Clinical Trials

Bioethics

What is a clinical trial ?

• “Any investigation in human subjects intended to discover

or verify the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. (Guideline for Good Clinical Practice, ICH*)

*International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

Phases

Tuskegee syphilis experiment

This study started in 1932 by the U.S. Public Health Service and recruited sharecroppers from Macon County Alabama to study the development of untreated syphilis.The study recruited 600 hundred men (400 had syphilis and the rest was the control group) and received incentives such as:-Free transportation to the hospital-Free hot lunches-Free medicine (not for syphilis)-Free burial (after autopsy)/ $50 for burial expensesAt the beginning of the trial there weren’t effective treatments; however, on the 1940’s the penicillin was a cure for the disease but it was not given to the patients. The study ended on 1972

Policies and organizations