Clinical Research

Introduction

Clinical research is a scientific study of the effects, risks, efficacy and benefits of a medicinal product. These are carried out prior to the release of the medicine in the market. These trials are undertaken at various stages and studies are conducted after the launch of a new product to monitor safety and side effects during large-scale use.

A Clinical Research Associate (CRA) is a professional who monitors the administration and progress of a clinical trial (pharmaceuticals, biologics, or devices) on behalf of a sponsor. A clinical trial is a scientific study of the effects, risks and benefits of a medicinal product, including new drug substances and currently marketed drugs. A CRA might also be called a clinical research (or trials) monitor, executive, scientist or coordinator, depending on the company.

Nature of Work

To begin with the individual works for the Investigator or a University/Academic institution. He/She handles most of the administrative responsibilities of a clinical trial, is the liaison between the clinical trial investigative site and the sponsor of the clinical trial, and reviews all data and records before a CRAs (Clinical Research Associate) visit. The title can be research nurse, trial coordinator, study coordinator, research coordinator, or clinical coordinator. Ideally speaking 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
  • They shoulder the responsibility of planning and implementing all activities required to conduct and monitor complex clinical trials and ensure that Good Clinical Practices are followed.

They assist in preparation of presentations, manuscripts of scientific meetings and technical journals. They attend scientific/professional meetings and training courses as appropriate.

A clinical researcher studies issues and concerns related to mental health and wellness. Clinical researchers have a wide array of goals: understanding the etiology of disease and the disease process, identifying and evaluating potential treatments and their outcomes, and studying policies related to the delivery of services.

Personality

This is a combination of Medical practice, Surgery and alike on one hand and Pharmacy & Research on the other. So the candidate should be mentally prepared to put in long working hours with compassion and humane attitude.

Prerequisites

B. Sc. 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.

Those with Nursing Degrees and or Nursing experience, Life Science degrees, Clinical Research Coordinators, Laboratory Technicians, Clinical Research Associates, Medical Research Associates, Clinical Scientists, members of an Institutional Review Board, Investigators, Investigator clinical trial site staff, Study Coordinators and Pharmacists can benefit from this course as the online training program gives an overview of conducting clinical trials, drug development process, and human safety protection.

No age is a barrier for pursuing Clinical Research, but surely, the age range allowed to pursue training in Clinical Research depends on a number of factors, with safety always first in mind.

Professional Courses

Almost all Institutes imparting training in Clinical Research conduct courses like Diploma and Post Graduation. The PhD facility is in selected few.

The CRCDM 6 month weekend course at Pune University is useful for:

  • Doctors - Principal Investigator, Co-Investigator, Medical Advisor, Drug Developers, Regulatory Affairs Manager, Clinical Research Physician.
  • Pharmacists, Life Science graduates, Science postgraduates in Biochemistry - Medical writers, Clinical Research Associate, Site Coordinator, Clinical Research Manager and Drug Development Associate, Biostatistician,Quality assurance
  • Management Graduates (MBA) - Business Development, Clinical Project Management, Clinical Research Management, Regulatory Affair Management.
  • IT professionals, Biostatistician, Engineers, postgraduates in Maths, Applied Maths, operational Research, Statistics - Clinical Data Manager, Drug Development Associate

After completion of this course Participants should be able to:

  • Have better understanding of Good Clinical Practice and Standard Operating Procedure for Clinical Research and Clinical Data Management.
  • Contribute more effectively in their profession pharmaceutical/ biopharmaceutical companies in drug development, CROs offering clinical research and clinical data management services, in bio-IT life science industry, or academic research institution or as clinical investigators at hospitals/ medical sites conducting trials on subjects.
  • Support overall clinical trial process electronically by implementing Electronic Data Capture (EDC) system and Project Monitoring.
  • Participate in design, conduct and management of global clinical trials conducted at multicentric sites in India and Overseas.
  • Have an understanding of evolving regulatory process standards and practices of ICH GCP in conduct of different therapeutic trials for preparing the submissions made to the regulatory authorities for seeking market authorization in India, US, EU, Japan etc

Selection of Institute and courses

It is an individual's call to select the course depending on socio-economic factors and personal vision. There are a number of Institutes in India. The right choice would be the one backed by Pharmaceutical Organizations for Clinical trails, Sponsorships in various forms, funds to support in long term commitment.

Colleges, Institutions and Universities

Well-known Institutes are Bombay College of Pharmacy, Academy for Clinical Excellence-Mumbai, Institute of Clinical Research-Delhi. Besides for a focused hunt for various topics within the Clinical Research the Internet has a Directory available for Institutes in India and Abroad. This is a vast topic; on a precise selection of area of Research, disease or disorder one can find the suitable Organization.

Series of workshops had been designed by Bioinformatics center, University of Pune, together with Synergy Network (I) pvt ltd. Renowned experts form industry and academics were invited for workshop and curriculum development meeting. Dr R. A. Mashelkar (DG CSIR), Dr. N. K. Ganguly (DG ICMR), Dr. Vasantha Muthuswamy (SDDG ICMR) and Dr M. K. Bhan (DBT) have appreciated the past three workshops on Clinical Research and Clinical Data Management and the syllabus for certificate courses developed by University of Pune, Bioinformatics center.

Fee Structure

Following Institutes charge around Rs 60,000-Rs 70,000 for the course:

  1. Department of Bioinformatics, University of Pune, Pune
  2. H.V. Desai Eye Hospital Mohammad Wadi, Hadapsar, Pune-28
  3. Bioinnovat Research Services Pvt.Ltd., The Elements, 465 Phase V, Udyog Vihar Ind. Area Gurgaon 122015
  4. Sankara Nethralaya ,18,College Road,Chennai-600006
  5. T John College 88/1 Gottigere, Bannerghatta Road Bangalore 560083
  6. L.V.Prasad Eye Hospital, Hyderabad
  7. L.V.Prasad Eye Institute, Patia, Bhubaneswar

Career Prospects

There are various growth opportunities for those who are willing to learn. For the ones interested in serious research work, a PhD is the ideal solution. There are post graduate degrees and diplomas offered by various colleges which come in handy to enhance one's career prospects. Specialization in branches of pharmacy, life sciences, biochemistry will be useful.

The CRA (Clinical Research Associate)will work and Interact with internal/sponsor company personnel working in clinical trials, e.g. Clinical Study Managers, other CRA's, Drug Safety, Regulatory Affairs, Quality Assurance, Medical Writers, Statisticians, Data Management, etc. External interactions can include people from the FDA, a Contract Research Organization, the Hospital Pharmacy Department, Study site staff particularly the Investigator and Study Coordinator. This means good amount of exposure with diverse authorities.

Career prospects include a professional career in Clinical Research industry either as a clinical investigator, site coordinator in at a hospital conducting clinical investigations or CRO (Clinical Research Organization).Jobs are also available in pharmaceutical industry, drug development, medical writing, biostatistics or as a Manager of Clinical Project, Clinical Research Business Development, Clinical Operations, Data Management, Regulatory Affairs and Auditing of Clinical Trials.

Remunerations

There is high demand for trained professionals in this field; the pay package is impressive at the entry level.

  • Freshers can expect a pay packet of around three lakhs or more per annum.
  • If you have a master's degree backing your qualifications, then the amount is almost doubled.
  • Clinical research is an industry where experience counts, thus the longer you are in this field; higher the salary you can expect.

Employment Opportunities

India is the second largest pharmaceutical market in Asia growing by more than nine per cent annually. According to a report, there are more than 50,000 jobs in clinical research in Pharmaceutical and Biotechnology companies and Contract Research Organizations are always seeking new Clinical Investigators to help study new drugs and devices. These organizations (called Sponsors) provide grant funds to physicians and institutions, which more than cover the cost of conducting the clinical studies. In addition to financial incentives, physicians participate in clinical studies so that they can publish their study results and become better known in their field.

Fact is that only one in five drugs tested ever becomes available to the public, it's important to conduct and support many different trials at the same time. For this specialized manpower is in constant demand.

A well known Research Organization recently reviewed the job positions in this avenue which are i.e. Business Development in Genomics, Product Manager Quality Control Research Scientist in Bioinformatics, Clinical Data\Archives Manager, Project Manager Regulatory Affairs Sales, Biostatistician Clinical Research, Associate Marketing\PR Proteomics Research Associate Technician, Skilled Trades etc. Medical Writing Technologist Patents\IP Positions Clinical Research Coordinator Technology Transfer Clinical Research Investigator.

The IBPA (International Biopharmaceutical Association) newsletters deliver up to date information on upcoming events in the biopharmaceutical industry around the world.

References

Information compiled from Websites of Bioinformatics Pune, Clinical research online, Institute of Clinical Research, Clinical Research Training in India