Navigation Links
ACRO Comments on NEJM Article on Globalization of Clinical Research
Date:2/20/2009

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 www.acrohealth.org.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... 24, 2016 Dehaier Medical Systems Ltd. (NASDAQ: ... develops, markets and sells medical devices and wearable sleep ... a strategic cooperation agreement with Hongyuan Supply Chain Management ... on June 20, 2016, to develop Dehaier,s new Internet ... agreement, Dehaier will leverage Hongyuan Supply Chain,s sales platform ...
(Date:6/24/2016)... Research and Markets has announced the addition of the ... to their offering. ... World Market for Companion Diagnostics covers the world market for ... report includes the following: , World IVD ... (N. America, EU, ROW), 2015-2020 , World IVD Companion ...
(Date:6/24/2016)... LEXINGTON, Mass. , June 24, 2016   ... specialty pharmaceutical company developing innovative inhaled drugs, announced today ... when Russell Investments reconstituted its comprehensive set ... 2016. "This is an important milestone for ... "It will increase shareholder awareness of our progress in ...
Breaking Medicine Technology:
(Date:6/26/2016)... Lake Orion, Clarkston, Michigan (PRWEB) , ... June ... ... direction with respect to fertility once they have been diagnosed with endometriosis. These ... tolerable intercourse but they also require a comprehensive approach that can help for ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding ... of its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. ... James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... A ... procedures that most people are unfamiliar with. The article goes on to state that ... but also many of these less common operations such as calf and cheek reduction. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg ... Legal Elite. The attorneys chosen by their peers for this recognition are considered among ... Greenberg Traurig Shareholders received special honors as members of this year’s Legal Elite Hall ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... at the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, ... journal articles published in Emergency Medicine Practice and Pediatric Emergency Medicine ...
Breaking Medicine News(10 mins):