Abstract

The application of globalized clinical trials represents a vast range of genetic variability among the human subjects within the inclusion criteria, naïve population and cost reductions in clinical trials. However, globalized clinical trials deal with multi-faceted ethical implications. Some of the ethical implications include the enrollment process issues, informed consent authenticity, application/compliance of good clinical practices (GCPs), patients’ respect and beneficence, and data security. Beyond the ethical qualms, other overarching challenges inherent in globalized clinical trials are cultural differences, the social constructs, economic implications, and operational concerns. Perhaps, in other to manage global clinical trials successfully and humanely, the ethical, regulatory and social issues within the target audience must be addressed appropriately.

Globalized Clinical Trials

Subjects’ participants are integral part of any product’s breakthroughs in clinical trials. The availability of human subjects is what makes a globalized clinical trial standards possible. The globalized standards establish a comprehensive project plan (treatment population, budget, expertise, timeline, etc.) (Glancszpigel, & Racaro, 2007). More importantly, the genetic variability and environmental constructs are vital determining factors for product’s safety and efficacy. In other words, the globalization capability offers enormous characteristic profiles on genetic variability and polymorphism impacts on the pharmacogenetics activities of the medicinal product. For instance, Pfizer conducted a massive global/multi-national study on Lasofoxifene–a non-steroidal selective estrogen receptor modulator (SERM) for the prevention and treatment of osteoporosis, and for the treatment of vaginal atrophy. The data from this trial showed an increase in mortality in Mexican and Central American regions than any other sites and regions where the drug was tested (Dombey, Kaitin, & Whitmore, 2013). The increase in mortality observed in these locations, and how it relates to subjects’ genetic variability and regional differences are some unanswered questions facing clinical scientists.

Many suggested that globalization of clinical trials introduce bias and naïve implications to research findings. After all, human subject participants in developing countries may not have been exposed to medicinal products or have access to basic healthcare or medical care prior to clinical trials (Dombey, Kaitin, & Whitmore, 2013). The prior exposure to drugs could induce an antagonistic or a synergistic effect. This set of interactive effect of medicinal products is a critical factor to consider because the level of therapeutic or treatment exposures for a condition or disease could affect the efficacy and reliability of the clinical data or findings. Fair enough, the concept is crucial especially in a cancer therapeutic intervention. For instance, persons with cancer that have undergone different therapeutic procedures (radiation, chemotherapy or other therapies, etc.) may experience a synergistic or antagonistic effect to the investigational treatment due to exposures to previous treatments. Therefore, conducting a reliable and vetted clinical trial in a region with naïve population, the inclusion/exclusion criteria should fit the naïve population medical and social criteria, and not the intended end-user population. Among other things, the ethical issues or conflicts for the “intended user” for a new investigational drug is one major challenge taunting clinical trial practices within a naïve population.

Considerably, clinical trials are unpredictable and expensive investments. The cost associated with clinical trials and product development is overwhelming. In most developed countries, the cost of conducting all the three phases of the clinical trials is between $150- $180 million dollars, accounting for about 60% higher cost than in India (Whitmore, 2004). In most developing countries, the budgeting cost associated with clinical trial procedures, salaries, sites, etc. is about 30-40% of the US cost (Jankosky, Jiang, & Farwell, 2007). In general, the cost associated with conducting clinical trials in a developing country is significantly lower than in any developed country.

In the effort to achieving cost-effective clinical trials process, globalization of clinical trials faces cultural differences and social impacts. The level of cultural competency implications depends on the investigational new product. For instance, it may be very difficult to obtain reliable and valid data on contraceptive studies from a conservative pro-life culture/ideology or region. For this reason, principal investigators (PIs) may be required to attain some level of cultural competence awareness.

Operational, ethical, social, economic, and regulatory implications are serious concerns PIs considers while conducting clinical trials among naïve population. More so, when naive population is not carefully monitored or when the informed consent is not accurately obtained from subjects participating in a clinical trial, the severity of the malpractice is taunting. Also, the level of compliance could be affected substantially. Furthermore, the lack of regulatory adherence to the ICH standards or guidelines expose human subjects’ well-being to unwarranted risks. Such inhumane negligence to the Belmont tenets and lack of good clinical practices (GCPs) in clinical trials create ethical qualms questioning the primary intent of the clinical trial itself and biomedical oath of the intent to heal, and “first, do no harm” principles.

References

Dombey, S., Kaitin, K., & Whitemore, E. (2013). Globalization and outsourcing. Retrieved from https://class.waldenu.edu/webapps/portal/frameset.jsp?tabtabgroupid=21&url=%2 Fwebapps%2Fblackboard%2Fexecute%2Flauncher%3Ftype%3DCourse%26id%3D_20992841%26url%3D.

Glancszpigel, D., & Rácaro, G. (2007). Create a successful project plan for global trials. Applied   Clinical Trials, 16(11), 52–54. Retrieved from http://ezp.waldenulibrary.org/login ?url=http://search.ebscohost.com/login.aspx?direct=true&db=a9h&AN=27459304&site=ehost-live&scope=site.

Jankosky, J., Jiang, Y., & Farwell, T. (2007). Grant budgeting and negotiating in India and China. Applied Clinical Trials, 16(11), 56–62. Retrieved from http://ezp.waldenulibrary .org/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=a9h&AN=27459305&site=ehost-live&scope=site.

Whitmore, E. (2004). Development of FDA-regulated medical products. Quality Press. Milwaukee, WI.