By Kristen Slawinski and Laura Moriarty
The typical success rate of a clinical trial is less than ten percent. While a single trial can cost upwards of $50 million, there is a strong sense of urgency to implement methods that reduce costs and increase a drug’s Likelihood of Approval (LOA).
Pharmaceutical companies are shifting to Electronic Data Capture (EDC), adopting earlier Phase II end-points, and even conducting trials in other countries in an effort to lower costs. Through early collaboration with regulatory agencies and use of Clinical Research Organizations (CROs), companies are also cutting trial timelines. Ultimately though, therapeutic efficacy and the safety of trial participants are the decisive factors for regulatory approval.