What Are Clinical Trials

A clinical trial is defined as a research study conducted on human test subjects. They are used to answer questions about the product and or the disease it is testing. It is known as one of the fastest and safest ways to find treatments that work in people in order to help improve their health and lifestyles.

Types of Clinical Trials

There are five different types of trials that are conducted by clinicians. The trials are Treatment, Prevention, Diagnostic, Screening, and Quality of Life. Each one has a slightly different purpose, but all are used in order to improve medical knowledge.

A Treatment Trial is a trial that tests experimental treatments, new drugs, or new therapies to the current treatment.

A Prevention Trial looks for different and hopefully better ways to prevent people from obtaining a disease or preventing the individual from re-obtaining a disease.

A Diagnostic Trial is conducted to find alternative tests or procedures for diagnosing a particular disease or condition.

Screening Trials are used to test the best way to detect a certain disease or condition.

Who's Involved

A clinical trial involves many people from many different places. From the company who wants to sell their product, they involve their clinicians and marketing personnel. A hospital involves their doctors, nurses and or support staff. Outside of the immediate people involved with implementing the trial are the patients who are test subjects and the Food and Drug Administration who is involved with approving the clinical trial. The main differences between these groups are listed below. 

Clinicians are individuals who devise the tests that are to be carried out by the doctors and nurses in a hospital setting. Clinicians are the ones who decide what type of individuals are wanted for this particular trial, and they also have the ability to decide where the tests should take place. Finally these are the individuals who analyze the information from the doctors to see how "well" the product has done, and then convey that information to the rest of the company especially the marketing and engineering branches of the company.  

Doctors/Nurses/Hospital Support Staff are those involved in carrying out the protocol for a product that was set up by a clinician. These individuals are very important because they have direct contact with the patient and their health. They must be able to take accurate and unbiased records of the health and any other information about the patient. They also must be able to convey that information to the clinician in a manner that the clinician can understand and manipulate so they can figure out how "well" the product is doing. 

Patients are to say simply the guinea pigs of the whole process. They are the ones who are subjected to the product, observed and analyzed. They main job is to strictly follow the directions given by their doctor and then to keep up with check ups so the physicians can ensure that their health is not in jeopardy. A patient that is involved in a trial is there voluntarily, they have the ability to quit the trial at any point in time. They have this ability due to a contract that they read and sign known as the Informed Consent. This form is there to inform the patient that they may experience reactions that they may not be used to and to allow them to have the choice to terminate their participation in a trial. 

FDA is an acronym for the Food and Drug Administration. This government organization is responsible for approving or denying the company FDA approval for either obeying FDA regulations or disobeying their regulations. Learn more about the FDA by scrolling down or clicking here. 

The Engineers/Scientist are involved before and after a clinical trial has been conducted. They are the ones who came up with the product, and throughout a clinical trial they may take note as different side effects and or comments from the patients and doctors, using these they can make adjustments to the product to see if it is better or worse. This is also done during Phase IV of a clinical trial, where the company may find alternative uses for their product. 

Marketing branch of Manufacturer is involved more after a trial has been given FDA approval. Once approval has been given the marketing branch comes up with a plan to market their product on the age group that has already been decided on by the clinicians. If the marketing group has any questions on results of the products they go to the clinicians, and they are also to publicize the product and it's safety and effectiveness. 

Different Types of Test Groups 

In many clinical trials there are more than one group of individuals that are studied. Typically, the group that is being treated with the product is considered to be the Experimental group. A group known as the Control group is treated with a placebo. A placebo is an inactive substance given to a patient, in order for their data to be used later as a control. This control allows the manufacturer see how well their product performs in comparison to the placebo, which in fact is like taking nothing at all. Not all control groups are given placebos. Depending upon the trial, a control may just treating a patient with a current treatment, and see how well the experimental treatment does in comparison to the current. A lot of times this does not occur. This is because a treatment that is currently used to treat patients will have already accrued plenty of data that the clinicians can use instead of treating more patients with the known treatment. This saves time as well as money for the company who is trying to get their product to market. 

The next two types of groups are not really different types of test groups. They are different ways of setting up the protocol for the test groups (control and experimental). A Blind is where the patient is not told if they are taking the actual experimental product or if they have been given a placebo. This allows doctors to see if there is some psychological factor that plays a role in the treatment of the disease. Sometimes to reduce bias even more a double blind is placed on the trial. A Double Blind is where both the doctor nor the patient know who belongs to the experimental or control groups. In a trial, a doctor who knows which patient belongs to a particular group may "see" things in a patient that may not be due to the product, or they may not pay enough attention to those who belong to the control group. A double blind reduces the possibility of this occurring, on both the patient and doctors part. 

Four Phases of a Clinical Trial

As you already know clinical trials are performed on human subjects. The process of a trial is an un-timed study, that is broken down into four different phases. Most of these phases must occur before the product, either a newly developed drug or device, can go to market. Each phase is able to answer different questions that the clinical trial needs to answer before approval form the Food and Drug Administration (FDA) can occur.  

Phase I is where the initial studies are used to determine the physiological reaction in humans to the new product. The product is used to treat a small group of individuals ranging from 20 –80 people. These studies are used to monitor and determine the different side effects that occur, its safety, and the product’s effectiveness. In the case of a drug, a safe amount of dosage is also determined.

During Phase II a larger group of people is used to study once again the products side effects, as well as its safety. With a larger group of approximately 100 to 300 people, the drugs effectiveness toward a particular disease of condition can be studied. This larger group provides a wider variation of the types of different people; it allows the manufacturer to see if the product affects people of different gender, age, and ethnicity differently.

The next step is to test the product on an even larger group. This phase tests the product on a group size of 1000 to 3000. Again the products effectiveness and side effects are monitored. Phase III also allows for comparison of the new product to what the commonly used treatment is. This data will allow the manufacturer to see how well the new product does in comparison as well as allows them to see any weaknesses in their product, which is known as the overall benefit-risk relationship of the product.  This stage is used to determine how physicians will prescribe and or use the product on patients. Information such as prescription dosage, treatment duration is all important characteristics of the product that are determined and finalized during this phase. Commonly Phase III is the last phase before the FDA approves the drug.

Once the FDA has approved the product the final phase, Phase IV, can be conducted. This phase is optional; however it is usually beneficial for the manufacturer to conduct this phase in order to maintain the product allowing for improvements to be made. These post-marketing studies define additional information like the risks, benefits, and optimal use of the product. 

Figure 1. Flow Chart of the Phases of a Clinical Trial

Food and Drug Administration

The Food and Drug Administration is known as the FDA. It is a part of the branch of the U.S. department of Health and Human Services agency. The FDA is in charge of ensuring the safety and effectiveness of drugs, medical devices, biologics, and vaccines that are used in medical treatment and or diagnosis.  

In a clinical trial, the FDA has the ability to grant approval or disapproval to a product that is undergoing a clinical investigation. The FDA looks at the data that has been taken by the study, and analyzes it to see how effective and safe the product is to the general health of the public. One of the main things that the FDA looks at is the risk benefit ratio that the product has. This ratio relates the number and types of risks a patient endures to the benefits the  product can provide. In most cases if the benefits exceeds the risks, then the product is more likely to be approved. However in some cases the risk benefit ratio may not be a good, so the risks would exceed the benefits, if this product were released then there would be a warning but it also provides an alternative treatment for patients who have tried everything and nothing seems to work.