test hypothetical protocols and patient reported outcomes (PROs) to assess the burden, barriers, and motivators to participation and completing the required assessments and diaries. We can also obtain direct feedback on all patient-facing materials including outreach, education, instructions, diaries, proposed data collection platforms, and more.
Question: How else can these patient insights be used in the industry?
YPrime: The feedback gathered from patient insights work can be translated into a robust patient persona/profile that allows patient recruitment teams and sites to identify and understand who is likely to qualify medically. More importantly, this feedback helps in formulating strategies to meet patients’ needs, to improve recruitment, retention, and ensure adherence to the protocol. These patient personas/profiles are also invaluable to the post-market commercialization of the product.
Patient-centric clinical studies are a critical outgrowth of the digital health revolution, giving patients an active role in the drug development process; from clinical study design through to expanding treatment opportunities for more patients. Deep patient insights are necessary for the pharmaceutical and medical device industry to improve patient engagement and retention and to support the development of messaging, outreach strategy, adherence modeling, and patient support programs that will resonate with patients and care partners across the globe.