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Considerations and Decisions

​What things should I know about a specific clinical trial before I decide whether I want to becomed involved in it?

In addition to you deciding whether the trial is right for you, your oncologist will have to make sure you are right for the trial! As mentioned, the eligibility criteria are written as part of the study protocol, to ensure that the particular question of interest can be answered in as safe a manner as possible for patients. Sometimes there is a requirement that your tumour be visible on a scan and measurable, and in that case, after the consent form is signed, a scan would be needed to determine your eligibility. Other baseline tests, such as blood, urine, or heart tests might also be necessary.

The use of any medical treatment potentially involves small risks, whether or not you are on a clinical trial. However, in a clinical trial, there is usually less known about the risks of the experimental treatment arm than there is about the standard arm or arms. You will be made aware of whatever knowledge is available about the risks of the new treatment, and will be informed that it is possible new information on side effects or risks will emerge during the clinical trial. If there is new information discovered during a trial that would potentially affect whether patients would consent to treatment, that information is shared with the investigators and patients. Sometimes, if the information is quite significant, the informed consent document will be revised to include the new information, and patients who have already consented will be asked to indicate whether they continue to consent to their treatment in the study.

As described above, a clinical trial often includes more tests and visits than would be standard, so that risks and side effects can be identified as clearly as possible. There are often small risks associated with medical tests. All of the anticipated risks of the study treatment and tests will be described in the informed consent document, to help you make your decision about the trial.

Due to the increased monitoring and testing that might be done as part of a trial, you may have more visits or longer visits to the Cancer Centre, or more tests done than usual, which may result in less convenience for you. In some cases, you might need to be admitted to the Cancer Centre or local hospital for part of the treatment. You may be asked to fill out questionnaires at intervals, to provide information about the side effects you are experiencing, or about how you perceive the quality of your life. At the end of the treatment phase of the trial, there is often a phase of follow-up that carries on for years, to observe the outcome of your treatment on the cancer and on you. Some people look forward to increased follow-up, tests, and questionnaires, whereas for others, these are experienced as more of an inconvenience. The length of time you will be followed up at the Cancer Centre will depend on the phase of research, your underlying condition, and the particular study issue.

Cancer clinical trials are performed to try to identify new or improved treatment options for cancer patients. The only way to find out about a new treatment is to test it in humans, as carefully as possible. At the outset of a study, it will not be possible for anyone to tell you whether a new treatment will directly benefit you, relative to standard treatment. A study treatment may give you an additional treatment option that might not otherwise exist. It is possible that an experimental treatment will in the end prove to be better than, as good as, or worse than, current standard treatment. It may take years before results are known. The most certain benefit involved in clinical trial research is the opportunity to be involved in improving the knowledge we have about treatment of your condition for future patients. As stated, some individuals view the increased tests and follow-up as a benefit, whereas others view this as an inconvenience.

You do not waive, or sign away, your legal rights by signing consent to a study. Taking part in a study is voluntary, meaning you may choose not to take part, or may withdraw your consent and leave the study at any time. If you withdraw from or decline a study, your doctor will discuss further treatments with you and continue to treat your cancer with the best means available. If there are other clinical trial opportunities relevant to you later in your treatment, these will be offered to you.

The increased tests and visits that may accompany a clinical trial may result in increased costs to you for things like parking or transportation to the clinic. In most cases, there is no payment to you for taking part in a trial, nor to reimburse expenses, but the study treatment, tests, hospital admissions (if appropriate) and appointments are provided without expense to you**. If there are medications needed to control side effects from treatment, these medications may or may not be provided as part of the study. The consent form will indicate whether any expenses will be reimbursed for the particular study you are considering. (**applies to residents of Canada)

As stated, participation in a study is voluntary, so that if you elect not to continue in a study, you have that right. In some cases, a study may close early as a result of new information learned during the study, or due to loss of sponsorship. Also, you may be withdrawn from the study if it is felt that the study treatment is no longer in your best interests or if you are not able to comply with the study treatment. The majority of studies are not closed early.

Your medical information is confidential, but individuals involved in monitoring the conduct of the study and recording information on the treatments may need to access your records in the presence of a study investigator. These individuals may be representatives of the study sponsors, such as the NCIC or the drug company supplying the trial drug, or may be representatives from regulatory bodies such as Health Canada's Health Protection Branch, which is involved in the oversight of drug treatments. The informed consent document will tell you what groups or individuals would have the right to examine some part of your records. Any forms or paperwork recording your information and results usually identifies you by code number and/or initials only, and your name will never appear in any publication resulting from the conduct of the study.

Usually, the results of a clinical trial will not be reported immediately, as it takes some time to treat patients on the trial and then to gather together the information about results. Some of the results of a phase I or II trial may be available and published within a year or two of the end of the study, and if the results are promising, may result in the development of a phase III trial, even before final publication of the study results. A phase III trial may take longer to be completed, as so many more patients are needed. Some studies examining prevention or secondary prevention will not report results for many years, as it will take that long to see differences between the study groups. You can ask your doctor how long it might be, in their estimation, before results are presented at a meeting or published in a medical journal.

There are many sources of information these days about cancer research. There is more and more interest in the general public about medical news. You may hear news items about cancer research on television or read them in the paper, and wonder whether they are relevant to you. Often the results that are reported in the news are from very early stages of research in the laboratory, and are concerned with new discoveries of abnormalities in cancer cells, that may allow scientists to develop new treatments for testing in future. Read or listen carefully, to find out whether the new treatment is being tested in the lab only, or in humans. If it is in the lab, often it will be years before the testing can proceed in humans, and many early discoveries will unfortunately not result in a new treatment. If the study seems to be in humans, try to find out from the story whether it is a Phase IPhase II, or Phase III study, so that you will know roughly how many patients have received the treatment, and what stage the research is at. If you think the study might be one that is relevant to you, you can try to look it up on the list of clinical trials for your Cancer Centre (link to Open Clinical Trials) or plan to discuss it with your oncologist at your next appointment. If the story you read is in the newspaper, it might be helpful to bring the clipping to the appointment with you.

SOURCE: Considerations and Decisions ( )
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