PROACTIVE trial

Dormandy et al Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive study (PROspective pioglitAzone Clinical Trial in macroVascular Events) A randomized controlled trial. Lancet 2005,366 1279. [PMID 16214598]... 

Many proactive QA measures can and should be installed during all phases of clinical trial activities, such as ensuring that assays used throughout the trials are properly developed and used clinical trial materials are adequately manufactured, packaged, and labeled appropriate communication between research personnel and other clinical departments is maintained and most important, creativity and flexibility are balanced with reasonable drug development timelines. 

Cleland JG, Freemantle N, Coletta AR Clark AL. Clinical trials update from the American Heart Association REPAIR-AMI, ASTAMI, JELIS, MEGA, REVIVE-II, SURVIVE, and PROACTIVE. Eur J Heart Fail 2006 8 105-1 10. 

As discussed in the chapter on Drug Surveillance, the safety surveillance mission is to implement the systematic review of spontaneous post-marketing data for proactive risk identification and assessment. In general, signal generation is done using clinical trials data, the medical literature, knowledge of class effects and spontaneous reports. 

Important considerations in trials of pharmacoinvasive strategies for STEMI include (a) careful selection of the appropriate target population, including the elderly and patients who require transfer to an invasive center, (b) determination of an acceptable time delay to invasive therapy, especially considering the policy complexity of interhospital transfer, (c) proactive steps to reduce risks of hemorrhagic complications, and (d) measurement of the appropriate endpoints. 

Buvanendran A, McCarthy RJ, Kroin JS, Leong W, Perry P, Tuman KJ. Intrathecalmagnesiuiii Toloi fentanyl analgesia a proactive, randomized, controlled trial. Anesfft Analg (2002) 95,661-6... 

Charbonnel B, DeFronzo R, Davidson J, Schmitz O, Birkeland K, Pirags V, Scheen A PROactive Investigators. Pioglitazone use in combination with insulin in the prospective pioglitazone clinical trial in macrovascular events study (PROactive 19). J Clin Endocrinol Metab 2010 95 2163-71. 

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