September 04, 2024
Clinical trials are the key to unlocking future treatments and preventive strategies for Lewy body dementia (LBD). Only by testing new medications in controlled experiments, called trials, can we know that the medications will be safe and effective. If you are participating in, or considering participating in, clinical trials or other human research, you should know your rights.
One of the most important concepts in research ethics is informed consent. Similar to the concept of informed consent in medical treatment, informed consent in research means that all participants must be informed of the potential risks and benefits of participating, along with their rights as a participant, when they consent to participate in a study. However, informed consent does not end when you enter a study. Consent to participate can be withdrawn at any stage of the study and for any reason. This is often referred to as the right of withdrawal. Participation in trials and other research studies is entirely voluntary for the duration of the study.
What does withdrawal mean?
Withdrawing from a trial simply means that a participant stops their participation in the study before it is completed. Generally, this means that the participant no longer takes the study drug or completes any more assessments of follow-up visits associated with the study.
It is important for all research participants to know that continuing in, or discontinuing from, a study is 100% their decision. They are not obligated to continue in the study, and withdrawing from a study is not “frowned upon” or considered a failure of any kind. Study teams respect the decision to withdraw and do not look down on participants who exercise their rights.
How to withdraw from a study
If you decide to withdraw from a study you are participating in, LBDA encourages you to contact a member of the study team of the clinical trial you are participating in to let them know about your decision. Sometimes, the study team can address concerns you have, and you may decide to stay in the study. Even if your decision is firm, it is still a very good idea to communicate your decision with the study team. Understanding why participants decide to withdraw is valuable information for the study. It can help researchers interpret the data that you have already contributed by your initial participation, and it can also help them design better studies in the future.
The study team of the clinical trial you are participating in is there to support you in your decision and help you navigate the withdrawal process.
Will withdrawing from a study affect the results?
Because clinical trial data is necessary to understand whether a drug is safe and effective, the more individuals who fully complete the study, the better. However, no clinical trials have data that is 100% complete. People leave studies for various reasons, and researchers have devised techniques for interpreting incomplete data. Moreover, even the act of withdrawing from a study is a data point that is useful for researchers – that is why it is important to inform the study team if you are considering withdrawal.
Final thoughts
If you are currently participating in a trial or considering participating – thank you! It is one of the most important contributions you can make. Your continued participation is a valuable gift to science and to the LBD community. If you change your mind, though, know that that is your right. You may stop participating at any time and for any reason. The best way to do so is in open and honest communication with the study team.
To learn more about trials and other studies that are currently seeking participants, please visit the LBDA clinical trials page. To be updated when new studies launch, consider signing up for the Lewy Trial Tracker.