How decentralized clinical trial models and technology can address common CNS study challenges
The push for more patient-centricity has been a prevalent theme throughout the healthcare system. As the FDA continues to publish recommendations and guidelines on how to nurture the ideal patient experience, the list of things to remember and common roadblocks is ever-expanding. Central nervous system (CNS) trials are particularly affected, many therapies and study components require high levels of patient engagement and compliance. Below are a few areas in particular that have been recently mentioned in FDA recommendations and guidance docs that can heavily impact the success of a trial.
Having the right research approach
A recent FDA guidance document entitled Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders, emphasizes the need for proper research in drug development studies. Research should be conducted on the specific disease symptoms and currently available therapies to get a scope of what patients are currently experiencing. In order to understand what really matters most to patients, the FDA recommends consulting with industry experts, caregivers, family members of patients, doctors, previous research publications, and any other relevant information sources before developing targeted questions for actual patients.
Patient surveying and interviews are some of the most useful resources in discovering what patients are struggling with and where the opportunities for innovation lie. Patient input when developing study methods and design can dramatically affect the patient experience of a study through retention rates, satisfaction reports, patient-reported outcomes (PROs), therapy and medication compliance, and more.
Having an experienced trial management solution at the helm of CNS study design can help ensure the desired patient experience outcome through validated approaches, clinician-endorsed technology, FDA compliant protocols, and patient-centric methods. Knowing what challenges patients face and how to address them in an efficient and effective manner is the key to successful CNS research. CNS trials can be long and thus require patient retention rates to remain stable and consistent throughout. Investing time and resources into cultivating the desired patient experience can be the key to reaching study goals.
Knowing how to collect patient experience data
Having the right type of research is important to elicit the intended data from patients, but that data needs to be captured and sorted properly in order to have any insights come of it. According to the FDA patient experience data “ include the experiences, perspectives, needs, and priorities of patients” as well as their views, feelings, actions, preferences, and interactions. Having the ability to capture this information is a crucial part of any clinical trial. These data points are subjective and often very specific for each individual patient requiring data collection methods to be flexible and versatile. Patient experience data may be collected throughout a trial and at various points to gain a more holistic illustration of the patient’s episode of care.
A robust data management platform that can develop intelligent dashboards and reports from extensive data points can save sponsors time and resources when interpreting patient experience data. A system that can integrate with pre-existing EMRs while concurrently capturing new data points independently ensures a well-rounded approach to data collection that can draw useful insights from desired topics. Having the ability to cross-examine important data points including geographic location, demographics, patient conditions (i.e. pain scale), medication adherence, prescribed therapies, etc., with patient experience reports is a valuable tool in CNS research. Especially when considering the extensive data points that need to be collected during a CNS study.
How to ensure patient retention
Trial phases in CNS clinical research can take months making patient retention an important part of maintaining participant volume. It’s important for researchers and sponsors to have a way of monitoring and communicating with patients throughout this time period. The use of technology to accommodate for longer trial timelines can help keep patients engaged for the entirety of the study to ensure high outcome reporting rates.
Having a technology platform capable of implementing advanced patient engagement tactics is crucial to patient retention in CNS studies. Some examples of tactics that keep patients actively engaged in studies include SMS/email reminders, gamification of patient activities, accessible study instructions, clear prompts for next steps, and more. Having a user-friendly patient platform that incorporates these tactics can enhance retention and boost engagement rates.
Considerations for digital solutions in CNS trials
There are many considerations that go into deciding which tools to incorporate into a study design. In its recommendations for choosing digital health technology (DHT) in a clinical investigation, the FDA encourages sponsors to consider “the clinical event or characteristic of the disease or condition of interest that is to be measured, the proposed trial population, the design of the clinical investigation, and the characteristics of the DHT that may influence trial participant use.”
A CNS trial typically involves the collection of large quantities of qualitative data from patients on their conditions and several clinician-administered surveys to evaluate and diagnose CNS conditions such as Major Depressive Disorder (MDD), ADHD, and Schizophrenia. Unlike clinical research in other therapeutic areas, CNS trial outcomes are often measured with patient and clinician-reported outcomes. Being so heavily survey-based, CNS trial data quality typically relies on the level of detail able to be captured in said surveys. Making CNS studies variable candidates for digital solution integrations. Furthermore, patients in the participant populations may appreciate a remote option for reporting difficult symptoms and experiences with their CNS disease, and having an FDA compliant technology solution to enable this could increase the quality of outcomes.
There are many factors that require careful planning and consideration when building out and executing a CNS trial. Finding a solution that can handle a diverse set of responsibilities throughout the study can save sponsors time and resources at multiple points in the trial phase. To better understand challenges that can be associated with CNS trials and the ways they can be addressed, download our latest whitepaper: A guide to navigating CNS clinical trials, or see how this information can be applied in a real world setting in out CNS cast study.