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)...   Pulmatrix, Inc ., (NASDAQ: PULM ... announced today that it was added to the Russell ... comprehensive set of U.S. and global equity indexes on ... milestone for Pulmatrix," said Chief Executive Officer Robert ... progress in developing drugs for crucial unmet medical needs, ...
(Date:6/23/2016)... , June 23, 2016 Any dentist who ... challenges of the current process. Many of them do not ... the technical difficulties and high laboratory costs involved. And those ... offer it at such a high cost that the majority ... Dr. Parsa Zadeh , founder of Dental ...
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on the ... announced that patient enrollment in its ongoing randomized ... has exceeded 50% of its 24-patient target. Capricor ... the third quarter of 2016, and to report ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 2016 , ... Experts from the American Institutes for Research ... June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR experts ... planning, healthcare costs and patient and family engagement. , AIR researchers will be ...
(Date:6/25/2016)... ... ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his Bachelors in ... School of Medicine at UCLA. He trained in Internal Medicine at Scripps Green Hospital ... at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to train in ...
(Date:6/24/2016)... ... 24, 2016 , ... Those who have experienced traumatic events may suffer from ... avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid this ... coping following a traumatic event. , Trauma sufferers tend to feel a range of ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas ... , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct ...
(Date:6/24/2016)... York, NY (PRWEB) , ... June 24, 2016 ... ... publication Haute Living, is proud to recognize Dr. Barry M. Weintraub as a ... that “the most beautiful women in the world, and the most handsome men, ...
Breaking Medicine News(10 mins):