Module 5 Presentations

05/07/2024

Development of GCP Randomisation

• 1948, D’Arcy Hart & Marc Daniels & Austin Bradford Hill designed a trial to evaluate the effects of streptomycin in tuberculosis

• Patients were assigned to groups using random sampling numbers

• Coded envelopes so that the allocation of treatment was not known by either the patient or the investigators

The first recognised “properly conducted randomised trial”.

The Organisation for Professionals in Regulatory Affairs

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”Ancestors” of GCP

1947 Nuremberg Code 1964 Declaration of Helsinki 1967 Drug Law, Germany 1977 Title 21 Code of Federal Regulations (21 CRF), USA 1974 The IRB National Research Act, USA 1979 The Belmont report, USA 1979 Regulation of Clinical Trials in Japan 1988 Principles of GCP adopted in France 1989 Guidelines on Clinical Trials of Drugs, Nordic Region 1990 Introduction of GCP in Europe 1991 EU Directive 91/507/EEC - Requirements for GCP 1996 ICH GCP - Unified standard for EU, USA and Japan

The Organisation for Professionals in Regulatory Affairs

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