Globalization of Clinical Trials: Another Hole in Pharma Regulation?
A recent article in the New England Journal of Medicine by researchers from Duke University raises concerns over the increased globalization of clinical trials and the need to strengthen regulation to address this phenomenon. As pharmaceutical companies conduct more trials abroad as part of overall cost-saving measures, such a finding has implications for all stakeholders—patients, suppliers, and the drug companies themselves.
Since 2002, the number of active investigators regulated by the US Food and Drug Administration that are based outside the United States has increased 15% per year while the number of US-based investigators has declined by 5.5%, according to the article. In using the ClinicalTrials.gov registry to examine recruitment in industry-sponsored Phase III clinical trials as of November 2007 for the 20 largest US-based pharmaceutical companies, the researchers found that approximately one-third of the trials (157 of 509) are being conducted solely outside the US and that a majority of study sites (13,521 of 24,206) are outside the US. Many of these trials are being conducted in developing countries, including Eastern Europe and the Russian Federation, says the article.
The data clearly show the globalization of clinical development, a situation that calls into question the adequacy of regulatory oversight of research, particularly in emerging markets. Regulatory bodies in established markets are typically structured to monitor studies in their own countries, not abroad, and are not sufficiently tasked to address this globalization. The researchers also raise concerns over the relevance of trials conducted on patients that may have environmental or genetic profiles specific to a population of a given country to patients outside that group as well as ethical concerns of using patients in developing nations, as these patients may participate more readily in trials for economic reasons.
These concerns over the globalization of clinical trials reflect similar problems on the pharmaceutical manufacturing side, namely the growing disconnect, either in organizational structure, resource allocation, or operation of regulatory agencies in dealing with the globalization of the pharmaceutical industry. The historic bent of pharmaceutical regulation is a framework consisting of national (i.e., FDA), regional (i.e., European Medicines Agency) or developed-nations’ (i.e., International Conference on Harmonization) interests, which simply do not fit a 21st-century reality where developing nations play a significant role in clinical development and manufacturing.
Although there have been recent efforts by FDA, EMEA, and ICH to address these shortfalls, for example, on the manufacturing side through location of national regulatory offices abroad and proposals and implemented measures to address drug import safety, the real question is whether these efforts or similar ones will be adequate to fully address the pace and extent of globalizaiton of the drug industry.
The researchers from Duke University say that long-term solutions to the problems stemming from the globalization of clinical research require input from all stakeholders—academia, industry, and regulatory agencies. They suggest beginning with a comprehensive review from representatives from developed and developing countries, perhaps commissioned by the Institute of Medicine or the World Health Organization, to build dialogue and consensus. But with these or other efforts on the clinical side, there needs to be a concomitant effort on the manufacturing side.
A cohesive and integrated system for global pharmaceutical regulation that incorporates the full continuum of functions in drug development and commercialization (clinical research, development, and manufacturing) and the myriad of players—patients, suppliers, and drug companies from both developing and developed nations need to be embodied into a solution. A tall task for sure, some might say improbable, but a truly strategic, not tactical approach, is needed.
The only folks that will profit from sending clinical research trials to other nations are the pharma companies and litigators.
Large Pharma is hurting the US by sending jobs to India just to speed up getting their drugs to market and to cut costs. The result is that people like me are out of work, study subjects in India are harmed because of a lack of regulatory oversight, and more patients will be hurt or die from harmful drugs that are rushed to market by unregulated clinical trials in India.
Eli Lilly and Pfizer are just 2 of the US drug companies that are taking their clinical research trials to India to speed up the time to market and reduce costs. To them efficiency and profit is everything. In the long run it is the US worker, and vulnerable patient that will bear the costs. Clinical research is not about efficiency and production but about taking the time to thoroughly and honestly look at a product’s safety and efficacy in both the short-term and long-term. Along with the FDAs “partnering” with big Pharma in the mid-1990s to speed up the drug approval process came a huge increase in the number of approved drugs that proved harmful and lethal. Hopefully, the FDA will not be fooled by data produced by the hasty and careless clinical trials of drugs tried out in India. Considering the FDA’s priority of protecting the interests of large Pharma over the welfare of consumers I am very afraid there is very little hope.
Litigators get prepared to make a ton of money handling class action suits resulting from people taking harmful drugs that were not adequately proven to be safe or efficacious because of Pharma using data to get market approval obtained from speedy and careless trials conducted in India. The risk for consumers in the US for taking a bad drug is sure to skyrocket to the moon. Patients will be turned into high-risk gamblers. A very unfortunate situation for US workers and consumer-patients.
Those of us in the US who have contacted by email and phone the “customer service agents” for US companies who are located in India, The Philippines, etc., know what Gambler is talking about.
Such outsourcing of information technology is undoubtedly cost-saving to companies. However, there is growing frustration among US customers over misunderstood communications, faulty implementation of customers’ requests, and failure of company follow-up. Inability of customer service reps to understand and respond in “American English” is a large part of the problem. And, our frustration is only about a dishwasher under warranty that refuses to work.
When language and cultural incompatabilities between nations are about testing medicines that save lives and reduce suffering, the stakes then reach critical status. It’s not just about mere faulty consumer products.
Fortunately, companies in Canada, US, and Europe are now receiving customer feedback about performance of many outsourced services. And, those reports aren’t pretty. Management of smart companies will make appropriate adjustments to policy.