$1-$13 million a day at risk from product launch delays

The pharmaceutical sector has witnessed the introduction of a record 44 new clinical research regulations since 1995, and is reluctantly bracing itself for more with only two months left for European Union member states to implement the Clinical Trials Directive into law, due May 1 (Marketletter March 15). All eyes are now on what could potentially be the greatest shake up of clinical trials in decades, says UK-based clinical trials data management specialist Phase Forward.

Driving these changes is medicine safety, as highlighted by GlaxoSmithKline's experience with the European Medicines Evaluation Agency's investigation into Seroxat/Paxetil (paroxetine) after claims of serious side effects, and AstraZeneca's need to delay the launches of two of its newest drugs, Iressa (gefitinib) and Crestor (rosuvastatin), due to safety issues, it notes.

This spotlight on safety means companies and regulators are looking to utilize the data collected by safety groups to better effect. This is unsurprising, comments Phase Forward, considering: