Category: Clinical Trials Master Certification Course

Clinical Trials – A concise conceptualization is a course for all. Certification in Clinical Trial is meant to offer desirable candidates a probability to obtain and prosper skills essential for effective clinical research. This certification course is one of the most sought-after career preferences especially for the candidates who desire to master the safety and effectiveness of devices and medications. The program is meant to meet the high demand for qualified personnel for human clinical trials. The course allows you to gather the practical features of clinical trials and its management including designing the phases, implementation, planning, regulatory and procedural guidelines, data analysis, and ethical considerations.

The course is very meticulously designed covering all the important aspects of Clinical Trials.

The entire module is divided into 14 sessions each of minimum an hour duration. These sessions cover the basics of clinical trials, guidelines, regulations, conduct, compliance, planning, management, quality assurance, pharmacovigilance, safety, calculations, statistics, applications and prospects. Along with it one also gets to test their understanding of the topic through knowledge test.

The eligibility for admission to this course is graduation in the Medical science courses (MBBS, BDS etc.) or Degree in Science, Pharmacology, Pharmacy, Life Sciences, Biotechnology etc. pursued from a recognized university. Any life science graduate can attend this course . The students who have graduated in science and have a specialization in subjects such as biotechnology, botany, zoology, chemistry, biochemistry, pharmacy are eligible for this course. Not only Students! Teachers, Researchers can also benefit from this course and they are also eligible. The course is not specific to the beginners or experienced, it could be taken by both of the categories and one could acquire an additional qualification. An individual from any field of Science can have this course and add extra points in their resume. The course could be eligible for many job opportunities. The hiring companies could be private companies or any government sectors, laboratories or academic institutes. Positions available in the markets could be from entry-level to intermediate and senior level. Certification courses add extra marks during your recruitment in any field of job.

Career Opportunities Available

Clinical Research is an alluring industry for researchers as it anticipates tremendous growth and job opportunities not only for trained pharmaceutical, paramedical and medical professionals , but also for regulatory authorities, project management staff , government and the society at large .

Opportunities in the field of Clinical studies and research are varied with employment starting from Pharmaceutical and Biotechnology , to medical device companies, hospitals, educational institutions and many more . Professionals with a strong pharma , science or medical background are well -placed to join the clinical trials / studies .

Being a critical and fast developing field, it offers many job opportunities. In clinical research, gaining of adequate knowledge, attaining practical skills and developing the right attitude are imperative.

Different functional levels of clinical research require specific skills and trainings. Such as CRA needs knowledge of guidelines, compliance etc., a team leader needs management skills and a head should posses business acumen. Skills such as teamwork, negotiation and interpersonal skills were also highlighted as the most important. So, effective training can improve the understanding in the domain and place one in a better position to be hired.

Different job prospects in this field are:

1. Clinical Research Coordinator
2. Clinical research Associate
3. Clinical Monitor or Trial Monitor
4. Clinical Research Scientist
5. Clinical research Data Specialist
6. Clinical Project Manager
7. Clinical Investigator / Researcher
8. Medical / Scientific Writer
9. Medical laboratory Scientist
10. Biostatisticians
11. The Clinical Quality Assurance Auditor
12. Pharmacovigilance Manager
13. Regulatory affairs Manager
14. Clinical Safety Analyst
15. Medical Writer

     And many more.

Salary Details 

The recent studies show that the Clinical Research field is having business growth of around 250 crores and will soon have a growth of 5000 crores approximately . This profession serves investigators to end up with a handsome salary similar to doctors. A lot of research sectors such as Biotech companies, research labs, Pharma industries have opened job opportunities for candidates willing to work in the Clinical research field . The starting salary is about INR 3, 50, 000 on an average which is always on an ascending journey.

Clinical Trials

Clinical research is an important part of healthcare science. It is medical research involving people that determines the effectiveness and safety of medications, devices, diagnostic products, and treatment regimens intended for human use.

Research using human volunteers/participants intended to add to medical knowledge is involved in a clinical study. Clinical studies consist of two main types: observational studies and clinical trials (also called interventional studies).

People are observed in normal settings in observational studies. Group volunteers, information, are gathered by the researchers, and they compare changes over time according to broad characteristics. For instance, in order to learn more about the effects of different lifestyles on cognitive health, researchers may collect data through tests, medical exams, or questionnaires about a group of older adults over time. New possibilities for clinical trials could be identified through these observational studies.

The major components involved in clinical trials are:

1. Clinical Research Associate (CRA) is a health-care professional who performs activities related to clinical trials.
2. Clinical data management (CDM) is a critical phase in clinical research. CDM leads to generation of superior quality, dependable, and statistically well-informed data from clinical trials.
3. Clinical Research Organisation (CRO) will organize and conduct clinical trials to check the test molecule in humans. As independent companies, they offer an objective assessment of a new drug in the clinical setting.

With the overall increase in the demand of new medicament and treatment technologies, Clinical research is a current booming industry. It is one of the industries, having a wide scope of employment opportunities for trained professionals.

What Are Clinical Trials?

A type of research that studies new tests and treatments, evaluating their effects on human health outcomes is called a clinical trial.

Clinical trials, also known as clinical studies, are the primary way to identify if a new treatment, such as a new medical device or diet or a drug is effective and safe in people. It involves research studies performed in people, aiming at evaluating surgical, behavioral, or medical intervention. In order to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment, researchers make use of clinical trials and decide the effectiveness of the treatment based on the research obtained from the clinical trials.

According to the research plan or protocol created by the investigators, participants enrolled in a clinical trial receive specific interventions in the trial. These interventions may be changes to participants’ behavior, such as diet; medical products, such as drugs or devices; or procedures. A new medical approach may be compared in a clinical trial to a standard one that is already available, to a placebo that has no intervention or contains no active ingredients.

Interventions that are already available to each other are compared in some clinical trials. When researchers study a new approach or a new product, whether it will be harmful, helpful, or no different than available alternatives is not usually known. By measuring certain outcomes in the participants, the investigators try to determine the safety and efficacy of the intervention. For example, in participants having high blood pressure, to see whether participant’s blood pressure decreases, investigators may give a drug or treatment.

Image Credits : Nordic Trial Alliance

Sometimes, even before any symptoms occur, some clinical trials test ways to find a disease early, and there are other clinical trials that test ways to prevent a health problem. Additionally, for people living with a life-threatening disease or a chronic health problem, a clinical trial may also look at how to make such people’s lives better. Sometimes, the role of caregivers or support groups are also studied in clinical trials. Depending on the research objective created by the investigators, clinical trials can be classified into different types further such as Prevention trials, Screening trials, Diagnostic trials, Treatment trials, Quality of life trails, Genetic trials, Epidemiological trials, Compassionate use trials, Fixed trials, Adaptive clinical trials, and more.

To test a potential therapy’s safety and efficacy, scientists perform laboratory tests and studies in animals, before the U.S. Food and Drug Administration (FDA) approves a clinical trial to begin. FDA gives approval for the intervention to be tested in humans if these studies show favorable results.

Who Conducts Clinical Trials?

A principal investigator, who is often a medical doctor is often the lead of every clinical study. Clinical studies also have a research team that may include health care professionals, doctors, nurses, social workers, etc.

Clinical studies can be sponsored or funded, by academic medical centers, pharmaceutical companies, voluntary groups, doctors, other health care providers, and other organizations and individuals, along with National and International government agencies.

Where Are Clinical Studies Conducted & How Long Do Clinical Studies Last?

The location of a clinical study depends on who is conducting the study, and it can take place in many locations, including universities, hospitals, doctor’s offices, and so on. Depending on what is being studied, the length of a clinical study varies.

A clinical study’s protocol or the research plan consists of all the necessary details regarding the reason for conducting the study, the length of the study, the schedule of tests, procedures, or drugs and their dosages. It includes detailed information regarding participants enrolled for the study, including the eligibility criteria of participants, the number of participants required, and the information that will be gathered about the participants. Based on these criteria, who can participate in the clinical trial is decided.

Why Conduct Clinical Trials?

Generally, clinical studies are designed to add to medical knowledge related to the diagnosis, treatment, and prevention of health conditions or diseases. Some common reasons for conducting clinical studies include:

• Treating a disease, syndrome, or condition by evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy).
• Finding ways for the prevention of the initial development or recurrence of a disease. These can include vaccines, medicines, or lifestyle changes.
• Diagnosing or identifying a particular disease or condition by evaluating one or more interventions
• Examining methods to identify a condition or the risk factors for that condition.
• To explore and measure ways to improve the comfort and Quality of life for people with a chronic illness through supportive care.

What Are the Phases of Clinical Trials?

Before a new drug or a treatment is being included in a trial, preclinical research is conducted. It

• Undergoes extensive testing in the lab to understand how it works
• Shows promise of activity
• Does not demonstrate too much toxicity in animal models

Clinical trials used in drug development takes place in different phases; these phases are defined by the Food and Drug Administration (FDA).

In order to test a treatment, find the appropriate dosage, and check for side effects, clinical trials advance through four phases. The FDA approves the treatment for clinical use and continues to monitor its effects if the researchers find a drug or other intervention to be safe and effective after the first three phases.

To determine if the drug can be approved for use, the FDA typically requires Phase I, II, and III trials to be conducted:

In Phase I trial, an experimental treatment is tested on a small group of often healthy people (20 to 80) to find the correct drug dosage and to judge its safety and side effects.

In the Phase II trial, more people (100 to 300) are involved. The emphasis in Phase II is on effectiveness, while the emphasis in Phase I is on safety. The aim of this Phase is to acquire preliminary data on whether the drug works in people who have a certain condition or disease. The safety of the treatment is also continued to be studied in these trials, including short-term side effects. This Phase can last for several years.

In the Phase III trial, the drug is used in combination with other drugs to gather more information about safety and effectiveness, and different populations and different dosages are studied. This trial could consist of subjects ranging from several hundred people to about 3,000 people. The experimental drug or device will be approved if the FDA agrees that the trial results are positive.

A Phase IV trial for devices or drugs takes place after their use is approved by the FDA. In large, diverse populations, a device or drug’s effectiveness and safety are monitored. Sometimes, until more people have taken a drug over a longer period of time, the side effects of a drug may not become clear.