Frequently Asked Questions for Clinical Trials
What is clinical research?
Clinical research is the study of health, disease, and medical care in people. It helps researchers better understand conditions such as Alzheimer’s disease and evaluate new ways to prevent, diagnose, monitor, or treat them.
Clinical research may involve medications, medical devices, blood tests, brain imaging, cognitive assessments, lifestyle interventions, or observational studies that follow participants over time. Clinical trials are one type of clinical research that evaluates a specific intervention or treatment.
Who sponsors clinical trials?
Clinical trials may be sponsored or funded by pharmaceutical and biotechnology companies, academic medical centers, hospitals, foundations, nonprofit organizations, physicians, or government agencies such as the National Institutes of Health.
Sponsors support the development and conduct of a study. The local research team is responsible for carrying out the study according to its approved protocol and protecting the safety and rights of participants.
Is clinical research right for me or my family member?
Clinical research may be an opportunity to take an active role in advancing the understanding and treatment of Alzheimer’s disease and other memory disorders. Some studies may offer access to investigational treatments or research-related evaluations that are not otherwise available outside a study.
However, participation does not guarantee that a participant will receive an active treatment or personally benefit from a study. Every study has different requirements, procedures, possible risks, and time commitments. Our team will review these carefully with patients and families so they can decide whether a study is appropriate and practical for them.
Who can participate in a clinical trial?
Each clinical trial has specific requirements for participation. These are called inclusion and exclusion criteria.
Inclusion criteria are characteristics that must be present for a person to participate, such as age range, diagnosis, memory-test score, medical history, or laboratory results. Exclusion criteria are factors that may prevent participation because they could affect safety, interfere with study results, or make it difficult to complete study procedures.
Some studies are designed for people with Alzheimer’s disease or another memory disorder. Others may enroll people with mild symptoms, individuals at risk for future disease, care partners, or healthy volunteers.
Not qualifying for one clinical trial does not mean that a person will not qualify for another study. Our research team can help identify current or future opportunities that may be a better fit.
What should I consider before participating?
Before deciding whether to participate, patients and families should understand the purpose of the study, what participation would involve, and whether the study is a practical fit for their lives.
Helpful questions include:
- What is the purpose of this study?
- What treatments, tests, or procedures are involved?
- How long will the study last?
- How often are visits required?
- What responsibilities will the participant and care partner have?
- What are the possible risks and potential benefits?
- Will the study involve placebo, an active treatment, or an open-label medication?
- Are there alternatives to participating in the study?
- Are there any costs or reimbursement for travel or time?
- Who should I contact if questions arise during the study?
Our team will review these issues carefully before enrollment and encourages patients and families to ask as many questions as they need.
Does a participant continue to work with a primary care provider while in a trial?
Yes. Clinical trials are designed to evaluate specific treatments, procedures, or research questions. They do not replace routine medical care, primary care, or ongoing care from a participant’s usual physicians.
Participants should continue to see their primary care provider and other treating clinicians as appropriate. With the participant’s permission, the research team can coordinate with outside physicians when needed to help ensure that medications and medical care remain compatible with the study protocol.
What are the possible benefits and risks of participating in a clinical trial?
Potential benefits vary by study. Participation may provide an opportunity to receive study-related evaluations, learn more about a memory disorder, or gain access to an investigational treatment or research procedure that is not otherwise available outside a study.
However, there may be no direct medical benefit to the participant. A study treatment may not work, a participant may receive placebo in a randomized study, or side effects and other risks may occur.
Clinical trials may also require time for visits, testing, medication administration, questionnaires, imaging, laboratory work, or follow-up calls. The specific risks, possible benefits, procedures, and time commitment are explained before a person decides whether to enroll.
What is a protocol?
A protocol is the detailed study plan that guides a clinical trial. It explains the purpose of the study, who may participate, the visit schedule, tests and procedures, medication dosing when applicable, safety monitoring, and how the study results will be evaluated.
The research team must follow the protocol when conducting the study.
What is informed consent?
Informed consent is the process of learning the important facts about a study before deciding whether to participate.
Before any study procedures begin, the doctor and research team will review the study in detail. This includes the purpose of the study, required visits and procedures, possible risks and benefits, alternatives to participation, privacy protections, and contact information for questions or concerns.
Participants and families are encouraged to take the consent form home, review it carefully, and ask questions before making a decision.
Signing an informed-consent form is not a contract. Participation is voluntary, and a participant may choose to withdraw from a study at any time.
What is a placebo?
A placebo is an inactive treatment designed to look like the study treatment but without the active medication or therapeutic component.
Some clinical trials compare a new treatment with placebo to determine whether the treatment is safe and effective. In these studies, participants may be randomly assigned to receive the investigational treatment or placebo. Other studies compare different doses, compare one active treatment with another, or are open-label studies in which all participants receive the study medication.
Some studies begin with a randomized, placebo-controlled period and are followed by an open-label extension. In an open-label extension, participants who complete the initial study may have the opportunity to receive the active study medication, regardless of whether they originally received active treatment or placebo.
The study team will explain whether placebo is used in a particular study and whether an open-label extension may be available before enrollment.
What is an Institutional Review Board?
An Institutional Review Board, or IRB, is an independent committee that reviews research studies to help protect the rights, safety, and welfare of participants.
IRBs include people with different backgrounds, which may include physicians, nurses, pharmacists, scientists, ethicists, and community members. Before a study begins, the IRB reviews the study plan, informed-consent materials, and participant protections. The IRB also continues to oversee the study while it is underway.
How will my private information be protected?
Research teams take steps to protect participant privacy and confidentiality. Study records are generally identified by a study number rather than by name when information is shared with the sponsor or other authorized research personnel.
The informed-consent process explains who may review study records, how information may be used, and the limits of confidentiality. Research findings are reported in summary form; participants are not identified in publications or presentations.
As with other medical information, there are limited circumstances in which information may need to be disclosed, such as when required by law or when necessary to protect a participant’s safety.
What happens if I decide not to participate?
Choosing not to participate in a clinical trial will not affect a person’s routine medical care. Patients and families may continue to pursue standard medical care and discuss other treatment or research options with their usual clinicians.
Participation is always voluntary. A person may also decide not to participate after learning more about a particular study, and may be eligible for another study in the future.
What happens if I am not eligible for a current study?
Not qualifying for one study does not mean that a person will not qualify for another clinical trial in the future.
Eligibility requirements differ from study to study. Our team may be able to identify another current study, place interested individuals on a list for future opportunities, or recommend that they return for re-evaluation if an appropriate study becomes available.
What if I need to stop participating in a study?
Participation in a clinical trial is always voluntary. A participant may decide to stop participating at any time, for any reason.
Patients and families are encouraged to let the research team know as soon as possible if they are considering stopping, so the team can discuss any safety considerations, next steps, and whether a final follow-up visit or assessment may be recommended.
Choosing to stop participation will not affect a person’s routine medical care or relationship with their usual physicians. The research team will review what stopping the study would involve and help ensure an appropriate transition of care.