Some treatments being studied turn out to be more effective or safer than existing treatments, and and some don’t. You only know that once the trial is over – but the IRB would not allow a trial protocol to proceed if there were obvious red flags upfront. In addition, the study plan needs to incorporate safeguards for patient safety, appropriate to the type of study being done.
Every clinical trial chooses the best clinical research courses of action to collect as much data as possible. Before any of these medications reach the patients, it has to undergo our clinical trial phases. The first phase is also known as the recruitment phase. This is a very crucial stage of the process. It involves the selection of participants for the testing of the new treatment or drug. These participants have to meet certain criteria based on the drug or disease being treated. It involves the enrolment of 20-100 volunteers whose condition has been studied well and monitored over a specified amount of time.
Clinical trials are studies performed for research in people who have an objective at evaluating a surgical, medical, or behavioral intervention. Clinical Trials are the primary method of researchers to determine whether a new treatment or drug, or diet is safe and effective in human beings. Clinical research requires trials conducted to collect information regarding the efficiency and safety of a new drug, device, or treatment. These are tested on certain individuals, and this process is termed clinical trial recruitment. The main aim of patient recruitment is to raise awareness about clinical research and to encourage the enrolment of patients. Clinical trials form the major portion of clinical research.
For treatments that might carry some risk, an independent expert board called a Data and Safety Monitoring Committee will periodically review the ongoing results of the trial. This committee doesn’t have any relationship to the researchers, so they don’t have a stake in the trial continuing or not; they just want to ensure safety. If one treatment turns out to be conclusively better than another in the middle of the trial, the board would stop the study. Likewise, the trial would be suspended if one treatment clearly causes harm.
Clinical research trainings are given to every professional involved in the trial. Clinical research trainings are continuously updated based on the disease and development of technology to ensure the complete safety of the participants of the trial.