The informed consent form should list the following:
- The reason for the clinical trial (what doctors hope to learn)
- Who is eligible to take part in the clinical trial
- What is known about the treatment being studied
- Possible, known risks and benefits
- Types of tests required to participate
- How often you need tests and doctor consultations
- Who pays the costs
- A statement about privacy protection
- Who to call if you have questions
The informed consent process does not end once you sign the form. Your research team will tell you if new risks or side effects from the treatment are found during the active and follow-up portion of the trial. If you have questions, we encourage you to ask.
A protocol is the map used for a clinical trial, which:
- Explains the treatment plan
- Lists the medical tests patients will receive
- Includes how many patients will take part in the clinical trial
- Lists rigid guidelines for patients involved with the clinical trial
- Explains safety information
Patients are closely monitored during a clinical trial. Methods of evaluation vary from study to study, but patient safety is always the primary goal. Decisions about patient care during a clinical trial are made according to evidence-based guidelines provided in the protocol standards of care practiced by the treating physician. Participation in a clinical trial is voluntary and a patient may choose to withdraw at any time.
In Phase I, trials are used to assess an experimental drug in humans for the first time. Generally, Phase I trials include a small group (20-100 people) that is monitored closely. The purposes of a Phase I trial are to determine the safety of the drug, to establish safe dose levels, to see how the drug interacts in the body on a molecular level, and to evaluate any side effects of the drug. Once the minimum and maximum dose is established and the drug is considered safe, the trial moves to Phase II.
In a Phase II trial, only people with the specific disease are able to enroll, and it includes a study population of 100-400 people. The main objectives are to determine the effectiveness of the drug and to continue safety evaluations. During this phase, the experimental drug is compared to a known drug or a placebo. After Phase II, the study broadens to include 400 to 1,000 people.
The purpose of a Phase III clinical trial is to determine the long-term efficacy of the drug and to compare it to standard-of-care drug or a placebo. If the experimental drug provides a better outcome than a standard-of-care drug, the sponsor applies for approval by the FDA. Once the FDA has approved the drug for its specific indication, the drug can be prescribed for its intended use.
Clinical trials involve a long, careful process that may take a few months to many years.
Yes, you would continue to see your doctor for treatment and follow-up care. Each clinical trial is different, so please ask your research team what the requirements are for the specific trial for which you are interested.
Each clinical trial includes its own risks and benefits. You may benefit from joining a clinical trial in one of the following ways:
- If the new treatment works, you may be one of the first people to benefit.
- You may help future cancer patients.
- Cancer experts design treatments used in clinical trials.
Just because a treatment is new doesn't make it better than, or as good as, standard treatment. As with any standard treatment, the new treatment may not work for you even if it works for other patients. Possible risks include:
- Side effects that may be worse than those of standard treatment.
- Side effects your doctor may be unable to forsee.
Every clinical research trial is different. The sponsor of a clinical trial may pay for the treatment, extra tests and extra doctor visits, as part of the trial. The clinical trial sponsor may be:
- US Oncology
- The National Cancer Institute
- A drug company
- A non-profit organization
Your health insurance may or may not pay for any of your care if you choose to participate in a clinical trial. Please ask your patient services representative to explain how your insurance benefits apply to clinical trials, and to learn more about what you might have to pay.
All patients included in clinical trials are volunteers. You can choose to quit a clinical trial at any time, but talk with your doctor first. Your doctor can tell you how quitting the trial might affect your health, and if there are other treatment options. Your relationship with your health care provider will not change based on your decision.
Patients may volunteer to take part in clinical research trials, which are an avenue to receiving new therapies that would otherwise be unavailable. Clinical trials help researchers determine new and better ways to prevent, diagnose and treat cancer.
The informed consent process is intended to protect the patient. This document lists all of the information that will help you decide whether a clinical trial is right for you. It also lists any known side effects of the drugs being tested and explains that a patient may withdraw from the clinical trial at any time.