What is a Clinical Trial?
A clinical trial ensures a treatment is tested and scrutinized before being standardized for public use. Also viewed as research studies, such trials desire to appraise medical, surgical, or behavioral interventions. By calculating the results of patient responses, clinical trials attempt to understand the safety and efficacy of the treatment. Essentially, a clinical trial can determine if a new drug, diet, or medical device is secure and effective enough for consumer use.
How do they work?
Any clinical trial must be orchestrated by an investigator, who is customarily a medical doctor. The investigator is charged with constructing the trial, composing a research team, and facilitating the study. As the trial requires resources to achieve its desired result, a sponsor will back the study as well as review the protocol (research plan) put forth by the research team. At this juncture, a member of the research team will explain the process of the clinical trial to potential participants (i.e. procedures to take place).
Next, the clinical trial must also meet the approval of an Institutional Review Board (IRB) to safeguard the rights and safety of the patients involved. After approval, a Data and Safety Monitoring Board (DSMB), often consisting of physicians and statisticians, may continue to monitor the study throughout its progression. DSMB’s can request for the early termination of a trial, based upon safety implications to patients or if the purpose of the study has already been answered/addressed. It’s important to note that not all clinical trials are reviewed by a DSMB, primarily just those who the IRB think need further inspection.
Who can participate?
Every trial has its own unique requirements and these requirements are spelled out in what’s called a “protocol” or the study research plan. It is recommended that a patient reviews the protocol before enrolling in a clinical trial. Eligibility, or inclusion criteria, deals with the characteristics of a volunteer including: age and sex, if you’re healthy, smoking habits, as well as the type and stage of a disease. Before joining a clinical trial, a participant must meet the eligibility criteria, and sign an informed consent form.
Not only can a clinical trial provide researchers with an opportunity to create breakthroughs in the industry, but it also allows participants to meet with experts who can provide up-to-date care. Such treatment will be monitored consistently throughout the trial, and the results may benefit those dealing with the primary disease in question.
Reasons for Clinical Trials:
Clinical trials have a variety of practical applications, many of which intend to add medical knowledge as it pertains to the treatment, diagnosis, and prevention of diseases or conditions.
The following are the fundamental motivations behind conducting clinical trials: