Large-scale clinical trials

Phase 3 trials are large-scale clinical trials on populations numbering in the hundreds to thousands of patients. These are the critical trials that the drug maker runs to show that its new drug is both safe and efficacious in the target study population. If the phase 3 trials are successful, they will form the keystone elements of a New Drug Application... 

Shork NJ et al. The use of genetic information in large-scale clinical trials applications to Alzheimer research. Alzheimer Dis Ass Disord 1996 10(Suppl 1] 22—26. 

Large-scale clinical trials are likely to be the only way by which any HIV vaccine may be properly assessed. In addition, a greater understanding of the molecular interplay between the viral and immune system may provide clues as to the development of novel vaccine and/or therapeutic products, e.g. a small proportion of infected individuals remain clinically... 

More recently, several large-scale clinical trials have been performed in patients with myocardial infarction and/or congestive heart failure. Some of the trials have confirmed a preventive effect on... 

When one examines the nature, sources, and funding of pharmaceutical innovation, certain principles become apparent. The areas where federal support has been most prominent are in basic research and in large-scale clinical trials. These happen to be areas where the benefits—while very real—are long-term, not immediately apparent ones. 

Expected to be completed before application for marketing approval (not needed prior to conduct of large-scale clinical trials unless cause for concern)... 

Passmore AP, Bayer AJ, Steinhagen-Thiessen E. Cognitive, global, and functional benefits of donepezil in Alzheimer s disease and vascular dementia results from large-scale clinical trials. J Neurol Sci 2005 229-230 1241-6. 

Furthermore, samples generated from large-scale clinical trials along with the ambitious development timelines to get safe and efficacious drugs to market warrant the use of HT bioanalysis. Numerous improvements in speed, sensitivity, and accuracy, augmented with innovations in automation in conjunction with mass spectrometry (MS) detection, have allowed for versatile and multifaceted platforms [6-8]. 

---