Montgomery General Hospital

A clinical trial is a study involving human volunteers that compares a currently recognized treatment with a treatment that the study's researchers believe may be more and effective. If the studies prove new treatments to be more effective, then standard treatments may be changed. These cutting edge therapies help make progress in the treatment of many diseases, including the battle against cancer.

Here are some resources that will help you prepare for participating in a clinical trial:

An Introduction to Clinical Trials

You should also know the benefits and risks of participating in a clinical trial:

Benefits

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

• Play an active role in their own healthcare.
• Gain access to new research treatments before they are widely available.
• Obtain expert medical care at leading health care facilities during the trial.
• Help others by contributing to medical research.

• There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
• The experimental treatment may not be effective for the participant.
• The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

What are side effects and adverse reactions?
Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports (See Confidentiality Regarding Trial Participants).

What should people consider before participating in a trial?
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.

Additional Resources:
www.clinicaltrials.gov
www.cancer.gov
www.cancertrialshelp.org/patientsCaregivers/patientsCaregivers.jsp
www.ctsu.org
www.clinicaltrialshelp.org