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Good clinical practice.

B Regnier1

  • 1Clinique de Réanimation de Maladies Infectieuses, Hôpital Bichat-Claude Bernard, Paris, France.

European Journal of Clinical Microbiology & Infectious Diseases : Official Publication of the European Society of Clinical Microbiology
|July 1, 1990
PubMed
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Implementing Good Clinical Practice (GCP) guidelines in Europe presents significant challenges, including investigator training and data verification. Despite these hurdles, GCP adoption promises improved clinical trial quality and data reliability.

Area of Science:

  • Clinical research
  • Regulatory science
  • Pharmaceutical development

Background:

  • Good Clinical Practice (GCP) is a global standard for clinical trial quality assurance.
  • European countries are increasingly adopting GCP principles.
  • Upcoming European GCP guidelines necessitate careful implementation.

Purpose of the Study:

  • To outline the challenges associated with implementing Good Clinical Practice (GCP) guidelines in Europe.
  • To highlight the key areas of difficulty in GCP adoption.
  • To underscore the benefits of successful GCP implementation.

Main Methods:

  • Analysis of implementation challenges in clinical trials.
  • Review of key components of Good Clinical Practice (GCP).

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  • Discussion of quality assurance in clinical research.

    • Main Results:

    • Implementation of GCP guidelines faces significant and costly challenges.
    • Key difficulties include investigator training, ethics committee function, informed consent, and data verification.
    • Quality control measures like audits and inspections are complex to establish.

    Conclusions:

    • Successful adoption of GCP requires addressing substantial practical and financial obstacles.
    • Overcoming these challenges is crucial for enhancing clinical trial integrity.
    • The benefits of GCP include improved data quality and international study recognition.