医学资料-外-gcp.ppt

GCP: The Global Standard for Clinical Research Audrey F. Jakubowski, Ph. D. Visiting Professor PUMCH November 29,1999 Outline Abbreviations to remember Background rush to develop new drugs need clinical quality standards Origins of Good Clinical Practices (GCP) Content of the ICH GCP Guideline (1997) Global implementation of GCP Glossary of relevant terms Abbreviations to remember GCP Good Clinical Practices ICH International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use IRB Institutional Review Board IEC Independent Ethics Committee SOP Standard Operating Procedure GMP Good Manufacturing Practices Background Western drug development exploded in the second half of the 20th Century synthetic antibiotics corticosteroids Simultaneously, advances in the understanding of pharmacology, toxicology, drug delivery Advent of biotechnology in the 1980s Result pharmaceutical companies rush to bring new drugs to the market tremendous expansion in the number of clinical trials. Many New Drug Applications sent to Regulatory Agencies The Agency (FDA, others) mandate: make new, proven therapies available protect public health and safety They were the Gatekeeper of progress approve drugs that are safe and effective insure benefit justifies the risk protect patients from undue harm, cost needed high quality data But…... Some Data Was Suspect! Some investigators (physicians) and sponsors (drug companies) were guilty of Data fabrication non-existent patients substituting records for better outcome Conflict of interest stock or cash incentives for good results Coercion clinical trials in prisoners, orphans Urgent need to develop reasonable quality standards for clinical trials. Serious Consequences Regulatory agencies were accused of taking too long to approve valuable new therapies. Credibility of pharmaceutical companies and investigators was in question. Pressure on regulators and the regulated