Clinical Research: Trials Involved before Formulating a Drug

The branch of healthcare science that deals with determining the safety and efficacy of medications, treatment regimens, devices and diagnostic products is called clinical research. Clinical research and clinical practice are two different concepts. Established treatments are practised in clinical practice, whereas, clinical research calls for collecting evidence for establishing a treatment. It is a systematic study for new drugs for human beings.

Clinical research in most cases is being taught at academic medical centres and several other affiliated research study centres. The ecosystem of clinical research involves a complex network of sites, academic research institutions and pharmaceutical companies. There are several institutions providing courses for different clinical disciplines.

Phases of Clinical Research
Any clinical research is conducted through different phases. The results from each of these phases answers different questions and therefore helps in deriving the desired conclusion. The clinical trials through these phases help to estimate the cost and effectiveness of the treatment. These phases are categorised into 4 stages. In these stages, the scientists conduct various experiments that include health intervention for obtaining enough evidence for establishing a medical treatment.

Phase I: In this phase, a small number of participants are involved. The studies are formulated in such a way that the medical doctors and scientists understand what the effects of the investigational compound on human subjects are. The subjects are monitored for the severity of any kind of side effects that might occur after the investigational compound is administered.

Phase II: In this phase, the study is conducted on a comparatively more number of people. Here the studies are formulated to evaluate the efficacy and safety of the investigational drug in the patients. The required dosage of the drugs is also determined in this phase by administering different doses to different people and monitoring closely for comparing the effects.

Phase III: This stage involves an even larger group of patients. The studies in this phase confirm the efficacy and safety of investigational medicine. The large number of patients involved helps in confirming the benefits and the safety of the drug prepared. The studies in this phase comprise one or more treatment arms for comparing the efficacy and safety of the new drug with the other available treatments. The results obtained from this phase are used for determining how the drug would be best prescribed in future to the patients.

Phase IV: This phase is also commonly known as post-marketing surveillance trials. This phase takes place after the new drug has got market authorisation or regulatory approval. The result collected from this stage provides broader information of efficacy and safety about the newly prepared drug. This is possible mainly because this phase involves a greater number of patients and a subpopulation of patients, again comparing and/or combining the new drug with other functional treatments also helps in the process.

By the final phase, the long term effects of the new drug are evaluated. And also any kind of adverse events are also detected.

Growth of Industry of Clinical Research in India
Clinical research happens to be a multinational, multidisciplinary and multibillion industry. In the present time, the graph of outsourcing of clinical research to India is showing a steeper slope. This is mainly because of the availability of a pool of talent for professionals in clinical research. Again, India also provides a number of prized attributes, apt for clinical trials. For example,
• A diverse and large pool of patients.
• Availability of science, medical and pharmacy graduates.
• Excellent facilities and infrastructures in our country.
• The relative advantages of cost.
• Various modifications in the regulatory framework.

With the revised framework, India is offering a tax concession on revenue for 10 years to various local companies that carry on several research and development (R&D). Hence a substantial increment in Research and Development activities for both domestic and multinational biopharmaceutical companies is certain. Different analysts have estimated that an increase in the total spending on clinical research in India would increase by 30 per cent or more.

There are various concerns in India that provide elaborate courses for different types of clinical researches and studies. These companies charge a fee of about INR rupees 18000 for these courses. Advanced course in clinical research [CR] is a course with duration of 3 months. Other advanced courses are also available with the eligibility of minimum bachelor degree is required in disciplines of Pharmacy, Technology or Science, for example,

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•    Global Regulatory Affair. It is a course for 6 months and the course charges are Rs. 40000.
•    Regulatory Affairs- Formulation. It is a course for 4 months and the online course charges are Rs. 18000.
•    Regulatory Affairs- API. It is a course for 4 months and the online course charges are Rs. 18000
•    CTD-eCTD Submission. It is a course for 3 months and the online course charges are Rs. 18000
•    Quality Assurance and Quality Management. It is a 3 months course and the online course charges are Rs. 18000.
•    Pharmaceutical Documentation. It is also a 3 months course and the course charges are Rs. 18000.
•    Pharmacovigilance. It is a 3 months course and the course charges are Rs. 15000.
•    Pharmaceutical Management. It is a course for 1 year and the online course fees are Rs. 35000.
•    Medical Writing. It is also a 3 months course and the course charges are Rs. 18000
•    Nutraceuticals. It is also a 3 months course and the course charges are Rs. 18000
•    Global Medical Device Regulation. It is a course for 6 months and the course charges are Rs. 40000.

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Created on Oct 6th 2021 04:40. Viewed 221 times.

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