nine. Clinical Trials

What are clinical trials?

The journey for new medications is a long one. The journey starts with an idea and ends up in your local pharmacy. New medications are tested in the laboratory and then on animals before moving on to clinical trials involving humans. Clinical trials may be sponsored by individuals, physicians, medical institutions, or voluntary groups such as disease foundations, drug companies, and government agencies.

People have different reasons for wanting to participate in clinical trials. "Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research," according to ClinicalTrials.gov. Not everyone can participate in a clinical trial. There are very specific criteria for who can be included and who will be excluded. The researchers have to put these restrictions in place so that they can have the best data in determining the effectiveness of a new treatment.

There are different kinds of clinical trials. Treatment trials test various kinds of experimental treatments. Prevention trials examine ways to prevent a disease for people who have never had it, or stop a disease from returning. Diagnostic trials seek to find better ways to diagnose particular diseases, while screening trials test the best way to detect certain diseases or health conditions. And finally, quality-of-life trials are designed to look for ways to improve the quality of life for people with chronic diseases.

According to ClinicalTrials.gov, clinical trials have different phases, each involving more participants.

• Phase I trials: Researchers test an experimental drug or treatment in a small group of people (20 to 80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

• Phase II trials: The experimental study drug or treatment is given to a larger group of people (100 to 300) to see if it is effective and to further evaluate its safety.

• Phase III trials: The experimental study drug or treatment is given to large groups of people (1000 to 3000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

• Phase IV trials: Post-marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

What are the risks and benefits of clinical trials?

Clinical trials have benefits. You may get access to new treatments before they are available to the general public. You get to play a very active role in your own health care. You can get expert medical care during the trial. And you have the satisfaction of knowing that you are contributing to medical research that may end up helping millions of people.

Clinical trials also have risks. In some kinds of trials you may receive a placebo and not get the study medication at all. This is necessary so that the researchers can truly measure the efficacy of the treatment. If you get the placebo, your disease could worsen. The treatment medications might have serious or life-threatening side effects. Or you may find that following the trial protocol is more involved and time-consuming than you are willing to endure. If you are accepted for a clinical trial, you always have the option of leaving the trial.

How can I find clinical trials?

The best way to find clinical trials is to go to ClinicalTrials.gov. The database of trials is searchable by condition, location, drug intervention, and sponsor. The National Institutes of Health suggest the following for people considering clinical trials:

People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

• What is the purpose of the study?

• Who is going to be in the study?

• Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?

• What kinds of tests and experimental treatments are involved?

• How do the possible risks, side effects, and benefits in the study compare with my current treatment?

• How might this trial affect my daily life?

• How long will the trial last?

• Will hospitalization be required?

• Who will pay for the experimental treatment?

• Will I be reimbursed for other expenses?

• What type of long-term follow-up care is part of this study?

• How will I know that the experimental treatment is working? Will results of the trials be provided to me?

• Who will be in charge of my care?

 
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