<h1>Citizens of developing countries - their destiny with clinical trials</h1>

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.