How Site and Patient Research Optimizes Clinical Trials

Digital health technology (DHT) solutions are now widely adopted and applied in today’s clinical trials. But how can sponsors and clinical research organizations ensure such technologies address the needs and goals of its most pivotal stakeholders – patients and research sites? 

At Signant, to ensure that our solutions are fit-for-purpose in terms of patient and site usability, we routinely engage with sponsors, sites, and potential or current trial participants in qualitative research. We ask them about our solutions’ features, design, usability, training, and how solutions fit within workflow or working practices. 

These research outcomes have helped shape our solutions and services and provide tangible evidence that the quality and reliability of our offerings are optimized for patient and site use. 

Site and patient research insights drive optimized solutions 

“There is huge value in site and participant research and feedback, especially when it drives change, which makes working and participating in clinical trials easier,” said Katie Garner, Signant Health Senior Manager, Patient- and Site-Centred Research. 

As a result, we conduct primary and secondary research including: 

• Evidence generation. Primary research with participant groups and clinical trial site staff, including focus groups, surveys, qualitative research interviews, usability testing, and cognitive testing. 
• Evidence assessment. Secondary research and evidence gathering, to draw from other sources to generate actionable insights, for example helpdesk data analysis, published usability evidence, and industry best practices.   

Patient research provides valuable insights 

• We researched ePRO and the older population to understand their experience with mobile technology. Specifically, we explored preferences and challenges affecting learning and device use when recording ePROs and establishing “fit-for-purpose” functionality in this population. 

• We synthesized patient perspectives on ePRO solution use to assess the usability of eCOA software from numerous study-specific cognitive interviews and usability studies.  

• We carried out user testing on a pulse oximeter device and related Signant app to establish how usable and acceptable the solution was to end users. 

• And many more examples… 

DHTs such as mobile devices, sensors and wearables can generate richer insights into clinical conditions and treatment efficacy and safety. However, to ensure complete and compliant data collection, solutions have acceptable usability properties to ensure their use as intended in individual clinical studies.  

Site research collaboration improves stakeholder experience of clinical trials 

By conducting site research, we learned how a sponsor and site interacted with the TrialConsent system, what benefits and challenges they identified, and whether they were acceptable. We also gained insights related to our SmartSignals solution, as well as our eCOA BYOD Site App experience.  

Findings from the research study have been, and will continue to be, used in product planning, including identifying opportunities for product and design improvements, updating our app, and enhancing training materials.  

Similar research projects have looked at general experience of data collection, technology and workflow in clinical trials and more specifically, experience of BYOD and app studies. 

Research leads to tangible outcomes 

Signant regularly undertakes research that leads to improvements in clinical trials. The conclusions from the research are the key to addressing the needs and goals of pivotal stakeholders: sponsors, patients and sites. 

The findings from this research lead to changes, including: 

• Input into product development to guide new features and capabilities; 
• Optimal solution design for individual study opportunities and patient populations; 

• Improvements and additions to service delivery and user training; 
• Verification of the suitability of hardware (mobile devices, wearables) for use with trial participants; and 
• Contribution to the ongoing industry knowledge base to drive adoption and best practices, including peer-reviewed articles, white papers, and posters.  

Read more about our patient and site research, and see the conclusions in our latest eBook, “Signant’s Site & Patient Research Compendium.”