Supporting Your Loved One in a Clinical Trial

Why do people participate in clinical trials?

Medicare Help Senior Patients and CaregiversAs a caregiver, you will play a critical role in your loved one’s participation in a clinical trial, starting with helping them find a trial suitable for their condition and needs. As a caregiver, you are the closest and most frequent observer of your loved one and will likely be the one to notice and report any side effects, physical or cognitive changes, make sure they get to any scheduled medical visits, and take their medication.

Clinical trials in Alzheimer’s and related dementias face a unique recruitment challenge. They must enroll two participants: a patient and a family caregiver. Patients with agitation in Alzheimer’s dementia often receive care from a team of friends and relatives. However, it’s typically the primary family caregiver who fulfills the role of study partner.

As a caregiver, your role is crucial in your loved one’s clinical trial participation. Understanding the pros and cons is essential. You should also know the steps you can expect during their participation.


Your loved one may take part in a clinical trial for many reasons. People with an illness or disease participate in clinical trials for various reasons. They may want to help others and contribute to scientific data. People also join clinical trials to potentially receive the newest treatments. They seek additional care and attention from the clinical trial staff. Clinical trials offer hope to many people. They provide a chance to help researchers find better treatments for others in the future.

Pros & Cons

PROS:

Access to medical professionals specializing in your loved one’s disease/condition.

Access to cutting edge research and medications not yet available to the public.

Your loved one’s participation increases your knowledge about their disease/condition.

CONS:

The treatment/drug may not work or your loved one may experience some side effects.

Depending on the phase of the trial, your loved one may be given a placebo instead of the actual drug.

Depending on the study, you and your loved one may be required to make a lot of visits, appointments, and possible hospital stays.

10 Steps to Expect

  • Identify possible Clinical Trials
  • Consult with your loved one’s doctor to see if he/she thinks participation in a trial is an option and if it could help them.
  • Determine if your loved one is eligible to participate in a particular trial.
  • Enroll in the trial.
  • Educate yourself on the drug or treatment protocol.
  • Learn what will be required.
  • Fill out and sign all the necessary paperwork.
  • Think about transportation to medical visits specific to the clinical trial—this may include facilities other than your loved one’s usual doctor, additional appointments, additional lab work, imaging, etc.
  • Comply with the treatment plan including:
  • Administering medication
  • Monitoring your loved one’s condition
  • Reporting to the organizers of the trial as required
  • Following the schedule of doctor or treatment visits—which vary by trial. Follow up visits could be weekly, monthly, or yearly and may change as the trial progresses.
  • Coordinate how to keep your loved one’s care team informed of any side effects, changes in your loved one’s condition or abilities, and concerns you have.

The Myths About Clinical Trials

Before a drug can be approved for use, it undergoes rigorous screening and preclinical testing. This process ensures its safety and effectiveness. Before a clinical trial can begin, researchers typically conduct years of testing. The entire process can take up to six years to complete.Additionally, every clinical trial includes a thorough informed consent process. This process ensures that you and your loved ones understand what participating involves. It also covers any side effects experienced by previous participants. Participants are also able to leave the trial at any time and for any reason.

Some clinical trials measure the effectiveness of a potential new drug or treatment against a placebo. A placebo is an inactive substance or treatment used as a control. However, placebos aren’t used in every trial. Some other trials test a potential new drug or treatment against the existing standard of care. The decision to use a placebo in a clinical trial depends on several factors. These include the seriousness of the illness and the availability of existing treatments. Ethical standards also play a crucial role in this decision-making process. For serious or life-threatening diseases, the best available treatment is used instead of a placebo.

Because clinical trials are done for research purposes, there is some level of risk. However, the drugs being studied are given to clinical trial participants only after the drugs have gone through a rigorous testing process and scientific evidence indicates that the drug is likely to be effective and safe for use in humans. The safety of the patients is a top priority for everyone involved in the trial. Before a clinical trial can even begin, it’s reviewed by an institutional review board (IRB)—a committee of doctors, scientists, and community members who have the responsibility to protect clinical trial participants. This review makes sure that both before and during the trial, steps are taken to protect the rights and safety of the trial participants. During the clinical trial, the safety of participants is closely monitored.

The amount of time required to participate in a clinical trial varies widely. For some, your loved one may only need to make a few visits every couple of months. Others may require weekly visits. Some trials require overnight visits. Before your loved one enrolls in a trial, the trial schedule will be explained and you will have an opportunity to ask questions or share any concerns that you have.

Costs related to participating in a clinical trial are rarely required to be paid by participants. The sponsor of the study covers research costs. Patient care costs that sponsors do not cover are often covered by the patient’s health insurance carrier. Before enrolling in a clinical trial, ask the research team about the costs your loved one would be expected to pay, and then check with your loved one’s health insurance carrier to see if they will cover it.

Participants in a clinical trial may have access to an investigational drug that is not yet available to people outside of the trial. Participants are closely monitored by clinical trial researchers—maybe even more closely than their regular doctor. Depending on the clinical trial treatment plan (or protocol), participants may receive additional tests and lab work that are outside of their usual care.

Regional hospitals and smaller research facilities also run clinical trials. In addition, some clinical trials—particularly those for rare diseases—offer compensation for any patients who need to travel in order to participate.

While participating in a clinical trial can be an option for patients who tried the other options without success, there are clinical trials for patients at all different stages of their diagnosis. Some trials that target newly-diagnosed patients. Others may recruit patients who exhibit specific symptoms or who were diagnosed many years ago.

Background Information