WHO has released guidelines on best practices for conducting clinical trials: what trials should look like today

WHO presents guidance on best practices for conducting clinical trials: what trials should look like today

The World Health Organization has published the document “Guidance for Best Practices for Clinical Trials”, which provides a modern understanding of what clinical trials should look like to generate real evidentiary value. The guidance is addressed to governments, research centers, regulators, ethics committees, and infrastructure organizations.

Why this guidance is important:

WHO emphasizes that research is being conducted ineffectively in many countries. The COVID-19 pandemic has become a critical test: of more than 22,000 registered trials, only a small fraction have produced data suitable for clinical recommendations. The main reasons are fragmentation, weak infrastructure, poor design, and an overload of formal procedures.

Key Principles of Qualitative Research

• Focus on Substance, Not on Formality

Quality is determined by the ability of a study to provide a reliable scientific answer, not by the number of documents or the complexity of procedures. The most important goal is to minimize systematic errors.

• An Ethical Approach Based on Justice

WHO recommends expanding the participation of previously excluded groups:

— children,

— pregnant women,

— elderly patients,

— people with comorbidities.

The "safety" exclusion often results in these groups lacking data for clinical decision-making.

• Modern Research Models

WHO supports the implementation of:

• adaptive designs,

• platform studies,

• decentralized trials,

• use of real-world data (RWD).

These approaches enable rapid evidence generation and the conduct of large-scale, sustainable studies.

How does WHO envision an ideal research ecosystem?

The document describes four key components:

• Research governance and funding,

• Effective regulation without unnecessary barriers,

• Modern ethical review,

• Clinical research infrastructure: centers, personnel, technologies, networks.

Funding as a Critical Factor

WHO recommends that countries allocate at least 2% of their health budgets to research and development of research infrastructure. Without sustainable funding, it is impossible to ensure the quality of clinical trials.

What the Guide Provides to Countries and Research Centers

WHO offers a practical framework for systemic reform:

• transition from many small projects to large, meaningful studies;

• replacing bureaucracy with risk-proportionate oversight;

• Developing human resources and research infrastructure;

• Strengthening ethical and regulatory review;

• Increasing transparency and openness of data;

• Supporting sustainable research networks rather than ad hoc initiatives.

The WHO document can be found at this link (https://drive.google.com/file/d/18_ubk_bikMaaSsK2lknCCsQRXSA3sQvo/view?usp=sharing)