When it comes to clinical trials, the informed consent process is one of the most critical — and most challenging — touchpoints in the participant journey.
The goal is simple:
✅ Ensure participants understand what’s involved.
✅ Explain the risks and benefits.
✅ Help participants make a truly informed choice.
Are Participants Informed — or Simply Overwhelmed?
🔹 Are patients informed?
🔹 Are they overly informed?
🔹 Or are they overwhelmed into simply signing?
The challenge lies in striking the right balance — enough information to make an informed decision, but not so much that participants disengage entirely.
When potential participants are faced with dense, technical, multi-page documents, do they truly understand what they’re signing up for? Or do they skim the content, sign the form, and hope for the best?
Real-World Example: Biomarker Breakdown – Necessary or Not?
Consider this scenario:
A clinical trial involves measuring Pyridinium crosslinks: deoxypyridionoline, pyridinoline — biomarkers used to assess bone resorption.
Should the informed consent form explain:
🧪 What these biomarkers are?
🧪 How they are measured?
🧪 Why they matter?
Plain Language is About More Than Simple Words
Using plain language isn’t just about replacing complex medical terms with simpler ones. It’s about structuring information so that it’s:
✔️ Easy to follow
✔️ Manageable in length
✔️ Highlights the most important points
✔️ Provides optional deeper dives for participants who want to explore further
What Do Participants Really Need (and Want)?
This raises a critical question:
💬 What do participants actually need to know upfront to make an informed decision?
💬 What information could be provided later, if participants want to dig deeper?
Would most participants prefer a clear summary of:
🔹 Procedures
🔹 Timelines
🔹 Key risks
Or should they receive a scientific deep dive — even if most will never read it?
💬 What do you think informed consent should look like in 2025?
Let’s work together to make trials more transparent, inclusive, and patient-friendly — without overwhelming participants or compromising compliance.
