Creating standards for basic, medical and market research.
Different types of standards that can be created are ideal, realistic, desirable and minimally acceptable. A different approach to viewing types of standards is to view them as existing along a spectrum from very formal to informal. Basic research, medical research and market research can each develop and use standards that are entirely formal or informal or that exist at any stage along that spectrum. Pharma sense dictates that there are times when high, medium or low standards are appropriate. The main goal of all professionals is to know when to use which approach. Situations where pharma sense requires using either high or low standards are mentioned for basic research, clinical research and market research. Standards for basic research are usually established to answer the question: What level of activity must the test compound exhibit to be worthy of passing onto the next test? Issues concerning standards are: Who sets standards? When do standards interfere with achieving useful results on a project? What are the possible consequences of using low standards in research? What are the tradeoffs between quality and quantity of standards? How should appropriate standards be taught? and What are the internal versus external pressures on decision making about standards? By using pharma sense and pharma think to approach any issue or question of research standards on its own, it is likely that a company will determine the appropriate level of standards.
Spilker
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Scientific and Regulatory Affairs of PhRMA, Washington, DC, USA.