Common Protocol Pitfalls and How We Help You Avoid Them
A clinical trial protocol is more than just a plan—it’s the foundation of your entire study. Yet too often, protocols are written without fully considering feasibility, regulatory alignment, or site and study subject realities. The result? Recruitment delays, costly amendments, data inconsistencies, and ballooning budgets. At NMCG, we work with sponsors to design protocols that are clear, compliant, and built for success from the start.
1. Overly Complex Study Designs
The Pitfall: Trying to capture too much—excessive criteria, complicated visit schedules, or unnecessary endpoints—creates burdens for sites and discourages patient participation.
How We Help: We streamline study elements to balance scientific rigor with operational feasibility, ensuring protocols are right-sized for both indication and pathway.
2. Misalignment with Regulatory Expectations
The Pitfall: Even strong science can stumble if protocols don’t match FDA or global standards. Vague endpoints, weak safety monitoring, or unclear data requirements invite rejections or costly revisions.
How We Help: With former FDA reviewers on our team, we design protocols that anticipate agency questions and align with global regulatory guidance.
3. Ignoring Site and Study Subject Burden
The Pitfall: Protocols that don’t reflect real-world workflows lead to recruitment struggles and high dropout rates.
How We Help: We evaluate designs through the lens of both sites and participants, identifying practical risks early and adjusting to support stronger recruitment and retention.
4. Weak Risk and Safety Planning
The Pitfall: Insufficient risk assessments or inadequate safety oversight can trigger IRB pushback or mid-study delays.
How We Help: Our experts embed risk management and safety oversight from the outset—including DSMB and CEC planning—for smoother reviews and safer execution.
5. Unclear Study Goals
The Pitfall: Vague or conflicting objectives create unnecessary endpoints, wasted resources, and data that fails to answer critical hypotheses.
How We Help: We help sponsors define clear, measurable, and strategically aligned study goals to ensure every trial generates meaningful, intentional evidence for regulatory, reimbursement, and market success.
6. Insufficient Statistical Planning
The Pitfall: Poor statistical foresight can leave studies underpowered or inconclusive, forcing amendments or additional trials.
How We Help: Our biostatistical partners work hand-in-hand with our clinical and regulatory teams to craft regulator-ready statistical plans that align endpoints, study size, and trial objectives.
7. Neglecting Downstream Needs
The Pitfall: Protocols missing payer considerations leave sponsors scrambling for reimbursement support.
How We Help: We align protocols with FDA and payer expectations, ensuring trials generate data that supports commercialization.
The best time to fix a protocol is before it’s finalized.
Protocol pitfalls don’t just slow down research—they can derail entire programs. At NMCG, we combine regulatory expertise, operational know-how, and a client-first mindset to help sponsors design protocols that are built for compliance, efficiency, and success.
