Skip to main content
  • 2779 Accesses

2

It is considered that the first properly controlled trial in history was performed by James Lind. This Scottish surgeon and ship’s doctor was the first who conducted a trial with an appropriately controlled design from a modern point of view. In 1747 when scurvy was a common disease among sailors James Lind administered different acidic substances to 12 sailors affected with scurvy to test who benefits most. Five pairs of the seamen were given vinegar, mustard and garlic purges, and elixir of vitriol. The sixth pair was given two oranges and one lemon per day and recovered within 6 days. Objective and reliable evaluation of appropriate treatments against diseases has become a great need in medical research especially in the last century. Today healthcare professionals are required to base their decisions on the highest level of evidence. Evidence based medicine aims to rationalize this decision process in medical treatment and legitimates a certain treatment - or rejects it. In the process of finding the best treatment available it became obvious that different kinds of clinical trials might not provide the same level of evidence and differences between study designs are more than trivial. Today clinical trials are currently seen to have the highest level of evidence and to be the “Gold Standard” in clinical research.

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 199.00
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Berwick DM (2008) The science of improvement. JAMA 299: 1182–1184

    Article  PubMed  CAS  Google Scholar 

  2. Cochrane AL (1989) Archie Cochrane in his own words. Selections arranged from his 1972 introduction to “Effectiveness and Efficiency: Random Reflections on the Health Services” 1972. Control Clin Trials 10: 428–433

    Article  PubMed  CAS  Google Scholar 

  3. Schulz KF (2001 ) Assessing allocation concealment and blinding in randomised controlled trials: why bother? Evid Based Nurs 4: 4–6

    Article  PubMed  CAS  Google Scholar 

  4. Schulz KF, Grimes DA (2002) Allocation concealment in randomised trials: defending against deciphering. Lancet 359: 614–618

    Article  PubMed  Google Scholar 

  5. de Craen AJ, Roos PJ, Leonard de Vries A, et al. (1996) Effect of colour of drugs: systematic review of perceived effect of drugs and of their effectiveness. BMJ 313: 1624–1626

    PubMed  Google Scholar 

  6. Chow SC, Liu J ( 1998) Design and Analysis of Clinical Trials: Concepts and Methodologies. John Wiley & Sons, New York

    Google Scholar 

  7. ICH Expert working group (1998) Statistical principles for clinical trials. In ICH Harmonized Tripartite Guideline. http://www.pmda.go.jp/ich/e/e9_98_11_30e.pdf

  8. Kenneth LD, Charney D, Coyle JT, et al. (2002) Neuropsychopharmacology. The Fifth Generation of Progress. Lippincott Williams & Wilkins, Philadelphia

    Google Scholar 

  9. Bacchieri A, Cioppa G (2007) Fundamentals of Clinical Research. Springer Verlag

    Google Scholar 

  10. Asmar R, Hosseini H (2009) Endpoints in clinical trials: does evidence only originate from ‘hard’ or mortality endpoints? J Hypertens 27 (Suppl 2): S45–S50

    Article  CAS  Google Scholar 

  11. O’Neill RT (1997) Secondary endpoints cannot be validly analyzed if the primary endpoint does not demonstrate clear statistical significance. Control Clin Trials 18: 550–556; discussion 561-557

    Article  PubMed  Google Scholar 

  12. Cannon CP (1997) Clinical perspectives on the use of composite endpoints. Control Clin Trials 18: 517–529; discussion 546-519

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2010 Springer-Verlag/Wien

About this chapter

Cite this chapter

Wolzt, M., Aschauer, S. (2010). Clinical trials - interventional studies. In: Müller, M. (eds) Clinical Pharmacology: Current Topics and Case Studies. Springer, Vienna. https://doi.org/10.1007/978-3-7091-0144-5_8

Download citation

Publish with us

Policies and ethics