Connecting Patients with Plain Language Summaries

The new ICH E6(R3) compliance requirements, combined with the updated Declaration of Helsinki (2024 revision) ethical standards, provide compelling backing for plain language initiatives. Use this regulatory foundation to build your business case with senior management. The question has shifted from "Why should we do this?" to "How do we implement this requirement effectively?"

Neither sponsor websites nor regional registries fully solve the access problem: company sites are fragmented, and registries remain limited to specific geographies. The only global, sponsor-agnostic solution available today is TrialSummaries.com, which addresses key implementation barriers by:

• Global accessibility: Summaries reach 165 countries with 17,000+ downloads, demonstrating genuine patient demand across diverse populations and regulatory environments
• Reduced legal concerns: Sponsor-neutral hosting minimizes promotional risk perceptions
• Simplified processes: Single point of submission rather than managing multiple company websites
• Site engagement: Provides a consistent link sites can share across all studies

Rather than implementing study-by-study, build systematic processes that work across your entire portfolio. This includes:

• Standardized consent language for new studies
• Template approaches for summary writing and review
• Clear role definitions between clinical, regulatory, and disclosure teams
• Site agreement provisions that build transparency expectations into contracts

Create clear communication bridges between your GCP compliance teams and disclosure teams. The new regulatory compliance requirements for treatment assignment disclosure and results sharing provide natural touchpoints for coordination. Many organizations are discovering efficiency gains when these traditionally separate functions work together.

Most successful organizations follow a phased approach: Start with two to three pilot studies to test your processes and identify workflow gaps. Use these learnings to develop standardized procedures, then scale across your portfolio. This approach typically takes six to 12 months from pilot to full implementation, but ensures sustainable, compliant processes rather than ad-hoc solutions.