Introduction: Clinical research is a field of science which people in India aren't aware of. Most don't have even a basic idea about this discipline. In brief, Clinical Research is a systematic study to evaluate the effectiveness and safety of medications or medical devices by monitoring their effects on large groups of people.
Clinical Research is conducted in 4 phases:
Phase 1 trials: This is the first time the new drug is administered to a small number around 20-80 healthy, informed volunteers under the close supervision of a doctor. The purpose is to determine whether the new compound is tolerated by the patient body and behaves in the predicted way.
Phase 2 trials: In this phase the medicine is administered to a group of approximately 100 - 300 informed patients to determine the effects and also to check for an unacceptable side affects.
Phase 3 trials: In this phase the group is between 1000 - 5000, for the company to use statistics to analyze the results. If the results are favorable, data is presented to licensing authorities for a commercial license.
Phase 4 trials: This is a surveillance operation phase after the medicine is made available to doctors who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.
Clinical research is a multinational, multi-billion and multidisciplinary industry.
Clinical research is all set to become the next big thing in India. Indian pharmaceutical industry is one of the fastest growing sectors of the Indian economy and has made rapid strides over the years. From being import dependent in the 1950s, the industry has achieved self-sufficiency and gained global recognition as a producer of low cost, high quality bulk drugs and formulations. According to industry reports, India is the second largest pharmaceutical market in Asia growing by more than 9% annually.
A number of factors favor India as a clinical research hub. Firstly, there are numerous government-funded medical and pharmaceutical institutions with state-of-the-art facilities, which can serve as ideal centers for multi-centered clinical trials. Secondly, India boasts of well-trained and qualified manpower, well versed in English. The research and the development process in India can be done at a more affordable price. More importantly, there is vast clinical material, which can be utilized, due to the prevalence of a large variety of diseases, including widespread cases of cancer and diabetes, India is viewed the world over as the ideal location for clinical research trials for the pharmaceutical industry.
Prominent Clinical Research Institutes in India: Some of the well-known institutes in India are - Agharkar Research Institute, Bhabha-Atomic Research Center, Birbal Sahni Institute of Palaeobotany, Visva-Bharati University, University of Madras, University of Delhi, Kurukshetra University, and Jawaharlal Nehru University etc.
Courses and Institutes: A growing demand for clinical trial professionals has led to an increasing number of institutions offering academic programmes in the same.
Academy for Clinical Excellence (ACE): It offers courses like Clinical Research; From Theory to Practice, Clinical Research and GCP for investigators, Quality assurance in clinical research etc.
Institute of Clinical Research (ICRI):
Two year full time - Masters in Clinical research + MBA
Two year full time - MSC in Clinical Research
Part-time post graduate diploma in Clinical Research (1 year)
PhD in Clinical Research.
Bombay College of Pharmacy: It Offers Bachelors, Masters, and Doctoral programme of study in Pharmaceutical Sciences.
Cliniminds - Academy for Clinical Research Training & Management Institute: It offers wide range of clincial research courses, diploma programs in Pharmacovigilance, Quality Assurance in Clinical Research, Biostatistics, Investigators, GCP Training, Monitoring and several other programs.
Clinical Research and Clinical Data Management (CRCDM),Pune: It offers 6 months (weekend course). Course offered by Pune University at Hyderabad, Bangalore, Pune, Bhuvaneshwar, Delhi, Chennai, Gurgaon.
Manipal University, Bangalore: The Diploma in Clinical Research and Regulatory Affairs (DCRRA),1 year duration with 2 semesters.
Eligibility criteria: Graduate / final year graduation students in Life Science, Pharmacy, Medicine, Dentistry, Paramedical Science, Allied Heath Sciences and Biotechnology.
Institute of Clinical Research India, Dehradun: Eligibility: The eligibility criteria for different courses at ICRI may be different.
Courses:
Part-Time courses offered by ICRI:
- Post Graduate Diploma in Clinical Research
- Duration: 1 year
- Post Graduate Diploma in Clinical Data Management
- Duration: 1 year.
- PG Diploma in Pharmacovigilance
- Duration: 1 year.
- PG Diploma in Clinical Trial Management
- PG Certificate in Clinical Research for Nurses
- Duration: Nine months.
- Certificate in Clinical Research for Nurses
- Duration: Six months.
- PG Diploma in Clinical Research specialization in Business Development
- Duration: 1 year.
- PG Diploma in Clinical Research Specialization in Quality Assurance and Audit
- Duration: 1 year.
Full time programs offered by ICRI:
- M.Sc. in Clinical Research Program
- Duration: 2 years.
- Post Graduate Diploma in Advanced Clinical Research
- Duration: 1 year.
The degree is conferred by the Cranfield University U.K. But the course is not recognized by either the AICTE or UGC.
Job Prospects: India is becoming a hub for clinical research; the demand for professionals in this field is growing rapidly. Clinical research business in India will be worth $1 billion by 2010. Thus, there will soon be a massive demand for clinical research professionals, making it an interesting career option with massive growth potential. According to a survey, there are 2, 50,000 vacancies available worldwide 50,000 job openings in India by 2010. Highest remuneration packages owing to the shortage of skilled professionals.
Job profile: Clinical Research branches off into various categories at the entry level.The most common entry-level position is that of a Clinical Research Associate (CRA. The role of a CRA is varied, they are key participants in the design, implementation and monitoring of clinical trials.
Bio-statistician is those who perform statistical programming, design, and analysis for clinical trial projects.
CRM are Clinical Research Managers,
They supervise design and writing of protocols, case report forms and informed consent forms for clinical trials.
There are other posts too such as Clinical Research Coordinator, Business Development Manager, Clinical Research Investigator, Clinical Data Manager etc.
Industry Demand: A BSc.degree is a must to enter this field. Ideally the industry is looking for science graduates from pharmacy, medicine, life science and bioscience. Within bioscience too there are various other fields such as botany, zoology, biochemistry and genetics. Anybody who fulfils these criteria can join the industry.
Placements: Many pharmaceuticals and clinical research organizations have already come forward to unlock the vast potential that India has and are conducting clinical trials in India. Thus, there is expected to be a huge demand for qualified and trained clinical research professionals. After the successful completion of course, the student can find work at ICON, GSK, PRA International, i3 Research, i3 Statprobe, Bilcare, Hindustan Unilever, Serum Institute, Macloeds, Emcure, Reliance Clinical Research Services, Aventis, Fortis, Apollo Hospital,Panacea Biotech, iGate, Quintiles, Cipla, GVK bio, CliniRx, Lundbeck, Jubilant Clinsys, Novartis, Ranbaxy, Fortis, Persistent, Neemans, Pfizer etc. Some of the IT companies engaged in clinical data management are as under: Tata Consultancy Services, Cognizant Technologies, Infosys, Accenture, etc.
Remuneration: There is high demand for trained professionals in this field; the pay package is impressive at the entry level.
Fresher's can expect a pay packet of around three lakhs or more per annul.
If you have a master's degree backing your qualifications, then the amount is almost doubles. Clinical research is an industry where experience counts, thus the longer you are in this field; higher the salary you can expect.
Scope Abroad: The clinical research industry worldwide is growing at unparalleled rate. It has opened up new vistas for employment for a large number of trained professionals. The clinical trials market worldwide is worth over USD 26 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 in the UK, and they form one-third of the total research & development staff. There are more than 2, 50,000 positions vacant globally and salaries vary in the region of approximately USD 40,000 per annul for a Clinical Research Coordinator.
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