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:10/2/2017)... Oct. 2, 2017 Diplomat Pharmacy, Inc. (NYSE: ... Software and Consulting, LLC , and named its founder ... based in Tennessee , will operate ... expands EnvoyHealth,s service offerings for health care partners to ... "In an interoperable world, technology ...
(Date:10/2/2017)... , Oct. 2, 2017  AllianceRx Walgreens Prime, ... formed by Walgreens and pharmacy benefit manager Prime Therapeutics ... new brand, which included the unveiling of new signage ... , as well as at a few other company-owned ... new brand to patients, some of whom will begin ...
(Date:10/2/2017)... , Oct. 2, 2017 The Rebound mobile ... the struggle to reverse the tide of prescription drug addiction. ... regulating their medicine intake and stepping down their dosage in ... to launch in December 2017; the first 100,000 people to ... more at http://www.rebound-solution.com/ ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... While it’s often important to take certain medications during the night, finding ... identified a solution. , She developed a prototype for MOTION LIGHT-UP PILL BOX to ... the need to turn on a light when taking medication during the night, allowing ...
(Date:10/13/2017)... Nevada (PRWEB) , ... October 13, 2017 , ... ... Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil ... required and providing a CBD form that can be easily incorporated into liquid products, ...
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , which ... evacuation of the facility as part of a disaster drill on October 3rd. , ... and Shelton City Emergency Manager, as well as the Connecticut Long Term Care ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
(Date:10/13/2017)... ... 2017 , ... Talented host, actor Rob Lowe, is introducing ... new episode of "Success Files," which is an award-winning educational program broadcasted on ... subject in-depth with passion and integrity. , Sciatica occurs when the sciatic nerve ...
Breaking Medicine News(10 mins):