Patient safety and concerns
Are clinical trials safe?
Many safeguards are put in place to protect the people who participate in clinical trials. These safeguards are meant to protect participants from possible harmful side effects of the treatments being tested, as well as to protect participants from being treated unfairly during the research study.
Some of the protections happen before the clinical trial starts, and some happen during the clinical trial.
Investigational New Drug (IND) application
Before a clinical trial begins, the drug (medicine) or treatment being studied must pass the Investigational New Drug (IND) process, which makes sure that the drug is safe enough for people. The IND application must be approved by the Food and Drug Administration (FDA) before clinical trials can start.
The application asks for:
- Information/results from the animal and laboratory studies of the drug
- Information about the group making the drug, and who is doing the research
- Detailed plans for the trial, for example who should be allowed to participate, and how long it will last
- Information about any research about the drug that has been done on people before
If the reviewers from the FDA see any problems with the application — for example, the risks are too big, or the researchers do not have enough experience — the study will be put on hold until these issues are corrected. Clinical trials will only start when the FDA thinks the study is safe for humans.
Institutional Review Board (IRB)
The Institutional Review Board (IRB) is a group of at least five experts that review and must approve the plan before a clinical trial can begin. The IRB looks out for the rights and safety of the participants who volunteer for a clinical trial.
IRBs will check to be sure:
- That the risks of participating are not too high
- That the right people are being asked to participate in the study
- That the informed consent form is easy enough for most people to understand
If the IRB finds any concerns about the planned research or research methods, the IRB members will not approve the clinical trial.
Before you can join in a clinical trial, you must fill out an informed consent form. The informed consent form explains all the details of the study so that you clearly understand what you will be asked to do as a participant.
Even after you sign the informed consent form, you still have the right leave the study at any time, for any reason.
Patient Bill of Rights
Any person who volunteers to participate in a clinical trial is protected under a Participant Bill of Rights.
Below is the Clinical Trial Participant Bill of Rights:
- To be told the purpose of the clinical trial
- To be told about all the risks, side effects, or discomforts that might be reasonably expected
- To be told of any benefits that can be reasonably expected
- To be told what will happen during the trial and whether any procedures, drugs, or devices are different from those that are used as standard medical treatment
- To be told about available options and how such options may be better or worse than what is being studied in the clinical trial
- To be allowed to ask any questions about the trial before giving consent and at any time during the trial
- To be allowed ample time, without pressure, to decide whether to consent to participate
- To refuse to participate, for any reason, before and after the trial has started
- To receive a signed and dated copy of the Informed Consent form
- To be told of any medical treatments available if complications occur during the trial
Courtesy of The Center for Information and Study on Clinical Research Participation (CISCRP)
Children in clinical trials
Children may also participate in clinical trials and are given special safeguards. In most cases, both parents must agree to have their child participate. If the child is more than seven years old, they also must agree to be part of a clinical trial.