Navigation Links
ACRO Comments on NEJM Article on Globalization of Clinical Research

WASHINGTON, Feb. 20 /PRNewswire-USNewswire/ -- The Association of Clinical Research Organizations (ACRO), which represents the clinical outsourcing industry to regulators, biopharmaceutical clients, policy makers and the public in the U.S. and worldwide, issued the following comment on the article "Ethical and Scientific Implications of the Globalization of Clinical Research" published in the February 19, 2009 issue of The New England Journal of Medicine:

The article by Duke University researchers raises several important scientific and ethical issues regarding multinational clinical research. ACRO appreciates several of the article's recommendations. For instance, the authors state "Industry sponsors, contract research organizations, and the academic community can meet the challenges of globalization by accepting full responsibility for the ethical conduct and quality oversight of these trials." ACRO members have been leaders in driving global standards for patient protection and safety and ACRO looks forward to engaging sponsors and academic institutions in a discussion to establish parameters in this regard.

Further, the article states "Investigators in developing countries would benefit from rigorous training in the design, conduct, and ethical oversight of trials, which would allow them to engage more fully in multinational clinical research at a leadership level." ACRO members invest millions of dollars annually to recruit and train high-quality investigators in more than 60 countries. A well-trained, global investigator network is in the best interest of all participants in the drug development process.

However, the globalization of the clinical trials enterprise is a complex endeavor involving many factors. Unfortunately, the authors' ignored one of the primary drivers behind the globalization of clinical research: the limited participation rate in clinical trials in the United States and Western Europe. According to the non-profit Center for Information & Study on Clinical Research Participation, 80% of clinical trials in the United States are delayed at least one month because of unfulfilled enrolment. The ramifications of this limited participation are clear. According to the National Cancer Institute, fewer than 5% of cancer patients participate in clinical trials; but if the participation rate doubled to just 10%, studies could be completed in one year, rather than the typical three-to-five years. ACRO and its members work extensively to increase clinical trial participation in the U.S. and Western Europe, yet multinational studies are not only necessary but also desirable in order to meet the demands of today's global pharmaceutical industry.

The article cites "the increasingly bureaucratic and expensive regulatory environment in many wealthy countries" as another force that is moving clinical trials to developing countries. Again, ACRO looks forward to working with sponsors, academic researchers and other participants in the drug development process to improve the environment for clinical research while maintaining an emphasis on participant safety. Among other collaborations, ACRO is an active participant in the Clinical Trials Transformation Initiative (CTTI), a joint project of the Food & Drug Administration and Duke University.

About ACRO

The Association of Clinical Research Organizations (ACRO) is the professional organization of companies whose focus is clinical research. The association provides an active voice for the CRO industry, which provides specialized services that are integral to the development of drugs, biologics and medical devices. ACRO helps its members improve the quality, efficiency and safety of biomedical research. ACRO member companies employ more than 70,000 professionals worldwide. For more information, please visit

SOURCE Association of Clinical Research Organizations
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Arpida Comments on FDAs Anti-infective Drugs Advisory Committee Outcome
2. SuperGen Comments on Preliminary Efficacy Update on EORTC Phase 3 Trial of Dacogen(R) Versus Supportive Care in Patients With Myelodysplastic Syndromes
3. Arpida Provides Further Comments on the Pivotal Phase III Trials
4. Pediatric Pulmonary Expert Comments on Study of Lung Transplants for Cystic Fibrosis
5. GeoVax Labs, Inc. Comments on Discontinuance of Mercks HIV Vaccine Trial
6. Novavax Reports Positive Preclinical Results for a Novel, Broadly Cross-Protective H5N1 Pandemic Influenza Virus-like Particle (VLP) Vaccine Candidate
7. InVitrias Cellastim Showcased in Nature Article
8. Particle Sciences Expands Its Combination Product Capabilities
9. Journal of Clinical Oncology Article Highlights CellSearch(TM) Circulating Tumor Cell Test in Treatment of Metastatic Colorectal Cancer
10. Ion Mobility Diagnostic Test from Quest Diagnostics is First to Provide Direct Physical Measurement of Lipoprotein Particles, Cardiovascular Disease Indicators, Study Finds
11. Celator(R) Pharmaceuticals Successfully Uses Nanoparticles to Administer Hydrophobic Drug Combinations
Post Your Comments:
(Date:11/24/2015)... The uptake of recently approved and pipeline premium products for Type 1 ... 2021, says GBI Research . --> ... Diabetes Mellitus (T1DM), will be a key driver of market growth to ... The uptake of recently approved and pipeline premium products for Type ... to 2021, says GBI Research . ...
(Date:11/24/2015)... PAUL, Minn. , Nov. 24, 2015  Enova ... with Novocam of Helsinki, Finland ... Both companies are at the cutting edge of medical ... Headlights in the United States ... dental cameras. Together, they provide the world,s most powerful ...
(Date:11/24/2015)...  BioPlast Manufacturing, a manufacturer of plastic components ... and biotech environments, announced today that it has ... dishes. This acquisition is aligned with BioPlast Manufacturing,s ... that are designed and tested by scientists for ... Bristol, Pennsylvania injection ...
Breaking Medicine Technology:
(Date:11/24/2015)... , ... November 24, 2015 , ... Autism Speaks, the ... global movement driven by social media and the generosity of people around the world. ... their social media networks to give – and share the personal stories behind those ...
(Date:11/24/2015)... ... 24, 2015 , ... World Patent Marketing , a ... invention that revolutionizes the vending machine industry by providing healthy and fresh smoothies ... billion," says Scott Cooper, CEO and Creative Director of World Patent Marketing. "Shakes ...
(Date:11/24/2015)... Nashville, Tennessee (PRWEB) , ... November 24, 2015 , ... ... 2015-2016 Pharmacy Quality Trend Report . Throughout the past year there have been multiple ... more mature state. During this transition, PharmMD has enabled their customers and partners to ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... Dehydration, defined ... much body water to perspiration in the hot sun, and heat stroke and death ... water advocate and radio host Sharon Kleyne. Every cell, system and structure requires water ...
(Date:11/24/2015)... ... November 24, 2015 , ... “I am so thrilled, as a newbie here, to leave a ... won a $7,500 School Lounge Makeover® from California Casualty . Stephanie is in her ... has a much longer tenure. , “This is such an amazing school and we deserve ...
Breaking Medicine News(10 mins):