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American Society for Experimental Neurotherapeutics Abstracts
February 2002

Conduct of Clinical Trials: The Pharmaceutical Perspective

Arch Neurol. 2002;59(2):324-325. doi:

The objectives of clinical research in the industry are identical to those in academia or government. The pharmaceutical industry seeks the truth about its compound or invention, and it seeks to find this truth as soon in the development process as is possible; such knowledge permits the company to make early decisions about increased support or abandonment of an individual compound.

All of our abilities to "know" the truth about any object are based on our powers of observation. We have been aware of the limitations of our observational powers since the time of Plato who noted that "the body disturbs . . . and hinders the soul from getting possession of the truth." Aristotle carried the concept further by noting, "we have the power to imagine things whenever we please, seeing them in our mind's eye.1 We have learned, however, to better control our powers of observation by a manipulation of the observational process—an experiment. It has taken us about 2000 years to learn how to create meaningful experiments, and clinical trials are among the most recent kinds of experiments to be accepted as an improvement of our observational powers. Yet even today we find that the "pure" experiment can be denigrated by inadequate control, either by sloppiness or by design, though only rarely by conscious design. To understand the reasons for improper, and less objective, experimental plans, we must examine the motivating factors that drive scientists to accomplish their tasks and then relate these motivations to the conflicts of interest in clinical trials.1

The major pharmaceutical companies of the world are concerned with everything from the conceptual foundations of drug discovery to post-marketing development of additional indications. From the time of first discovery to the time of clinical testing and beyond, industry scientists are dependent on a "chain of truth" from every department that contributes to the knowledge about the potential drug. This truth-seeking effort will hasten the day when better drugs will be available to the patients who need them.

Porter  RJMalone  TE Biomedical Research: Collaboration and Conflict of Interest.  Baltimore, Md: Johns Hopkins University Press; 1992.