Clinical Trial Transparency & Disclosure

How to Design Plain-Language Summaries & Layperson Results That Meets FDA, EMA and MHRA Expectations How to Design Plain-Language Summaries & Layperson Results That Meets FDA, EMA and MHRA Expectations In the complex landscape of clinical trials, the importance of clear and accessible communication cannot be overstated. Regulatory authorities such as the FDA, EMA, and…

Read More “How to Design Plain-Language Summaries & Layperson Results That Meets FDA, EMA and MHRA Expectations” »

Plain-Language Summaries & Layperson Results: Compliance Strategy for US, EU and UK Clinical Programs Clinical trials are a critical component in the development of new therapies, particularly in complex therapeutic areas such as oncology. As clinical research continues to evolve, regulations surrounding clinical trial transparency have become increasingly stringent. This article provides a comprehensive, step-by-step…

Read More “Plain-Language Summaries & Layperson Results: Compliance Strategy for US, EU and UK Clinical Programs” »

Common Pitfalls in Plain-Language Summaries & Layperson Results—and How to Avoid Costly Findings As clinical trials evolve, so does the necessity for transparency in conveying results to a broader audience. Plain-language summaries and layperson results provide crucial insights to stakeholders, including patients and the public, facilitating a better understanding of clinical research outcomes. However, crafting…

Read More “Common Pitfalls in Plain-Language Summaries & Layperson Results—and How to Avoid Costly Findings” »

Plain-Language Summaries & Layperson Results in Practice: Step-by-Step Guide for Sponsors and CROs Plain-Language Summaries & Layperson Results in Practice: Step-by-Step Guide for Sponsors and CROs Clinical trials are integral to advancing medical knowledge and improving patient outcomes. As part of an increasing emphasis on transparency in clinical research, the need for plain-language summaries (PLS)…

Read More “Plain-Language Summaries & Layperson Results in Practice: Step-by-Step Guide for Sponsors and CROs” »

Plain-Language Summaries & Layperson Results Playbook for High-Profile and Late-Phase Trials Plain-Language Summaries & Layperson Results Playbook for High-Profile and Late-Phase Trials Within the landscape of clinical trials, particularly in late-phase development and high-profile studies, the emphasis on transparency and effective communication has never been more critical. Among the key components of regulatory compliance is…

Read More “Plain-Language Summaries & Layperson Results Playbook for High-Profile and Late-Phase Trials” »

Aligning Plain-Language Summaries & Layperson Results With ICH, GCP and Transparency Regulations In the evolving landscape of clinical research, ensuring clear communication of trial results is paramount. Regulatory bodies such as the FDA, EMA, and MHRA emphasize the importance of transparency, specifically through the use of plain-language summaries and layperson results. This article aims to…

Read More “Aligning Plain-Language Summaries & Layperson Results With ICH, GCP and Transparency Regulations” »

Inspection and Audit Readiness: Documenting Plain-Language Summaries & Layperson Results for Regulators Inspection and Audit Readiness: Documenting Plain-Language Summaries & Layperson Results for Regulators As clinical trials become increasingly complex and subject to scrutiny by regulatory bodies, ensuring transparency through proper documentation has never been more crucial. This guide aims to equip clinical operations, regulatory…

Read More “Inspection and Audit Readiness: Documenting Plain-Language Summaries & Layperson Results for Regulators” »