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Could a Clinical Trial be Right for You?

Drug testing is fairly commonplace in today's mainstream concept of medicine and how new drugs are provided to those patients waiting for a cure. Stories are all over the news discussing new Cancer, AIDS, Alzheimer's, etc. therapies that are being studied and are available to a small number of patients participating in a clinical trial.

To clarify, a clinical trial is simply a study used to determine the safety and efficacy of a new treatment before it becomes available to the general public. These trials involve patients suffering from the problem the new product/device is designed to treat. They traditionally are the end of a long and exhaustive series of tests, which can include mechanical and animal testing.

Participants in clinical trials gain access to cutting edge treatments that aren't currently widely available. However, it is important to note that these treatments should not be entered into lightly. If you are interested in participating in a clinical trial or have a family member who is considering participating, there are several factors to consider before making a final decision.

Risks & Benefits


As with every treatment there are a series of risks and benefits. Where a clinical trial differs is that the risks of the particular treatment are under investigation. Your physician should be able to explain to you the potential risks, but keep in mind that the reason why the clinical trial is underway is to determine the safety and efficacy of the treatment.

On the other hand, there are a lot of benefits to participating in a clinical trial. Most clinical trials are held in leading facilities with physicians who are experts in their fields. With the amount of money that the medical industry pours into research and development, they are very cautious in choosing the physicians who will participate in the final clinical trial. By participating in the trial you gain access to not only the new treatments before they are available, but also you will be under the care of a leading physician.

All clinical trials in the US are reviewed and monitored by an Institutional Review Board (IRB). This review board consists of a group of independent physicians, statisticians, community advocates, and others who work to ensure that the clinical trials, the institution they work for enters in to, are as low risk to the patients as possible.

Inclusion & Exclusion Criteria


Obviously getting accepted into a clinical trial is not as easy as simply saying that sounds like an interesting option. All clinical trials are based around a series of "rules" that determine how the clinical trial will be held, but what type of patient can participate.

Inclusion and exclusion criteria are, simply stated, the "rules" surrounding what confines a person must fit into in order to participate. These "rules" include certain elements such as:

  • The patient must be a certain age
  • The patient must be in relative healthThese "rules" exclude certain elements such as:
  • The patient can not be in another clinical trial
  • The patient can not be diagnosed with a particular disorder

Control Group


Most clinical trials utilize a control group. The control group is the basis by which the treatment being studied is compared to. Plainly this means that even though you decide to participate in a clinical trial and are accepted, you still may or may not receive the treatment being studied. This is most commonly understood in the concept of a placebo. Often drug manufacturers use a placebo or "pseudo" treatment to compare a new treatment to. In spinal surgery clinical trials, often the control group receives the "current standard of care." What is often being studied is a shift in technology and philosophy.

Your Responsibility


More often than not, a clinical trial requires you to participate a little more fully in your treatment. Some of the requirements you should be aware of typically include routine checkups and visits with your physician often up to two years after you received the new treatment. There are also economic considerations, as many health insurance providers will not cover an experimental treatment. You should be aware of any financial responsibilities you may have, or if the treatment is being paid for by a third party. The other factor to consider is that your recovery may be very different from the traditional recovery with the current treatment. Your doctor should be able to explain the depth of your recovery responsibilities.

Expanded Access


For patients who do not qualify for a clinical trial could potentially receive the treatment under an expanded access protocol. The FDA can provide a treatment IND (Investigational New Drug application). There are two main reasons why the FDA would grant an IND:

  1. To provide access to a new treatment for people with life-threatening or serious disease for which there is no current good alternative to the new treatment
  2. To generate new information about the treatment, especially regarding its safety

The clinical trial sponsor and the physicians/hospitals participating in them manage expanded access protocols.

The materials on this Web site are for your general educational information only. Information you read on this Web site cannot replace the relationship that you have with your health care professional. We do not practice medicine or provide medical services or advice as a part of this Web site. You should always talk to your health care professional for diagnosis and treatment.

  • Published: November 05, 2003
  • Updated: July 22, 2008