CINCINNATI, Jan. 31 /PRNewswire-FirstCall/ -- Kendle , a leading global full-service clinical research organization (CRO), is enthused by a landmark study indicating that CROs increase the speed and efficiency of the pharmaceutical and biotechnology industry’s product-development pipeline. The study, conducted by the Tufts Center for the Study of Drug Development, found that CROs provide a growing proportion of the skilled staff and facilities involved in clinical research around the world, and that this realignment has increased the speed and efficiency of drug development efforts while maintaining clinical-trial data quality and high levels of regulatory compliance.
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“This landmark report will encourage further discussion on the significant role and contribution of CROs in bringing new life-enhancing and life-saving drugs to market,” noted Candace Kendle, PharmD, Chairman and Chief Executive Officer of Kendle and current Chair of the Association of Clinical Research Organizations (ACRO). “As one of the world’s largest global CROs, Kendle is proud to be part of this growing industry, which is projected to reach $15.4 billion in 2006.”
The study was commissioned by ACRO, which represents some of the world’s leading CROs, including Kendle. The association wanted to examine the contribution its members make to the pharmaceutical industry’s overall development capacity, and assess the impact clinical outsourcing has on development-project performance.
Evidence has been accumulating for some time that CROs are, in effect, expanding development capacity without requiring drug or biotechnology firms to increase the size of their staffs or expand their facilities, said ACRO Executive Director Douglas Peddicord, Ph.D. However, the amount of research into the measurable contributions made by CROs has been limited. “We wanted to document the crucial contribution CROs are making to drug development,” Peddicord said. “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.”
Among the study’s key findings were: - Since 2001, spending by pharmaceutical and biotechnology companies on contract clinical research services has grown 15 percent annually, outpacing the 9 percent annual increase on overall development spending. - Between 2001 and 2004, headcount among major CROs grew 6 percent 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. - Even larger, more complex trials are completed more quickly when they have a high degree of CRO involvement.
To conduct the study, Tufts held a series of wide-ranging interviews with representatives of 31 pharmaceutical and biotechnology companies of varying size. The researchers gathered data on 79 New Drug Application (NDA) and four Biologics License Application (BLA) submissions made between 2000 and 2004. In addition, the researchers, Senior Research Fellow Ken Getz, M.S., MBA, and Research Assistant Laura Faden, collected data from ACRO member companies, including Kendle.
About Kendle
Kendle International Inc. is among the world’s leading global clinical research organizations. We deliver innovative and robust clinical development solutions - from first-in-human studies through market launch and surveillance - to help the world’s biopharmaceutical companies maximize product life cycles and grow market share. With the expertise of our nearly 2,000 associates worldwide, Kendle has conducted clinical trials or provided regulatory, pharmacovigilance and validation services in 70 countries. Additional information and investor kits are available upon request from Kendle, 1200 Carew Tower, 441 Vine Street, Cincinnati, OH 45202, or from the company’s Web site at http://www.kendle.com.
About ACRO
The Association of Clinical Research Organizations (ACRO) represents the world’s leading clinical research organizations. Its members, which represent 65 to 70 percent of all CRO revenues worldwide, provide specialized services that are integral to the development of drugs, biologics and medical devices. ACRO advances clinical outsourcing to improve the quality, efficiency and safety of biomedical research. For more information, visit http://www.acrohealth.org.
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CONTACT: Patty Frank, Investors, +1-513-763-1992, or Lori Dorer, Media,+1-513-345-1685, both of Kendle International Inc.
