The Guidance for Best Practices for Clinical Trials has been developed in response to the 2022 World Health Assembly resolution (WHA75.8) on strengthening clinical trials. This guidance provides Member States with a framework for integrating robust and ethical clinical trial practices into their national health systems, enhancing the quality, transparency, and inclusivity of trials worldwide.
Based on the latest evidence, the guidance outlines key principles for conducting clinical trials, including ethical standards, regulatory considerations, and the promotion of patient-centered research. These best practices are designed to improve the efficiency and equity of clinical trials, and ensure that clinical research benefits all populations, especially in low- and middle-income countries.
Collaborative development
The Guidance was developed through a global, consultative process led by WHO with support from the WHO Technical Advisory Group on Development of Best Practices in Clinical Trials. The final guidance reflects a rich input from global stakeholders, ensuring it addresses diverse perspectives and strengthens clinical trials worldwide, in line with WHO's rigorous standards.
Aim
The aim of this guidance is to enhance clinical research efficiency, minimize research waste and provide guidance on sustained clinical trials that are always functional and active for endemic conditions and can pivot in time of emergency or pandemics. By integrating these best practices, WHO's Member States and non-State actors can contribute to better health outcomes, promote research equity and support universal health coverage.
Key messages
The tagline for the dissemination of this guidance is "strengthening clinical trials", emphasizing the following key messages:
- Prioritize public health needs: The guidance underscores prioritizing improvement of public health through clinical research, to ensure equitable health advancements.
- Strengthening research ecosystems: It advocates reforming national clinical research ecosystems, involving patients, the public, and communities to align research with public needs and sustain trust.
- Enhancing randomized controlled trials (RCTs) design and oversight: It emphasizes that RCTs should be ethical, efficient, and informative, using risk-based and proportionate methods.
- Reducing excessive bureaucracy: It seeks to address the issue of excessive bureaucracy, uncoordinated approvals, and lack of supportive environments that impede clinical research in some countries.
- Sustainable financing: It advocates for sustainable financing from domestic resources, urging countries to prioritize and fund a reformed clinical research ecosystem, which enables the work of clinical researchers.
- Economic and health benefits: Investing in a robust clinical research ecosystem yields economic benefits, strengthens the science and innovation sector, boosts public trust in health research, provides better evidence for clinical and public health decisions, enhances health outcomes, and advances health-related Sustainable Development Goals (SDGs).
- Proactive engagement with participants and communities: Researchers should proactively address local health research needs, engage communities throughout the research lifecycle, design ethical and innovative trials, and expand cross-border collaborations, where mutually beneficial.
- Supportive policymakers: Policymakers should ensure an enabling environment for clinical research. Policymakers should engage with clinical researchers to ensure that trials address local needs, and the results translate to policy and practice.
- WHO support: WHO is ready to support countries in applying the guidance to strengthen their clinical research ecosystems.
Structure of the Guidance
The guidance is structured around four core themes:
- Why clinical trials matter and persistent challenges: The role of clinical research in resolving public health challenges.
- Key scientific and ethical considerations for clinical trials: Ensuring good clinical trials that are reliably informative, ethical and efficient.
- Strengthening clinical trial ecosystem: Addressing holistic view on how to strengthen clinical trial ecosystem.
- Conclusion and how to transform clinical trials: Recommendations for diverse stakeholders including Member States, funders, and researchers.
Call to Action
"Integrate best practices for clinical trials within national health research to ensure ethical, equitable, and efficient research that improves health for all."
Different stakeholders strengthen clinical research in many ways as outlined below.
Ethics committees
Ethics committees are key to safeguarding the integrity and fairness of clinical trials. Ensure that trials comply with the highest ethical standards, particularly regarding informed consent, protection of vulnerable populations, and risk-benefit analysis. Build capacity for ethical review committees and encourage multi-country collaboration, where mutually beneficial. Support access to interventions in under-represented populations through generation of evidence in these groups. Ensure efficiency and timeliness in ethics committee review processes.
Funders
Funding plays a critical role in strengthening clinical trials. Invest in equitable, efficient, sustainable trials, with a focus on innovation, capacity-building and multi-country collaborations, where mutually beneficial.
Industry
Embrace transparency, engagement and under-represented population groups, prioritize participant safety, and collaborate with public institutions to contribute to building robust research ecosystems and support inclusive research.
International organizations
Promote global cooperation and support capacity-building for ethical and scientifically rigorous clinical trials. Foster the harmonization of regulatory and ethics standards across countries. Advocate for multi-stakeholder engagement, supporting the generation of evidence and capacity-building for quality trials that can help achieve health-related SDGs.
Member States
Member States play a pivotal role in creating an enabling environment for clinical trials. Ensure regulatory and ethics frameworks are adequately resourced, coordinated and efficient; develop sustained infrastructure and careers for clinical researchers; promote streamlining and an enabling environment to support trials that meet public health priorities.
Patient/community advocates
Advocates are essential to ensuring that clinical research are accessible, equitable, and responsive to community needs. Engage actively in trial design and implementation, so that populations are representative, interventions are feasible, and outcomes measured are meaningful. Promote responsible information sharing and demand transparency from researchers and sponsors.
Policy makers
Policy makers are essential in shaping the environment for effective, ethical, and equitable clinical trials. Create policies that foster ethical, efficient and informative trials and support ethical collaboration across sectors and countries. Support capacity building and create frameworks that promote multi-stakeholder collaboration. Ensure that policies foster transparency, inclusivity, and accountability in clinical trials, while aligning with international best practices to protect participants and generate robust evidence for health decision-making.
Regulators
Ensure that clinical trials adhere to global best practices, promoting accountability, transparency, and quality. Oversee trial quality and participant safety through risk-based proportionate oversight and harmonize requirements. Monitor timelines for approval processes to promote efficiency. Develop joint review processes and ensure that monitoring and audits are risk proportionate.Foster regional and international collaboration.
Researchers
Adopt best practices in innovative trial design, transparency, ethical conduct, and collaboration with relevant stakeholders including patients and communities. Recognize that proportionality, and risk-based quality management, is an aspect of best practices in clinical research.
