Clinical trails are an important first step in advancing medical science. A clinical trail is defined as a scientific study that determines whether a specific medical procedure, device, like those used in spine surgeries, or treatment is effective and safe for humans. While most people are familiar with the term, there’s often a need for clarity when it comes to what’s involved with a typical clinical trial.
From Lab Tests to Human Tests
Clinical trials usually start as laboratory tests involving animals such as mice and rats. If initial studies on test animals show promise, then clinical trails on humans are often approved to determine if similar results can be achieved. For safety reasons, human trials typically involve:
• Smaller groups of people
• Individuals who are otherwise healthy beyond the condition that’s involved with the study
• Careful observations by qualified medical personnel
Clinical Trial Basics
A clinical trial is headed by a lead investigator who is often a scientist or medical doctor. The lead investigator assembles a research team that usually includes other healthcare professionals, including doctors and nurses. Clinical trials can take place in hospitals, doctors’ offices, or at university or college facilities. Sponsors of such studies often include:
• Pharmaceutical or medical device companies
• Universities or university medical centers
• Local, state, or federal health agencies
How Participants Are Selected
There is typically a detailed screening process to determine who is eligible to participate in a clinical trail. Some trials may involve participants who have the condition being studied while other studies may focus on people are at risk for developing the condition being studied. Participants will be told:
• How long the study will last
• What risks are involved with the study
• What compensation they will receive
Establishing a Control Group
Clinical trials often include what’s termed a “control group,” or participants selected for the purpose of comparison with other subjects in the study. The control group may consist of healthy individuals who do not have the condition being studied or who are at risk for developing the condition. The control group may also include individuals who are being treated with a different procedure or participants who are given a placebo medication.
Participants in clinical trials sign an informed consent document. However, they may withdrawal from the study at any time. The purpose of clinical trails is to gather useful information to improve early detection and treatment of various conditions or advance the approval process for new medical devices or procedures.
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