What is clinical research?
- September 10, 2018
- Posted by: Subash Chandran
Clinical research basically means testing of the effectiveness of medications on humans for their accuracy and ability to control a particular symptom. It is generally used for the good benefit of mankind and is often related to prevention, cure, diagnosis or treatment of a particular disease.
Generally, When a particular medication is tested for the various aspects of medication properties, it is subjected to be tested on a medium which is generally animals or in some cases humans too. The subject is tested for various properties of the medication including that of toxicity. Once the medicine passes all the set parameters only when the medication is approved by the Food and Drug control authority of any particular country.
Without proper affiliation of these bodies, the medication is illegal to be used on human subjects. Clinical research is often conducted at academic medical centers and the concerned research study sites. These centers and sites provide the benefits of the theoretical knowledge as well as gateways to larger study areas, providing a larger pool of medical test subjects.
Types of Clinical Trials/ Types of Clinical Research:
There are two main types of clinical trials – observational and interventional :
Observational clinical trials
These Trials are limited to ‘observation of patients only and no other testing of drugs is done on the subject during an observational clinical trial phase. This phase helps to know the basic characteristics of and any disease or in other words, we can say that it helps in the diagnosis of the symptoms related to any disease. Different stages of observational clinical trials are as follows ;
Interventional clinical trials used for testing the safety and effectiveness of medication on the subject candidate based on therapy or experimental treatment.
Within these broad categories, trials also can be classified as follows:
Treatment trials used to test treatments, drug combinations or surgical effectiveness on a particular disease or illness.
Prevention trials used to observe methods implemented for prevention of any symptom or disease on a test subject.
Screening trials test ways to detect any symptom in early stages or progressive stage of any disease.
Quality of Life trials used to find ways to improve the quality of life of patients with the effectiveness of current drugs being tested.
Genetics trials are designed to improve the ability to look for an inherited risk of any disease.
Trial phase generally tests the effectiveness of any drug on a subject. It involves four Phases of the trail which are discussed as below. Each phase is important for clinical research:
Phase I trials: This phase involves testing of medication or drugs on a subject matter for the very first time. The most important factor at this time is to ensure the safety of any drug or medication on human subjects.this is the reason the total no of subjects for testing of medication is very less during this phase. This phase yield important results such as side effects, reactions, and effectiveness of any medication on humans.
Phase II trials: This phase involves the similar tests on subjects but the group size is potentially very large as compared to phase I tests. This is done in order to study the same tests on a variety of subjects and hence increase the overall scope of different trials.
Phase III trials: One of the most important phases of trial phases is this phase. It compares the study of the first two phases with the set standard that the drug is supposed to follow. In other words, it sets the benchmark levels a drug has been able to achieve against the set standards for any particular disease or symptom.
Phase IV trials: This is generally the final phase and involves majorly the part of getting approvals for the commercial sale of the drug on humans based on observations of the above three phases. These trials help further evaluate long-term side effects and potential new uses for other conditions.
Clinical Research Associate:
A clinical research associate who is sometimes
also known as a clinical monitor or trial monitor is a professional who performs all the clinical trial related work including experiments and observation of the effects of any drug on a subject. Their jobs are not only limited to clinical research laboratories and they can also be found at various government agencies and medical institutes particularly those which involve research work also. Depending on the specialization clinical research associate may be required to obtain different certificates for different roles.
In India, a CRA requires knowledge about schedule Y amendments in drug and cosmetic act 1945. It basically involves all the requirements and guidelines for permission to import and/or manufacturing of new drugs for sale or to undertake any kind of clinical trials.
Clinical Orthopedics and related research:
Clinical orthopedics involves the study of bones and related complications so as to provide a relief to the underlying problems. The basic process involves studying the symptoms and trying to zero in upon the exact cause of the condition. As the study involves bones, therefore often a physical examination of subject matter is carried out in order to derive at a particular conclusion. Generally, the researchers conducted in this are of specialized clinical research are published in journals.
Clinical Research Laboratories :
Clinical research laboratories are nowadays very common in
existence and often found in every nook and corner of any city. These laboratories involve the in-depth use of biomedical engineering devices in order to perform various tests related to a particular disease or symptom. In fact, these laboratories help in the diagnosis of any medical condition and often the treatment is given to the subject is totally dependent upon the parameters observed through these tests. These labs are often widely used by various other industries other than pharmaceutical industries like a cosmetic industry which often make use of these laboratories to study the effects of sunscreens, creams, and oils on humans. More and more new laboratories are opening as the demand for clinical research is huge and often the demand exceeds the services that the providers are able to provide. This is the reason why clinical research is in huge demand and the job prospects it offers are also very bright.
Finally, Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people.
Share this with your friends
- A complete guide to Biostatistics and its usage
- What is brand management for you?
- The wholesome insight into behavioral science
- Corporate lifestyle: How to manage for best results?
- Top 5 open source LMS with premium features
- The Most Important Sales and Marketing strategy to Skyrocket your business
- Kick start your business with E-Business
- What is clinical research?
- Best Courses in Business And Administration
- Best Information Technology courses for beginners in 2018