ABSTRACT

In broad-scale clinical investigation studies, the goal is to develop a sufficient volume of controlled clinical data to define the clinical efficacy and safety of a new drug compound. In clinical development studies, which take place once a drug has been approved for marketing, the Clinical Research Monitors will develop more extensive clinical experience with the new drug for approved indications and, at times, for new indications. On the positive side of motivations, physicians entering industrial clinical research are attracted by the opportunities to participate in the clinical development of important new therapies, even breakthroughs at times. Clinical Research Directors will have mastered the science and art of multicentered, double-blind clinical research methodology and data handling. Clinical Pharmacists will have obtained the Bachelor of Pharmacy degree and the Registered Pharmacist license initially, then they will have had more or less additional training in which the knowledge and techniques of pharmacy will have been correlated with clinical pharmacology and drug therapeutics.