You asked, we answered.
FREQUENTLY ASKED QUESTIONS ABOUT CLINICAL TRIALS
Clinical Trials FAQ’s
Choosing whether to participate in clinical research is a personal decision, and we believe it should always be an informed, comfortable, and pressure-free decision.
At Altoona Clinical Research Center (ACRC), our research team is here to help you understand each opportunity before you decide whether participation is right for you. We will explain the purpose of the study, what will be expected of you, how much time it may require, potential risks and benefits, possible compensation, and your rights as a research participant.
Completing an online questionnaire or speaking with our research team does not enroll you in a study or obligate you to participate. It simply helps us determine whether a current research opportunity may be a potential fit for you.
ABOUT CLINICAL RESEARCH
-
A clinical trial is a research study involving volunteers that helps researchers learn more about health conditions, medications, treatments, medical devices, or other approaches to healthcare.
Clinical trials are an important step in determining whether potential treatments are safe and effective, and they can also help researchers better understand existing treatments and medical conditions.
Every treatment available today was made possible, in part, through research and the people who volunteered to participate.
-
Clinical research helps answer important medical questions.
Researchers may be studying:
A potential new medication or treatment;
A new use for an existing medication;
Different doses or combinations of treatments;
Ways to prevent or diagnose disease;
Medical devices or procedures; or
Better ways to manage a health condition.
The information collected from volunteers can help researchers understand whether a potential treatment should continue to be studied and may ultimately contribute to future advances in medicine.
-
Everyone has a different reason.
Some people are interested in learning about potential research options for their condition. Others appreciate the additional study-related monitoring that may be part of a trial.
Many participants also volunteer because they want to contribute to research that could help people living with the same condition in the future. However, an investigational treatment may or may not provide a medical benefit to an individual participant.
-
An investigational medication, device, or treatment is being formally studied.
It may be a product that has not yet been approved by the U.S. Food and Drug Administration (FDA), or it may already be approved but is being studied for a different condition, population, dose, combination, or use.
Because the treatment is being researched, some of its effects—including potential benefits and risks—may not yet be fully understood.
-
Drug trials are commonly described as Phase I, Phase II, Phase III, or Phase IV.
Phase I research generally focuses on safety, dosage, and the body's response to a treatment.
Phase II studies continue evaluating safety while looking more closely at whether the treatment appears to have the intended effect.
Phase III studies usually involve larger groups of participants and gather additional information about safety and effectiveness, often comparing the investigational treatment with another treatment or placebo.
Phase IV studies occur after a treatment has been approved and may gather additional information about its longer-term or real-world use.
Not every research study follows these phases, and the ACRC research team will explain the phase and purpose of any study you are considering.
GETTING STARTED
-
Your questionnaire is an initial pre-screening tool.
Our research coordinator will review your responses and contact you to ask additional questions about your medical history, diagnosis, medications, previous treatments, or other factors related to the study. We encourage you to schedule a time on our self-scheduling calendar with our coordinator to guarantee a full pre-screen opportunity.
If the study appears to be a potential match, we may invite you to take the next step in the screening process.
Completing the questionnaire does not mean you qualify for the study or enroll you in it.
-
Every clinical trial has very specific eligibility criteria describing who can and cannot participate.
Criteria may involve:
Age;
Diagnosis;
How long you have had a condition;
Current or previous medications;
Previous treatments;
Other medical conditions;
Laboratory results;
Medical history; or
Other study-specific requirements.
These criteria are not a judgment about you or your health. They are part of the study design and help protect participants while allowing researchers to accurately answer the scientific questions being studied.
If you do not qualify for one study, you may still qualify for another research opportunity.
-
The exact process varies by study.
Before you agree to participate, the research team will discuss the study with you and provide an Informed Consent Form.
You will have an opportunity to read the information, discuss it with the research team, and ask questions.
If you choose to provide informed consent, screening may then include things such as:
Reviewing your medical history;
Reviewing medications;
Physical examinations;
Blood or urine tests;
Vital signs;
Questionnaires;
ECGs or other diagnostic testing; or
Other study-specific procedures.
The research team will explain what is required for your particular study before you make a decision.
SAFETY
-
Participant safety is a central part of clinical research, but no clinical trial can be described as completelyrisk-free.
Investigational treatments can have known and unknown side effects, and researchers may not yet know everything about how a treatment will affect every participant.
Clinical trials use multiple safeguards designed to protect participants.
Depending on the study, these may include:
Review by an Institutional Review Board (IRB);
A detailed study protocol;
Informed consent requirements;
Regular medical monitoring;
Reporting and review of side effects and adverse events;
Oversight by the study sponsor;
FDA oversight when applicable; and
Additional independent safety monitoring for certain studies.
Before deciding whether to participate, the research team will discuss the known and reasonably foreseeable risks of the particular study with you.
-
Tell your research team about any changes in your health, including symptoms that may seem unrelated to the study.
Before you begin participating, you will receive instructions explaining how to contact the research team if you experience a problem or have questions.
Research staff will evaluate the situation and explain what should happen next.
If you experience a medical emergency, call 911 or seek emergency medical attention immediately. Notify the research team as soon as reasonably possible afterward.
The informed consent form will explain any study-specific provisions regarding treatment or compensation for research-related incidents.
-
Yes. Researchers, study sponsors, Institutional Review Boards, regulators, or independent safety-monitoringgroups may recommend changing, pausing, or stopping a study if safety concerns arise or for other reasons specified by the study.
Your study doctor may also determine that continuing participation is not appropriate for you individually.
-
An Institutional Review Board, often called an IRB, is an independent group responsible for reviewingresearch involving human participants.
The IRB reviews important aspects of a study, including the study plan and informed consent materials,with a focus on protecting participants' rights and welfare.
IRBs can require changes to research before approving it and continue to have an oversight role during thestudy.
STUDY TREATMENT, PLACEBO & RANDOMIZATION
-
Not necessarily. The design of every study is different.
Some studies provide the investigational treatment to everyone. Other studies compare it with:
A placebo;
An existing approved treatment;
Another dose of the investigational treatment; or
Another study group.
The research team will explain the possible treatment groups before you agree to participate.
-
A placebo is an inactive treatment designed to look or be administered like the treatment being studied but without the active investigational ingredient.
Placebos are used in some—not all—clinical trials to help researchers determine whether observed effects are actually caused by the investigational treatment.
If a study uses a placebo, that possibility will be explained to you during the informed consent process.
-
Randomization means assignment to a study group happens by chance rather than being selected by you or the research team.
Researchers use randomization to make comparisons between study groups more scientifically reliable.
Depending on the study, neither you nor some members of the research team may know which treatment group you are in. This is known as blinding or masking
You will be told if randomization or blinding is part of the study before you participate.
-
It depends on the study. Some studies provide treatment-assignment information after the study has been completed or unblinded. Other protocols may not provide individual treatment assignments to participants.
The informed consent form and research team can explain what is expected for the specific study.
COSTS, INSURANCE & COMPENSATION
-
Study-related medications, procedures, tests, and visits are often paid for by the study sponsor, but the exact arrangement varies by study.
Some routine medical care may remain your responsibility or may be billed to your health insurance.
Before you agree to participate, the informed consent process will explain:
Which study-related services are provided at no cost;
Whether any costs could be your responsibility;
Whether insurance may be billed; and any reimbursement or compensation that may be available.
Ask us before enrolling if you have any questions about costs.
-
Requirements vary by study.
Some studies may not require health insurance because study-specific procedures are paid for by the sponsor. In other situations, routine medical care that is unrelated to the research may remain the responsibility of you or your insurance.
Our research team can explain the requirements for the particular study you are considering.
-
Many clinical studies offer compensation, but compensation varies by study.
Compensation may recognize the time, travel, number of visits, procedures, or inconvenience associated with participation.
The amount, payment schedule, and requirements will be clearly explained before you decide whether to participate.
Compensation is not payment for receiving a medical benefit and does not guarantee that you will qualify for or complete the study.
Some studies may provide reimbursement or additional assistance for expenses such as mileage, transportation, parking, lodging, or other study-related travel.
Availability varies by study. Ask the research team about travel assistance when discussing a particular opportunity.
-
It depends on the study. Some studies provide treatment-assignment information after the study has been completed or unblinded. Other protocols may not provide individual treatment assignments to participants.
The informed consent form and research team can explain what is expected for the specific study.
Still have questions?
Asking Questions Is Part of the Process.
You should never feel rushed or pressured to join a clinical research study.
Our team wants you to understand the opportunity, ask questions, discuss participation with the people you trust, and decide whether it is right for you.
Completing a questionnaire simply starts the conversation.
There is no obligation to participate.
Ready to Learn More?