A myriad of problems can cause clinical studies to fail. For example, many research studies don’t accrue the anticipated number of participants, biostatistical approaches may be flawed, or the institution might be lacking the infrastructure or staffing to successfully carry out the study.

To address these common but persistent issues, researchers at the Southern California Clinical and Translational Science Institute (SC CTSI) wanted to do something tangible to improve study completion and overall success rates. By identifying and mitigating known barriers and risks, many problems can be anticipated, dealt with, or avoided altogether. A framework called Quality by Design (QbD), first used in the automotive industry, made this approach possible.

The team implemented the QbD approach–which involves building quality measures into the scientific and operational design of studies–with recipients of SC CTSI-funded pilots, Health System Innovation Awardees, and SC CTSI KL2 Scholars, many of whom are just initiating their first research studies. The program involves three components: QbD Design Studios, project management, and team science support. Together, these elements aim to enhance study quality and efficiency, increase the likelihood of successful study completion, and ultimately advance innovation in healthcare and public health. The SC CTSI team wrote about their approach and lessons learned in a new publication in the Journal of Clinical and Translational Science, and hope that other CTSA hubs replicate the approach to improve study completion at their institutions.

“The beauty of the program is that it maximizes the researchers’ novel ideas with logistical know-how from other seasoned experts,” added Allison Orechwa, PhD, MBA, who has been leading the initiative and served as first author of the manuscript. “We are encouraged by the preliminary findings of added value and faster study completion.”

For the QbD Design studios, the QbD specialist assembled a multidisciplinary group of faculty and staff members with expertise in a variety of areas, such as participant recruitment, biostatistics, community engagement, qualitative research, and research operations. This varied group met with the KL2 Scholar, their mentor, and a patient advocate or participant when relevant to provide their unique perspectives, help them work through various identified roadblocks, and suggest solutions. The project management element involved monthly check-ins with the QbD specialist to track progress against milestones and help resolve any issues that cropped up. Finally, the team science support ensured that collaborations went smoothly.

“By bringing together scientific, operational, and stakeholder perspectives, the Design Studio creates a structured space for study teams to identify and discuss feasibility challenges early,” said Cathelin Huang, MHS, who serves as the QbD specialist. “We aim to reduce avoidable delays and course corrections, with the goal of increasing the likelihood that studies reach completion and generate meaningful impact.”

The QbD program has been around since 2019. Now, the program offers QbD sessions to awardees of CTSI Pilot Grants, comprised of a $50,000 award for one to two years to support the development of new clinical and community-based research projects, research projects of varying size conducted over three years by the KL2 Scholars at SC CTSI, and recipients of the Health System Innovation Awards at $125,000 over two years, which are focused on improving healthcare delivery within partner health systems. In total, the team completed QbD implementation with 28 studies. The study topics were multidisciplinary and varied in nature, and included the efficacy of group versus individual medical visits in neurology clinics, a study of AI-based glaucoma screening, and more.

As for next steps, the team plans to assess the implementation and impact of the QbD program in an ongoing manner over six years, covering at least two subsequent funding cycles and three-year follow-up following award completion. In that timeframe, they plan to obtain a sample of 30 to 35 studies to further evaluate and track progress.

Read the published article:  Journal of Clinical and Translational Science