Participating in a clinical trial is a personal decision, and making that decision will look different for everyone. As a caregiver, you are among the closest people to your loved one, and one of the best people to identify when they may be ready to participate in a clinical trial. Below is a useful guide to help you decide if your loved one may be ready for a clinical trial.
What is a clinical trial?
Clinical trials are studies investigating a new medication, therapeutic, procedure, or medical device. They are important for identifying the health-related effects of these treatments. Clinical trials are conducted in phases: Phase I evaluates safety and treatment dosage; Phase II determines effectiveness and potential side effects of the treatment; Phase III compares the new treatment to existing treatments for the diseases or disorder; and Phase IV identifies long-term effects of the treatment in a broader population. Before the Phase I clinical trial, the treatment in question will have already undergone extensive preclinical testing. Additionally, the phase a clinical trial is in may impact the criteria for eligibility.
It is important to understand that a critical part of clinical trials are control groups. This means there is the possibility that your loved one may not receive the experimental treatment, but instead may receive a placebo treatment. Receiving a placebo can still be an important role for your loved one. Progress towards a new treatment can benefit them and many others with the same ailment. Importantly, not all clinical trials include placebo treatments; they could be measuring treatment efficacy against an existing treatment.
Participation in a clinical trial
Participation in a clinical trial is a big decision. Clinical trials can be a good fit for your or your loved one if the existing treatments aren’t proving effective. However, clinical trials aren’t simply a last resort for patients, they are important at all stages of diagnosis. Your healthcare team may feel the progress your loved one has made could be furthered with the addition of an experimental trial. Some clinical trials are exclusively tailored to early diagnosis, while others may be for patients experiencing only minimal symptoms.
Open communication between you and your loved one, their doctors or healthcare team, and any additional support systems is very important. Informed consent is necessary to take part in a clinical trial. Each participating individual must be informed about the trial and understand the risks and benefits of participation. Your healthcare team will help you understand the risks and potential benefits of participating in a clinical trial. Additionally, patients should be made aware of alternative treatments for their condition, and be provided with the trial purpose and design for review before participating.
Part of determining if your loved one is ready is also determining if you are ready. If you are your loved ones primary caretaker, additional responsibilities may be required of you, such as administering medication, transporting your loved one to doctors appointments, and monitoring symptoms and overall condition. Having an extended support system in place can be especially helpful for navigating a more demanding clinical trial.
