What is Clinical Research?
Clinical Research is the deep study that takes observations of people to learn more about the health of humans and their diseases. It is a study of medicine that helps in improving the medical knowledge about what we already know. Clinical Research also helps us in creating new therapies and treatments for patients and enables us to provide better care for them. To understand how these different diseases can affect different people, Clinical Research contains the study of people who are healthy as well as those who are not healthy.
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Objectives of Clinical Research
To determine how effective and safe new treatments, drugs, or medical devices are.
To improve the patient management.
Discovering new drugs, medical devices, and treatments
To expand the knowledge of diseases, how they progress, and their treatment responses.
To provide necessary data required for the regulatory bodies for the evaluation of new interventions.
What Are The Types of Clinical Research?
Clinical Research can be classified into two different types, that is, Observational Studies also called as Cohort studies or Epidemiology, and Clinical Trials, also called as the Interventional Studies. Let us discuss them in further detail.
1) Observational Studies (Cohort Studies, Epidemiology)
This type of studies usually involves groups of people to see how different factors affect their health, without changing anything. The researchers study patterns, causes, and effects of health issues in a big population.
2) Clinical Trails (Interventional Studies)
In clinical trials, people are given specific treatments or instructions. This is to see how it affects their health. These trials happen in four phases. They are planned very carefully to test new medicines and treatments.
What are the Different Phases of Clinical Trials?
Phase I : Phase I includes the testing of safety and dosage on a small population who is healthy. They usually include 15 to 50 patients, divided into small groups called cohorts. Medical professionals collect their blood or urine samples to measure drug levels. If the first group doesn't have side effects, 2nd group is given a higher dosage and it keeps increasing with groups. This is to see if patients are responding to treatments, if the treatment is safe, then it moves to Phase II.
Phase II : Phase II includes focusing on the efficacy and side effects of the testing that happened in a larger group. They are usually larger than Phase I trials and less than 100 patients join Phase Two of the trial. People can still have side effects that medical professionals don't know about because treatments affect people in different ways. Hence, in this phase, medical professionals closely monitor if they see any side effects on the patients even if the main goal is to see if the treatment works. If it works, it gets sent to Phase III.
Phase III : Phase III consists of the comparison of the new treatment with standard existing medicines in an even larger population. It usually involves more patients than the first two phases. It might involve thousands of patients in different countries or hospitals. It involves two groups– control and study, where the standard treatment is compared with a completely new treatment. The patients are put in groups by the decision of a computer and not the doctor or patient, which helps in avoiding bias. After Phase III, the results get reviewed by the FDA to ensure safe and effective treatment and it gets sent to Phase IV
Phase IV : Phase IV is the monitoring of the treatment that happens after the medication is approved. Researchers keep a note of the safety of the new treatment or drug in the population after it has been approved by the FDA and made available to the public. This phase aims to seek more information about the long-term risks and benefits of treatments for further advancement.
Importance of Clinical Research
Clinical Research plays a very important role in the growth of the healthcare industry by developing new treatments and improving those that already exist. It makes sure that the treatments, medications, drugs, and medical devices are effective and safe for the use of the normal public. This field also helps in the discovery of new cures for difficult conditions and enhances life quality worldwide. Globally, Clinical Research supports the healthcare system by improving accessibility of treatments. By collaborating across countries, it makes sure the sharing of knowledge and resources takes place and ensures improved healthcare outcomes for the communities all over the world.
Why Should You Choose Clinical Research as a Career?
A career in clinical research is experiencing a very speedy and significant growth. Working as a Clinical Researcher can allow you to make a direct impact on public health and contribute to new medical developments. There is a plethora of opportunities in so many job roles that can also give you a chance to work internationally and with global organizations. Because of this rising demand for Clinical Researchers, good salary packages are given along with the job stability you will need.
How to Become a Clinical Researcher?
The steps to becoming a Clinical Researcher are pretty simple if you have passion and enough determination. Here are simple steps about how you can become a Clinical Research Professional:
Understanding the Role: The first step of becoming a Clinical Research Professional is understanding their role and learning what responsibilities do they have.
Educational Background: The next step in becoming a Clinical Research Professional is to enroll or to check if you are from a Life Sciences background and have any degrees in
D Pharm/ B Pharm/ M Pharm
BSc/ MSc in (Bio / Chem /Nursing /Zoo / Botany)
MBBS/ BHMS/ BAMS/ BDS/ Pharm D
B Tech/ BE (Biotechnology)
MBA (Healthcare)
Practical Experience:Next up is gaining practical experience by volunteering or looking out for training programs and internships.
Certification: Getting certification courses in Clinical Research can be optional but it has a lot of advantages as it puts you above other candidates.
Key Skills: Next up is building your key skills and networking in the industry that would help you connect to the various people in the field.
Mock Interviews:Learn and do mock interviews to prepare, and once you feel ready, you can start applying for the jobs in the field of Clinical Research.
What are the Career Options after Pursuing Clinical Research?
A lot of Pharmaceutical Companies, Contract Research Organizations (CROs), Hospitals, and Academic Institutions are always on the lookout for the new hires in the industry.
Here are some positions in the companies along with their roles and salary that you can aim for:
1) Clinical Program Manager
Salary: ₹14,50,000 to ₹29,30,000
Role:Plans and implements clinical programs in healthcare organizations.
2) Clinical Research Manager
Salary: ₹14,00,000 to ₹46,00,000
Role:Oversees clinical trials to ensure the quality of treatment methods and drugs
3) Regulatory Affairs Specialist
Salary: ₹6,00,000 to ₹12,00,000
Role:Ensures that all clinical trials comply with legal regulations.
4) Clinical Research Associate (CRA)
Salary: ₹5,80,000 to ₹8,50,000
Role:They monitor clinical trials to make sure they follow the regulatory standards.
5) Biostatistician
Salary: ₹7,00,000 to ₹12,00,000
Role:They analyze data from clinical trials to come to conclusions that are meaningful and related to study
What are the Top Companies Hiring in India?
IQVIA
Jubilant Biosys Limited
ICON plc
Medpace
Syneos Health
Alkem Laboratories Ltd.
Teva Pharmaceuticals
HealthFlex
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