The Trifecta of Protocol Review: Patients, Sites, and Sponsors Building Better Studies
Protocols are designed with the best intentions but do not always include the most important perspectives. By incorporating patient and site feedback early and often in the design phase, sponsors can ensure studies are feasible, inclusive, and ready for real-world execution.
Rethinking Protocol Review
Protocol design is the most consequential stage in clinical research. It defines everything that follows, including study burden, feasibility, timelines, and whether participants stay engaged long enough to deliver meaningful data. Despite its importance, protocol development still tends to happen in silos.
Protocols are most often developed within sponsor teams, which means the broader perspectives of sites and patients are missed at the outset. The process can appear efficient on paper but risky in practice. When recruitment lags or retention drops, the reasons are rarely mysterious. Procedures may be too frequent, visit schedules unrealistic, or study demands may overwhelm already stretched site teams. These challenges do not appear during execution; they are built in during design.
To create studies that work in the real world, all three perspectives must be represented. Patients bring lived experience, sites bring operational insight, and sponsors bring scientific and regulatory leadership. When these viewpoints align, protocols become both achievable and meaningful.
The Patient Perspective: Seeing Beyond the Schedule
Patient involvement in protocol design remains more aspiration than routine practice. Yet patients bring the one perspective no data model can replicate, which is the lived experience of managing a condition while navigating healthcare demands.
When patients review a protocol, they notice what others may not. They see whether visit frequency or duration would make participation unmanageable, how travel expectations fit with daily life and caregiving, and which procedures feel burdensome even when medically justified. They also see where study language confuses rather than informs.
"To create studies that work in the real world, all three perspectives must be represented. Patients bring lived experience, sites bring operational insight, and sponsors bring scientific and regulatory leadership. When these viewpoints align, protocols become both achievable and meaningful."
What may look like a small inconvenience in design often becomes a major barrier in reality. Patients frequently tell us, “I would do this once, but not every month,” or “I would need someone to come with me for that visit.” These observations reveal more about feasibility than any spreadsheet of assumptions.
By surfacing these insights before the protocol is finalized, sponsors can make practical adjustments such as spacing visits differently, refining reimbursement, or simplifying consent materials to make participation realistic. The outcome is not a diluted study but a stronger one that reflects how patients actually experience it.
Importantly, patient insight is the starting point, not the endpoint. It sets the foundation for the next perspective in the trifecta: the sites that bring these designs to life.
The Site Perspective: Turning Feasibility into Function
Sites occupy a unique middle ground. They bridge sponsor ambition with patient experience, translating complex protocols into daily workflows. Site insights build directly on what patients identify by confirming what is truly feasible within clinical settings.
"[Sites] can flag unclear instructions, misaligned visit windows, or unrealistic expectations before they become costly delays."
Site teams evaluate the same elements that matter to patients but from a practical standpoint. They know which data collection processes are sustainable, how long visits truly take, and what staffing and infrastructure are required to meet study demands. They can identify when a study schedule will overwhelm coordinators or when a small design change will ripple through pharmacy, contracting, and IT systems.
When sites are invited to review protocols early, their feedback prevents these friction points. They can flag unclear instructions, misaligned visit windows, or unrealistic expectations before they become costly delays. Site feedback is not just operational; it is strategic. It builds on patient insights by grounding them in executional reality.
When patients and sites both contribute early, the conversation becomes richer. Sponsors gain visibility into what matters to patients and what is manageable for sites. This collaboration allows sponsors to refine design choices before they become challenges.
The Sponsor Perspective: Managing Risk by Listening Early
Sponsors hold the responsibility for ensuring scientific integrity, regulatory compliance, and timely execution. Their role completes the trifecta by translating what they learn from patients and sites into design improvements that strengthen the overall study.
Sponsors also have the most to gain from early collaboration. Mid-study amendments are costly, both in dollars and in lost time. Many of these revisions stem from predictable issues such as excessive visit burdens, redundant procedures, or misjudged recruitment timelines. When sponsors integrate patient and site insights before submission, they can anticipate and avoid those risks.
Collaboration also supports regulatory confidence. Demonstrating that a protocol has been reviewed for feasibility and participant impact shows proactive attention to quality and ethics. Regulatory bodies and review boards increasingly value this approach because it leads to better retention, safer studies, and more reliable data.
For sponsors, listening early is not an act of courtesy; it is an act of risk management. It connects scientific vision with lived experience and operational expertise to create studies that are both rigorous and realistic.
The Intersection: Where Insight Becomes Prevention
The strength of the trifecta lies in how these three perspectives intersect. Patients, sites, and sponsors each bring unique expertise, but the most valuable insights arise when their views overlap and inform one another.
"For sponsors, listening early is not an act of courtesy; it is an act of risk management. It connects scientific vision with lived experience and operational expertise to create studies that are both rigorous and realistic."
Consider a recent oncology example. Patient reviewers noted that consecutive-day visits following treatment would be physically taxing. Site staff confirmed they would likely see high no-show rates during that period. By spacing those visits slightly further apart, the sponsor avoided a retention issue before enrollment began.
In another study, site feedback revealed that an electronic data capture system required hospital IT permissions that would delay activation. The issue was not apparent during feasibility planning, but it would have affected every site globally. Early identification saved time, resources, and frustration.
These examples demonstrate how collaboration among patients, sites, and sponsors transforms protocol review from a formality into a form of prevention. Small changes informed by real insight can make the difference between a smooth study and a struggling one.
Building the Framework for Sustainable Collaboration
Moving from ad hoc inclusion to consistent collaboration requires structure and expertise. Patient insight professionals play a critical role in guiding this process by connecting patients, sites, and sponsors in a way that ensures all perspectives are heard and effectively translated into action.
Across our work, several principles help make the trifecta approach sustainable:
- Engage early and clearly. Invite patients and sites to review the protocol before it is finalized, with specific questions, clear context, and realistic expectations for input. Patient insight experts can help frame these discussions so feedback is relevant, constructive, and actionable.
- Respect expertise. Compensate contributors appropriately and value their perspectives as equal to scientific and regulatory considerations.
- Close the feedback loop. Show how patient and site input shaped revisions. This transparency builds trust and encourages continued participation.
- Measure impact. Track tangible outcomes of collaborative review, such as fewer amendments, shorter start-up times, and higher participant satisfaction.
- Promote shared learning. Encourage open dialogue among patients, sites, and sponsors, not only during a single protocol but across programs, guided by those who specialize in patient engagement and insight translation.
Each of these steps reinforces the same principle: collaboration is not an optional extra; it is an essential safeguard that strengthens both science and relationships.
Conclusion: Partnership as Prevention
Protocol review is more than a procedural step. It is a chance to design studies that work for everyone involved. When patients, sites, and sponsors contribute their expertise early, the process shifts from reactive correction to proactive prevention.
The trifecta model does not replace scientific rigor or regulatory oversight. It complements them. It ensures that what looks sound in theory also functions in practice and that participants and sites are set up for success rather than strain.
When patients, sites, and sponsors collaborate from the start, they move from parallel goals to shared purpose. That is not only good collaboration. It is good science.
