Facing Immunotherapy: A Guide for Patients and Their Families by Kerry Reynolds & Justine Cohen & Leyre Zubiri

Facing Immunotherapy: A Guide for Patients and Their Families by Kerry Reynolds & Justine Cohen & Leyre Zubiri

Author:Kerry Reynolds & Justine Cohen & Leyre Zubiri [Reynolds, Kerry]
Language: eng
Format: epub
Tags: Medical - Immunotherapy
Publisher: The Massachusetts General Hospital Psychiatry Academy
Published: 2020-02-04T17:00:00+00:00


Note: Traditionally, Phase 1 trials have been considered as dose-finding studies. It should be noted, however, that Phase 1 trials sometimes provide access to cutting-edge therapies and in recent years, several drugs have been given accelerated approval by the FDA based on single-arm Phase 1 trial.

Figure 17-1: Phases of clinical trials.

How Is a Clinical Trial Conducted?

The most common type of clinical trial is one in which participants are randomized and “double-blinded”. Randomization is an important part of Phase 3 (and some Phase 2) clinical trials because it helps to prevent bias in the results. Preventing bias helps to prevent unknown factors from affecting how reliable the results are. Practically speaking, this means that when you participate in a clinical trial, you will be randomly assigned to either the “study” group receiving the drug, or to the “control” group receiving standard treatment. In cancer clinical trials, it is very uncommon for the control group to receive a placebo (i.e., an inactive drug). If this is the case, you will be told about this before joining a clinical trial.

Clinical trials have a team that is involved in planning and coordinating the trial; the person in charge is called the Principal Investigator (PI). The PI will prepare a plan for the clinical trial, which is commonly called the protocol. Other critical team members in a trial include a research nurse, data manager, and a staff physician or nurse.

There is also an informed consent process, which involves a written form and a discussion providing the details of the study and the opportunity to answer any questions. Most of these forms will include the reason for the clinical trial (i.e., the study question), eligibility criteria, how the study is designed, what is known about this new treatment type, the risks and benefits of this new treatment type, other treatments available, the logistics of participating in the trial (such as the number of visits and testing), financial costs (and who will incur these costs), how your identity will be protected, and information about who you can contact throughout the trial. This form should also emphasize that your participation is entirely voluntary and that you have the right to leave at any time without fear of your decision impacting your care.

Once you have decided to take part in a clinical trial, you will likely need blood tests and imaging studies before starting the treatment. You may have testing done more often to check on how the treatment is going and to see if you are having any side effects (called adverse events). For some of these treatments, the full range of side effects may not be known. Therefore, you should let your medical team know about anything you are feeling that is not normal for you to help determine whether it is related to the treatment.

Taking part in a clinical trial is voluntary—you can stop the trial at any time and for any reason. Some reasons for stopping include: the treatment does not seem to be working;



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