How do we evaluate the safety and benefit of new drugs? What tasks do we hold the government responsible for and which ones do we leave to the medical profession? Harry Marks explores the origins of our contemporary system of drug regulation and the modern clinical trial. He shows that the story of modern drug regulation is synonymous with the history of therapeutic reform. Accompanying this history of public policy is a detailed account of changing experimental ideal and practices. Marks follows the history of therapeutic experimentation, from the 'collective investigations' of the last century to the controlled clinical trial which emerged after 1950 as the paradigm of scientific experimentation. The result is the first general history of clinical research in the United States, a book which examines therapeutic experiments in a wide range of diseases, from syphilis and pneumonia to heart disease and diabetes.