You all must have come across these types of news. But have you ever wondered: Why these types of news flash on a daily basis? What’s the point behind this? What do the trials mean?
New trials and experiments aren’t offered to the public as soon as they’re produced. They need to be analyzed and confirmed first. A clinical trial is a type of investigation or experimentation that examines a test or treatment given to individuals. Clinical trials include various studies like how shielded and beneficial tests and treatments are. When they passed the trials and found to be safe and helpful, they may become tomorrow’s standard of care.
Clinical Research includes various trials and experiments, such as :
- Different usage of drugs already approved by the FDA,
- Drugs not yet accepted by the U.S. FDA (Food and Drug Administration),
- New methods of drug intake, such as in pill form,
- Use of other possible medicines, such as herbs and vitamins,
- Innovative tests to detect and track disease, and
- Drugs or methods that relieve symptoms and much more!
To know more about these trials and how they are performed, let’s explore :
What exactly Clinical Research Is?
Clinical research is a field that deals with the study & analysis of health & illness in Humans. It is the means through which scientists analyze how to prevent, diagnose and treat illness. Clinical research describes many different elements of scientific investigation. It involves human participants and helps translate basic research into new treatments and information to beneficial for patients.
Clinical Trials or Clinical Studies involves human volunteers. These type of research or experimental studies enables various groups of researchers and investigators to search for new and more effective ways to understand, discover, regulate as well as deal with different types of human disorders/ diseases/ abnormalities. In other words, we can say that these trials are the best way to get answers to any difficult scientific / health-related queries.
Goals of Clinical Research :
All clinical trials should meet certain goals to fulfill their design or use of conduct. It must :
- Enhance therapeutic understanding
- Be implemented by adroit persons,
- Take all important steps/actions to protect those who accommodate themselves to research,
- Acquire regulatory acceptance and take all the obligatory legal and ethical steps.
- Gather the assent of those involved in research
Basically clinical trials conducted for clinical research studies are of various types. The two main types are :
- Observational Studies: These clinical research studies do not examine any drugs or their effects on human illness. Examiners are involved in observing participants of the trials by monitoring their health over a period of time and collect relevant data. Examiners enhance their medical knowledge by continuous follow-up of the patients in the reference centers.
- Interventional Studies: These studies furnish scientific verification of the efficacy and welfare of an innovative drug, a new caution device or a new organization in the context of a disease or illness. These clinical trials or interventional studies are obligatory steps for the conversion of a new molecule into an innovative drug or any newly discovered device to be noticed.
Apart from the above-mentioned types of Clinical Studies, there are different types of clinical research that are used in a different way depending on what the examiners or investigators are studying. Some of them are Treatment Research, Prevention Research, Diagnostic Research, Screening Research, Quality of Life Science, Genetic Studies, Epidemiological Studies. Researchers require different types of participants for their study. They can have ‘outpatient ’ or ‘ inpatient’, participants do not stay at the hospital overnight or stay for at least one night respectively.
During the development of new drugs, clinical trials are conducted in basically 5 steps :
- Phase I- Administration in Humans: Performed in healthy individuals. Its main objective is to examine Clinical and Biological tolerance. With this phase of the trial, various effects on the models are determined as well as this trail allows examination of the fate of different molecules in the body depending on its route of administration.
- Phase II- Administration in Patients: For the first time molecules are inserted in patients. It is confined to a limited number of patients over a short duration of treatment.
- Phase III- Therapeutic Efficacy: This phase is considered a Pivotal Study as it is the last and final step followed before the drug is marketed. It is used to measure the medicinal efficiency of the molecule as well as its tolerance level close to real-life circumstances.
- Phase IV- The Marketing Authorization: Based on the data collected through various phases (1-3), submission of the Marketing Authorization Application is allowed to the National Agency of Medicines & Health Products. Once authorization is obtained, the Molecule is acknowledged as a drug and finally, it is marketed.
- Phase V- Monitoring and Evaluation of side Effects: Also called as Surveillance Phase in which various side effects are monitored, recorded and examined to assess patient safety.
In today’s scenario, Clinical Research is one of the most upcoming and demanding fields of Science that requires highly dedicated and determined individuals.
I think most of you are already gaining interest in this particular research field and some of you are aware of this. More about Clinical Research Courses, Eligibility, Scope, Salary, and Companies hiring, Are discussed below:
List of Clinical Research Courses With Eligibility, Scope, Salary Details :
Various courses are available nowadays for Clinical Research studies. You can get yourself enrolled in Diploma courses, Masters courses or even in Certification courses in Clinical research.
Diploma in Clinical research :
This course is usually annual having term examinations conducted every year by concerned universities. Enrolled candidates learn basic bioethics related to clinic or hospital. The course includes presentations, manuscripts preparations of various scientific meetings and journals of technical medicine. Students enrolled in this course will be modulated and trained to transform them into quality clinical research analysts having all the set of skills required to work in any hospital or clinic.
Candidates having Diploma in this field can have a wide array of career options. Be it a Medical department (hospital/ clinic) or working as a lecturer/teacher, candidates can choose any options according to their wishes.
Duration: 1-year full-time course.
Eligibility: 55 % score in graduation in any Medical science courses (MBBS, BDS, etc.) or Degree in Science, Life Sciences, Pharmacy, Pharmacology, Biotechnology, etc. from a recognized university.
Scope/ Job positions: You can choose any job profile as you wish from plenty of career options available. You can be absorbed as a Clinical research Analyst, Clinical Research Associates, Clinical Research Coordinator, Clinical Research Physicians, Biostatistician, etc.
Average Salary: INR 2,50,000 – INR 5,00,000
Master of Science (M.Sc. Clinical Research) :
As of now, you all are aware of Clinical research and its benefits. It is known that this field utilizes a diverse array of experiments as well as research in clinics, especially with organisms. This master course includes various components like Drug studies & its medical management, Performing organic activities in the clinic, Study of various sub-related disciplines like Biostatistics, Epidemiology, Transplantation, etc. You can always choose your specialization after getting enrolled.
Duration: 2 years course
Eligibility: You should be a graduate in any discipline of Science with at least 50 % marks in aggregate. Fields / Disciplines included here are Life Sciences (Zoology, Microbiology, Botany, Toxicology, Biochemistry, Pharmacology or Biotechnology); B. Pharma, M. Pharma, Nursing, Physiotherapy. Candidates waiting for their final year/semester results are also eligible on a provisional basis.
Top Institutes: Galgotias University, Sharda University, Periyar Maniammai University, Amity University, Indian Institute of Public Health, School of Bio-Science, Apeejay Stya University, Indian Institute of Clinical Research India.
Scope/ Job positions: You can choose any career options from a wide range available after having this course of Clinical research according to your interest. To quote some – you can be a Project Manager – Clinical Research, Clinical Research Coordinator, Clinical Research Physician, Biostatistician, Clinical Research Analyst; Programmer – Clinical Research, Clinical Research Associate and such. You can also work as Medical Assistants – professionals in clinics, hospitals and Health Services Managers.
Average Salary: INR 3 – 12 Lacs per annum
Top Recruiting Areas: Pharmaceutical industry, educational institutes, CROs, SMOs, hospitals, DCGI office, and other govt. drug and food regulatory/ research organizations, etc.
This is a certification course of a very short duration which involves Hospital and Healthcare Management Programme. The aim of this course is to examine the safeguarding of general views on the moral values connected to bioethics and some highly complex issues of executing this basic knowledge to a different sets of situations.
Duration: Short course of 6 months
Eligibility: Graduates of Medical background (MDS, MBBS, BAMS, MS, MD, BUMS), UG & PG candidates of various allied streams of Science like – Pharmacology, Life Sciences, Medical laboratory, Pharmacy, Nursing, Biochemistry, Biotechnology, etc. All the professionals working with various Clinical Research organizations / Pharmaceutical companies are also eligible for this course.
Scope/ Job positions: Candidates after completing this certification course can assist in the presentations and manuscripts preparations of various scientific lectures/meetings including technical sessions of conferences or training programs. Candidates can also choose a teaching career (gov./private). Employment areas include Clinical research labs, Medical Universities / Colleges, Private clinics, Government hospitals, and Pharmacist shops.
Average Salary : INR 1,50,000 – INR 3,00,000
List of Top Companies Hiring In the Field of Clinical Research Are:
- CDSA – THSTI
- Teva Pharmaceutical
- Fortis Hospitals
- Panacea Biotec
- St. John’s Research Institute
- inVentiv Health
- Novo Nordisk
All the above-mentioned courses will lend you to so many career options, you can choose according to your interests. Clinical Research is one of the fastest-growing industries at a surprising rate opening a wide array of career options for skilled and trained professionals. As of now, you can understand how important Clinical Trials are and its study as well as examination to market any drug or device. This research field provides vivid scientific analysis related to its impact, benefits, and risks associated with drugs. The procedure used to run clinical trials are cautiously changing with the execution of modern technologies. Virtual, Wearables, Artificial Intelligence, In silico trials, Digital biomarkers and Personalized medicines are all probably to play a major role in the upcoming future of Clinical Trials and Research. You can be a part of this astonishing future by choosing a career in Clinical Research.
Here’s to the future, when the variations we cuddle today will forefront a healthier world.
All the Best!