ABSTRACT
The development of the research process probably had its genesis in Renaissance Europe, becoming fully evolved as a self-conscious process in the seventeenth century. One of the principal problems of the industry has been to formalize and to ensure the integrity of the clinical research process. The pharmaceutical industry quickly adopted experimental designs to develop and screen new compounds, improve production, and test the drugs for therapeutic value. Legislative decisions have impacted upon the form of the clinical research process. The development of the contemporary formalized clinical research process was also dependent upon the emergence of a corps of highly skilled scientific research personnel, the organization of research, the favorable economic growth of the pharmaceutical industry, and by social forces exemplified by legislatively mandated objectives. At the same time, the highly visible Congressional hearings of the 1950s and early 1960s led to a rather widely held social impression that the pharmaceutical industry was not acting in the public interest.
