Clinical trials - World Health Organization (WHO)
May 11, 2022 · Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and ...
Coronavirus disease (COVID-19): Vaccine research and development
Aug 10, 2021 · This means enrolling people from diverse geographic areas, racial and ethnic backgrounds, genders, and ages, as well as those with underlying health conditions that put them at higher risk for COVID-19. Including these groups in clinical trials is the only way to make sure that a vaccine will be safe and effective for everyone who needs it.
A starting point, not an endpoint: WHO's new clinical trials …
Mar 22, 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, conduct, and ...
Ethical considerations - World Health Organization (WHO)
An ad hoc committee of NASEM Clinical Research issued a report (2024) that finds limited evidence of legal liability for inclusion of pregnant and lactating women in clinical research, contradicting perceptions of heightened liability, and makes recommendations to improve the evidence base for the safety and efficacy of medications for pregnant ...
How are vaccines developed? - World Health Organization (WHO)
Dec 8, 2020 · If the vaccine triggers an immune response, it is then tested in human clinical trials in three phases. Phase 1. The vaccine is given to a small number of volunteers to assess its safety, confirm it generates an immune response, and determine the right dosage. Generally in this phase vaccines are tested in young, healthy adult volunteers. Phase 2
Guidance for best practices for clinical trials
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 always functional and active for endemic ...
New global guidance puts forward recommendations for more …
Sep 25, 2024 · The World Health Organization (WHO) today released guidance to improve the design, conduct and oversight of clinical trials in countries of all income levels. This guidance aims to support stronger country-led research and development (R&D) ecosystems to advance health science so that new, safe and effective health interventions can be made more accessible and affordable globally for people ...
Clinical trials - World Health Organization (WHO)
Jan 16, 2020 · The ICTRP is a country-led initiative. Clinical trial registration happens when countries seek to improve the transparency of clinical trial research involving nationals of that country, and to be more accountable to the individuals who consent to participate in clinical research, and to better oversee and monitor that research.
COVID-19 vaccine tracker and landscape - World Health …
Mar 30, 2023 · Provides summary tables of COVID-19 vaccine candidates in both clinical and pre-clinical development; Provides analysis and visualization for several COVID-19 vaccine candidate categories; Tracks the progress of each vaccine from pre-clinical, Phase 1, Phase 2 through to Phase 3 efficacy studies and including Phase 4 registered as ...
Manufacturing, safety and quality control of vaccines
Dec 8, 2020 · For more information on the three phases of vaccine clinical trials, click here. Once a vaccine has reached pre-approval stage following clinical trials, it is assessed by the relevant regulatory body for compliance with quality, safety and efficacy criteria.