Things to Consider
Participating in a clinical trial is an important decision. Here is some information about what it's like to participate in a trial and the pros and cons of participating.
To participate in a trial, please call (415) 476-0661, or email [email protected].
Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
Many families find that the biggest benefit of participating in a clinical trial is the regular contact with the study team. These visits provide an opportunity to get state-of-the-art care and also to talk on an ongoing basis with experts who have lots of practical experience and a broad perspective on neurodegenerative diseases. The study team can provide advice on the emotional and physical aspects of the patient’s and caregivers' experience. They can suggest ways to cope with the present and give insights into what to expect in the future. They also can share information about support groups and other helpful resources.
What should people consider before participating in a clinical trial?
Expectations and motivations. Clinical trials generally don't have miraculous results. Many patients are under the impression that if a new drug works, they will know it immediately, but this is usually not the way medical treatments work. The test drug or treatment may relieve a symptom, change a clinical measurement, make the patient better only over a long time, or make it less likely that the patient will get sicker or die from the disease.
With a complex disease like Alzheimer’s, it is unlikely that one drug will entirely cure or prevent it. Some people choose not to participate or drop out of a study because this reality doesn't meet their expectations. Others participate because they realize that even if the benefit to them may be slight, they are making a valuable contribution to knowledge that will help future patients.
Uncertainty. Some families have a hard time with the uncertainties of participation - not knowing whether the person is on the test drug or the placebo, not being able to choose which study group to be in, not knowing for a long time whether the study was successful or not. Ongoing and open communication with study staff can help to counter this frustration.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. Some clinical trials want participants who are cognitively healthy or have only mild symptoms because they are testing a drug that might delay the decline in cognitive function. Other trials are interested in working with participants who have more advanced neurodegenerative diseases because they are testing a drug that might lessen behavioral symptoms, or they are testing new strategies to help caregivers. Even though a participant may not be eligible for one trial, another trial may be just right.
What are the risks of participating in a clinical trial?
There may be unpleasant, serious or even life-threatening side effects to experimental treatment. The experimental treatment may not be effective for the participant. Some interventional studies may require more of their time and attention than an observational study would, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers may report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.
Before a clinical research study can begin, the research plan must be approved by an Institutional Review Board. An Institutional Review Board, also called an IRB, is a committee of doctors, scientists, and people from the community where the clinical research is taking place. An IRB reviews the clinical research plan to make sure people in the research study will be treated fairly and that any risks will be explained to them.
The IRB at UCSF is composed of researchers from UCSF who are not involved in UCSF Memory and Aging Center clinical trials. IRB does not profit from review or oversight of clinical trials.
The telephone number for the UCSF IRB is (415) 476-1814. You can always call the IRB if you have questions, concerns, or complaints about one of the studies at the UCSF Memory and Aging Center.
Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should let the research team know about their reasons for leaving the study.
Does a participant continue to work with a primary health care provider while in a trial?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about the protocol, the care expected while in the trial, and the cost of the trial. The following questions might be helpful to discuss with the health care team. Some of the answers to these questions are also found in the informed consent document.
- Who will be in charge of my care? Will (s)he profit from my participation in the study?
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects, and benefits of the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this study?
- How will I know that the experimental treatment is working? Will results of the trials be provided to me?
For more information about the UCSF Memory and Aging Center Alzheimer’s Disease and Frontotemporal Dementia Clinical Trials Program,
Other resources include:
- NIH Clinical Trials website (www.clinicaltrials.gov)
- UCSF Human Subjects Protection Program Website (https://irb.ucsf.edu/)
- National Institute on Aging Alzheimer’s Disease website (www.nia.nih.gov/alzheimers).