Guidance on evidence generation for health product R&D
What is WHO's guidance on evidence generation
WHO provides guidance on evidence generation (GEG) to help researchers and product developers understand how to effectively design and conduct studies for new health products like diagnostics, drugs, vaccines, and vector control tools that will meet the evidence needs of WHO to make policy and quality decisions. The aim is to ensure that the studies produce reliable and robust data. This data is crucial for WHO's evidence review process, which in turn informs decisions on public health policies and the scaling up of successful interventions.
By following this guidance, researchers can align study designs and avoid pitfalls in execution and reporting that may lead to uncertainty about a product's true effectiveness. This reduces delays in policy decisions and helps in the swift adoption and implementation of new health technologies, ultimately improving global health outcomes
Benefits of the WHO guidance on evidence generation
Following WHO guidance on evidence generation for public health products can
- Enable developers and funders to align their product pipeline with public health priorities
- Integrate implementation and end-user needs and considerations into product R&D phases with a specific focus on the most vulnerable populations
- Improve likelihood of policy development through robust aligned evidence from multiple researchers
- De-risk investment in health product R&D
- Support ethical R&D for product development
- Facilitate product review and accelerate guideline development
Content and structure of WHO guidance on evidence generation
Guidance on evidence generation is an in depth indication of outcomes and measures to align researchers and developers and allow informative and comparable evidence to be generated in such a way that it accelerates policy and guideline development. Many of the areas proposed to be included in guidance on evidence generation are those that are included in the WHO handbook for guideline development. By preparing a specific single document on the evidence needs for a health product, the evidence developed should be of better quality to allow public health decisions.
Please read the publication on how to develop GEG for further in depth information on each area.
Guidance on evidence generation development process
The development process may be similar to a target product profile (TPP), or may build upon a TPP
- Identify the need
- Prepare the scope including anything which is already known (eg known gaps in the evidence, areas where evidence is not aligned and has caused issues in guideline development)
- Convene stakeholders with necessary experience to be involved in the development
- Develop a draft
- Consult, especially with those who will be developing the evidence
- Publish and disseminate to the necessary stakeholders
- Monitor and evaluate the outcomes
- Determine when the document needs to be retired or updated
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