Risk and Benefits

Clinical Trials

Clinical Trials is one tool that is used to further medical knowledge. It helps in learning about how illnesses behave, how people react to certain drugs, and also what type of products work and do not work in the treatment of different conditions. Any "failure" as a clinical trial, is not totally a mess. This failure can be used as a stepping stone to figure out what was "bad" about the product, and then come up with ways on how it can be changed to work better. It also helps narrow down the lists of possible treatments, so a treatment may soon be found. 

The risks to the process of a clinical trial is the small number of participants needed for each stage of the trial. As can be seen in the following flow chart. Each Phase has a small population of subjects. The problems with the small number of subject is it is not representative of the whole population of individuals who may use the product. In this case, not all side effects are seen, which can lead to problems. Another problem to clinical trials is that the trial even though it doesn't have a specific time frame to work within, it is usually quite short. The time does not usually allow enough data to be taken to see the long term effects. This can also be an issue if the product is being used by younger people. They may have an increased chance of developing other effects during their life span because of the lack of knowledge on how well the product does with time.  

Figure 1. Phases of Clinical Trial Flow Chart

Patients

Clinical trials in a way can be said to be patient driven. It is the patients who need more and alternative treatments for different illnesses, and so engineers and scientists are merely pawns who attempt to create products to answer these needs. 

Those who participate in clinical trials benefit by having the ability play a more active role in their own health care, gain access to new research treatments before they become more widely available, and are able to help others by contributing to medical research. The risks that they may endure are unpleasant, serious or even life-threatening side effects to experimental treatment, an ineffective treatment, and a protocol that requires more time and attention their their health through more doctor visits, hospital stays, and or trips to treatment centers. 

There are many things that should be taken into consideration before entering a trial. 

• What is the purpose of the trial?
• Where is it conducted?
• What is the product supposed to help with?
• What other tests have been done on this product
• How will my daily life be affected?
• How long is the trial expected to be conducted for?
• What type of compensation is received?

How do you prevent people from participating in a trial that they may not qualify for?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". Criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. 

Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

Food and Drug Administration

This administration is responsible for the approval or denial of the product being tested in the clinical trial. The benefit to have an organization that does this is that it reduces the marketing of products to the public which are unsafe, and may do more harm than help to the general public. The FDA has set up regulations that must be abided before approval, and this sets the standard toward which the public health is kept safe. 

A limitation that the FDA posses is the short time that is required to make a decision to approve a product. This short approval period reduces the time that patients are observed and may lead to unnoticed side effects. Before 1992 the approval process took anywhere from 6-7 years, now it takes about 6-12 months. This is a drastic reduction in time, and may be the reason to premature approval to products that are released to market and then shortly taken off the market. An example would be the weight loss drug, Phen-Fen. (see examples for more details). Currently in the market, several different allergy medicines have also been taken off the market due to severe health risks that they cause due to long term use. Another example would be silicon breast implants. These were let onto the market and then taken off because they were thought to cause several different problems with in the body, however recently in April of 2005 they are being re-released due to additional clinical trials that have been conducted and the data that has been presented.