Why Is Careful Clinical Research Required - ACRI India

1. Why Is Careful Clinical Research Required? The field of healthcare is a very challenging discipline, which requires quick yet safe results. In the rush to do good, one cannot risk one’s life or health. Trying to cure one health aspect, while bringing another one into risk, is not a good idea. After all, there is lots of exhaustive research done before coming up with a drug that proves to be successful at curing the required disease. However, even then, some drugs are shown to have adverse side-effects on other parts of the body. While common side-effects like headache, nausea, bloating, dizziness, constipation, etc. are normal with any medicine, other serious adverse side-effects shouldn’t be accepted. For example, certain anti-diabetic drugs are linked with curing diabetes, while bringing on increased risk of other issues like heart attack, stroke, low blood sugar, bladder cancer, etc. One can't compromise on other health issues as these, only in order to reduce his diabetes levels. This is why it is very important that a rigorous clinical trial practice is followed for every new drug developed to check not only for its efficacy, but also safety. How are clinical trials performed? Performing a clinical trial on a drug is a very responsible job. Even a minor lapse may result in a major issue like death! Thus, it is important that every clinical trial step is carefully followed and successfully accomplished.

2. Pre-clinical studies – New drugs are first tested on animals or test tube cell cultures to obtain preliminary efficacy information. These tests confirm if the drug is approved for further trials on humans. Phase 0 – This phase decides whether the drug behaves in a similar fashion in human subjects, as was expected from the pre-clinical studies. This involves testing a single sub- therapeutic dose of the drug on 10-15 people only to gather preliminary data on how the drug behaves in the human body. The dose here is too low just in case of a risk to the human body involved. This low dose helps depict a simple investigation for further testing or rejection, without putting the trial subjects at risk. Phase I – This phase is the actual testing of the drug on humans. Anywhere from 2 to 100 candidates can be taken up for testing the drug for safety, side-effects, and best dosage. The candidates are monitored 24x7 to check for any changes – good or bad. This phase helps in deciding if the drug is good to be shifted to the next phase or rejected right away. Also, if approved for further investigation, this phase depicts the right dosage to be given. Phase II – 100 to 300 candidates are tested here with the suggested dosage of the drug, to assess how well the drug works, along with the safety aspects, which can be better decided in a large group of people of different ages, sexes, regions, castes, and health conditions. Phase III – Now, the drug is tested on even larger groups involving 300-3000 candidates; the trial being aimed at being the definitive assessment of how effective the drug is. This is the most expensive, time-consuming, and difficult phase. Phase IV – Finally, once everything is successful, the last stage is the confirmatory trial. This phase involves safety surveillance and ongoing technical support of a drug even after receiving permission to be sold into the market. Any rare or long-term adverse effects on a larger patient population are detected here. Any harmful effects seen here means the drug will be rejected right away, or being restricted only to certain specific uses. Get on with a career in this amazingly challenging yet satisfying field of clinical research by taking up professional education and training at a reputed clinical research virtual learning center Bangalore, one like Avigna Clinical Research Institute.