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[Good clinical practice]

H Mix1, J Marovac

  • 1Boehringer Ingelheim Chile y Quintiles Latin America, Clinical Research Organization Chile. hmix@bi.cl

Revista Medica De Chile
|November 27, 1998
PubMed
Summary
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Good Clinical Practice (GCP) ensures ethical and scientific quality in human subject research. Adherence to GCP is crucial for pharmaceutical research and increasingly important for Latin American clinical research centers.

Area of Science:

  • Clinical Research
  • Pharmaceutical Development
  • Regulatory Science

Context:

  • Good Clinical Practice (GCP) provides international standards for ethical and scientific quality in human subject research.
  • GCP guidelines are integral to pharmaceutical research for new medication registration and are now standard clinical research procedures.
  • Developed nations have enforced GCP for over a decade, with current implementation initiatives in Latin America driven by the pharmaceutical industry.

Purpose:

  • To highlight the significance of Good Clinical Practice (GCP) in ensuring the integrity of clinical trials.
  • To underscore the growing importance and adoption of GCP in Latin America for pharmaceutical research.
  • To emphasize the need for Chilean research centers and professionals to understand and implement GCP standards.

Summary:

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  • Good Clinical Practice (GCP) establishes international standards for ethical and scientific quality in clinical trials involving human subjects.
  • The adoption of GCP is essential for pharmaceutical research and regulatory approval of new medications globally.
  • Latin America is emerging as a key region for conducting clinical studies due to cost and saturation in other markets, provided studies adhere to GCP.

Impact:

  • Facilitates the acceptance of international clinical trial data by regulatory bodies like the FDA, Europe, and Japan.
  • Positions Latin America as a viable and cost-effective region for conducting high-quality clinical research.
  • Empowers Chilean research institutions to participate effectively in global pharmaceutical development by adopting GCP standards.