There have been suggestions that the current recession will inevitably squeeze the market for outsourced clinical research, with some of the less robust contract research organisations (CROs) falling by the wayside. A new report takes a more bullish view.
According to the publishers, Cutting Edge Information, the pharmaceutical industry is “looking into every available option to save money without sacrificing clinical development goals. Clinical research organisations) are reaping the benefits”.
The report, Clinical Outsourcing Strategy: Selecting Partners and Managing Relationships, says 58% of pharmaceutical and biotechnology companies choose to outsource fully every clinical trial task.
That proportion rises to 68% for data management, indicated responses from companies surveyed for the report, while most companies look after trial supplies management and medical writing themselves. “Protocol development tends to be the last activity kept in-house,” Cutting Edge Information adds.
The surveyed companies identified meeting deadlines as the most important consideration in selecting CROs. “It is also one of the most difficult [tasks],” the authors note. Deadlines consistently run over due to problems with patient recruitment, pushing up costs for internal management and external CRO input while eroding patent life and competitive advantage.
Ranked next in order of importance were professional clinical research associates, and then overall service quality; ability to deliver patients; experienced personnel; reputation for success; the trial manager to project ratio; and good protocol design.
The reports puts the relatively low status of protocol design as a factor in CRO choice down to most contract research organisations handling this work in-house.
Nor is the trial manager to project ratio such a worry. “While some trial managers may be squeezed for time if they are conducting too many trials, others may have little trouble conducting multiple trials simultaneously if the trials are similar and are being conducted by the same company or department,” the authors comment.
A report published by Cutting Edge Information last October warned that companies across the pharmaceutical industry had significantly cut expenditure on outsourcing as a percentage of clinical development budgets over the last couple of years.
Comparisons with research by Cutting Edge in 2006 showed that outsourcing as a proportion of the clinical development budget had dropped by an average of 20% for every phase of clinical trials.
“Companies are now realising that outsourcing does not necessarily make things easier, cheaper, or remove a burden from their plate,” said the report’s lead author, David Richardson, at the time. “Research has appeared arguing against the cost-saving effects of outsourcing. Also, companies are being more frugal.”
