By Anosheh Afghahi, M.D., Senior Medical Director, Ivy Altomare, M.D., Vice President of Clinical Research
A protocol can be scientifically rigorous and still be difficult to execute.
Complex eligibility criteria can shrink the viable patient population. Study procedures may conflict with routine care. Biomarker testing can delay treatment decisions. Additional visits, data collection, and operational requirements can increase burden for sites and patients.
Too often, those barriers become clear only after sites begin translating the protocol into practice. By then, meaningful changes can be difficult to make without delaying the trial.
Paradigm Health Protocol Optimization solves these problems by helping sponsors incorporate operational considerations into the protocol design process. Protocol Optimization achieves this by combining quantitative modeling and protocol analytics with clinical review and direct engagement with investigators and site teams, helping sponsors anticipate the operational implications of protocol choices and identify avoidable design barriers before protocol lock.
Design for Execution Before Operational Problems Emerge
The consequences of protocol complexity can extend throughout study execution. Sites may decline participation when the potential patient pool is too small, struggle with requirements that do not fit within clinical workflows, or face additional burden when protocol changes require retraining, revised materials, rescreening, and renewed recruitment efforts.
A 2024 Tufts Center for the Study of Drug Development analysis found that 91.1% of oncology protocols had at least one amendment, with an average of four amendments per protocol at a cost of over $500,000 per amendment.¹
Identifying avoidable barriers before startup is far less disruptive than correcting them after sites are activated.
Sponsors are increasingly looking for ways to bring those execution considerations into development earlier. Paradigm Health has already applied its Protocol Optimization approach to projects with several top 20 pharmaceutical companies, helping development teams evaluate protocol choices before they are fixed and creating a foundation for broader adoption of the solution.
Sponsors appropriately build protocols around scientific objectives, regulatory requirements, patient safety, and development strategy. Operational feasibility, however, often receives less attention until key design choices are already established, creating a gap between what appears reasonable on paper and what site can carry out in real clinical settings, especially outside of academic settings.
Paradigm Health Protocol Optimization for Trial Sponsors
Paradigm Health Protocol Optimization helps sponsors identify avoidable execution barriers before protocol lock.
Through scenario modeling and protocol analytics, the solution helps sponsors anticipate the operational impact of protocol choices before they are finalized, testing how changes to eligibility criteria, study procedures, data collection, and other requirements may affect patient availability, site execution, and enrollment.
This supports more pragmatic protocol design by identifying opportunities to reduce unnecessary complexity, data collection, and operational burden while preserving the evidence needed to answer the study question.
What differentiates Protocol Optimization is how those analytics are combined with clinical expertise and direct engagement with investigators and research teams across Paradigm Health’s diverse network of community health centers, academic and non-academic health systems, and independent practices. This gives sponsors a more complete view of how proposed study requirements are likely to work across the patients, sites, and care settings needed to execute the trial.
The solution enables sponsors to optimize protocols across:
- Eligibility criteria and patient availability, including the impact of individual criteria on recruitable patient volume, demographic representation, and where eligible patients receive care
- Clinical alignment, including whether requirements reflect current guidelines, standard practice, and the realities of clinical care
- Study procedures and patient burden, including visit cadence, research-only procedures, biomarker and screening requirements, and treatment timelines
- Site execution and data requirements, including workflow, staffing, technology, CRF design, and other factors that influence readiness and execution
Paradigm Health Protocol Optimization translates findings into structured recommendations sponsors can use to refine the protocol, improve operational fit, and strengthen readiness for feasibility, site selection, and study activation. By combining quantitative insights with clinical judgment and direct site perspectives, the solution helps carry those recommendations forward into downstream study execution.
Learn how Paradigm Health Protocol Optimization can help design your next trial for operational success.
Reference
- Botto E, Smith Z, Getz K. New benchmarks on protocol amendment experience in oncology clinical trials. Therapeutic Innovation & Regulatory Science. 2024;58(4):645-654. doi:10.1007/s43441-024-00629-2.
