Clinical Research - The Ultimate Saviour of Mankind

An epitome of altruism to heave a sigh of relief from the sufferings
By: Sanjay Gupta
DELHI, India - Dec. 2, 2021 - PRLog -- The emergence of the COVID-19 pandemic has necessitated the rapid development of newer drugs, vaccines, and diagnostic tools on an urgent basis. This once again has reinstated the importance of clinical research as the ultimate saviour of mankind. Clinical research in many ways is the epitome of altruism, where patients/volunteers, investigators, and sponsor organizations put everything at stake to turn down the sufferings, disabilities, and deaths globally. The first documented evidence of clinical trials dates back to 1747 when James Lind discovered citrus fruit as a cure for scurvy. In the modern world, clinical trials are conducted in four different phases, where each phase is aimed at addressing a scientific question. As clinical trials are conducted in a phase-wise manner, the next phase is initiated only if the drug passes the earlier phase.

Phase-I clinical trials are conducted to establish the initial safety, maximum tolerance, and pharmacokinetics of a new drug in 20-80 healthy human volunteers. During Phase-I trials, sufficient information is obtained to plan a well-controlled, Phase-II trial.

Phase-II clinical trials are universally accepted as a standard requirement for the evaluation of efficacy and safety of a new drug. Careful observations are made to determine the dose and adverse reactions in 100-200 patients with the relevant indication. If a new drug is found to be effective and safe in Phase-II trials, it is moved to the next phase of development.

Phase-III clinical trials are the final pre-marketing phase of clinical trials. These are large, multi-centric trials to establish the safety and efficacy of a new drug vis-à-vis the existing standard of care/placebo that forms the basis for marketing permission.

Phase-IV clinical trials are post-marketing studies that are conducted for generating additional safety data on a drug once it is marketed.

Being a highly specialized field, clinical research requires a specific skill set to carry out various activities. However, an unmet need for the required training and competency exists at the level of graduates/postgraduate students from medical, pharmacy, and Life-sciences disciplines. Catalyst Clinical Services Pvt. Ltd., is pleased to announce the intake for the December batch of its specialized courses viz. Professional Diploma in Clinical Research (PDCR) and Professional Certificate in Pharmacovigilance (PCPV). These are skills development courses to equip the participants with the knowledge and competencies required for the clinical research and pharmacovigilance profession. Over the past 17 years, more than 10,000 participants across 27 countries have participated in the research training courses offered by Catalyst. Explore the exciting field of clinical research and be the next one to save the world.

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