Do any of them have ovarian cancer? How many patients have received the same dose that I am going to get? Am I the first one to get this dose? What side effects have other patients experienced? How many patients had those side effects? If the trial is combining two drugs and one is already approved for treating cancer, you could ask if the dose you will get is the same as the dose typically given. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.
Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers. Some studies need both types.
Inclusion and exclusion criteria are not used to reject people personally; rather, the criteria are used to identify appropriate participants and keep them safe, and to help ensure that researchers can find new information they need. Clinical trials involve risks, just as routine medical care and the activities of daily living do. When weighing the risks of research, you can consider two important factors:.
Most clinical studies pose the risk of minor discomfort, which lasts only a short time. However, some study participants experience complications that require medical attention. In rare cases, participants have been seriously injured or have died of complications resulting from their participation in trials of experimental therapies.
The specific risks associated with a research protocol are described in detail in the informed consent document, which participants are asked to read and sign before participating in research. Also, a member of the research team explains the major risks of participating in a study and will answer any questions you have about the study.
Before deciding to participate, carefully consider possible risks and benefits. The goal of clinical research is to develop knowledge that improves human health or increases understanding of human biology. People who participate in clinical research make it possible for this to occur. The path to finding out if a new drug is safe or effective is to test it on patient volunteers. By placing some people at risk of harm for the good of others, clinical research has the potential to exploit patient volunteers.
The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science. Ethical guidelines in place today were primarily a response to past research abuses. Informed consent is the process of learning the key facts about a clinical trial before deciding whether to participate. The process of providing information to participants continues throughout the study. To help someone decide whether to participate, members of the research team explain the details of the study.
The research team provides an informed consent document, which includes such details about the study, as its purpose, duration, required procedures, and whom to contact for various purposes. The informed consent document also explains risks and potential benefits. What are the possible short- and long-term effects of the treatment? How do the possible risks and side effects compare to my current treatment? Find out about the benefits of being in the study There are lots of great reasons to participate in a clinical trial, but the specific benefits will depend on the study.
How might the treatment help my condition? How else will I benefit from joining this trial? How will the results of this trial benefit other people like me?
Questions to Ask Before joining a clinical trial, it is important for you and your family members to ask questions before deciding to participate. What is the purpose of the study? What kinds of tests and treatments are involved?
How do the possible risks, side effects, and benefits in the study compare with my current treatment?
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