Clinical research involves experiments conducted on human
beings to evaluate the efficacy and safety of new drugs, new drug delivery
systems, and medical devices. Because of the vast geographical and biological
diversity, lower trial costs, faster recruitment rate, and a large number of
patient population, India has become a hub for conducting clinical trials.
Every year large pharmaceutical companies are coming up with newer elements
that help to develop better, safer, and more effective drugs in the market.
And, to make sure that these drugs are not only useful, but also safe, it is
vital to test the same on a group of humans first, before putting out the drug
into the market. The human body is unique, and no computer generated model or
animal can accurately determine the effect of drugs on humans. This is why it
is imperative to check the effect of drugs on humans. But, there are many who
consider such experimenting and research as a wrong doing.
Although the concern of people towards humans and humanity is
acceptable, but the belief that the process of clinical research is wrong, is
in itself wrong. The belief is only due to the lack of appropriate knowledge
and understanding about clinical trials and research. What people fail to
understand is that there are checks and measures made, and guidelines and
regulations followed at every stage of a clinical trial to ensure the safety
and well-being of the participants at all times.
First and foremost, there is an informed consent process
involved. this means that the eligible patient is informed about all aspects
including the benefits as well as the risks involved in the proposed clinical
trial. This information is given to the patient by the concerned doctor, and is
provided sufficient time to think about it. Once the patient decides that he is
ready to participate in the trial, only then is the trial executed on him.
Then, there is an ethics committee comprising of a number of
physicians, legal persons, non-scientific persons, as well as laymen who
approves the conduct of the study and the informed consent forms being used for
the process. Moreover, the ethical conduct of the study is verified throughout
the study by the sponsors representative who visits the study site at regular
intervals to check the study conduct, examine the procedures, and verify
adherence to guidelines and regulations.
With so much in place along with constant and consistent checks
and verifications, there is no reason why there must be any negative reviews
about the entire clinical research procedure. Moreover, the Central Drugs
Standard Control Organization (CDSCO), headed by the Drug Controller General of
India (DCGI), is always putting in efforts to improve the rules, regulations,
and ethical practices regarding clinical trials, to make people’s lives better
in times to come.
With
all of this in place, clinical research is growing and is sure to make India a
global leader in the clinical research industry. Join the league and enroll
yourself at Avigna Clinical Research Institute, one of the top clinical research institutes in Bangalore, to get the finest
education in the clinical research field so that you can also put in your
efforts to make India a better and healthier place to live.
No comments:
Post a Comment