The Food and Drug Administration (FDA) is collaborating with Duke
University researchers to find ways to improve the efficiency and quality of
The Clinical Trial Transformation Initiative (CTTI), first announced in
November 2007, is a public-private partnership hosted and coordinated by Duke
University with participation from all areas of clinical research.
The FDA has been criticized in recent years for inefficiency and lack of
sufficient oversight. The number of new drug approvals, especially new
compounds, has declined in recent years. In 2007, the FDA approved only 19 new
drugs, the lowest since 1983, according to a Bloomberg/Arizona Daily
Star report on January 10. Meanwhile, the cost of conducting a late-phase
clinical trial can amount to tens of millions of dollars.
Drug companies are increasingly conducting global clinical trials outside
of the United States so that more patients can be enrolled at more sites
simultaneously and more data can be obtained sooner to meet FDA requirements
for new-drug review. However, global trials, including some conducted in Third
World countries, increase the agency's difficulty in monitoring the quality of
The CTTI partnership is intended "to develop new standards and
identify new methods and technologies that improve safety, boost the quality
of information derived from clinical trials, and make the research process
more efficient," according to its Web site.
The CTTI "was set up by the FDA in response to growing frustration
over the complexity in conducting clinical trials and the long time frames
involved in completing them," said Judith Kramer, M.D., executive
director of the CTTI and an associate professor of medicine at Duke University
School of Medicine. She told Psychiatric News that the CTTI has heard
from many people directly involved in clinical trials who are frustrated by
the inefficiencies in the system.
The cost and time of conducting trials limit the number of clinical
questions that can be answered. Industry-sponsored clinical trials tend to
focus on data needed for regulatory approvals. Physicians often find
themselves in a position of prescribing FDA-approved drugs"
off-label" without adequate clinical-trial data for diseases
affecting a small patient population without an approved treatment.
Fundamentally changing the existing framework, however, requires
stakeholders from different fields with different perspectives to develop
global solutions for these problems, Kramer emphasized. Although the CTTI is
still in the planning and organizing stage, Kramer expressed optimism that it
can achieve its goals: "We ... announced the executive committee in May
that consists of FDA representatives in the drug and medical device divisions;
a patient advocate; representatives from the pharmaceutical industry,
biotechnology, device companies, and contract research organizations; academic
researchers; an at-large representative from the Tufts Center for the Study of
Drug Development; and a liaison from the National Institutes of
Kramer explained that CTTI plans to solicit ideas and participation from a
variety of members. "We already have 36 organizations that have
committed to join CTTI," she said. "So far our membership includes
a broad cross-section of industry, contract research organizations,
professional societies, academic institutions, investigators, trade
organizations, even a law firm specializing in regulatory law, and a private
Among the current members are the American College of
Neuropsychopharmacology and American College of Clinical Pharmacology.
If successful the findings derived from the CTTI will lead to changes in
not only industry-sponsored clinical trials but also in pure academic
research. "The quality of clinical trials is important to not only new
drug approvals but also for medical practice," said Kramer.
The FDA has committed personnel but provides no funding for the research
and other activities in the CTTI. The projects are expected to be funded by
membership fees, which are based on a tiered structure depending on the type
of the organization or company.
Additional information about the CTTI is posted at<trialstransformation.org>.▪