The Ask the Expert Column appears in the Palm Beach Post every Tuesday!
Question – My wife has just been diagnosed with Alzheimer’s disease. What should we know about clinical trials?
Answer: Scientific research into the causes, prevention and treatments for Alzheimer’s disease and related illnesses continues to increase in size and scope. Many research projects rely on the participation of human volunteers; these are called clinical trials.
Participation in a clinical trial requires careful consideration and a full understanding of the potential risks and potential benefits. Consultation with your primary healthcare professional is an important part of making an informed decision. Here are some issues to consider:
- Risks versus benefits—In order to make an informed decision about participating in a study, it is critical to fully understand all of the potential benefits to both volunteer and to society, as well as all of the potential risks to the volunteer. This is especially true for any drug trial.
- Intervention or observation—Certain research studies focus on new medications by assessing the effects of these medications on volunteers. Other trials do not evaluate any new medicines, but rather examine other issues, such as risk factors, disease prevalence, familial inheritance or diagnostic procedures.
- Changes to current treatment—Enrollment in some clinical trials may require changes to a volunteer’s established medical treatments or care plans.
- Administration of medication versus placebo—Many studies monitor the effects of investigational medications in comparison to a control group who randomly receives a placebo, an inactive substance that contains no medication and is used as a control in place of specific medication.
- Consent to participate (informed consent)—Individuals with moderate to advanced dementia may lack the mental capacity to make informed decisions, as well as the legal authority to give their consent to participate (informed consent) in a clinical study. In such cases, seek the advice of an attorney.
- Purpose of the study—Each research project tests some theory, and it is important to understand these goals and how the theory will be tested.
- Enrollment criteria—Volunteers for any study must fit a specific profile set by the research investigators. Criteria may include age, gender or disease state.
- Expectations—Determine the duration of the study, frequency of required participation, and types of tests or medical exams to be used.
- Costs—Check if there are any costs associated with participation, such as costs of medications or travel expenses.
- Procedures—Obtain information about what will happen during the study and how effects will be measured. For example, drug trials may require taking pills, routine testing, reporting on effects of the medication, and periodic blood samples.
To find the best clinical trials in our area, call us at 561-588-4545.