Wednesday 26 October 2016

Clinical Research


Clinical

Clinical Research, a branch of medical science and one of the most knowledge intensive industry 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 pharmaceutical 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 pharmaceutical 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. Clinical research can be defined as the systematic and scientific study of effects, risks, efficacy and benefit of a new medicinal product (drug) that may be used for prevention, treatment, diagnostic or for relieving symptoms of a disease. It is the clinical research which determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens that intended for human use. 

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 interventions 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 companies 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. Then, it enters into clinical trials. 

The main four phases in the clinical trails include :
  • Phase I trials : Phase I trial is designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. In phase I trial, a new drug is administered to a small number around 20-80 healthy, informed volunteers under the close supervision of a doctor.   
  • Phase II trials: Phase II trial is designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. In phase II trial, the medicine is administered to a group of approximately 100 – 300 informed patients to determine the effects and also to check for unacceptable side affects.
  • Phase III trials: Phase II trials sometimes known as 'pre-marketing phase' are the most expensive, difficult and time-consuming trial which are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. In this phase the group is between 1000 – 3000, 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 IV trials: Phase IV trial also known as Post marketing surveillance Trial involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. The effects are monitored on thousands of patients to help identify any unforeseen side effects.
Clinical research is a very sensitive field and is directly attached to human life. It is a field which demands scientific approach with quality, ethics, emotions and perfection. Future of the medical science is in the hands of clinical research professionals and a single mistake in this field can cost a lot for our upcoming generations. So, those who want to built up a career in the field of clinical research, should be aware of their big responsibility. 

Eligibility & Course Areas

Undergraduate and post graduate degree holders in life sciences, includes nursing, physiology, biochemistry, molecular biology or pharmacy are the potential candidates for entry level positions in clinical research. Those who want to built up a lucrative career in clinical research could pursue medical studies, pharmaceutical studies or life sciences and then enter a doctoral program in their field of interest. 
B.Pharm graduates / B.Sc. graduates in Life Science with relevant knowledge in clinical research can go for post graduate course in clinical research, i.e M.Sc. Clinical Research or MBA Clinical Research or M.Pharm Courses. After that they can opt for a Ph.D program or Post Graduate Diploma or Diploma Program in Clinical Research and can join the industry.

Educational : 

The basic eligibility for MBA, M.Pharm and M.Sc courses in clinical research is B.Sc ( Botany, Zoology, Chemistry, Biochemistry, Biotechnology, Microbilogy, Genetics, Nursing), M.B.B.S / B.D.S / B.A.M.S / B.H.M.S /B.V.Sc. Pharmaceutics and pharmacology students has 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 :

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). 

Personal skill:

Clinical research professionals are involved in all phases of clinical trials. Clinical research is a responsible job which requires integrity, thoroughness, determination, innovation and analytical thinking. A clinical research professional should possess good knowledge of English language, reading comprehension skills, active listening skills, writing skills, critical thinking, coordination and communicating skills. They should have the knowledge of the information and techniques needed to diagnose and treat human injuries, diseases and deformities. Concern for Others, flexibility, social Orientation, cooperation, reliability, ability to work as a team are the other attributes needed for this professional. 

Job Prospects & Career Options

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. With the inflow of multinational players in research, the industry is poised to grow exponentially and open up new vistas of employment for a large number of people.

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
  • Auditing of Clinical Trials
Basically Clinical Research is conducted by the Pharmaceuticals, Biotech and Medical Device companies. They outsource their work to Contract Research Organizations (CRO Company). The CRO perform the clinical trial on behalf of the company in collaboration with the Site / Hospital or SMO (Site Management Organization). Before conducting clinical trials, approval is required from regulatory authorities of that country where the trial has to be conducted. This approval process is done by the Regulatory Affair Company or by CRO itself if they have their own Regulatory Affair department. Data is generated during clinical trial in the form of CRF (Case Report Form) which is designed and managed by the Clinical Data Management Company. Sample collected during the trial is sent to the Central lab through a logistics and courier services company and is analysed and reported by the Central Lab. After completing the trial, publication is done with the help of Medical writing company.

Every clinical study is led by a principal investigator. These investigators can be researchers, professors, medical practitioners and scientists/ medical specialists. Besides them, clinical studies may also have a research team that may include nurses, social workers and other health care professionals. 
Varied options are available in the field of Clinical Research Organisations. Clinical Research Associate, Clinical Research Investigator, Clinical Research Managers, Clinical Research Coordinator, Clinical Data Manager, Clinical Research Auditor, Biostatisticians, Pharmocovigilance Manager, Quality assurance etc.are some of the designations in the field of clinical research. Their work areas include :
  • Clinical Research Associate : The most common entry-level position in the field of clinical research is that of a Clinical Research Associate (CRA). Clinical Research Associate has the responsibility to design, implement and monitor clinical trials. The administration and progress of a clinical trial is examined or monitored by him /her. They assist in preparation of presentations and manuscripts of scientific meetings and technical journals, and attend scientific/ professional meetings and training courses.
  • Clinical Research Managers (CRM) : Clinical Research Managers have the responsibility to supervise the design and writing of protocols, case report forms and informed consent forms for clinical trials. It is the CRM's who ensure that case report forms are evaluated within a reasonable time and submitted to the data management group.
  • Biostatisticians : Biostatisticians are responsible for New Drug Applications and Biological License Application submissions. Their duties involve planning, coordinating and providing statistical analyses, summaries and reports of studies for clinical trial projects.
  • Clinical Research Investigator/ Physician : Clinical Investigator will be generally a physician possessing a license to practice anywhere in the country. They are responsible for recruitment and treatment of patients. 
  • Clinical Research Coordinator : Clinical Research Coordinator has to co-ordinate the clinical trials using good clinical practice under the direction of the Chief Investigator.
  • Pharmacovigilance Manager : They ensure that the individual reports are accurate and perform other related duties as assigned or requested by the Senior Director.
  • Quality Assurance (QA) : Quality assurance department supremely deals with validation of all aspects of the clinical trial process which includes proper vigilance of safety, efficacy, purity, and stability of end products.
  • Project Manager and Marketing Executives : It is the duty of these professionals to make sure that a particular drug is not only safe and effective but is also cost-effective for efficient disease management.
  • Account Directors: This includes a number of other designations like Business Development Analyst, Clinical Project Director, and Clinical Program Manager. A degree in Life Sciences and interest in medical writing and pharmaceutical marketing is a must.
  • Clinical Auditors: This includes GCP specialist and QA auditors. A graduate level qualification in Life Sciences with a strong knowledge about GCP, GMP, GLP auditing processes is the requirement.
  • Contract Managers: This includes Contract Associates, Senior Proposal and Contract Managers, and Senior Project Managers. One must possess a bachelor's degree in life sciences with work experience in proposal writing and thorough understanding of complete clinical development process.
  • Drug Safety Scientist: This includes Drug Safety Monitor, Drug Safety Officer, Drug Safety Associate. A masters degree in Life Sciences/Pharmacology with good experience in medical writing, computers, regulatory requirements, drug information and other clinical processes.
  • Regulatory Affairs Manager: This includes Senior Regulatory Associates, Manager (Regulatory Affairs) etc. A graduate degree in Life Sciences, Clinical research experience and knowledge of FDA requirement is a must.
Career opportunities in clinical research is based on the academic qualification of the individuals.
• Doctors - Doctors are appointed in Clinical trials as Principal Investigator, Co-Investigator, Medical Advisor, Drug Developers, Regulatory Affairs Manager, Clinical Research Physician.
• Pharmacists, Life Science graduates, Science postgraduates in Biochemistry - They are appointed as Site Coordinators, Clinical Research Associate, Medical writers, Clinical Research Manager and Drug Development Associate, Biostatistician, Quality assurance
• Management Graduates (MBA) - MBA graduates can choose the areas of Business Development, Clinical Project Management, Clinical Research Management, Regulatory Affair Management.
• IT professionals, Biostatistician, Engineers, postgraduates in Maths, Applied Maths, operational Research, Statistics - These professionals can find opening as Clinical Data Manager, Drug Development Associate
There are various growth opportunities along the way for those who are willing to learn. For those 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. Studying further will also help one in bettering their current job profile. For instance doing masters will enhance the job prospects of a CRA to become a Project Manager. Similarly a PhD in a related discipline is needed to become a Medical Director. 
Institutes

There are several institutes conducting courses in public health. To get the institute list click on the course name.

1 comment:

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