Clinical trials can be termed as the research studies carried out on people. This research is required to evaluate the surgical, medical, or behavioral intervention of participating individuals. They are also the basic way a researcher finds out if new treatments are effective and safe for use. They often test to know if the new treatments have fewer side effects compared to the standard treatment.

Some other clinical trials perform tests on several ways to discover diseases even before their symptoms appear. Others also carry out tests on ways to avoid health challenges. One of the major aims of clinical trials is to make life better for people living with chronic health issues and life-threatening diseases. Clinical trials also study the role of support groups or caregivers.

Before a clinical trial can be approved by the FDA (Food and Drug Administration), laboratory tests have to be carried out in animals. This is done to get a potential therapy's efficacy and safety. If this test result is favorable, the FDA then gives an approval to carry out a test in humans.

Phases of Clinical Trials

Clinical trials are carried out in four phases when testing a treatment, looking for side effects, and finding an appropriate dosage. If researchers could come up with a positive and effective intervention of drug, the FDA then gives approval for clinical use and also supervise its effects.

Drugs that have undergone clinical trials are primarily described according to their phase. The FDA generally requires clinical research of a drug to go through three phases (I, II, and III) before it's approval for use.

Phase I Trial

In this phase, experimental treatments are tested on a small group of people who are often healthy. These people are between the number of 20 and 80. The aim of this test is to evaluate the side effects and safety of the drug and to deduce the correct dosage.

Phase II Trial

In this phase, more people are used to test the drug. They are between 100 to 300 in number. The emphasis of the phase II trial is majorly on effectiveness rather than safety. This phase is also intended to collect preliminary data on the effectiveness of the drugs on people with certain conditions and diseases. In addition, this phase studies safety, and also short-term side effects. It is also important to know that phase II trials can linger for several years.

Phase III Trial

A phase III trial is a phase that collects more information about effectiveness and safety. It also studies various dosages and populations. This is accomplished by using the experimental drug with other drugs. Subjects generally range from a couple of hundreds to about three thousand(3,000). If the trial results are effective, the FDA will approve the experimental device or drug.

Phase IV Trial

This phase takes place when the drugs have been approved by the FDA. A drug or device safety and effectiveness are examined in vast and different populations. In some cases, the side effects of a drug may be a bit unclear. However, it'll only get clearer when the usage of the drug has increased over a long period of time.

Analyzing the Results/Data of Clinical Trials

When clinical trials are carried out, the only details that are collected are medical ones and not identities. These details are obtained in a computer database. The results of any measurements made are also collected. Afterward, statistical analysis is carried out formally to assess the trial outcome. Data analysis of clinical trials covers three major aspects. They are detailed below.

Baseline and Demographic Information

This aspect of analysis is concerned about the details of a patient that participated in the clinical trial. This is important because the effect of drugs may differ widely between several patients. The details that are required include:

• Sex
• Age
• Ethnic origin
• State of their illness

Efficacy

This aspect of data analysis tells how well an experimental drug works. It is also centered on pre-defined endpoints. Endpoints are typical measurements that are related to the ailment in question. However, before a trial protocol is carried out, endpoints are specified. Below are the categories of endpoints in clinical trials.

• Soft Endpoints: this is a category of patients who are potentially influenced by questionable reproducibility or by the measurement process.
• Hard Endpoints. This is the category of patients that take the form of facts that are numerical with some inherent clinical importance.
• Surrogate Endpoints: This is the category of people who have not really experienced the illness been studied. But they can relate to it.

The choice of endpoints to use solely depends on the nature of ailment that is been studied.

Safety

This aspect of analysis gives more detail on the side effects of the drug. Before clinical trials are conducted on a patient, questions on their experiences will arise. The information gotten at this point will then be analyzed. Afterward, the result will be placed in contrast with the drug that was studied. This is done to establish a causal relation. Once the establishment has been made, the usage of the drug will have side effects. However, great attention is given to extreme side effects that are dangerous.