WHO guidance for best practices for clinical trials

Clinical trials have a central role in generating the evidence needed to inform the development and implementation of health interventions. This is because they can reliably determine whether a health intervention has any effect by ensuring that any biases or random errors inherent in the study design are small with respect to the expected treatment effect. The results have been transformative in advancing global public health. 

The intent of the ‘World Health Organization guidance for best practices for clinical trials’ document is to support implementation of universal ethical and scientific standards and strengthen the clinical trial ecosystem, with a focus on under-represented populations. It is also complementary to other good clinical practice initiatives. 

Join us for an overview presentation on the WHO document which spans all regions and nations and is applicable across all health product lines: any design, health intervention, purpose, setting and role. 

Target audience 

Any clinical trial staff member whose work is related to clinical trials in any way. This includes in planning, conduct, analysis, oversight, interpretation, education and funding of all clinical trials in which randomization is used to assess the effects of any health intervention for any purpose in any setting. 

Learning objectives 

The learner will be able to: 

• have an awareness of the main issues and steps required to facilitate good clinical trials and reduce waste, 
• identify the qualities of a well-designed, well-implemented and clinically relevant trial, 
• use a framework and tools to self-evaluate whether a team has adequate infrastructure (physical and trial personnel) required to conduct an efficient high-quality trial, 
• list the competencies that should be demonstrated by a clinical research team to undertake a successful study, 
• lead a discussion on the strenuous efforts needed to be made, to recruit diverse populations to clinical trials.

Presenter

Jean Smart, PhD, MGH, MIDS

Regulatory Affairs & Quality Officer, Clinical Trials BC