WASHINGTON, July 21 --

- Clinical Research Organizations urge full funding for FDA to conduct foreign
safety inspections

Clinical trials conducted in the developing world meet the same safety, ethical
and quality standards as those conducted in the developed world. That is the
conclusion of a major report released today by the Association of Clinical
Research Organizations (ACRO). The report, commissioned against a backdrop of
declining participation rates in the United States and recent criticism of
international research by several academic journals, was developed for ACRO by
VOI Consulting, Inc, a Ft. Lauderdale-based life sciences advisory and
publishing company.

Based on the report’s findings, ACRO, which represents the leading global
Clinical Research Organizations (CROs), is urging several steps to ensure that a
robust global research infrastructure continues to facilitate accelerated drug

ACRO initiated the report because of the dramatic increase in clinical trials
conducted in emerging markets over the past decade and the concern expressed by
some regarding their quality. Last year, ACRO members conducted more than 9,000
clinical trials in 115 countries adhering to the highest standards of research
ethics, safety and quality. Two factors are fueling the growth in developing
world trials: because fewer Americans are enrolling in trials, and because
global trials enable pharmaceutical companies to bring drugs to market more
quickly and cost-effectively.

With the changing landscape for CROs, the report has several key findings:

-- Global trials speed drug development -- The report concludes that globalized
trials can reduce development time by half while lowering costs and maintaining
quality and safety. For example, phase III cancer trials are conducted three
times as fast if both U.S. and global sites are used, compared to U.S.-only
sites. What takes 5.8 years to enrol takes 1.9 when a global trial is
implemented. -- Research quality standards must be met worldwide -- The report
found that trials in emerging countries, such as China and India, are subject to
the same standards as those conducted in the U.S. and Western Europe. CROs train
research staff around the world in good clinical practice (GCP) principles and
proof of compliance is required by drug regulators in every major pharmaceutical
market. -- Clinical research improves local economies -- Clinical research
offers huge advantages for host countries, including an influx of advanced
equipment, trained personnel and high-paying jobs. The presence of CROs also
results in improvements in local health systems. Clinical trial sponsors in
Poland, for example, fund 30 percent of hospital cancer therapy. -- Emerging
market equals growth market -- CRO activity in Central European countries, South
Korea and Taiwan is very robust, medical infrastructures are advanced and
capabilities are just about on par with Western Europe.

On a flattened earth with waning U.S. participation in clinical trials, global
trials are helping speed important drugs to market, said Doug Peddicord,
executive director of ACRO. CROs are making sure quality and ethical standards
remain consistent throughout the world, Peddicord added.

With all the advantages of globalized clinical trials have come some rare but
well-publicized lapses in standards. Most notable among them is a 1996 Nigerian
trial of the antibiotic Trovan, which resulted in the deaths of 11 children.

While Nigeria has made strides to tighten its standards, ACRO makes several
recommendations to make sure the quality and ethical standards match the
international spread of the trials. Among them, ACRO recommends that:

-- The U.S Food and Drug Administration be provided sufficient resources to
conduct inspections on a global basis in order to ensure that research quality
is protected and improved around the world. -- All governments take measures to
foster the development of a clinical research infrastructure and encourage
clinical research participation. -- Overseas regulatory bodies recognize drug
development as a global enterprise and that globalization leads to faster cures.
-- All participants in clinical research -- no matter where they live or the
environment in which research takes place -- be protected by the same level of
safety and ethical considerations, and that they be afforded the same standard
of care, including adherence to the GCP principles promulgated by the
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH).

The public will never have confidence in trials conducted in emerging regions
like Asia and Latin America unless we level the playing field with the U.S.,
Canada, Western Europe and Japan, Peddicord said. If the entire world plays by
the same rules and gets the same resources, patients worldwide will benefit from
life-saving drugs more quickly and more cost-effectively, he added.

About ACRO

The Association of Clinical Research Organizations (ACRO) represents companies
whose focus is clinical research. The association provides an active voice for
the global CRO industry, which provides specialized services that are integral
to the development of drugs, biologics and medical devices. Through its member
companies, ACRO helps improve the quality, efficiency and safety of biomedical
research. ACRO member companies employ approximately 70,000 professionals
worldwide and last year conducted more than 9,000 clinical trials in 115
countries. For more information, please visit www.acrohealth.org.

SOURCE: Association of Clinical Research Organizations (ACRO)

Aaron Cohen, Office +1-202-261-2869, Mobile +1-301-633-6773,
aaron.cohen@mslworldwide.com, for Association of Clinical Research Organizations