ICH E6(R3) & Patient Experience
- maryrburrell
- Jan 21
- 1 min read
What the New Clinical Research Guidelines Mean for You
Clinical research is changing. Here is what it actually feels like for you.
When you’re a patient or a caregiver in a clinical trial, you don’t care about "regulatory updates" or "global compliance."
You care about whether the study fits into your life. You care about whether you feel heard, safe, and respected. 👂❤️🩹
There is a new global guideline called ICH E6(R3) that is currently reshaping the future of research. But most people are never told what it actually means for them—or that these guidelines even exist.
At HeartBridge Collective (HBC), we believe you deserve to understand the systems that shape your care—in plain language, without pressure or jargon.
That’s why I’m launching a new blog series: 👉 The ICH E6(R3) Patient Experience Lens
Over the next few weeks, I’m breaking down the big ideas to answer one simple question: What does this actually feel like for patients and caregivers?
We’ll be diving into:
🏗️ Quality by Design: Why trials work better when patients help build them from day one.
⚖️ Risk-Based Thinking: Focusing on what truly affects your safety, not just paperwork.
🗣️ Informed Consent: Moving from "signing a scary document" to a real, honest conversation.
📱 Technology & Access: When digital tools actually help you—and when they cause "digital fatigue."
🤝 Clear Roles: Knowing exactly who to call so you never feel like just a number.
Our goal is Clarity, not persuasion. Understanding, not overwhelm. Trust, built through transparency.
💜 HeartBridge Collective Bridging the gap between clinical research and the patient experience.
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