Clinical Trial Global Clinical Development

Clinical Trial

Global clinical development of drug and biologic products

At some point, all prospective drugs must be tested upon a human population. This always raises profound ethical questions regarding the safety of the drug for volunteers. There is also an additional question of the use of controls: if a drug is found early on to be extremely helpful in mitigating the effects of a deadly disease, should the study's results be compromised by offering the drug to the members of the trial that are known to be getting a placebo?

Ethical questions grow even more troubling regarding global clinical trials. The question of using a population that is not of the same socioeconomic, ethnic, or racial background as the researchers calls to mind the infamous Tuskegee experiments in the American South, where white researchers denied penicillin to black men suffering syphilis, to see if the effects of the medicine were partially psychosomatic. At the time, there was already considerable biological evidence about the efficacy of penicillin and many men needlessly suffered damage to their health (Research ethics: Tuskegee Syphilis study, 2010)

Even though clinical drug trials may have legitimate scientific designs and be legitimately 'experimental' in nature with the ability to potentially help humanity, opponents of trials argue that many of the medications being tested are not going to benefit the communities where the tests are conducted. The drugs are too expensive and the population lacks access to even basic medical care, much less new and experimental drug treatments. Proponents of clinical trials state that "apart from a wider availability of patients" on a global scale, "for such patients, clinical trials can be seen as a means to receive medical treatment and care for free" (Kermani 2010). While it is true that a "limitation for pharmaceutical companies in emerging markets is that, at present, only a proportion of the population can afford modern medicines…this section of society is sufficiently large to offer companies a promising consumer base for the future. Companies believe that in the long-term the section of society that can afford new medicines and healthcare services will increase" (Kermani 2010). Conducting clinical trials in the developing world also enables drug companies to keep costs lower for the trials and therefore renders the final product more affordable. This is an outcome which benefits all individuals in the long run.

Demand for drugs that will treat increasingly common global problems such as diabetes is expanding, and proponents of these trials further add that it is necessary and beneficial that the populations they are tested upon are diverse. This enables researchers to gain a more broad-based sense of the extent to which drugs may affect different populations. Opponents would counter that the diverse range of factors that can affect the results of global trials (such as the effects of poverty) is a detriment to the scientific purity of the results. Furthermore, many individuals in the developing world are attractive to researchers because they do not take additional medications. They can thus provide more straightforward experimental groups and controls. But this may fail to take into consideration how other drugs can impact the side effects and results of the medications, as in the developed world drugs are more likely to be used in combination with other medical treatments.