Safety is imperative when conducting clinical research. In order to ensure the safety of everyone, clinical trials undergo a thorough and strict review process. Authorities develop a set of rules and enforce them to make sure the study is executed safely and legitimately. The staff and doctors part of the study must abide by the rules and regulations. The study plan, which is referred throughout the clinical trial, illustrates the researchers’ roles. The Federal Government enforces the rules; an Institutional Review Board (IRB) and Data and Safety Monitoring Committee (DSMC) monitor the clinical trials.
IRB is composed of experts, statisticians, doctors, and community members, who verifies that the study is ethical and does not pose unnecessary risks to the participants. After reviewing the trial’s protocol and they approve the clinical trial, doctors are able to launch the study. During the trial, the IRB will also frequently monitor the study and results. Research conducted in the U.S. must have an IRB. Furthermore, DSMC are specialists who analyze data and supervise the study to ensure that the participants’ safety are not jeopardized and it is providing doctors useful data. They also determine if a trial should be modified, continued, or terminated early. Trials can be stopped if it is apparent that the treatment is beneficial, so an improved strategy can be introduced. Clinical trials can also be interrupted if there are harmful results from the treatment. The Food and Drug Administration (FDA) collaborates with the research team when new medicine or medical devices are involved. The FDA evaluates the application of medications and devices before any human testing and verifies the informed consent and protection for human subjects are obtained.
Participants must be educated to make sure that they are safe and comfortable with the study. Informed consent is provided to the selected individuals before they agree to partake in the study. It is an opportunity to receive all the information and facts about the trial, like the risks and benefits. Any questions the individual may have will be addressed at this time by a member of the research team. Then, individuals decide whether or not to join the study and sign all the required paperwork if they agree. Informed consent is not a contract and participants have the option to leave the study at any time without repercussions.
Clinical research is a crucial process for revolutionizing medical knowledge and practice. The studies undergo numerous obstacles in order to guarantee an ethical, safe, and reliable operation. There are numerous trials that do not succeed or are even unable to start. According to a study by the Biotechnology Innovation Organization of clinical success rates in advancing drugs to market between 2006 and 2015 revealed that only 9.6% of drugs entering phase I will reach the market. Without the participants, there would be no studies performed; the health and comfort of the participants are priority for clinical research.