Abstrakt: |
THE INITIAL clinical trial is a crucial matter in the development of a new drug. The risk inherent in its first use in man, and the need to obtain a true evaluation of its action before large sums of money are invested in materials, make it imperative that the initial trial be a well-controlled study. It should be conducted by a physician who is trained in this form of clinical research and the investigation should be performed in an environment that permits accurate observations. Years of effort in research and testing which may have preceded the first clinical trial will have been wasted if the first tests in man are not appraised accurately.The physician who administers a new compound has a responsibility to the patient or volunteer who will be taking the drug. It is necessary, therefore, that all available information be made known to the physician before he undertakes an |