The pressure to develop new drugs that are best in class within strict budgets has led most pharma and biotech companies to focus on core research and pipeline development, while outsourcing clinical research. Since 2001, spending by drug sponsors on CROs has grown 15% annually, outpacing the 11% rate for overall spending on drug development, according to a Tufts Center for Study of Drug Development report.
In addition, the size of the CRO market is growing—$17.8 billion reported in 2008, according to CenterWatch Monthly. In response, CROs are expanding their services—evolving toward a full-service model—by offering safety studies, operating on an international scale, and utilizing electronic data reporting and management. A recent outsourcing conference organized by Arena International Events Group provided information on how companies can best utilize CROs.
“Anyone who does outsourcing understands that you want to keep what you’re good at and what’s important in house and consider outsourcing everything else,” said Timothy McNamara, Pharm.D., vp, clinical research and medical affairs at ISTA Pharmaceuticals.
The company’s decision-making plan focuses on balancing costs and quality and consists of three key elements: clinical development (studies required, timeline completion), capabilities assessment (resource assessment, clinical expertise), and financial and human resource (buy or build) considerations. Dr. McNamara reported that his company always outsources data management and biostatistics since these are two departments it lacks in house. Also, based on the size of the study, ISTA often needs CRAs (clinical research associates).
Some of the main challenges for sponsors include high expectations, competition for sites and subjects, data and regulatory requirements, unexpected costs, personnel turnover mid-project, and development time.
“We had been working with an outsourcing biostatistician who left his company in the middle of the study, and we were assigned a much more junior biostatistician. This person didn’t have the expertise the original person did, and we were concerned. We had to get an agreement from the CRO that the junior biostatistician would be overseen by the vice president to ensure the integrity of the data,” explained Dr. McNamara, who advised that companies plan for this sort of thing up front and have it part of the contract.
Additional contract considerations include milestones, agreement about pass-through costs, the scope of work and format, staff turnover, and final payment. Data management and format are important because the FDA will review the NDA file. “The FDA is starting to require data in new formats, and it has to be filed electronically.”
According to Dr. McNamara, it is important for new companies not to sacrifice quality for dollars. “The biggest point is due diligence—you have to get to know the company you are outsourcing to. It’s almost like dating.” He added that it’s also important that the company provides attention when needed.
“These are very expensive endeavors; they make or break the company.” There is no one-formula-fits-all approach though. Many larger companies use functional outsourcing programs where they have a select number of vendors under master-service agreements, whereas smaller companies tend to bid their business out as needed.