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Over One Third of Clinical Trials Outsourced by Pharmaceutical Companies: Kalorama Informations

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Over a third of clinical trials conducted by pharmaceutical companies are now outsourced outside of the organization, according to the healthcare market research publisher's findings detailed in Outsourcing in Drug Development: The Contract Research (Clinical Trial) Market. The portion of global R&D expenses outsourced to contract drug developers reached $36.6 billion in 2011, up 6.6% from $31.8 billion in 2009.

Clinical trials differ by type and phase, but all involve rigorous scientific testing. Clinical trials focus on developing new strategies for prevention, detection, treatment, and overall improvement of the care and quality of life of people with various diseases and disorders. Planning, coordinating, organizing, and running a clinical trial can be a difficult, time-consuming, and expensive task. Kalorama notes that drug development expenditures dedicated to in-house core activities declined from 74% to 62% in the past year.

"Drug development regulatory requirements have become increasingly complex over the last 20 years, requiring pharmaceutical companies to generate great quantities of more complex data to gain regulatory approval," said Bruce Carlson, publisher of Kalorama Information. "Many pharmaceutical and biotech companies bring only a limited number of compounds to market and have relatively little experience dealing with the regulatory environment. So they are outsourcing to companies that can take a drug through the regulatory process, and most importantly, reduce the time required to bring a drug to market."

The report indicates that there has been a change in the types of trials companies are outsourcing. Phases II-III clinical trials were the first clinical research operations to be outsourced. However, growth in R&D spending in Phase I trials began to outpace Phases II-III in 2003, and was the fastest-growing area of drug development until about 2006. Today, growth in Phase I and Phases II-III is about equal.

"At present, the testing phase that is quickly evolving into a hot opportunity for contract research competitors is post approval, or Phase IIIb/IV," Carlson said.

The major objectives of Phase IIIb/IV programs are to satisfy regulatory commitments and extend knowledge about efficacy, safety, and effectiveness within actual use settings. In addition, post approval studies have emerged as a powerful tool for companies to distribute their drug more broadly and for longer periods.