How do Clinical Trials Work?
The journey of a clinical trial starts through many pre-steps. Scientists first test their newly found compounds and interventions in a laboratory space using animal models. This pre-clinical testing is done to test the safety of the molecule. If this is a promising experimental intervention, then it is moved into clinical trial testing in humans. A clinical trial will help to gather more insight into the effectiveness and safety of the new intervention in humans.
Running a clinical trial is a costly process and the funding must be borne by the sponsor of the study which could be a government or a public entity. Usually, pharmaceutical companies bear the expenses to develop a drug of choice for a certain therapeutic area. Clinical trials are conducted not just for medications, but also for surgical interventions, supplements, vaccines and even behavioral patterns.
The sponsor of a clinical trial carries the medico-legal responsibilities associated with clinical trial conduct and as an organization, institution or a person or company, the sponsor holds the responsibility for the initiation, management and financing of the clinical trial. According to the definition by the FDA, the sponsor is the person who takes responsibility and initiates a clinical investigation.
In a clinical trial, the new intervention is compared against an existing medication or procedure, which is called a control. This control could either be a placebo (a substance which has no drug) or against an established intervention in practice. Thus, the active ingredient and placebo will be given in a double blind randomized clinical trial usually.
Clinical trial conduct is usually governed by a code of conduct and has to be GCP compliant. Prior to initiation of a clinical trial, the trial should meet national ethics guidelines. There should be a review by an independent ethics committee. This review by an ethics committee is done to protect trial participants and help them in maintaining the integrity of the research. Volunteers who take part in a clinical trial undergoes an informed consenting process. This is to ensure that the subjects are fully informed about the objectives of the research so that they are aware of what is expected of them and any potential risks and inconveniences which they might face, helping them with an informed decision making. Thus, clinical trials are carefully controlled by a clinical trial protocol. As the trial progresses, there will be scientific meetings held regarding the trial to discuss the safety of the intervention and any serious adverse events and adverse events reported. At all times the subject details and data is kept confidential.
The number of people participating in a clinical trial is based on the numbers given by statisticians. The effect of an intervention can vary from one person to another. Therefore, it is essential to test the intervention in question on a large number of people. This helps in better data interpretation after data analysis. Mathematical calculations show if the results of a certain clinical trial is significant or not. Further, to reduce any bias in clinical trial conduct, the participants are randomized or allocated into different groups independently, usually by an electronic system like IWRS. Each patient is carefully monitored throughout the clinical trial process to ensure their safety.