Data from non-clinical trials is important as a predictor and decision-making tool in the medicines development process. Adequate and satisfactory non-clinical results are required before a medicine may be administered to healthy human volunteers, and non-clinical data is closely reviewed before a medicine is allowed to enter the market.
After they are published, clinical study results should be critically reviewed and assessed for such things as reliability, bias, significance, and fit with existing literature.
When performing a critical reading of clinical study results, the reader should take relevant information into account from the best available sources and should consider questions about the reliability, methodology, results, discussion, significance, and conclusions of the study.
Risk management is important in medicines development and pharmacovigilance in order to avoid crisis situations and harmful consequences. There are various kinds of risk; risk management strategies must assess and minimise these, and balance them with the benefits of the medicine being developed.