As the clinical trials enterprise becomes ever more outsourced and offshored, it also becomes increasingly decentralized and more difficult to track. While we have estimates of numbers of investigators involved, estimates for the number of clinical trials actually being initiated worldwide vary considerably. In March 2006, a member of a World Health Organization initiative to create a global registry of clinical trials told me, "Our best guess is that 20,000 new trials are initiated worldwide annually. But take this 'guesstimate' with a grain of salt." A global field of experimental activity is booming and experts struggle to simply keep count.ll Companies are free to move medical research to cost-effective sites around the globe. Meanwhile, the subjects of research depend upon local and national communities to mediate their participation in clinical trials and to protect them from harms that may be associated with such participation. An international trial registry could help us to better account for this corporate—human subjects disjuncture and to gauge the relevance of international ethical guidelines and capacities of local and national institutions to protect patient-citizens in an era of global experimentality.
Hundreds of CROs operate worldwide, employing nearly one hundred thousand professionals who implement clinical trials protocols for the pharmaceutical industry?
The geography of clinical testing is changing dramatically. In 2005, 40 percent of all trials were carried out in emerging markets, up from 10 percent in 1991 (Lustgarden 2005:68). Figures are available for some firms. GlaxoSmithKline ran 29 percent of its trials outside the United States and Western Europe in 2004; by 2007, that figure grew to 50 percent. Wyeth Pharmaceuticals conducted half of its trials outside the United States in 2004; that figure rose to 70 percent in 2006. Merck conducted half of its clinical trials outside the United States in 2004, an increase of 45 percent since 1999 (Schmit 2005). According to recent industry statistics, Central-Eastern Europe has the highest volume of patients (6.27) enrolled per investigative site, followed by the Asia-Pacific region (5.78), South-Central America (4.56), Western Europe (3.08), and the United States (1.92) (Parexel 2008: 135). Between 1995 and 2006, the highest annual growth in active investigators occurred in Russia, Argentina, India, Poland, Brazil, and China. Of these select countries, as of 2006, Russia had the highest number of investigators.
Why should we As medical professionals worry about this booming Clinical trials offshoring?
For a country well respected and looked upon as a spiritual destination, we are all aware of Indian loose Ethical, Moral and Human standards.
When my own Colleagues are going on Junkets to Bangkok, Singapore, Kathmandu where the bill is paid by the Pharma companies, is it an exaggeration on my part to be worried?
Who is going to keep track of the integrity of clinical trial investigators and their experiments and results?
" In 2000, representatives from diverse interest groups met to reflect on the state of clinical research in the United States, which, they said, was contributing to an overall decline in drug innovation. They agreed that, in spite of greater research funding from the National Institutes of Health (NIH) and revolutions in basic biomedical science, clinical research is "increasingly encumbered by high costs, slow results, lack of funding, regulatory burdens, fragmented infrastructure, incompatible databases, and a shortage of qualified investigators and willing participants" (Sung et al. 2003:1278). Moreover, the U.S. clinical research environment limits the translation of basic scientific concepts into human studies and medical practice. The environment must be improved, and the president and U.S. Congress must enact bold new approaches. If not, they claimed, the "data and information produced by the basic science enterprise will not result in a tangible public benefit" (ibid.:1279; see also Rosenberg 2003).7"
Certainly, the human research enterprise is about obtaining valuable data that can get drugs approved. But it is also about creating new experimental infrastructures, remediating old ones, and expanding market frontiers.3 "Pharmaceuticals are the new gold," as Dr. Paulo Picon, a southern Brazilian cardiologist and public health expert, told me skeptically. He is a staunch critic of the increasing use of clinical trials as a means of introducing high-cost medicines in Brazil's ailing public health-care system. "After a trial ends, the industry enlists doctors to prescribe and patients to demand drugs from the state." Pharmaceutical costs overburden the system, and "often these new drugs have not even been approved here and their benefits are not yet clearly established." Whether they work in the United States, Poland, or Brazil, my informants raise crucial issues that go to the heart of the globalized clinical trial.
Are clinical trials exploitative or are they social goods or some combination?
Hundreds of CROs operate worldwide, employing nearly one hundred thousand professionals who implement clinical trials protocols for the pharmaceutical industry?
The geography of clinical testing is changing dramatically. In 2005, 40 percent of all trials were carried out in emerging markets, up from 10 percent in 1991 (Lustgarden 2005:68). Figures are available for some firms. GlaxoSmithKline ran 29 percent of its trials outside the United States and Western Europe in 2004; by 2007, that figure grew to 50 percent. Wyeth Pharmaceuticals conducted half of its trials outside the United States in 2004; that figure rose to 70 percent in 2006. Merck conducted half of its clinical trials outside the United States in 2004, an increase of 45 percent since 1999 (Schmit 2005). According to recent industry statistics, Central-Eastern Europe has the highest volume of patients (6.27) enrolled per investigative site, followed by the Asia-Pacific region (5.78), South-Central America (4.56), Western Europe (3.08), and the United States (1.92) (Parexel 2008: 135). Between 1995 and 2006, the highest annual growth in active investigators occurred in Russia, Argentina, India, Poland, Brazil, and China. Of these select countries, as of 2006, Russia had the highest number of investigators.
Why should we As medical professionals worry about this booming Clinical trials offshoring?
For a country well respected and looked upon as a spiritual destination, we are all aware of Indian loose Ethical, Moral and Human standards.
When my own Colleagues are going on Junkets to Bangkok, Singapore, Kathmandu where the bill is paid by the Pharma companies, is it an exaggeration on my part to be worried?
Who is going to keep track of the integrity of clinical trial investigators and their experiments and results?
" In 2000, representatives from diverse interest groups met to reflect on the state of clinical research in the United States, which, they said, was contributing to an overall decline in drug innovation. They agreed that, in spite of greater research funding from the National Institutes of Health (NIH) and revolutions in basic biomedical science, clinical research is "increasingly encumbered by high costs, slow results, lack of funding, regulatory burdens, fragmented infrastructure, incompatible databases, and a shortage of qualified investigators and willing participants" (Sung et al. 2003:1278). Moreover, the U.S. clinical research environment limits the translation of basic scientific concepts into human studies and medical practice. The environment must be improved, and the president and U.S. Congress must enact bold new approaches. If not, they claimed, the "data and information produced by the basic science enterprise will not result in a tangible public benefit" (ibid.:1279; see also Rosenberg 2003).7"
Certainly, the human research enterprise is about obtaining valuable data that can get drugs approved. But it is also about creating new experimental infrastructures, remediating old ones, and expanding market frontiers.3 "Pharmaceuticals are the new gold," as Dr. Paulo Picon, a southern Brazilian cardiologist and public health expert, told me skeptically. He is a staunch critic of the increasing use of clinical trials as a means of introducing high-cost medicines in Brazil's ailing public health-care system. "After a trial ends, the industry enlists doctors to prescribe and patients to demand drugs from the state." Pharmaceutical costs overburden the system, and "often these new drugs have not even been approved here and their benefits are not yet clearly established." Whether they work in the United States, Poland, or Brazil, my informants raise crucial issues that go to the heart of the globalized clinical trial.
Are clinical trials exploitative or are they social goods or some combination?
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