Career Prospects In Clinical Trial Research and Management

Dr. K. Jeyaprakash

Clinical Research, a branch of medical science and one of the most intensive industries, is emerging as a promising career, with the boom in healthcare sector in India. Indian pharmaceutical industry is growing exponentially and has become a very preferred destination for global phar-maceutical companies to conduct their drug research and development. As a result India, which is considered as the second largest pharmaceutical market in Asia, is becoming a hub for clinical research.

The implementation of the General Agreement on Tariffs and Trade (GATT) has opened new opportunities for India to concentrate on the clinical trial market. Moreover, the country has numerous government-funded medical and phar-maceutical institutions with state-of-the-art facilities, which can serve as ideal centers for multi-centered clinical trials. Due to the prevalence of a large variety of diseases such as cancer and diabetes, India is viewed as the ideal location for clinical research trials for the pharmaceutical industry.

Clinical research is an integral part of the drug discovery process to ensure the safety and efficacy of any new drug. It is the complete biography of drug from its inception in the lab to its introduction to the consumer market and beyond.

The Clinical research of the new medicinal product is carried out through an organized Clinical Trial, prior to its release in the market. Clinical trials are used to determine whether new biomedical or behavioral inter-ventions are safe, efficacious and effective. These trials are conducted in 4 phases and each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will get approved by the FDA (Food and Drug Administration ) and then marketed for public use. Phase IV are 'post-approval' studies.

Before pharmaceutical comp-anies start clinical trials on a drug, they conduct an extensive pre-clinical studies. These involve in vitro (test tube or cell culture) and in vivo (animal) experiments using wide-ranging doses of the study drug to obtain preliminary efficacy, toxicity and pharmacokinetic information. After this, the data obtained from the studies are submitted as an IND (Investigational Drug Application) to take permission for human studies.

ELIGIBILITY & COURSE AREAS

The basic eligibility for MBA, M.Pharm and M.Sc courses in clinical research is B.Sc (Botany, Zoology, Chemistry, Biochemistry, Biotechnology, Micro-biology, Genetics, Nursing), M.B.B.S / B.D.S / B.A.M.S / B.H.M.S /B.V.Sc. Pharmaceutics and pharmacology students have greater scope in clinical research. Several institutes in India offer M.Sc. Clinical Research Courses. Sikkim Manipal University, Indian Institute of Clinical Research (ICRI) at Jaipur, Bangalore, Mumbai, New Delhi etc. are some of the institutes offering Post graduate clinical research courses.

For Diploma and Post Graduate Programs in Clinical Research, candidates must possess a graduation in any of the fields namely Life Science, Pharmacy, Medicine, Dentistry, Paramedical Science, Allied Health Sciences and Biotechnology with a minimum of 50% marks in aggregate. Working professionals/ practicing doctors meeting the above criteria can also apply for these programs.

SELECTION PROCESS

Admission to the Post Graduate Programs, Diploma Programs and PhD Programs will be based on entrance test and interview. The selection process varies according to the institute and courses. Admission to the M. Pharm and MBA clinical research course in National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad is through CGPA (Cumulative Grade Point Average).

VARIOUS FIELD OF EMPLOYMENT SCENARIO

Clinical research is an attractive industry which foresees tremendous growth and job opportunities not only for trained medical, pharmaceutical and paramedical professionals, but also for regulatory authorities, government and the society at large.

Candidates can make their career in the fields of

• Contract Research Organizations (CRO)
• Pharmaceutical Industries
• Biotechnology Companies
• Medical Device Compamy
• Patient Recruitment Organisations (PRO)
• Clinical Data Management
• Regulatory Affairs
• Pharmacovigilance
• Medical Writing
• Central Lab
• Logistics and Courier Services
• Research Sites

REMUNERATION

The remuneration depends on the status of the industry and experience, qualifications and ability of the employee. Freshers can expect an impressive salary range from Rs. 35,000 - Rs. 50,000 per month. At the initial stage of their career, those with masters degree can earn between Rs. 5 lakhs-  Rs. 6 lakhs per annum. The longer you are in this field, higher the salary you can expect, as clinical research is a field where experience counts.

LIST  OF  INSTITUTES  OFFERING CLINICAL TRIAL COURSE

• Indian Institute of Clinical Research (ICRI) (Mumbai, Jaipur)
• Asian Institute of Health sciences (Mumbai )
• Apeejay Stya University (ASU, Gurgaon), Gurgaon
• Saveetha University, Poonamallee, Chennai
• ICBio Clinical Research, Yelahanaka, Bangalore.
• C B Patel Research Centre, Mumbai.
• Anonus Institute of Clinical Research, Chandigarh.
• Apheta Institute of Clinical Research, U.P.
• Institute Mumbai India Cliniminds Mumbai India (CRIMSON), Mumbai
• India Academy for Clinical Excellence Mumbai, India.
• Institute of Bio IT & Pharma-med-Research Mumbai, India
• Clinical Research Education and Management Academy, (CREMA) Mumbai, India
• Focus Institute of Pharma Skills, Bangalore, India
• Lotus Clinical Research Academy Pvt. Ltd.Bangalore, India
• Aakson Institute for Management Studies (AIMS), Bangalore, India
• Apheta Institute of Clinical Research, Delhi, India
• R G Stone Urological Research Institute, Delhi, India
• Clini india - Academy For Clinical Research and Management, Hyderabad, India
• Institute of Clinical Research India, Hyderabad (ICRI), India
• Advance Medicare And Research Institute, Kolkata, India
• The Calcutta Medical Research Institute, Kolkata, India
• Bilcare Research Academy, Pune, India
• Global Institute of Regulatory Affairs , Pune, India

(Lists are indicative only)

(The author is the Head, PG & Research Dept. of Biochemistry, Rajah Serfoji Govt. College (Autonomous), Thanjavur -TN.)

Views expressed are personal.

(Image Courtesy : Google)