- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Safety and Efficacy
- Palabras clave > adverse drug reactions (ADRs)
- Palabras clave > clinical trials conducted - new medicines approved/New Drug Application (NDA)
- Palabras clave > clinical trials in humans
- Palabras clave > clinical trials registration
- Palabras clave > efficacy and safety of medicines
- Palabras clave > ethical practices and standards
- Palabras clave > Good Clinical Practice (GCP)
- Palabras clave > harmonization of pharmacovigilance
- Palabras clave > marketing authorization
(2005; 89 pages)
The document Good Clinical Practices: Document of the Americas was officially adopted by the IV Pan American Conference on Drug regulatory Harmonization on March 2005.
A clinical trial is a systematic study of drugs and/or medicinal specialties in human volunteers that strictly follows the guidelines of the scientific method. Its purpose is to discover or confirm the effects and/or identify the adverse reactions to the product investigated and/or to study the pharmacokinetics of the active ingredients, in order to determine their efficacy and safety.
Prior demonstration of the efficacy and safety of a drug (to approve either its marketing or a new indication) is currently required in the different national regulations, as well as in the international area. However, efficacy and safety can only be demonstrated through controlled clinical trials. The results obtained in those studies are the principal factor that determines whether a drug is authorized and subsequently marketed. These facts illustrate the need for national and international standards for clinical pharmacological research. In the past decade, in an effort to avoid duplication of efforts there arose the need to facilitate the acceptance of data from clinical trials, even though these were conducted in different countries. This led different regions to harmonize standards for good practice in clinical research. Within the framework of the International Conference on Harmonization there emerged Guidelines for Good Clinical Practice, which set forth a series of guidelines for the design, implementation, auditing, completion, analysis, and reporting of clinical trials in order to ensure their reliability.
In the Region studies of earlier phases of development are also being conducted. Within this framework, it becomes necessary to establish harmonized criteria for good clinical practice in our Hemisphere, in which various stages of development are visible. The objective of the Document of the Americas is to propose guidelines for good clinical practice that can serve as a foundation for regulatory agencies, as well as for investigators, ethics committees, universities, and businesses.