Frequently Asked Questions (FAQs)

What is a Clinical Trial?

Clinical trials are medical research studies that involve volunteers to help scientists explore new ways to prevent, detect, or treat diseases and their symptoms. These investigational treatments may include new drugs, drug combinations, new drug delivery methods, or medical devices. Before a new medication is approved, it undergoes a series of tests starting in laboratories, then in animals, and ultimately in humans. A new drug or medical device must demonstrate safety, effectiveness, and, in many cases, offer a superior benefit compared to existing treatments. Clinical studies are conducted based on a research plan, known as a protocol, which is developed by a pharmaceutical company and reviewed by both the FDA and an Institutional Review Board (IRB) to protect public interest. These agencies monitor the progress of the trials. The protocol outlines the study’s purpose, participant numbers, eligibility criteria, test schedules, study duration, participant data to be collected, and more.

Clinical trials are led by a principal investigator, typically a medical doctor, along with a research team consisting of doctors, nurses, and other healthcare professionals. Participants in these trials are volunteers, and it is crucial to include diverse populations to better understand how the investigational product might affect different people.

Do I have to pay to participate in a clinical research trial?

If you are enrolled in a clinical research trial, all costs associated with the clinical research trial will be available at no cost to the participant.  You may be compensated for your time and participation in the clinical research trial.

What do the Different Phases of a Clinical Trial Mean?

Investigational products undergo various clinical trial phases to collect different types of information.

Phase 1 Studies

Phase 1 studies involve a small group (20-80) of participants, typically healthy volunteers or patients with advanced diseases. These studies often represent the first time a product is tested in humans. The primary goals are to evaluate safety, identify side effects, determine a safe dose range, and understand how the body absorbs and processes the investigational product. Phase 1 studies typically last several months, and about 70% proceed to Phase 2.

Phase 2 Studies

Phase 2 studies include more participants (100-300) with the disease being studied. Researchers further evaluate safety and assess whether the product produces the intended effects in humans. These studies often include randomized controlled trials, where some participants receive the investigational product, while others receive a standard treatment or placebo. To eliminate bias, the studies may be “blinded,” meaning neither the participants nor researchers know who is receiving the investigational product. Phase 2 trials can last up to two years, with about 33% progressing to Phase 3.

Phase 3 Studies

Phase 3 studies involve thousands of patients and aim to confirm the product’s effectiveness, monitor side effects, compare it to standard treatments, and collect data needed for FDA approval. These trials are usually randomized and blinded, lasting one to four years. Approximately 25-30% of Phase 3 studies are completed successfully and are submitted to the FDA for market approval.

Phase 4 Studies

Phase 4 studies, also known as Post-Marketing Surveillance Trials, occur after a product is approved and sold. These studies collect additional data about the product’s risks, benefits, and use in various populations over time. Findings from Phase 4 studies can influence whether a product is withdrawn from the market or if restrictions are placed on its use.

Why Should I Participate in a Clinical Trial?

Participating in a clinical trial gives you the opportunity to try new treatments that may be better than existing options. Your participation helps researchers understand how treatments work in diverse populations, as people of different ages, races, and genders may respond differently.

Some reasons to participate include:

  • Access to new treatments not yet available on the market.
  • Free medication.
  • Compensation for participation (in some trials).
  • Satisfaction from advancing medical research.
  • Participation is voluntary, and you can leave the study at any time. Clinical trials have specific eligibility criteria, so not everyone who applies will be accepted.

Types of Clinical Research Studies

Clinical research studies vary in focus, including:

  • Prevention Studies: Focus on preventing diseases in people who have never had the disease or preventing its recurrence.
  • Treatment Studies: Test new therapies, combinations of drugs, or new therapeutic approaches.
  • Diagnostic Studies: Aim to find better diagnostic tests or procedures.
  • Screening Studies: Evaluate the best methods for detecting specific diseases or conditions.
  • Quality of Life Studies: Explore ways to improve comfort and life quality for individuals with chronic conditions.

In many studies, new products or therapies are compared to existing treatments or a placebo to assess their effectiveness.

What is a Study Protocol?

A clinical research study is conducted according to a detailed plan known as the study protocol. This plan outlines:

  • The reason for conducting the study.
  • Eligibility criteria (who can and cannot participate).
  • The number of participants needed.
  • The schedule for tests, procedures, medications, and dosages.
  • The length of the study.
  • The information to be collected from participants.

What Happens During a Clinical Research Study?

The process of conducting a clinical research study generally includes the following steps:

Pre-Screening

Potential participants are identified through existing patient databases, advertisements, or health screenings. Interested individuals are contacted and briefly interviewed to determine eligibility.

Informed Consent

If you qualify, you’ll be scheduled to meet with the research team, where you’ll sign an informed consent form. This form explains the study, its risks and benefits, your rights, and whom to contact for questions. You will also have the chance to ask any questions about the study.

Screening Visit

During the screening visit, your medical history and general health will be assessed to ensure you meet the study’s inclusion/exclusion criteria. Tests, such as physical exams, blood work, and questionnaires, are often performed.

Study Visits (Treatment Visits)

If you meet the study’s criteria, you will return for regular study visits. During these visits, you may receive the investigational product or a comparator (which may be a placebo). The frequency and number of visits vary by study.

End of Study Visit

At the conclusion of the treatment phase, a final visit is conducted to repeat assessments and discuss follow-up treatment options.

Follow-up Safety Visit

Follow-up visits are conducted to ensure there are no lingering side effects from the investigational product or the study itself.

What is Informed Consent?

Informed consent ensures that you fully understand the study before agreeing to participate. The informed consent form must include:

  • The study’s purpose and duration.
  • What will happen during the study and any experimental aspects.
  • Potential risks and benefits.
  • Available alternatives to participation.
  • The right to withdraw from the study at any time.

You should feel comfortable asking questions, and you should be given time to review the consent form and discuss it with others before making a decision.

What Questions Should I Ask the Research Staff?

Before agreeing to participate, here are some questions to ask the research team:

  • What is the study trying to find out?
  • What tests will I need to undergo, and how long will they take?
  • How often will I need to visit the clinic?
  • Will I be hospitalized?
  • What costs will I incur, and will my insurance cover them?
  • What follow-up care will I receive after the study?

What Are the Risks?

Every clinical study carries risks, including side effects that may be temporary or long-term. Some side effects are unexpected because the treatments are new. Risks are detailed in the informed consent form and explained by the research team.

Who Can Participate in a Clinical Research Study?

Eligibility for a clinical study is determined by inclusion/exclusion criteria, which consider factors like age, disease stage, previous treatments, and other health conditions. A research subject is anyone who meets these criteria and agrees to participate.

Who Conducts Clinical Studies?

Clinical studies are led by a Principal Investigator (PI), often a medical doctor, supported by a research team that may include doctors, nurses, and other professionals. The PI ensures that the study is conducted ethically and in compliance with regulations.

Is My Information Kept Confidential?

Your personal health information is kept confidential. It will not be shared without your permission, except when required by law.

How Long Do the Appointments/Visits Last?

The length of study visits varies, but initial visits typically take longer to include assessments like medical history review, laboratory samples, and consent signing. Follow-up visits may be shorter depending on the study’s requirements.

How do I find out more information about clinical research trials?

Visit www.clinicaltrials.gov  to find out more information about clinical research trials.

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