AWARENESS OF CLINICAL TRAILS

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AWARENESS OF CLINICAL TRAILS AND ITS IMPACT ON SOCIETY

WHAT IS A CLINICAL TRAIL?

Clinical research is medical research involving people. there are two types of clinical research .they are observational studies and clinical trials.

Observational studies are those where the researchers gather information from specific group of volunteers with wide range of characteristics and compare changes over specific period of time. for example, researchers May collect data through different medical exams, medical tests,  and basic questionnaires about a group of older adults over specific period of time to learn more about the various effects of different lifestyles on cognitive health . these studies may help us to identify new and various different possibilities for this clinical trials.

Clinical trials are those experiments or the observations in clinical research . such biomedical or behavioral research studies on the human healthy volunteers  are designed to rectify specific questions about these biomedical or behavioral interventions , including the new advanced treatments (including new and advanced vaccines, drugs ,dietary supplements , and medical devices) and are known about these interventions that confirm for next study and comparison .

Clinical trials mainly provide the data on safety and efficacy on the new and upcoming drug interventions. they are performed only after and when only they have received the approval from health authorities/ethics committee in the country where approval of the therapy is identified. these health and ethical committee authorities are mainly responsible for risk/benefit ratio of the performing trial and their approval does not mean that the therapy is either safe or effective, only then that the trial may be conducted after the approval.

Clinical trials of drugs are mainly classified into various phases. the FDA  requires these five different phases. They are:

A. Phase:0

B. Phase:1

C. Phase:2

D. Phase:3

E. Phase:4

These trails of four different phases are conducted to identify the safety and efficacy of the drugs and to determine whether the drug has to be approved for the next the next phase of clinical trials i.e., the phase: four (post marketing survillenance)

The zeroth phase of the clinical trial is recently implemented, Drug with small dose subjected to human being (15 patients) and try to find out whether drug reaches tumour and how drug act in body and how cancer cell respond to drug .In this study need extra biopsy, scan, and blood sample.

Greater difference between Phase 0 and Phase 1.In “0”Phase, there is no any chance to get benefit for volunteer due to same dose.

The first phase of the clinical trial is conducted on a small group of healthy volunteers      (20 to 80) to identify safety and side effects and to identify the correct dose of drug.

The second phase of the clinical trial is conducted on   more people  (100 to 300).in the first phase of clinical trial explains about the safety alone but whereas the second phase of clinical trial explains about the safety along with the efficacy. This phase mainly aiming at getting of the preliminary data reared to the drug whether the drug we choose to release in to the whether it works on people are not who have a particular disease or condition .this type of clinical trials are not only for efficacy but also to study the safety of the drug including its short term effects and this clinical trials are lasts for several years.

The third phase of the clinical trial is conducted from hundred to 3,000 people. this trail is mainly done to more information related to safety and efficacy by studying on various population of people and different dosage forms of drugs along with the different drug combinations. If the FDA agrees with the third phase of clinical trial about the  results are positive, then it will be approved for the further experimental drug or device.

The fourth phase of clinical trial is conducted only when the FDA is approved for its marketing. The safety and efficacy of the drug is monitored on large group and diverse group of population. Some of these side effects of the drug may not be identified and be clear until it is observed on large multiple people over a long period.

WHY DO WE NEED CLINICAL TRAILS?

Clinical trials are important for the development of the new medications, treatments and various diagnostic tests. Without these clinical trials, we do not know how to determine and whether the new treatments and medications are developed in labs or performed on, animal models are effective, safe and whether the diagnostic test works out or not .only because of this computer stimulation and animal testing only tell us that treatment has been worked out or not. In addition, there is no substitute for testing it on a healthy living human being.

Not only this , clinical trials also allows for the testing of the drugs and monitoring them in large group of population to make sure that there is any development in drug characteristics and its effect because it is tested on large number of people and not just the random effect of one person, most of the now modern treatments are the effective ones only after the clinical trials are done and show the direct result of the clinical research studies, various new and advanced treatments for various type of diseases such as cancer ,heart problems, high blood pressure and asthma are mainly due to effect and improvement in clinical research studies.

clinical tail studies mainly lead to developments of various new and advanced treatments to help the society to have people stay and live along life and to have less pain and disability and discomfort.

Clinical trail awareness:

Clinical trial awareness mainly focuses on improving the patients experience by better informing patients.

Clinical trial active participation is often not only consideration by the patients or the health care providers, and considering among the other factors i.e. general public engagement with related to the clinical research. In addition, in the simultaneously the responsibility of the patients and the healthy consumers initiate themselves to take the ownership of their own health and decisions regarding their health conditions.

The clinical trial awareness mainly done to develops and creates awareness and educates the public about the clinical trials and encourages discussions about the clinical trials between the patients and their health care providers.

NEED FOR AWARENESS OF CLINICAL TRAILS?

Clinical research should been considered under the social prospective. the first step in tackling this challenge is regularly getting the public to think about participating link clinical research. people need to consider how they can help themselves in getting the advance prevention, diagnosis and treatment of disease. it is never too early to consider participation whether or not someone ultimately chooses to join a study.

The ethics of promoting the awareness of the clinical research must be carefully monitored. The focus of this awareness programs is to educate people and considerate them to participates. providing resources to help individuals to the make informed decisions about research linvolvement promotes the understanding of the true benefits and risks of this clinical trial participation. it also increases awareness about the importance of the clinical research studies.

IMPACT OF CLINICAL TRAILS ON SOCIETY?

Each and every clinical rail have its own benefits and risk based upon the type of the trail and what it’s going to conclude .but even though there are some potential benefits and along with the risk that are common to the clinical trial studies.

Potential benefits:

1. Assessments  to the treatment, which is not available until now.

2. Treatment may be free and low of cost.

3. Contributing and engaging to research that may save many lives in the future.

4. The feeling that you are taking a active role in your self-healthcare.

Potential risks:

1. Not being able to choose the treatment, you get.

2. Severe  side effects than current treatments.

3. The insurance company may not cover all the costs related to clinical trails

4. Frequently testing and monitoring and regular visit of doctors.

-Mani Deepika

Clinosol Research Pvt. Ltd...