Clinical Trials

Conducting clinical trials has seen significant advancements and changes in guidelines, emphasizing improved efficiency, inclusivity, and ethical standards. Here are the key aspects of conducting clinical trials today:

The World Health Organization (WHO) launched a landmark publication titled « Guidance for best practices for clinical trials » in September 2024.

This guidance serves as a foundational resource for improving the design, conduct, and oversight of clinical trials worldwide. It focuses on:

• Embedding research into health systems
• Developing sustained networks of clinical researchers
• Greater inclusivity of diverse population groups
• Simplifying complex trial approval processes
• Ensuring a risk-based, proportionate approach to design and oversight

Key Pillars of the Clinical Trial Ecosystem:

The WHO guidance outlines four key pillars for strengthening the global clinical trial ecosystem:

1. Clinical research governance, funding, and policy frameworks
2. Regulatory systems
3. Ethical oversight
4. Clinical research infrastructure

European Union Regulations:

In the European Union, the Clinical Trials Regulation (CTR) No 536/2014 has been in effect since January 31, 2022. The goal is to streamline the clinical trial application process and harmonise the assessment of interventional clinical trials among the EU Member States.

Key  milestones in 2024 and 2025:

• All new initial clinical trial applications must be submitted under the CTR using the Clinical Trials Information System (CTIS)
• By January 31, 2025, all ongoing clinical trials with active sites in the EU/EEA must transition to the CTR using CTIS

Decentralized and Pragmatic Trials

There’s an increasing focus on decentralized and pragmatic clinical trials:

• The FDA issued final guidance on « Conducting Clinical Trials with Decentralized Elements » in September 2024
• Pragmatic clinical trials are being conducted in everyday clinical settings to evaluate treatment effectiveness while maximizing applicability to real-world scenarios

Transparency and Data Sharing

Transparency in clinical trials has been emphasized:

• The revised CTIS transparency rules became applicable on June 18, 2024
• There’s a push for greater data sharing and accessibility of trial information

Conducting clinical trials involves adhering to new global and regional guidelines, embracing technological advancements for decentralized trials, focusing on inclusivity and real-world applicability, and ensuring transparency throughout the process. Researchers and sponsors must stay informed about these evolving standards to conduct effective and compliant clinical trials.