For decades, the clinical trial industry has asked patients for their data, their time, and their bodies. It’s time we started asking for their expertise.
True patient-centricity means shifting from passively collecting patient “input” to actively seeking patient “partnership.” This is most powerfully realized in protocol co-creation, where patients are given a seat at the design table before a single word of the protocol is finalized.
This isn’t a new idea born in a boardroom; it has deep roots in patient activism. During the HIV/AIDS crisis of the 1980s, activists didn’t ask for friendlier trials—they demanded a systemic overhaul. They fought for, and won, a role in shaping the research that would ultimately save their lives, forever changing the power dynamic between researcher and participant.
Today, the business case for this approach is undeniable. A co-created protocol is a de-risked protocol. By vetting procedures and endpoints with patient experts, you can:
- Prevent costly amendments: A single Phase 3 amendment can cost over $500,000.
- Improve feasibility: Design a trial that patients are actually able and willing to complete.
- Increase the probability of success: The FDA and EMA are clear: patient relevance is a cornerstone of trial quality.
Co-creation is the ultimate form of risk mitigation. It designs failure out of your trial from the very start. To help you begin this process, we’ve developed a practical planning tool.
Download our free worksheet: “The Protocol Co-Creation Blueprint” and start designing smarter trials, together.
