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[Clinical trials. An overview].

K Wegscheider1

  • 1Universität, Hamburg. wegsch@econ.uni-hamburg.de

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
|May 12, 2005
PubMed
Summary
This summary is machine-generated.

Clinical trials have become the standard for evaluating medical therapies since the 1950s, shifting from subjective methods to objective, evidence-based research. These prospective studies ensure treatment safety and efficacy through rigorous statistical analysis and controlled comparisons.

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Area of Science:

  • Medical Research Methodology
  • Evidence-Based Medicine

Background:

  • Shift from subjective assessments to objective evaluations in medicine since the mid-1950s.
  • Driven by side effect tragedies and regulatory requirements for drug licensing.
  • Expanded application to medical devices and surgical procedures.

Purpose of the Study:

  • To highlight the evolution and importance of clinical trials in medical therapy evaluation.
  • To explain the fundamental principles and benefits of clinical trials.

Main Methods:

  • Prospective study design comparing therapies against controls.
  • Utilizing randomisation for initial group comparability.
  • Employing blinding to ensure observational and treatment equality.

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Main Results:

  • Clinical trials provide a range of interpretations, not definitive answers, on therapy efficacy and safety.
  • Reduce uncertainty in medical decision-making.
  • Enable decisions based on objective evidence.

Conclusions:

  • Clinical trials are indispensable for modern medical research and progress.
  • They have substantially improved medical decision-making over the past 50 years.
  • Form the objective foundation for assessing new and existing medical interventions.