(Download) "An Intervention to Improve Cancer Patients' Understanding of Early-Phase Clinical Trials." by IRB: Ethics & Human Research # Book PDF Kindle ePub Free
eBook details
- Title: An Intervention to Improve Cancer Patients' Understanding of Early-Phase Clinical Trials.
- Author : IRB: Ethics & Human Research
- Release Date : January 01, 2009
- Genre: Health & Fitness,Books,Health, Mind & Body,
- Pages : * pages
- Size : 247 KB
Description
The consent process for human subjects research educates potential participants about research risks, benefits, and procedures so they can make an informed decision about whether to enroll in a clinical trial. Yet numerous studies demonstrate that trial participants sometimes have difficulty distinguishing research from clinical care--i.e., they believe the experimental innovation is therapy. (1) This "therapeutic misconception" is widespread, (2) including among research participants in oncology clinical trials. For instance, Joffe and colleagues found that 30% of oncology trial participants believed that the investigational therapy was proven to be the best treatment for their cancer. (3) In another study, Daugherty et al. found that 73% of 144 participants in a phase I trial joined the study seeking an "anticancer response" including cure or remission, and 61% reported the main purpose of the trial was to determine efficacy. (4) In a study we conducted, 17% of cancer patients recruited for phase I trials believed the trials promised a cure, 60% reported a purpose related to efficacy, and only 17% mentioned a purpose related to dosing, safety, or side effects. (5) If these reports regarding participants' beliefs about clinical trials reflect a true misconception that investigational interventions are actually proven treatments, this is ethically troubling, particularly for early phase clinical trials where the primary purpose is to determine toxicity and dosing rather than efficacy. Our own work has further documented that oncologists often couple discouraging statements about research benefit with longer encouraging ones. They also sometimes emphasize the chance of a great breakthrough and suggest that the decision regarding trial enrollment depends on whether the patient likes to "play the lottery," or wants to "try for the home run." (6) Yet other studies have shown that phase I oncology consent forms do not overestimate the benefit of early phase clinical trials. (7) Such work, when taken together, suggests that consent interventions may be useful as a means of providing supplemental or more detailed information to patients being recruited to participate in these types of trials.
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