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 Cancer

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To Trial or Not to Trial: That Is the Question

By Hilary Wright

(Page 2 of 4)

Phase III trials: test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). This phase often enrolls large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide.

In order to assure the safety of those who are about to undergo a clinical trial, the government has designed a system that requires a trial plan, known as the protocol, to first be approved. After approval, a review committee is then assigned to the clinical trial in order to continually monitor the study, making sure that the original protocol is being followed and that the participants are being protected. Government regulations also require a patient to go through a process called “informed consent” prior to deciding whether or not they want to participate in a specific clinical trial. Informed consent is when researchers performing the study thoroughly inform patients about the treatments and tests, and what the possible benefits and risks will be. Along with talking with the research doctor or nurse, a written consent form will also be given to take home to read and discuss. The consent form will include details about:

- the approach of the study
- the intervention given in the trial
- the possible risks and benefits
- the tests you may have to undergo

Remember to continually ask questions until satisfied that all the information needed is understood. Although informed consent begins prior to your loved one agreeing to participate in the clinical trial, always feel free to ask the healthcare team any questions at any point. Informed consent continues as long as your loved one is involved with the study. A participant has the right to change their mind and leave the clinical trial whenever they want, whether it’s before the study starts, during the actual study or during the follow-up period.

Clinical trials are conducted in a number of places, including large cancer centers,
university hospitals, at local medical centers, or at a doctor's office. Depending upon the type of clinical trial and based on the intervention it's designed to study, the trial may include participants at one or two highly specialized centers, or it may involve hundreds of locations at the same time. Clinical trials are conducted under the guidance of a healthcare team which includes your loved one’s doctor, along with other health professionals. The information from all the participants is then used by experts who evaluate the intervention that the trial is testing.

Deciding upon whether or not your loved one becomes a participant in a cancer clinical trial is completely up to them. However, there are some very important questions you and your loved one both should get answered:- What is the purpose of the study?

- Why do researchers think the approach may be effective?
- Who will sponsor the study?
- Who has reviewed and approved the study?
- How are study results and safety of participants being checked?
- How long will the study last?
- What will the responsibilities be if I participate?

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