Know all about Clinical Research and Trials!

Having personally conducted and supervised over 20 clinical trials across a wide range of therapeutic areas like Oncology, Endocrinology, Psychiatry, Critical Care etc, Dr Piyush Juneja, a project manager has over four years of extensive clinical research experience. In an interview with Madiha Jawed of shiksha.com, Dr Juneja shares insights about this emerging field of Clinical Research.

Q. What is Clinical Research?

A. Clinical Research refers to an organised research conducted on human beings to investigate the safety and efficacy of a new drug.

Q. Is the term Clinical Trials the same as Clinical Research?

A. Yes, the term clinical trials also refers to clinical research.

Q. Who conducts Clinical Research Studies/Clinical Trials?

A. Clinical research studies/clinical trials are generally conducted by pharmaceutical companies, biotech companies, contract research organisations (CROs), medical device companies, cooperative groups, research and academic institutions etc.

Q. How are Clinical Trials conducted?

A. A clinical trial is conducted in a phase-wise manner. There are four phases of a clinical trial (I, II, III, and IV) each designed to address different questions. The knowledge gained from one phase is assessed before progressing to the next phase. Phase-I clinical trials are generally done to establish the initial safety of a drug usually on healthy human volunteers. Phase-II and Phase-III clinical trials are done to establish the safety and efficacy of a drug in patients with relevant indication. Phase-IV clinical trials are post marketing studies done to collect the additional safety data on a drug after its marketing authorization.

Q. What are Good Clinical Practices (GCP) Guidelines?

A. These are international ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve participation of human subjects.

Q. What are the career options in this field?

A. The entry level job positions include clinical research coordinator (CRC) position at Investigator site level and clinical trial administrator (CTA), or trainee clinical research associate (CRA) position at Sponsor/CRO level. Career growth at Sponsor/CRO level includes the positions of Senior CRA, Project Manager, Team Leader, Quality Assurance, Manager-Clinical Operations and Director/Vice President etc.

Q. What educational qualification is required to enter the field of Clinical Research?

A. The ideal educational qualification includes graduation/post-graduation in pharmacy, medicine, dental sciences, alternate medicine and life-sciences disciplines.

Q. Is it essential to undergo a Clinical Research Training/Clinical Trial course to enter the field?

A. Recent trends in clinical research industry are suggestive of employment preference for personnel having a basic orientation and certification in clinical research. A basic level of clinical trials training not only increases the visibility of the CV but also provides the required knowledge/skills to address the specific questions during the interview.

Q. What factors should be considered while selecting a Clinical Research training institute/course?

A. As the entry in clinical research filed is largely dependent on the basic educational qualification of a candidate, the important factors to be considered while selecting a clinical research training institute/course include:

• Duration of the training program (optimal duration 3-6 months)
• Fee of the training program in terms of its worth and employability
• Reliability of the training program/institute in terms of years of existence, quality of training‚ and relevant industry experience of the core faculty
• Mode of the training in terms of the ease of undertaking it along with other commitments.

Q. Where are the majority of clinical research organisations situated in India?

A. The majority of clinical research organisations in India are situated in Delhi, Mumbai, Bangalore, Hyderabad and Chennai. Apart from this investigator sites are present across the country.

 Other interesting reads:

Career as a Clinical Research Analyst
The Need for Management Courses in Clinical Research