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Clinical Research Safety and Ethical Standards in Developing World Up to U.S. Levels
Date of Release: 21 July 2009
CLINICAL RESEARCH SAFETY AND ETHICAL STANDARDS IN DEVELOPING WORLD UP TO U.S. LEVELS, REPORT SAYS
Clinical Research Organizations urge full funding for FDA to conduct foreign safety inspections
WASHINGTON, D.C., July 21, 2009 –- Clinical trials conducted in the developing world meet the same safety, ethical and quality standards as those conducted in the developed world. That is the conclusion of a major report released today by the Association of Clinical Research Organizations (ACRO). The report, commissioned against a backdrop of declining participation rates in the United States and recent criticism of international research by several academic journals, was developed for ACRO by VOI Consulting, Inc, a Ft. Lauderdale-based life sciences advisory and publishing company.
Based on the report’s findings, ACRO, which represents the leading global Clinical Research Organizations (CROs), is urging several steps to ensure that a robust global research infrastructure continues to facilitate accelerated drug development.
ACRO initiated the report because of the dramatic increase in clinical trials conducted in emerging markets over the past decade and the concern expressed by some regarding their quality. Last year, ACRO members conducted more than 9,000 clinical trials in 115 countries adhering to the highest standards of research ethics, safety and quality. Two factors are fueling the growth in developing world trials: because fewer Americans are enrolling in trials, and because global trials enable pharmaceutical companies to bring drugs to market more quickly and cost-effectively.
With the changing landscape for CROs, the report has several key findings:
- Global trials speed drug development – The report concludes that globalized trials can reduce development time by half while lowering costs and maintaining quality and safety. For example, phase III cancer trials are conducted three times as fast if both U.S. and global sites are used, compared to U.S.-only sites. What takes 5.8 years to enroll takes 1.9 when a global trial is implemented.
- Research quality standards must be met worldwide – The report found that trials in emerging countries, such as China and India, are subject to the same standards as those conducted in the U.S. and Western Europe. CROs train research staff around the world in good clinical practice (GCP) principles and proof of compliance is required by drug regulators in every major pharmaceutical market.
- Clinical research improves local economies – Clinical research offers huge advantages for host countries, including an influx of advanced equipment, trained personnel and high-paying jobs. The presence of CROs also results in improvements in local health systems. Clinical trial sponsors in Poland, for example, fund 30 percent of hospital cancer therapy.
- Emerging market equals growth market – CRO activity in Central European countries, South Korea and Taiwan is very robust, medical infrastructures are advanced and capabilities are just about on par with Western Europe.
“On a flattened earth with waning U.S. participation in clinical trials, global trials are helping speed important drugs to market,” said Doug Peddicord, executive director of ACRO. “CROs are making sure quality and ethical standards remain consistent throughout the world,” Peddicord added.
With all the advantages of globalized clinical trials have come some rare but well-publicized lapses in standards. Most notable among them is a 1996 Nigerian trial of the antibiotic Trovan, which resulted in the deaths of 11 children.
While Nigeria has made strides to tighten its standards, ACRO makes several recommendations to make sure the quality and ethical standards match the international spread of the trials. Among them, ACRO recommends that:
- The U.S Food and Drug Administration be provided sufficient resources to conduct inspections on a global basis in order to ensure that research quality is protected and improved around the world.
- All governments take measures to foster the development of a clinical research infrastructure and encourage clinical research participation.
- Overseas regulatory bodies recognize drug development as a global enterprise and that globalization leads to faster cures.
- All participants in clinical research – no matter where they live or the environment in which research takes place – be protected by the same level of safety and ethical considerations, and that they be afforded the same standard of care, including adherence to the GCP principles promulgated by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
“The public will never have confidence in trials conducted in emerging regions like Asia and Latin America unless we level the playing field with the U.S., Canada, Western Europe and Japan,” Peddicord said. “If the entire world plays by the same rules and gets the same resources, patients worldwide will benefit from life-saving drugs more quickly and more cost-effectively,” he added.
The report finds other advances:
- Ethical Considerations – Disparities in education, economic and social status and healthcare systems may jeopardize the rights of research participants. While the analysis did not find that patients in developing countries were treated differently than those in developed countries, rising experience levels have strengthened the institutions charged with oversight in developing countries.
- Social Issues – The report found that patients enrolled in a trial suffer from the disease condition being studied, despite complaints that the pharmaceutical industry uses poor countries to test drugs that will benefit rich countries.
- Informed Consent – Literacy rates in host countries are relevant to the execution of a fully informed consent to participate in research The report found that literacy rates in the developing countries where clinical trials are conducted are similar to those in the U.S. and in most cases the average literacy is well above the world average of 82 percent.
- Undue Influences – Research norms dictate that any payments associated with the trial be examined as part of the ethical review process and payments cannot unduly encourage participation. Standard practice is to reimburse for meals, transportation and similar out-of-pocket expenses.
To view the full report, please go to www.www.acrohealth.org/globalization.
About ACRO
The Association of Clinical Research Organizations (ACRO) represents companies whose focus is clinical research. The association provides an active voice for the global CRO industry, which provides specialized services that are integral to the development of drugs, biologics and medical devices. Through its member companies, ACRO helps improve the quality, efficiency and safety of biomedical research. ACRO member companies employ approximately 70,000 professionals worldwide and last year conducted more than 9,000 clinical trials in 115 countries. For more information, please visit www.www.acrohealth.org.
About VOI Consulting, Inc.
VOI Consulting is a life sciences advisory and publishing company dedicated to providing pharmaceutical and biopharmaceutical clients with fact-based analysis and business intelligence to meet market challenges in today’s highly competitive global environment. By skillfully employing innovative research techniques and advanced analytical tools, VOI’s services help clients minimize risks, cut costs and maximize commercial opportunities. The company also publishes the annual PharmaHandbook: A Guide to the International Pharmaceutical Industry and GenericHandbook: A Guide to the U.S. Multisource Drug Industry, which have become the standard resources on their respective topics with customers in more than 45 countries. For more information, please visit www.voiconsulting.com.