The Next Generation of Clinical Trial Patient- Reported Outcomes: Ambient Data

Technology is integrated into clinical trials in various ways, and as the trial landscape continues to develop, so does the role of technology. The transition from paper to electronic patient-reported outcomes (PROs) demonstrates how clinical trial assessments have evolved over time, and the next generation of data capture has arrived.

The utilization of wearables and personal devices for electronic patient data collection has increased as sponsors incorporate decentralized clinical trial (DCT) elements within the trial design. The use of hybrid trial models, which includes a mix of DCT and on-site components, has grown in popularity, particularly with the prioritization of patient-centric data capture methods.

Patient centricity has depended heavily on the collection of patient data via electronic PROs (ePROs) or electronic clinical outcome assessments (eCOAs). By meeting patients where they are and gathering real-time insights directly from the source, these tools boost patient engagement and retention. ePROs and eCOAs provide additional data points around patient experience, leading to improved clinical trial outcomes. However, the introduction of consumer technologies capable of collecting ambient data points promises to enhance outcomes even more, providing treatment faster to those who need them most.

Innovation is the Future

The next generation of clinical trial technology is already ingrained in patients’ lives. Devices such as smart watches, home pods, and smart assistants can provide new forms of data to help inform clinical trial progress.

The new patterns and signals identified by ambient data collection cannot be gathered through conversations. They provide even more insight into individual experiences through identifying data points such as patient inflection, tone, or emotional state. Alongside a reflection of the patient’s state, smartwatches can measure the location and impact of activities through real-time, individualized interactions. The amalgamation of the data obtained from conventional ePROs/eCOAs alongside consumer technologies such as smart assistants or home pods may pave the way for additional, otherwise undetected signals or outcomes.

The ultimate objective of ePROs and eCOAs is to better inform clinical trials, allowing safer, more effective treatments to reach the market sooner. Gathering ambient data provides more visibility into the patient experience, increasing overall trial efficiency and sharpening findings.

The Implementation Essentials

Though consumer technology has the potential to be an extremely valuable asset in clinical trials, there are a few factors that influence the integration of these tools.

Trust

Establishing trust between patients and the technology is crucial. If trust is not built, patient reliance and confidence in the tools will rapidly decline. A collaborative effort between global health authorities and industry leaders will be required to begin fostering a sense of trust and comfort. Engaging regulatory bodies and exploring novel use cases are needed to establish the foundation of trust in consumer technologies within the clinical trial environment.

New Use Cases

New use cases support the credibility and feasibility of ambient data capture within trials. The validation of use cases demonstrates the ways these devices can be assets for further visibility into the patient experience. Prior to integration, sponsors, regulatory agencies, and patients alike will need evidence of the feasibility of ambient data capture tools.

Regulatory Bodies

The process of publishing regulations around technology that interacts directly with patients is time-consuming. Thus, health authorities must engage in the conversations around these regulations. The successful application of innovative tools relies on the input of regulatory bodies to not only build confidence in the technology but also highlight the ways ambient data can enhance trial outcomes and patient experience.

Ambient data has the potential to transform clinical trials, however, the gap between its promise and the existing clinical trial infrastructure remains an obstacle. The industry continues to search for ways to improve clinical trial outcomes and accelerate the delivery of improved therapies, and ambient data holds unique opportunities for innovation.

The success of ambient data integration hinges on an industry-wide collaborative effort to build trust with patients, leverage use cases to demonstrate the dependability of ambient data, and promote regulatory body engagement. By implementing these measures, ambient data can be transformed into a critical aspect of clinical trial innovation, establishing a future where the development of safer, more effective therapies is driven by comprehensive patient data.

Author Details 

Anthony Mikulaschek, Vice President of eCOA -IQVIA

As vice president of eCOA operations at IQVIA, Anthony Mikulaschek manages all operations, data management, quality management, training, and eCOA project work associated with IQVIA eCOA. Anthony has extensive experience in validated system implementation, systems integration, business process reengineering, IT operations, and consulting. He has successfully led the development, delivery, and management of technology solutions for over 30 years including 26 years in the pharmaceutical sector.

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