What is Clinical Research Profession?
Clinical research is medical research where people volunteer to participate in carefully conducted investigations that ultimately uncover better ways to treat, prevent, diagnose, and understand human disease. Clinical research includes trials that test new treatments and therapies as well as long-term natural history studies, which provide valuable information about how disease and health progress.
Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions.
Phase I trials
Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects.
Phase II trials
The experimental drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III trials
The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
Phase IV trials
Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use.
Below Different types of clinical studies:
a. Treatment Research- generally involves an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy.
b. Prevention Research- looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes.
c. Diagnostic Research- refers to the practice of looking for better ways to identify a particular disorder or condition.
d. Screening Research- aims to find the best ways to detect certain disorders or health conditions.
e. Quality of Life- Research explores ways to improve comfort and the quality of life for individuals with a chronic illness.
f. Genetic studies- aim to improve the prediction of disorders by identifying and understanding how genes and illnesses may be related. Research in this area may explore ways in which a person’s genes make him or her more or less likely to develop a disorder. This may lead to development of tailor-made treatments based on a patient’s genetic make-up.
g. Epidemiological studies- seek to identify the patterns, causes, and control of disorders in groups of people.
Global Clinical Research Industry & India Advantage
The global clinical trial service market will likely reach more than $64 B by 2020, up from $38.4 B at present, representing a CAGR of 9% between 2015 and 2020. By 2020 the average clinical trial outsourcing penetration will likely reach around 72%. In other words, by then close to three fourths of clinical trials will likely be performed by professional CROs.
The report, “The New Trends of Global Clinical Development Outsourcing Market,” provides unique insights into the current development states and the future growth potentials of the global clinical trial service market.
Key Findings of the Report:
- Among the emerging countries, Asia has become a prominent location for clinical trials.
- As clinical trial cost is still a concern to all drug companies, the CRO model in the low cost regions (like India) is considered a right model as long as they are able to deliver the desired quality of service.
- In the forecasted global market, the developed countries will likely account for about 66.8% by 2020, down from 76% at present; whereas the emerging countries combined together will likely account for 25.2%, up from 15.7% at present.
Scope for Clinical Research in India
India is an emerging hub for clinical research, because of advantages of conducting clinical trials in India:
- Indian clinical research industry has very strong fundamentals including
- Genetically diverse patient pool
- Vast population in need of medical treatment
- Qualified medical professionals
- Availability of required infrastructure
- Clinicians and data specialists
- Good regulatory policies
There is also a huge gap between demand and supply making it a lucrative career option. Many Pharma companies, CROs, Hospitals, IT companies are offering attractive career in Clinical Research. They are Quintiles, ICON, Parexel, Inventive, Pfizer, TCS, Cognizant, Syntel, Cipla, Novartis, Ranbaxy, Novo Nordisk, Johnson and Johnson, Nicholas Piramal and many other reputed international players. As developing countries are outsourcing the clinical trials to India, the prospective in India is much better. There are huge multiple opportunities for highly competent and trained professionals in different segments of clinical research like clinical operations, clinical data management, medical writing, pharmacovigilance, medical coding etc.