One of the best ways to receive cutting-edge treatment, often at no cost, is through a clinical trial. For diseases with rapidly evolving treatments, sometimes the only way to use the latest medication or take advantage of the latest procedure is by joining a trial. Furthermore, you can be part of medical history by contributing to a clinical trial; without trials, most medications would never have enough proof of success to be approved by the FDA and, in the process, be made available to wide audiences.

Clinical trials are, by definition, health research studies that follow established protocols. Qualified individuals can participate as long as they meet the “inclusion criteria.” Criteria can include medical history, age, gender and details on their form of the disease being treated. Not all qualified applicants will be accepted into any given clinical trial.

Considerations

Many people wonder how safe it is to participate in a clinical trial. Participants must understand that while the FDA and the study leaders make every effort to ensure a safe and profitable experience, some risks are inherent in the process of trying out untested medications and procedures. Careful reading of the study literature, as well as the documents provided as part of informed consent, should make participants feel comfortable with the level of risk they may be taking.

All individuals accepted into a clinical trial will sign a consent form. In providing informed consent, patients state that they have had the opportunity to learn the major elements of the study, and have made knowledgeable decisions about whether or not to participate. Generally speaking, participants can withdraw from clinical trials at any point during the process, although their own treatment results might be affected or compromised.

What to Expect

When deciding whether or not to take part in a clinical trial, individuals should consider several factors:

• The nature and purpose of the study

• Why the study is being conducted, and results of similar studies

• The doctors and other health professionals running the study and providing patient care

• The length and requirements of the trial

• Any costs involved with participating, as well as other reimbursable expenses

• Follow-up care after completion of the study

All clinical trials are different in terms of the details of the study protocols. Most begin with a physical and/or psychiatric examination. Participants receive instructions, including how often they need to present themselves at the medical facility or hospital. There are usually strict rules for participants to follow, and individuals can expect to be ejected from the study if they prove incapable of adhering to those guidelines. Generally, most clinical trials allow participants to continue working with their own personal physicians.

Clinical trials for drug testing consist of several phases:

• Phase I: a relatively small sampling of participants test an experimental medication, treatment, or procedure, most often in an attempt to identify doses of the drug that are potentially effective yet free of potentially toxic side effects.

• Phase II: after the Phase I dose is determined, the trial group is expanded to a larger group of people to test whether the drug shows actual effectiveness in treating the condition in question.

• Phase III: the trial group is expanded again, but this time the trial group is divided into one or more groups in which one group will receive the trial drug, and another group will receive a comparison drug or often a placebo, a pill or procedure made to look like the drug or procedure being tested. The assignment to these different groups is random so participants in one of these phase III trials may be as likely to receive the trial drug as a placebo. This procedure is absolutely necessary to confirm the effectiveness of a new treatment; many studies have shown that patients with a variety of conditions, especially migraine, can often respond quite effectively to placebo.

• Phase IV: studies are performed after a drug or treatment has made it to market in order to assess the efficacy of a treatment in the larger population of patients and to determine the occurrence of any side effects associated with long-term use.

Study participants may or may not be paid for their participation in a clinical trial. The trials that pay are typically the ones with less of a chance of medical benefit to the subject, since there is an underlying assumption that those trials may have a harder time attracting qualified applicants. Also, payment usually correlates to the length of the study, requirements upon the participant, and expected level of discomfort as a result of study medications or procedures.

Risks and Benefits

One of the primary benefits of participating in a clinical trial is getting access to new treatments before they are available to the general population. Trial participants typically can work with medical experts in their field, and they have the side benefit of knowing that they are playing an important role in medical history.

Clinical trials are, however, not without their risks. Some medications being studied could have unpleasant side effects, and the study could be more draining than the participant anticipated. In addition, there is always the possibility that the therapy being tested by the trial will not help.

Not everyone who takes part in a clinical trial will have the opportunity to test new medications or therapies. When you take part in a phase III randomized and blinded controlled trial, there is the possibility that you will be assigned to the control group, or the group of study subjects that do not receive the treatment being tested and instead receive a placebo. If the study is blinded, you will not know which group you are in. Keep in mind that even if you do end up in the control group, you are still playing a vital role in medical research.

Locating Trials

There are several ways to locate clinical trials. Working directly with special interest groups responsible for various trials is the best way to find a trial in a specific field. The U.S. National Institutes of Health has a database of clinical trials, sorted by topic. The listings include almost 50,000 trials in over 100 different countries. The migraine list can be found online.

Another clinical trial listing service can be found at Center Watch, which also has a listing for pediatric migraine clinical studies./p>