Clinical Research and Pharmacovigilance
Conducting clinical trials in emerging markets with reduced expenses and a bigger pool of patient benefits sponsor pharmaceutical companies, and it is also beneficial for the local healthcare system and the economy of the developing country.
As per reports of clinicaltrials.gov, 1.4% of global clinical trials are done in India, while the country has 16% of the world’s population and carries 20% disease burden in the world. However, the number of clinical trials in India is expected to grow by 2018-19 as a result of regulations for clinical trials in India becoming more stable and predictable, according to Dr. Chirag Trivedi, President, Indian Society for Clinical Research (ISCR).
Non-Clinical and Clinical Research is a branch of healthcare that evaluates the safety and efficacy of medications, devices, diagnostic products and treatment regimens intended for human use. The continuous research by the pharmaceutical and biomedical industry have a direct impact on products/molecules reaching the pharmacy outlets. Clinical research aids this process of development through its activities traversing from the ethics, conduct, management of man and material, data and its analysis and finally the report generation. Seeing the demand and supply gap in skilled Clinical Researchers, where demand is huge and supply very low.
DCS wants to fill gap of demand and supply. DCS Drug discovery and development programs are available for GLP, Clinical Research, Pharmacovigilance, Regulatory Affairs and Health Economics Outcomes Research.
What is Clinical Research
A Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamics and pharmacokinetic) or adverse Effects with the objective of determining safety and efficacy of the new drug.
Clinical Research Industry has grown around the world at an unparalleled rate in the past few years. It has opened up new vistas of employment for a large number of people. The Clinical Trials market worldwide is worth over US$ 45 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 people in the UK and they form one third of the total Research and Development staff. These large numbers can be attributed to the fact that this industry offers lucrative employment opportunities. The average nominal annual salary growth across all the positions is 4% as against less than 1% for other segments.
Clinical Research Job Profile:
- Clinical Research Coordinator
- Clinical Research Associate
- Drug Safety Associate
- Case Processing Expert
- Pharmacovigilance Associate
- Pharmacovigilance Scientist
- Regulatory Affairs Executive
- Regulatory Affairs Officer
- Clinical Data Analyst
- Medical Writer
- Project Manager
What is Pharmacovigilance
Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. In general, Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to: identifying new information about hazards associated with medicines preventing harm to patients. Pharmacovigilance is particularly concerned with adverse drug reactions, or ADRs, which are officially described as: “A response to a drug which is noxious and unintended, and which occurs at doses normally use for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.
Pharmacovigilance Job Profile:
- Drug Safety Associate
- Case Processing Expert
- Pharmacovigilance Associate
- Pharmacovigilance Scientist
What is Regulatory Affairs
Pharma regulatory affairs professionals play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry.
The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:
- Pharmaceuticals
- Medical devices
- In vitro diagnostics
- Biologics and biotechnology
- Nutritional products
- Cosmetics
- Veterinary products
The regulatory professional’s roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labelling and advertising and post market surveillance.
Regulatory Affairs Job Profile:
- Drug Safety Associate
- Regulatory Affairs Executive
- Regulatory Affairs Officer
- QA
What is Health Technology Assessment (HTA)?
HTA is basically a multidisciplinary policy approach which uses clinical effectiveness, cost-effectiveness, policy and ethical perspectives to provide insights and evidence upon which rational policy decisions on the usage of health technology can be made. HTA can be applied for either a single technology (such as a drug or device) or complex interventions (such as rehabilitation). It can be used for individual patient care or public health.
What is Health Technology Assessment (HTA)?
HTA is used as a tool to enable the assessment and comparison of health technologies using same metric of cost-effectiveness. Its outcome results in benefit of the patient as well as technology producers because only those technologies which are cost effective are promoted for widespread use.
What would be the job profile of someone graduating from this course?
Academic/research centres or universities – undertake HTA research projects funded by HTA agencies, national research bodies or health technology companies to support reimbursement or develop HTA methods. Private industries including pharmaceutical companies, bio-technology companies and health insurance companies design and undertake evaluations (effectiveness and/or cost-effectiveness) for presentation to reimbursement agencies in support of health technology products. Local or national government agencies, regulators, health service providers and international health organisations (example: WHO) commission and review assessments submitted to support reimbursement of health technologies; undertake systematic reviews, evidence synthesis and evaluations to focus and direct health care policy; evaluate policy and programmes previously funded. National or international consultancy companies undertake HTA projects for governments, HTA agencies or industry clients.
