Written by WHO Secretariat for Strengthening Clinical Trials
“Clinical trials should serve the public. This guidance helps make that promise real.”
For decades, clinical trials have been a cornerstone of health progress, informing what works, what is safe, and what needs more testing. But ask a patient in a low-income setting still waiting for life-saving treatment, or a mother whose child couldn’t join a trial because of age or geography, and you’ll hear a different story. Access, equity, and participation haven’t always been at the heart of clinical research.
That’s why the World Health Organization (WHO) recently launched its new Guidance for Best Practices for Clinical Trials, a milestone document rooted in one goal: making clinical trials work better for everyone, everywhere.
So, what is this guidance?
It’s a practical, global resource that sets out what good clinical trials should look like. Not just scientifically, but ethically and equitably, too.
The guidance defines five essential attributes of a “good” trial:
- It answers a relevant health question in a scientifically sound manner.
- It respects and protects participants
- It is collaborative, transparent, and inclusive
- It fits its local context and priorities
- It delivers quality evidence without unnecessary complexity
Whether you are designing, regulating, funding, or participating in a trial, this document offers principles and concrete suggestions for making research work better, especially for those who have been historically left behind.
Why was the guidance written?
The world learned some powerful lessons, thanks to the COVID-19 pandemic. While some trials in the pandemic have delivered rapid, life-saving results, others have been too small, duplicated efforts, or failed to include the people who needed help the most.
In 2022, the World Health Assembly adopted a resolution WHA75.8 on strengthening clinical trials, urging countries to strengthen clinical trials so they are more efficient, more ethical, and more inclusive. The resolution called on WHO to develop Guidance, which was co-created with voices from around the world.
The Guidance recognizes a global truth: poorly designed or inequitable trials delay care, waste resources, and undermine trust.
How was the guidance developed?
Thousands of people across countries, cultures, and sectors helped shape this guidance.
Over the course of more than a year, WHO gathered input through:
- Global public consultations
- Regional dialogues with over 48 countries
- Technical discussions with diverse perspective holders including ethics committees, regulators, patients, and researchers
- Feedback from communities, especially in low- and middle-income settings
The result is a truly global resource grounded in real-world realities, one that speaks to both the science and humanity of clinical trials.
What is in the guidance?
The guidance is divided into practical sections focused on:
- Trial design: Aligning with real-world health needs, minimizing unnecessary complexity
- Participant engagement: Ensuring respect, consent, and fair access
- Regulatory oversight: Making ethics review and regulation efficient and risk-based
- Operational capacity: Supporting long-term systems and staff development
- Results and transparency: Sharing outcomes responsibly and accessibly
One of the strongest threads running through the guidance is this: clinical trials must include, and be shaped by, the people they are meant to help.
That means:
- Involving patients, communities, and the public from the start
- Designing trials that are accessible to underrepresented groups like children, pregnant women, older adults, displaced persons, and people with disabilities
- Building systems that are context-specific—not one-size-fits-all
The guidance doesn’t just say, “do better.” It explains how to do better, backed by global examples and recommended actions.
Regulations and Policy
To protect the important role that cash plays in the lives of communities facing vulnerabilities, policies for better cash management need to be created. Currently there are no requirements to justify the type of incentive provided or vendor choice for gift cards to research ethics boards. Ethics boards should review the choice of incentives used in research, especially when it has implications on autonomy, equity, and respectful engagement.
Recommendations
- Advocate for policy shifts within institutions.
- Collaborate with finance departments to enable safe, trackable cash distribution.
- Listen to community partners and prioritize their compensation needs.
- Inform ethics boards of the unintended harms of gift card incentives.
What is next?
WHO is moving fast from guidance to global action.
Earlier this year, WHO launched the Global Action Plan for Clinical Trial Ecosystem Strengthening (GAP-CTS). Built around nine action areas, this plan offers a step-by-step roadmap for countries and institutions to bring the Guidance for Best Practices for Clinical Trials to life, whether that means reforming ethics review, investing in digital infrastructure, or creating more inclusive trial designs.
To support this, WHO has also established the Global Clinical Trials Forum (GCTF)—a WHO managed network of interest holders from across all regions, including those in patient engagement, regulators, researchers, and funders. The Forum is a space for shared learning, co-developing implementation tools, and helping countries align research with their health system priorities.
Key initiatives already in motion include:
- A WHO Clinical Trial Training Hub to build the skills needed for inclusive, ethical, and high-quality research
- Development of a WHO Maturity Framework for Clinical Trial Units (CTUs), a self-assessment tool that helps institutions to strengthen clinical trial capabilities
- Collation of model SOPs, templates, and guidance for ethics committees, regulators, and sponsors
The goal is clear: to move beyond fragmented, project-based trials toward a globally coordinated, people-centred system of research.
Why it matters
If trials are the engines of progress, then people must be their drivers, not just passengers.
WHO’s new guidance reminds us that clinical trials are not only about data. They are about people.
About making sure everyone has a fair chance to be part of the research that shapes tomorrow’s health care.
Because trials that leave people out produce evidence that leaves people behind.
Learn more or get involved
Read the full WHO Guidance: www.who.int/publications/i/item/9789240097711
Contact us: wha758@who.int
Follow the journey: Strengthening clinical trials