Every caregiver hopes for a miracle for their loved one with Parkinson’s disease. The promise of new drugs or therapies making a difference is exciting.  A caregiver may encourage their loved one to take the jump and become part of a clinical trial, in hopes of seeing a positive outcome. The decision, however, is ultimately left to the person living with the disease. A caregiver can learn the facts, discuss options and weigh the pros and cons, being a source of information and support. Finding the study is the easy part; thousands are conducted every year. The decision of whether to participate or not is more complicated.

What is a Clinical Trial?
Clinical trials are carefully designed research studies that evaluate new treatments for diseases. The purpose of a trial is to test the safety and results of medications or treatments not yet available to the general public. They are regulated by the Food and Drug Administration (FDA) and overseen by science and medical experts, who ensure the trials are safe and designed appropriately.

There are phases to a study, so each medication or treatment is not evaluated just once and then considered safe for use. Phase I is a study typically done on 20-80 healthy people, to establish how the medication, for example, metabolizes and the reactions of different dosages.

Phase II trials further define the safety of the therapies and are usually conducted on a larger amount of participants, 100-300 people.

Phase III is where a current patient will be introduced into the study. These are longer, more involved trials, with even larger populations of participants (1,000-3,000). Many of these are known as “double-blind” studies, and determine the actual benefit of the treatment to the patient and whether the benefits outweigh the risks.

Finally, if the treatment is successful in all previous mentioned phases, it is up for approval from the FDA. Phase IV trials test the effect of different dosages in patients and give a good look at long-term effects.

Consent
Federal guidelines state that each participant in a clinical trial must be given very in-depth information about the trial before agreeing to participate. Legally, this is known as “informed consent.” The study’s staff will tell a caregiver and loved one about the purpose and length of the study, benefits and risks, confidentiality and more.  It’s a long process, completing the informed consent, but trial administrators need to ensure each participant is doing so voluntarily, with complete awareness of what to expect.  Both caregiver and loved one should know that informed consent is NOT a contract and the person can withdraw from the study at any time.

Pros and Cons
Many people enjoy participation in clinical trials because they feel compelled to the greater good. They believe this trial could help them and also those who will be diagnosed with Parkinson’s in the future. They realize that the medications and treatments available to them currently are only because others volunteered for previous clinical trials.

In addition, there is a great benefit to being treated by leading health care professionals. A loved one will be surrounded by the cutting-edge new treatments, at no cost. They will gain knowledge and understanding about Parkinson’s in general and how their body responds to treatment.

Being a part of a clinical trial can change the schedule of a loved one and most likely, a caregiver too. Depending on the nature of the trial, a loved one with Parkinson’s may need extra help with transportation to and from multiple appointments.  A trial participant still works with their primary medical provider as well as the study team. It is a great opportunity to learn and receive care many others with the same disease will not have access to.

A Caregiver’s Role in a Clinical Trial

Communicating During the Study
When your loved one is a study participant, communication is essential. Make sure to talk often about their feelings throughout the study.  Be aware of what your loved one is thinking and feeling.  You should discuss feelings when they arise, while appreciating the need for personal privacy.  Remember to always respect your loved one’s ability to make their own decisions.

Recognize that negative emotions can arise for both you and your loved one. It is OK for either of you to feel sad or frustrated. Expressing these emotions is, in fact, healthy and normal.

Other ways to keep communication flowing smoothly:

Encourage your loved one to keep a journal. You can also discuss your loved one’s diary entries for the study or help your loved one to fill out the diary.

Set aside time each day or week to talk about the most recent study visit.
Learn basic relaxation techniques to keep tension and stress low.

Supporting Your Loved One
Those who participate in clinical trials must be sure to take the study medication as prescribed. If the instructions are not followed correctly, doses are missed, or study medications run out, then the research results could be negatively affected. It could even affect the health of your loved one.  It also undermines the very reasons your loved one volunteered for the trial.

Seek advice on how to organize your loved one’s medications.

Create a system to ensure study medication has been taken.

If using a weekly pill organizer, include the study medication for each day.
Make sure refills are received at each appointment.

Don’t let your loved one skip an appointment because they could run out of study medication.

Clinical trials are an essential part of medical advancements and these advancements only come when people step up to participate. Being a part of a clinical trial can take extra time and effort for both caregiver and loved one.
The key is to finding a trial that is attainable and encourages that sense of purpose a person, especially someone with a debilitating disease, hopes to have. Parkinson’s slowly may be taking away independence, but knowing that they can still make a difference for themselves and others may be just the positive reinforcement a loved one needs.

 

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