|
|
| Tufts CSDD Study on Clinical Outsourcing |
 |
 The January/February 2006 Tufts CSDD Impact Report, published by the Tufts Center for the Study of Drug Development, focuses on clinical outsourcing and its effects on drug development performance and capacity. The report reviews the results of an extensive study of contract research organization (CRO) usage by drug sponsors. The goals of the study were to quantify the impact of outsourcing on drug development performance and to determine the operating capacity contributed by leading CROs.
In recent years, the Tufts study found, contract clinical research organizations (CROs) have become an integral participant in the drug development process, providing the pharmaceutical and biotechnology industries with the skilled workforce and facilities necessary to increase the capacity of the product-development pipeline without sacrificing regulatory compliance or data quality, and without incurring undue financial investment.
Currently, the research workforce of ACRO member companies is nearly 60 percent the size of the workforce maintained by members of the Pharmaceutical Research and Manufacturers of America (PhRMA) and it is estimated that the CRO industry as a whole accounts for well over 40 percent of the total number of clinical research personnel engaged in drug development activities. This increasing involvement of CROs in the drug development process has allowed the drug and medical device industries to increase the number of development projects they conduct, complete many of them more quickly, and do so without compromising data quality. For example, sponsors reported to Tufts that development projects in which CROs were greatly involved were submitted to the FDA more than 30 days closer to the projected submission date than were projects with less CRO involvement.
Tufts study finds clinical outsourcing associated with faster development times at comparable quality. |
- Since 2001, spending by drug sponsors on clinical research services has grown 15% annually, outpacing the 11% rate for overall spending on development.
- Drug sponsors have increased their reliance on contract research organizations (CROs): headcount among major CROs grew 6% annually between 2001 and 2004, while sponsor headcount remained flat.
- In 2004, leading CROs managed 23,000 phase I-IV clinical trials worldwide, monitored more than 150,000 clinical investigators, and enrolled more than 640,000 new subjects.
- According to sponsors, projects with high CRO usage stay closer to schedule: in general, high CRO usage projects are submitted more than 30 days closer to their projected submission date than are low CRO usage projects.
- Although pivotal trials involving high CRO usage tend to be larger than those with low CRO usage, they are completed faster, especially during the study close-out period.
|
Read Tufts News Release "CROs Usage Associated with Faster Drug Development Speed at Comparable Quality"
For a one page summary of the Tufts CSDD study click here
Purchase a copy of the Tufts CSDD Impact Report |
| Media Coverage of Tufts CSDD
Impact Report |
|
Clinical
Research Organizations Expand Speed and Capacity
of Pharmaceuticals' Product Development Pipeline,
Tufts Study Finds
Source: PharmaLive.com, January 23, 2006
|
CROs
vital to flaging drug pipelines
Source: OutSourcing-Pharma.com, January 24, 2006 |
PRA
International Lauds Research Showing CROs Expand
Speed and Capacity of Drug Development Pipeline
Source: PharmaLive.com, January 27, 2006 |
Kendle
Lauds Research Showing CROs Expand Speed and Capacity
of Drug Development Pipeline
Source: DrugNewswire, January 31, 2006 |
The
Year of the CRO: Rapid growth, partnering, and flexibility
are the key indicators
Source: Applied Clinical Trials, March 1, 2006 |
CRO
Industry Update: Growth, expansion and new opportunties
Source: Contract Pharma, May 2006 |
Insights
from Today's CRO Renaissance
Source: Applied Clinical Trials, June 1, 2006
|
|
|
|
|
