Jun 26, 2024 · The ICTRP is a global initiative that aims to make information about all clinical trials involving humans publicly available. It also aims to: improve the comprehensiveness, completeness and accuracy of registered clinical trial data; communicate and raise awareness of the need to register clinical trials; ensure the accessibility of registered ...

Sep 25, 2024 · This guidance updates and adapts the previous work of the World Health Organization (WHO) on research capacity for the context of well-designed and well-implemented clinical trials as framed in resolution WHA75.8 (2022). It aims to enhance clinical research efficiency, minimize research waste and provide guidance on sustained clinical trials that are …

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 ...

For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials.

Biomedical clinical trials of experimental drug, treatment, device or behavioral intervention may proceed through four phases: Clinical trials test a new biomedical intervention in a small group of people (e.g., 20-80) for the first time to evaluate safety (e.g., to determine a safe dosage range and to identify side effects).

Participants discussed the scope of clinical research in different countries to identify critical needs the TB trial platform could address. The discussions focused on developing a pragmatic and streamlined trial platform to evaluate new and improved TB treatment regimens that are shorter, safer and more effective for diverse patient populations.

Oct 15, 2024 · In September 2024, the World Health Organization (WHO) launched its landmark publication "Guidance for best practices for clinical trials". This pivotal document is described as "not an endpoint but a starting point" (1) for enhancing global health through robust, ethical, and inclusive clinical research. It serves as a foundational resource aimed at improving the design, …

In response to the World Health Assembly resolution (WHA75.8) on Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination, the guidance emphasizes the importance of patient, participant, and community engagement in clinical trials to ensure research aligns with public needs and maintains trust. …

Sep 25, 2024 · In May 2022, the World Health Assembly adopted Resolution 75.8, "Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination". This resolution emphasizes the urgent need to enhance both global and national clinical trial ecosystems.

Important stakeholder groups for this technical guidance include, (but are not restricted to): public sector researchers, private sector entities engaged in clinical trials, national health authorities or research councils involved in health research, clinical trial registries, research ethics bodies, national or transnational medicinal product ...