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)... June 24, 2016 The Academy of Managed ... recommendations that would allow biopharmaceutical companies to more ... that make formulary and coverage decisions, a move that ... new medicines. The recommendations address restrictions in ... on the drug label, a prohibition that hinders decision ...
(Date:6/24/2016)... 24, 2016 According to a ... (Standard Pen Needles, Safety Pen Needles), Needle Length (4mm, ... Hormone), Mode of Purchase (Retail, Non-Retail) - Trends & ... studies the market for the forecast period of 2016 ... 2.81 Billion by 2021 from USD 1.65 Billion in ...
(Date:6/23/2016)... -- MedSource announced today that it has selected Datatrial,s ... choice.  This latest decision demonstrates MedSource,s commitment to ... by offering a state-of-the-art electronic data capture (EDC) ... the EDC platform of choice in exchange for ... long been a preferred EDC platform by our ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... 2016 , ... Marcy was in a crisis. Her son James, eight, was out of control. ... and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... rocks at my other children and say he was going to kill them. If ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... ... is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience ... Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... People across ... in Genome magazine’s Code Talker Award, an essay contest in which patients and their ... award to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative ... has initiated cultivation and processing operations at its production facility, and opened its ... Puradigm is the manufacturer of a complete system of proactive air and surface ...
(Date:6/24/2016)... ... 2016 , ... Venture Construction Group (VCG) sponsors Luke’s Wings ... at the Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, 20852. The ... members that have been wounded in battle and their families. Venture Construction Group is ...
Breaking Medicine News(10 mins):