Clinical trials are carefully done in human volunteers to address issues such as, “Does a treatment work?”
- Is it more effective than other treatments?
- Are there any adverse effects?
Clinical trials can give valuable information on a therapy’s cost-effectiveness, the clinical utility of a diagnostic test, and how a treatment improves quality of life.
Each study is carried out in accordance with a detailed strategy, or protocol. The plan specifies the sorts of patients who may participate in the trial, the order of tests and procedures, the medications and doses, the required follow-up, and the duration of the research. It also outlines the outcomes (endpoints) to be monitored and the kind of data to be collected, which we will subsequently share with regulatory authorities to acquire marketing authorisation and payers to receive reimbursement.
Clinical studies are carried out in stages. Each phase is meant to answer specific concerns while also taking the necessary precautions to protect those taking part. Before regulatory organisations deem a new medicine safe and effective, it is normally studied in three rounds of clinical trials. Trials are also carried out in accordance with Good Clinical Practise (GCP) criteria, which are mandated by authorities in order to preserve patient safety.
What exactly are clinical trials?
A clinical trial is a human research study that aims to answer specific questions concerning novel medicines, vaccinations, diagnostic techniques, or new methods of utilising existing treatments. Clinical trials are used to test the safety and efficacy of novel medications, diagnostics, and therapies. Clinical trials are the quickest and safest approach to uncover therapies that assist people.
After researchers evaluate novel medicines or procedures in the laboratory and on animals, the most promising candidates are pushed into human clinical trials. Clinical studies are divided into many stages. During a study, researchers learn more about the prospective therapy, its hazards, and how effectively it may or may not work, as well as issues connected to quality of life.
What are the several stages of a clinical trial?
Clinical trials are classified into four phases: I, II, III, and IV. They are broadly defined as follows:
Phase I (small number of participants, usually 6-10 healthy volunteers or severely ill patients with no treatment alternatives)
Phase I studies are intended to help scientists and clinicians understand the effects of an experimental chemical on human participants. The purpose is to investigate what happens to the substance in the body in terms of safety and tolerability when it is ingested, injected, or infused.Participants in the study are monitored for the onset and severity of any adverse effects that may arise.
Phase II trials (after the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups of patients, generally 20-300 depending on the type of disease) Phase II studies are designed to begin evaluating the safety and efficacy of an investigational medicine in patients, and are frequently used to determine if different dosages of the treatment have different effects. Patients are given different dosages of the substance and are continuously watched in order to compare the effects and identify the safest and most effective dosing schedule. Multiple Phase II studies are often done to examine the chemical in a range of patient demographics or indications.
Phase III (huge patient groups, 300-3,000 or more depending on the condition being researched)
Phase III trials are intended to validate an experimental medicine’s safety and effectiveness. In order to thoroughly confirm benefit and safety, large numbers of patients are usually included. These trials, like the previous stages, may include one or more ‘treatment arms,’ which enable the new investigational drug’s safety and effectiveness to be compared to other existing treatments, or to be examined in combination with other medicines. The results of Phase III research are utilised to decide how the substance should be given to patients in the future.
Phase IV (also known as Post-Marketing Surveillance Trials) Phase IV studies are designed to provide broader efficacy and safety information about the new medicine in large numbers of patients, subpopulations of patients, and to compare and/or combine it with other available treatments after the medicine has received regulatory approval (market authorization). These studies are intended to assess the drug’s long-term effects. Less common adverse effects may be discovered under these conditions.