Newsletter:  October 2024

Welcome 

Welcome to the inaugural issue of the Global Clinical Trials Forum (GCTF) Newsletter—your go-to source for the latest updates and insights on strengthening clinical trials (infrastructure and environment). As we embark on this journey, our mission is to keep you informed, engaged, and inspired by the incredible work shaping the future of clinical trials globally.

In each edition, we’ll spotlight key initiatives, share progress on the implementation of the World Health Assembly resolution on strengthening clinical trials (WHA75.8), and amplify voices from across our global community. This issue focuses on the recently launched Guidance for Best Practices for Clinical Trials.

Together, we’re part of a movement to ensure clinical trials are robust, ethical, and inclusive. Your contributions are essential, and we’re excited to have you with us.

Thank you for being part of this journey!

Stay ahead in clinical trials! Subscribe to the Global Clinical Trials Forum newsletter today!"

Strengthening clinical trials, new guidance launched

On 25 September 2024, World Health Organization (WHO) launched the Guidance for Best Practices for Clinical Trials through a webinar featuring leading experts across diverse sectors of clinical trials. This timely guidance, developed as part of the implementation of WHA75.8 resolution, addresses the evolving challenges in clinical research, offering practical recommendations to enhance the quality, relevance, and impact of trials worldwide. It is a critical resource for stakeholders’ as we work together to strengthen clinical trial ecosystems.

Key messages from the guidance are highlighted in the next section. Explore the full guidance here.

What is new and how will countries benefit from the new guidance?

Maria Dutarte, Executive Director, The European Patients’ Academy on Therapeutic Innovation (EUPATI) commented on the importance of patient involvement in research.

“I am delighted to see that the WHO guidance recommends that researchers should work in partnership with patients and communities. This is likely to increase trust and confidence while decreasing the risk of important groups being excluded or the needs of local populations or sectors being overlooked or misunderstood.”

The Guidance complements other existing clinical trials guidance, with a special focus on efficiency, engagement, and under-represented populations. Countries that choose to implement it will gain the following benefits.

• Improved trust between the public and research community.
• Better locally derived evidence for public health and clinical care decisions.
• Improved health outcomes, equitable access to innovation and medical products, and progress on health-related sustainable development goals.
• National resilience and security with robust clinical trial ecosystem that can respond to health crisis.
• Healthier populations and productive economies.
• Economic benefits from a thriving science and innovation ecosystem.

Unlocking the future of clinical trials: Key actions from the new guidance

To ensure clinical trials are ethical, inclusive, and impactful, collaboration across sectors and countries is essential. The Guidance provides practical steps for diverse stakeholders:

• Ethicists: Places ethics and engagement centrally within health care and health research. Supports access to interventions in under-represented populations through generation of evidence in these groups. Ensure efficiency and timeliness in ethics committee review processes.
• Funders: 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 support inclusive research.
• International Organizations: Promote global cooperation, harmonize regulatory standards, and support capacity-building for quality trials that can help achieve health-related SDGs.
• Member States: 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: Seek to ensure that trials are patient-centered and inclusive, engage in trial design so that populations are representative, interventions are feasible, and outcomes measured are meaningful, and demand transparency from researchers and sponsors.
• Policy makers: Create policies that foster ethical, efficient and informative trials and support ethical collaboration across sectors and countries.
• Regulators: Oversee trial quality and participant safety through risk-based proportionate oversight and harmonize requirements. Monitor timelines for approval processes. Promote efficiency. Develop joint review processes. Ensure monitoring and audit is risk-proportionate.
• 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 practice in clinical research.

The guidance emphasizes inclusion as a key feature of good clinical trials, ensuring diverse populations are represented. Explore the full recommendations in the guidance here.

Now that the Guidance is here, what next?

WHO and partners, including GCTF partners, will focus on widespread dissemination. The guidance is available for free download, and key messages will be shared via diverse media including LinkedIn, conferences, policy briefs, and journal publications.

The Guidance will soon be available in other WHO official languages (Arabic, Chinese, French, Portuguese, Russian and Spanish).

You can view the launch webinar here, or access downloadable PowerPoint slides with key messages here.

In the coming weeks and months, we will share weekly threads on the practical changes the Guidance is calling for through social media.

A Global Action Plan is being developed to drive key reforms included in the WHO guidance. These include actions related to trial funding, design, approval processes, trial conduct, reporting and stakeholder coordination, aiming to accelerate timelines and ensure trials are ethical, efficient and informative.

Simultaneously, WHO is developing a number of training modules to help stakeholders apply the Guidance recommendations to real-life scenarios, covering essential elements of the clinical trial lifecycle.

WHO and partners are ready to support Member States in adapting the guidance to their national contexts and advancing the wider implementation of WHA75.8.

Stay connected for updates and contact us at wha758@who.int for any questions.

Stay ahead in clinical trials! Subscribe to the Global Clinical Trials Forum newsletter today!"