Skip to main content

Overview of Clinical Trials

  • Chapter
  • First Online:
The CAPRISA Clinical Trials: HIV Treatment and Prevention

Abstract

Data emanating from randomised controlled clinical trials are regarded as the highest level of evidence when evaluating new drugs, vaccines or health interventions and hence in undertaking these types of studies at CAPRISA this study design has been used extensively. This chapter describes key elements of clinical trials, such as blinding and randomisation, and how CAPRISA has implemented these elements. The limitations of clinical trials and when other designs would be more applicable to the research question being asked are also described. The implementation of less traditional designs, such as cluster randomised trials and factorial designs is also described.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 119.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 159.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 159.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Friedman LM, Furberg CD, DeMets DL. Fundamentals of clincial trials, fouth edition. New York: Springer; 2010.

    Google Scholar 

  2. Concato J. Observational Versus Experimental Studies: What’s the Evidence for a Hierarchy? NeuroRx 2004; 1(3): 341–7.

    Google Scholar 

  3. Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, et al. Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women. Science (New York, NY) 2010; 329(5996): 1168–74.

    Google Scholar 

  4. Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray A, et al. Timing of Initiation of Antiretroviral Drugs during Tuberculosis Therapy. The New England Journal of Medicine 2010; 362(8): 697–706.

    Google Scholar 

  5. National Research Council. The prevention and treatment of missing data in clinical trials. Washington DC: The National Academic Press; 2010.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Anneke Grobler .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2017 Springer International Publishing AG

About this chapter

Cite this chapter

Grobler, A. (2017). Overview of Clinical Trials. In: Abdool Karim, Q., Abdool Karim, S., Baxter, C. (eds) The CAPRISA Clinical Trials: HIV Treatment and Prevention. Springer, Cham. https://doi.org/10.1007/978-3-319-47518-9_3

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-47518-9_3

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-47517-2

  • Online ISBN: 978-3-319-47518-9

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics