Toby Jane Hindin, EdD
|
Two years ago, ACT published a supplement entitled CRO Retrospective, Looking Back, Moving Forward. We asked CROs to look into our crystal ball and predict what challenges and changes they foresaw for the industry.
Dennis Gillings, Quintiles, wrote, "We are a healthy, growing industry that has a significant role in the drug development
process....With more targets and greater selectivity of medicines, the number of trials needed will greatly increase." Rich
Shea, PharmaLinkFHI, noted the companies "that will be successful will be those service providers that re-engineer their operating
model in a way that enables transparency between sponsor and service provider."
This month's issue featuring articles on the innovative relationship between Wyeth and Accenture and the unique partnership
entered into by Solvay and Quintiles validates what many CRO leaders predicted back in 2004.
The latest Tufts Center for the Study of Drug Development Impact Report (Jan./Feb. 2006) further develops the case for why
2006 may well be "The Year of the CRO." The Tufts CSDD study reports that sponsors who used CROs more extensively tended to
complete projects faster, especially during the study close-out period. The report also estimates that 15% of global drug
development spending has gone to contract clinical services since 2001. In addition, sponsor spending on outsourcing has increased
beyond the 12% growth in overall global development. Although the Tufts CSDD study was limited to only 31 sponsors and ACRO member organizations, the data is exciting and is good
news for the CRO industry. Sponsor outsourcing likely enhances a company's ability to concentrate on research and drug discovery.
Outsourcing to CROs allows smaller sponsor companies to concentrate on moving new drug entities from the preclinical stage
to Phase I and beyond.
The transformation of the CRO industry has occurred over a short period of time. And the change has, in turn, been a stimulus
for the growth of companies that support CROs.
So what will the future hold? Will CROs absorb the companies they outsource to? Will the larger CROs move away from generalized
services to specialty services? Will CRO partnerships lead to investment and ownership in smaller sponsor companies? And how
will CROs prepare for the increase in clinical services while maintaining high-quality standards for reporting safety and
efficacy information?
We look forward to continuing this discussion at the Applied Clinical Trials U.S. Conference, to be held in the fall of this year.
Toby Jane Hindin, EdD
Editor-in-Chief
email: thindin@advanstar.com
http://www.actmagazine.com/
Facebook
