|Scientific Excellence vs. Research Quality||Regulated vs. Non-regulated|
|Scientific excellence is the key to advance science and to develop novel drugs. However, scientific excellence does not guarantee that the conducted experiments deliver robust results. There are two primary reasons for that.
First, education in science does not always focus enough on the requirements for delivering of robust data (e.g. statistical power, blinding, randomization, etc.).
Second, excitement associated with a scientific hypothesis or conveyed by a scientific leader may introduce bias in study design, conduct, analysis and/or reporting.
|In the drug discovery and development process, there are several steps that have adequate quality control and are covered by GxP policies (e.g. Good Laboratory Practice, GLP).
For non-regulated areas (most specifically, biology and pharmacology of drug discovery projects), GLP-like procedures would not be acceptable and may not even help to secure the quality of research. In fact, one may indeed imagine a lab running under GLP conditions but nevertheless still failing to design and execute robust studies.
Thus, for non-regulated areas of drug discovery, one needs to have a specialized set of Good Research Practice conditions that focus on study design, unbiased conduct, analysis and reporting.
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