Skip to main content
Medicine LibreTexts

22: Phase IV studies

  • Page ID
    • 22.1: Introduction to Phase IV studies
      The main focus of this book is on randomized controlled field trials of health interventions in LMICs, many of which can be classified as Phase III trials (see Chapter 2, Section 3). This chapter gives a brief overview of Phase IV studies that are often carried out after an intervention has been shown to be efficacious in Phase III trials. We give a brief description of the rationale and some of the terminology used in such studies, outline the main types of Phase IV study, discuss some key issu
    • 22.2: Types of Phase IV study
      Pharmacovigilance is defined as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems’ (World Health Organization, 2006). Pharmacovigilance studies are designed to detect and assess both long-term and short-term adverse effects of medicines (including drugs and vaccines). Regulatory agencies will often require that specific monitoring is conducted after a product is licensed (post-marketing s
    • 22.3: The conduct of Phase IV studies
      Phase IV studies should follow the general guidelines, as described elsewhere in this book, with respect to the selection of the study population and study design, sample size calculations, ethics clearance and consideration of other governance issues, and the training and supervision of study staff.
    • 22.4: Examples of real-world effectiveness studies
      The development of new drugs and drug combinations for the treatment of malaria has created the need for countries to select and integrate new anti-malarial drugs into their health systems.
    • References
      Aponte, J. J., Schellenberg, D., Egan, A., et al. 2009. Efficacy and safety of intermittent preven- tive treatment with sulfadoxine-pyrimethamine for malaria in African infants: a pooled analysis of six randomised, placebo-controlled trials. Lancet, 374, 1533–42. Bonell, C. P., Hargreaves, J., Cousens, S., et al. 2011. Alternatives to randomisation in the evaluation of public health interventions: design challenges and solutions. Journal of Epi- demiology and Community Health, 65, 582–7.