A clinical trial, by definition, means a study involving human subjects. Because of this, there is a rigorous approval and review process that ensures the trials are ethical, the risks are minimal, and the participants' rights are protected. There can even be some incentives, such as free medications, screenings and access to specialised medical care for the subjects .Importance of clinical trialsClinical trial is a key research tool for advancing medical knowledge and patient care and is an integral part of new drug discovery. It helps the doctors to decide if the side effects of a new drug are acceptable when weighed against the potential benefits.For example: Covid vaccines trials have really helped people to realise the importance of clinical trials. What is clinical research?These types of studies can fall into several different categories and examine any number of scientific questions, but they all look at new ways to better prevent, detect, treat or understand diseases. Clinical trials to investigate treatments may focus on a new drug, combination of drugs, surgical procedure, device, or a novel use for existing therapies. Other studies simply look at how a disease progresses in a person in order to understand it better.How does a clinical trial begin?Clinical trials, particularly those looking at new drugs, often start after successful animal studies. The most promising treatments then move into clinical trials. No matter a clinical trial's origin, each clinical trial has a master plan called as Protocol. A Clinical trials are highly regulated and carefully controlled patient study, often studying newer methods for prevention, early detection and treatment to improve quality of life. It also shows researchers how the new drug works on people and highlights its pros and cons. Therefore, a new drug must be evaluated in volunteers for its efficacy and toxicity because the extrapolation of the data obtained from the animal studies is not completely reliable.Principal Investigator leads the clinical trial. It is carefully designed study plan on which the clinical trials are based. It is designed to safeguard the health of the participants and simultaneously answer specific research questions.Protocol outlines the types of patients who can enter the trial, the schedule of tests and procedures, drugs and dosages, necessary follow up and the length of the study. Each institute or research centre that is dealing with same study trials will receive the same protocol copy which is dated and signed by the sponsor and investigator.clinical trials go through initial institutional review board approval and then are periodically reviewed. Informed consentAnother very important protection for clinical trial participants is called informed consent. This means that a potential participant is made aware of and understands the risks and benefits of a particular trial, as well as what participation entails. After going over all these details, the person may then decide whether to sign the consent document and participate in the trial. Also, it's important to remember that informed consent is not a contract, so a participant can withdraw from the study at any time. Types of clinical trialsThere are four categories of clinical trials. The fourth occurs after the enforcement agency has cleared a certain drug or therapy and continues to track the safety of the treatment.Phase 1The goal of a Phase 1 trial is to evaluate the safety of a new drug or treatment and identify any side effects. This is the first time the new drug or therapy is used in humans, and in this phase the group of participants is small, between 20 and 80 people.At this stage, trials are looking at pharmacokinetics (what the body does to the drug) and pharmacodynamics (what the drug does to the body).Phase 2Phase 2 trials involve 100 to 300 people and continue to gain safety data as well as efficacy data on the experimental drug or treatment. At this stage, the therapy is tested in patients with the disease. For drug trials specifically, this is when researchers determine effective dosages.Phase 3By the time the trial gets to Phase 3, researchers should have an idea of what the correct dose is in a wide cross section of people, including different ethnicities. This phase involves 1,000 to 3,000 people to confirm effectiveness, look at side effects and compare with standard of care. Advantages of clinical trials. Have access to new and possibly more effective treatments or medicine available only to those participating in the trial. Gain focused health care for a particular disease or health condition. Learn more about the disease or health condition. Have the chance to help society and other people with the disease or health condition by contributing to medical research.Distadvantage of Clinical Trial . The study treatment or medicine may not make you feel better. In rare cases, there may be negative or serious side effects from the study treatments or medicines.. Can result in unpleasant, serious or even life threatening side effects.. Drug may not be effective for the participant.. Protocol may require more of their time and attention than would anon-protocol treatment, including trips to the study site, more treatment hospital stays or complex dosages requirement. To concludeClinical trials help develop newer and better treatments and the advantage as a whole may far outweigh the disadvantages.
A clinical trial, by definition, means a study involving human subjects. Because of this, there is a rigorous approval and review process that ensures the trials are ethical, the risks are minimal, and the participants' rights are protected. There can even be some incentives, such as free medications, screenings and access to specialised medical care for the subjects .Importance of clinical trialsClinical trial is a key research tool for advancing medical knowledge and patient care and is an integral part of new drug discovery. It helps the doctors to decide if the side effects of a new drug are acceptable when weighed against the potential benefits.For example: Covid vaccines trials have really helped people to realise the importance of clinical trials. What is clinical research?These types of studies can fall into several different categories and examine any number of scientific questions, but they all look at new ways to better prevent, detect, treat or understand diseases. Clinical trials to investigate treatments may focus on a new drug, combination of drugs, surgical procedure, device, or a novel use for existing therapies. Other studies simply look at how a disease progresses in a person in order to understand it better.How does a clinical trial begin?Clinical trials, particularly those looking at new drugs, often start after successful animal studies. The most promising treatments then move into clinical trials. No matter a clinical trial's origin, each clinical trial has a master plan called as Protocol. A Clinical trials are highly regulated and carefully controlled patient study, often studying newer methods for prevention, early detection and treatment to improve quality of life. It also shows researchers how the new drug works on people and highlights its pros and cons. Therefore, a new drug must be evaluated in volunteers for its efficacy and toxicity because the extrapolation of the data obtained from the animal studies is not completely reliable.Principal Investigator leads the clinical trial. It is carefully designed study plan on which the clinical trials are based. It is designed to safeguard the health of the participants and simultaneously answer specific research questions.Protocol outlines the types of patients who can enter the trial, the schedule of tests and procedures, drugs and dosages, necessary follow up and the length of the study. Each institute or research centre that is dealing with same study trials will receive the same protocol copy which is dated and signed by the sponsor and investigator.clinical trials go through initial institutional review board approval and then are periodically reviewed. Informed consentAnother very important protection for clinical trial participants is called informed consent. This means that a potential participant is made aware of and understands the risks and benefits of a particular trial, as well as what participation entails. After going over all these details, the person may then decide whether to sign the consent document and participate in the trial. Also, it's important to remember that informed consent is not a contract, so a participant can withdraw from the study at any time. Types of clinical trialsThere are four categories of clinical trials. The fourth occurs after the enforcement agency has cleared a certain drug or therapy and continues to track the safety of the treatment.Phase 1The goal of a Phase 1 trial is to evaluate the safety of a new drug or treatment and identify any side effects. This is the first time the new drug or therapy is used in humans, and in this phase the group of participants is small, between 20 and 80 people.At this stage, trials are looking at pharmacokinetics (what the body does to the drug) and pharmacodynamics (what the drug does to the body).Phase 2Phase 2 trials involve 100 to 300 people and continue to gain safety data as well as efficacy data on the experimental drug or treatment. At this stage, the therapy is tested in patients with the disease. For drug trials specifically, this is when researchers determine effective dosages.Phase 3By the time the trial gets to Phase 3, researchers should have an idea of what the correct dose is in a wide cross section of people, including different ethnicities. This phase involves 1,000 to 3,000 people to confirm effectiveness, look at side effects and compare with standard of care. Advantages of clinical trials. Have access to new and possibly more effective treatments or medicine available only to those participating in the trial. Gain focused health care for a particular disease or health condition. Learn more about the disease or health condition. Have the chance to help society and other people with the disease or health condition by contributing to medical research.Distadvantage of Clinical Trial . The study treatment or medicine may not make you feel better. In rare cases, there may be negative or serious side effects from the study treatments or medicines.. Can result in unpleasant, serious or even life threatening side effects.. Drug may not be effective for the participant.. Protocol may require more of their time and attention than would anon-protocol treatment, including trips to the study site, more treatment hospital stays or complex dosages requirement. To concludeClinical trials help develop newer and better treatments and the advantage as a whole may far outweigh the disadvantages.
