Many procedures have been created to protect the safety of the people who participate in clinical trials. The U.S government strictly enforces the guidelines that regulate all medical research in which people participate. Eligibility criteria are employed to make certain each specific trial is safe and appropriate for patient participation. Every patient participating in a medical research study, by law, in the United States, must sign an informed patient consent form that explains the research study, potential advantages and disadvantages of the new versus standard treatments, and where supplementary information can be obtained. Additionally, it explains the patient's rights as a participant in the trial, their right to withdraw at any time if they feel uncomfortable with the process and the assured confidentiality of their records. Signing the informed consent form indicates that the patient understands and agrees to treatment in a particular trial.

The benefits to participation in a clinical trial might include:

• Access to treatment that is not otherwise available
• Increased number of treatment options
• Supplementary monitoring of progress and side effects of treatment
• Potential to be involved in a new treatment that could help others in the future
• Possibility to have costs covered by sponsor of the study

The risks to participation in a clinical trial might include:

• Unknown side-effects or other risks which may or may not be as harsh as in standard treatments
• Experimental treatment may not be as effective for you
• Choice of treatment option may not be possible if trial is randomized
• Insurance may not cover costs of treatment
• Extra time and other commitments may be necessary

Certain criteria must be met that detail the conditions by which patients will be included or excluded from a study. It is important to enroll patients who are alike in key ways in order to answer specifically designed questions pertaining to the trial. Typical eligibility criteria include:

• The type and stage of the cancer
• The type and number of previous treatments
• The length of time since last treatment was received
• The extent of cancer growth
• Previous history of other cancer(s)
• Other medical conditions
• Level of daily activity

The choice to take part in a clinical trial is a personal one. You may wish to discuss the potential advantages and disadvantages of participation with your family and loved ones, as well as members of your health care team, in order to make an informed, well-considered decision. As with all current standard treatments, there are possible risks as well as benefits from taking part in a clinical trial. Study drugs may be found to be more or less effective than current treatments and could have unknown side effects. Develop a list of questions to ask your clinical research team so that they may assist you in making the decision that is right for you.