Drug development resource shifts to CROs
The balance of resource in pharmaceutical product development has shifted from drug and biotechnology companies to contract Clinical Research Organisations (CROs) over the past five years, according to a survey by the Tufts Center for the Study of Drug Development. The study found realignment has increased the speed and efficiency of the industry's product-development pipeline.
The balance of resource in pharmaceutical product development has shifted from drug and biotechnology companies to contract Clinical Research Organisations (CROs) over the past five years, according to a survey by the Tufts Center for the Study of Drug Development. The study found realignment has increased the speed and efficiency of the industry's product-development pipeline.
Commissioned by the Association of Clinical Research Organisations (ACRO), which represents some of the world's leading CROs, the study examined the contribution CROs make to the pharmaceutical industry's overall development capacity and assessed the impact clinical outsourcing has on development-project performance.
Among its key findings were, that since 2001, spending by pharmaceutical and biotechnology companies on contract clinical research services grew 15% annually, outpacing the 9% annual increase on overall development spending. In addition, between 2001 and 2004, the headcount among major CROs grew 6% annually while project-sponsor headcount remained flat, indicating an increased reliance on CROs by the pharmaceutical industry.
Drug companies reported that projects with a high reliance on CROs stayed closer to schedule than those making less use of CROs. Typically, projects that relied heavily on CRO participation submitted their data to regulators more than 30 days closer to the projected submission date than projects with less CRO participation.
The data was collected from interviews with 31 pharmaceutical and biotechnology companies of varying size. The researchers gathered data on 79 New Drug Application and four Biologics License Application submissions made between 2000 and 2004. They also collected data from ACRO member companies, including Covance, Kendle, MDS Pharma Services, Medifacts International, Parexel International Corp, PharmaNet, PPD, Quintiles Transnational Corp, Omnicare Clinical Research and PRA International.
CROs are expanding development capacity without requiring drug or biotechnology firms to increase the size of their staffs or facilities, said ACRO executive director Douglas Peddicord. 'We wanted to document the crucial contribution CROs are making to drug development. To answer these questions, ACRO was pleased to sponsor the first independent, third-party examination of why the CRO industry is growing at such a strong rate,' he said.