The idea for a clinical research study or clinical trial
often originates in the laboratory. Further, the most promising experimental
treatments are moved into clinical trials, which are conducted in phases.
During a trial, more information is gained about an experimental treatment, its
risks, and its effectiveness.
The civic is unknowing of the innate differences between
medical treatments and clinical trials, and therefore, the two terms are often
interchanged. As a participant or volunteer, you play an integral role in
determining whether these drugs are suitable for patients with the targeted
condition on a mass level. FDA works to protect participants in clinical trials
and to ensure that civic have reliable information before deciding whether to
join a clinical trial.
Developing countries ironically have conflicts in the goals
of interests of clinical trials and treatments (refers to volunteers without
proper consent)."Less stringent ethical review, anticipated
under-reporting of side effects, and the lower risk of litigation make carrying
out research in the developing world less demanding," said Ames Dhai,
director of the Steve Biko Centre for Bioethics at the University of
Witwatersrand, South Africa.
“India is another example, where a recent trial of two
vaccines against the virus responsible for cervical cancer has had a lot of
negative publicity after some deaths that were later shown to be unrelated to
the trial, but exposed ethical irregularities in the Indian system” Dhai added.
Civics of developing and under developing countries was
vulnerable to trials, because they could not afford high quality treatment,
rather expensive treatment though they are seriously ill. Paradoxically these
trials also violate national and international ethical guidelines.
Researcher Wolfe and Lurie have observed that the number of
clinical studies taking place in developing countries has increased
dramatically. Unfortunately, the troubling rotavirus vaccine trial in India
indicates that we still have a long way to go to achieve implementation of a
single international ethical standard for human subject research.
The trials conducted in developing countries happening due
to lack of access to quality and inexpensive care and therefore civics may
accept the challenging offers. At the same time benefits of research is not
reaching the people on which they were tested. Such practices are in violation
of the Declaration of Helsinki as well as the general principles laid down in
the Indian Council of Medical Research (ICMR), the Government of India’s
ethical guidelines for biomedical research. The infrastructure for regulation,
ethics review and monitoring is insufficient.
The government’s priority seems to be ensuring that clinical
research in developing countries produces good quality data according to Good
Clinical Practice (GCP) standards; perhaps people desperation for the
affordable and appropriate health care may escalate the rate of trials. Hence
the infrastructure of trials has to be universal and civic awareness campaigns
are much needed for the betterment.
