Provision of investigational drug after clinical research: review of literature, national and international guidelines

Rev Assoc Med Bras (1992). Nov-Dec 2011;57(6):710-6. doi: 10.1590/s0104-42302011000600021.
[Article in English, Portuguese]

Abstract

The post-trial access to investigational drugs has been the object of discussion since the late 1980s at least, initially linked to trials carried out in acquired immunodeficiency syndrome and, particularly, in developing countries, where the concern with patient vulnerability is more important. National and international guidelines do mention the subject; however, the complexity of the issue is not easily addressed and usually requires additional and specific discussions. The decision on providing the investigational drug after the trial shall rest on at least two dimensions: efficacy and safety assessments, as the new drug is still on the experimental phase. Each clinical trial shall have its own assessment, taking into account the disease being studied, as well as the study population and their specific needs. Therefore, the nature of post-trial obligations cannot be considered the same in all situations and contexts; nevertheless, it should be assured that the relationship developed between investigators and patients during the study must be always terminated with respect and responsibility.

Publication types

  • Review

MeSH terms

  • Biomedical Research / ethics*
  • Biomedical Research / legislation & jurisprudence
  • Continuity of Patient Care / ethics*
  • Continuity of Patient Care / legislation & jurisprudence
  • Drugs, Investigational / therapeutic use*
  • Ethics Committees, Research / ethics
  • Human Experimentation / ethics*
  • Human Experimentation / legislation & jurisprudence
  • Humans
  • Practice Guidelines as Topic

Substances

  • Drugs, Investigational