The Federal Drug Administration (FDA) is responsible for the approval
and regulation of various medical drugs and treatments. Before the FDA approves
a drug or treatment, it must go pass a series of phases during the clinical
trial. Phase I of the clinical trial process uses a small, healthy group of human subjects
to determine safe doses. Phase II experiments divide participants with the
disease or condition into control and experimental groups to determine if the
drug or treatment is more beneficial than no treatment. Phase III trials are large-scale
and aim to confirm external validity and to monitor adverse side effects. Phase
IV has the largest sample size and is the final phase of the process. Only
after this extensive clinical research will a drug be available in the
pharmaceutical market. While the clinical
trial process is highly regulated and relatively thorough, ethical concerns
arise when considering aspects such as source of funding, participation of
minority racial groups, and compensation for participation.
One ethical concern for clinical trials is the source of funding
for the experiment. The pharmaceutical industry provides funding to conduct
clinical research, but because many clinical trials are published after Phase
III is complete, financial conflicts of interests during the clinical trial
process are not clearly revealed. The public may have reason to be weary of
privately-funded or industry-funded research, considering the industry’s
benefit when drugs get to market.
Compensation is a tool used for participant recruitment for clinical
trials. Under current regulations, disclosure of the monetary value of compensation
is not required. Individuals with low socioeconomic status are often recruited
for Phase I trials by means of compensation. Some research has indicated that
people of low socioeconomic status from minority groups are over-represented in
Phase I experiments but underrepresented in later phases, possibly because
these individuals are utilizing compensation as a means of income.
There is also reason to be concerned that samples in clinical
research do not accurately reflect the population. While minority groups are
under-represented in the later phases of the trial process, it is difficult to
ethically recruit people of ethnic minorities if they have low socioeconomic
status or poor education. Additionally, in 2016, the FDA reported that during
2011-2015, 42% of participants in Phase II and III trials worldwide were residing
in the United States, reflecting a possible lack of global external validity
for the treatment in question. In addition, globally, males participate in
clinical trial research at higher rates than females. Even with compensation
for participants, clinical trials are not always indicative of the diversity
within the general population. (by AP and BH)
First do harm. Walter M. 2012.
Nature. 482:148-152. This article highlights the unethical Tuskegee and
Guatemalan syphilis experiments.
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