The Fundamentals of Clinical Research. P. Michael Dubinsky

has published its own version by modifying the standard to include requirements that fit their regulatory model.

      In the next Chapters we will outline the regulatory environment within which GCP is enabled.

1.5 Summary

      The advent of the GCP Guideline and its adoption as a global reference for the conduct of human biomedical clinical trials is a story that emerges from a number of business and regulatory objectives that came together in the early 1990s. The chronology of regulatory legislation, historical incidents, and ethical policy development listed earlier formed the backdrop for the success of the ICH organization. It is noteworthy that GCP stood out as a key early guideline development project. Protection of trial subjects and the assurance that data can be trusted were central themes for regulators and the pharmaceutical drug manufacturers were keen to find the protocols which would have a universal appeal. The story of the ICH in general and the development of GCP in particular is one where everyone was a winner.

      Knowledge Check Questions

      1 The emergence of legislative regulatory controls over pharmaceutical drug development and clinical trials was often prompted by:Protests from university medical students ______________Tragic outcomes from administration of unsafe and/or ineffective drug products_____________Promises made to voters by candidates for political office:______

      2 Failure of medical researchers to apply ethical principles has never been a problem that needed solving? True ____ False ______

      3 The Belmont Report was authorized by the National Research Act of 1974. True ____ False _______

      4 The ICH Efficacy Guideline – GCP – is considered the industry standard for the conduct of human biomedical clinical trials with drug products. It was developed because:Of continuing abuses against study subjects by drug researchers _________The United States, Japan, and the European Union wanted manufacturers in their countries to have a monopoly on drug marketing _____________Manufactures and regulatory authorities wanted to establish harmonized standards to facilitate the mutual acceptance of clinical data supporting drug approval________

      5 The ICH headquarters are located in the United States and the organization is under the US FDA. True __________ False ________

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