Frequently Asked Questions - Digestive and Liver Health Specialists

Learn the basics about clinical trials

Learn the answers to the most frequently asked questions about the clinical trial process including what happens during the trial, the research conducted, participation, and more.

FAQs

Overview

What are clinical trials?

Clinical trials are crucial for researching and testing new treatments or vaccines to determine their effectiveness and safety. If you've ever taken medication or received a vaccine, you've already benefited from the results of clinical trials.

These trials are designed to address specific health questions, such as whether a new treatment provides any benefit, if it offers improvements over existing options, or if it poses any risks to individuals. Some of the treatments being investigated in these trials have not yet been approved by regulatory agencies, which is why they are referred to as "investigational" treatments. However, if clinical trials demonstrate that a new treatment is both effective and safe, it can be approved for widespread use among those who need it.

Your participation in clinical trials or your willingness to learn more about them can contribute to advancements in medical research and the development of better treatments for various health conditions. If you have any questions about clinical trials or are interested in participating, please reach out to our team for more information. Your involvement could make a difference in improving healthcare for everyone.

Why do we need clinical trials?

Clinical trials play a crucial role in evaluating the effectiveness and safety of new treatments or vaccines. If a clinical trial demonstrates that a new treatment is both effective and safe, it can then be approved for use by those who need it.

These trials have significantly contributed to important medical breakthroughs that aid researchers in identifying improved methods for diagnosing, preventing, and treating diseases. These advancements in medical science can ultimately lead to individuals living healthier and longer lives.

Clinical trials aim to answer various questions, including:

Is a new drug or medical device safe for use?
Does a new treatment offer better outcomes compared to existing treatments?
Can a treatment effectively help individuals battling cancer?
Does a treatment enhance patients' overall quality of life?
What is the optimal method for utilizing a particular treatment?

By participating in or learning more about clinical trials, you have the opportunity to contribute to ongoing medical research efforts and potentially benefit from the development of more effective healthcare interventions.

Who is eligible to participate?

Participating in a clinical trial involves meeting specific requirements known as inclusion criteria. These criteria may involve having a particular disease or medical condition, as well as considerations such as age, sex, body type, and current treatment plan.

Additionally, trials may have exclusion criteria, which are rules designed to safeguard individuals whose conditions could potentially worsen by participating in the trial. These criteria ensure the safety of participants and help researchers obtain the most accurate results.

Inclusion and exclusion criteria are carefully implemented to ensure the validity and safety of clinical trials.

It's important to note that not all clinical trials involve testing new treatments or vaccines. Some trials, known as "observational" studies, gather information about individuals' health during routine care. These studies contribute valuable insights into specific health issues and aid researchers in understanding various aspects of healthcare.

Should I participate?

Before deciding to participate in a clinical trial, it's crucial to ensure you're making an informed decision. This means taking the time to learn all you can about the trial to determine what's best for you.

Participating in a clinical trial can have a significant impact on your life, so it's perfectly acceptable to take your time with the decision-making process. The most important aspect of this process is weighing the potential risks and benefits associated with the trial. By carefully comparing these factors, you can determine whether participating in the trial aligns with your needs and preferences.

It's essential to recognize that the potential benefits and risks of each trial vary. Therefore, it's vital to gather as much information as necessary to feel confident about your decision. Remember, there's no right or wrong choice when it comes to deciding whether to participate in a clinical trial. Your decision should ultimately reflect what you believe is best for your health and well-being.

What Happens in Clinical Trials?

What treatment do participants get, and how is it given?

When you agree to participate in a clinical trial, you may receive either a trial treatment or a placebo, which resembles a treatment but lacks active ingredients. Alternatively, you may receive a treatment already approved for public use.

Participants do not have the option to select their treatment, as it is typically assigned randomly. Treatments may be administered in various forms, such as pills, injections, infusions, or other methods.

In some trials, you may only provide consent for researchers to collect health information through surveys or medical records. Additionally, certain clinical trials include participants who are considered "healthy" and do not have the condition being studied.

You may be required to visit the trial site for tests, treatments, and health check-ups by doctors.

Understanding these aspects of clinical trial participation can help you make informed decisions about your involvement in research studies. If you have any questions or concerns, don't hesitate to discuss them with the research team or your healthcare provider. Your well-being and comfort are important throughout the trial process.

What is a placebo, and what is the placebo effect?

In some clinical trials, participants may receive a placebo, which resembles a treatment but does not contain any active medication. Placebos are used by researchers to ensure that any changes in participants' health are genuinely caused by the trial treatment.

Participants do not have the option to choose whether they receive the trial treatment or the placebo, and they may not know which they are receiving until after the trial. It's important to note that not all trials use placebos.

Sometimes, participants who receive the placebo may experience a sudden improvement in their condition because they believe they received a real treatment. This phenomenon is known as the placebo effect. Researchers compare the results of participants who received the placebo with those who received the trial treatment to understand how the treatment works and its safety.

Typically, participants are unaware that they are receiving the placebo. Occasionally, even the doctors may not know, which ensures that each participant is treated consistently throughout the trial.

How long do trials take?

Clinical trials can vary in duration, lasting anywhere from weeks to months or even years. The frequency of visits and the overall length of participation differ for each trial. You may be required to visit the trial site for tests, treatments, and health check-ups by doctors.

Before a trial begins, there is extensive preparation, and trials undergo thorough review even after all participants have completed their involvement. It may take several years before a treatment is approved and available for public use.

Participants have the right to withdraw from a trial at any time and for any reason. Your comfort and well-being are paramount, and you should feel empowered to make decisions that are best for you throughout the trial process.

How am I protected? What are my rights?

All clinical trials adhere to federal laws and ethical guidelines to safeguard participants' well-being. Before a trial can proceed, it must receive approval from an institutional review board (IRB), an expert group tasked with ensuring the trial's fairness and safety. The IRB evaluates whether the potential benefits of the trial outweigh any risks to participants.

Each trial operates based on a protocol, which outlines the trial's overall plan and provides instructions for the doctors and staff involved. This protocol undergoes scrutiny and approval by the IRB to ensure compliance with ethical standards.

You have the right to take the time you need before deciding whether to participate in a trial. Understanding the trial and feeling comfortable with the planned procedures are essential before consenting to participate.

Participation in a trial is voluntary and does not infringe upon your rights. You have the autonomy to withdraw from the trial at any time and for any reason, and the trial staff will assist you in doing so safely. If you have any concerns about potential harm or any aspect of the trial, you can discuss them with the trial staff or the IRB at any time. Your safety and well-being are paramount throughout the trial process.

How do I know what will happen in a specific trial?

Understanding a clinical trial before deciding to participate is crucial. Researchers are required to ensure that you fully comprehend what will happen in the trial before providing any treatment.

Each clinical trial follows a process called informed consent, where the trial doctor and research team thoroughly explain the trial's details and discuss reasons why you may or may not wish to participate. They will outline the potential treatments, the expected duration of the trial, the procedures during visits, the potential risks and benefits, and other important information.

Before participating, you must read and agree to an Informed Consent Form, which you will receive and have the opportunity to review. As a potential participant, you are encouraged to ask as many questions as you need to fully understand the trial before signing the Informed Consent Form. Your understanding and comfort are paramount throughout this process.

Can I leave after a trial has begun?

Do participants still see their primary care doctor?

Is the treatment in a clinical trial the same as standard of care?

Clinical Trial Research

Who is needed to participate in clinical trials?

When you decide to participate in a clinical trial, you may receive a trial treatment, a placebo (which looks or tastes like the treatment but doesn't contain any active ingredients), or a treatment already approved for public use.

It's important to note that participants typically do not have a choice in which treatment they receive, and the assignment of treatments is usually determined randomly. The treatment may be administered in various forms such as pills, injections, infusions, or through other methods.

Some trials may only require permission to collect health information through surveys or medical records. Additionally, certain clinical trials may involve participants who are considered "healthy," meaning they do not have the condition being studied in the trial.

Throughout the trial, you may need to visit the trial site for tests, treatments, and regular health check-ups. These visits can also be arranged to take place at your home or conducted via telemedicine, depending on the trial's protocol and your preferences.

Why is diversity important?

Ensuring diversity among participants in clinical trials is crucial for understanding how treatments and vaccines work across different populations. If trials lack diverse participants, we cannot accurately assess whether these interventions are effective for everyone who needs them.

It's important to recognize that trials provide insights into how treatments function specifically within the group of participants involved in that trial. However, the effectiveness of treatments and vaccines may vary across individuals of different races, ethnicities, ages, or sexes.

By including a diverse range of participants in clinical trials, researchers can better understand how treatments and vaccines perform across various demographics. This comprehensive approach helps ensure that healthcare interventions are effective and beneficial for all individuals, regardless of their background or characteristics.

What kind of research is done?

Clinical trials come in various types, each serving a unique purpose:

Treatment Trials: These trials assess new treatments, combinations of treatments, or innovative procedural approaches.
Prevention Trials: Aimed at finding improved methods for preventing diseases in individuals who have never experienced the illness or preventing its recurrence.
Diagnostic Trials: Focus on discovering better tests or procedures for diagnosing specific diseases or conditions accurately.
Screening Trials: Evaluate the most effective approaches to detect certain diseases or health conditions early on.
Quality of Life Trials: Explore strategies to enhance comfort and improve the overall quality of life for individuals coping with chronic illnesses.

Understanding the different types of trials can help patients make informed decisions about participating in research studies that align with their health needs and goals. If you have questions about any specific type of trial or wish to learn more, don't hesitate to discuss with our research team and healthcare providers.

What are the phases of clinical trials?

Clinical trials progress through four distinct phases, each serving a specific purpose and providing answers to different questions:

Phase 1: In this initial phase, researchers test a new treatment on small groups of participants to assess its safety and determine safe dosage levels. They may also investigate how the treatment functions within the body.
Phase 2: During this phase, the trial treatment is administered to larger groups of individuals to evaluate its effectiveness and further examine its safety profile.
Phase 3: In the third phase, the trial treatment is tested on even larger groups of participants to confirm its effectiveness and gather additional data on safety. Researchers often compare the treatment to existing therapies or a placebo.
Phase 4: Once a treatment receives approval from a government agency for public use, Phase 4 trials commence. These trials aim to gather more information about the treatment's risks and benefits, as well as determine the optimal methods for its utilization.

Throughout all phases of clinical trials, researchers also monitor and document any medical issues or problems experienced by participants.

Phase 1 and 2 trials typically have shorter durations compared to Phase 3 and 4 trials. If researchers conclude at any phase that a treatment is ineffective, further clinical trials for that treatment may not proceed.

Understanding the distinct phases of clinical trials can empower patients to make informed decisions about their participation in research studies. If you have any questions or concerns about clinical trial phases or wish to learn more, please don't hesitate to discuss with your healthcare provider or research team. They can provide tailored guidance and support based on your individual needs.

Before I Participate…

How should I prepare for a meeting with the research coordinator or doctor?

It is extremely important to understand a trial before you agree to participate. Plan ahead by making a list of questions to ask the research team. Talk to family, friends, counselors, and other people you trust. Talking to people with different views and information can also help. You can ask a friend or family member to come along for support and to help you understand the trial.

See below for important questions to consider.

What are some questions I should ask before joining a clinical trial?

Every clinical trial is different. You should ask as many questions as you need until you fully understand what to expect in a trial. Here are some examples:

Questions to Ask Yourself

Do I want to participate? Why or why not?
Does participating fit with my values, beliefs, and preferences?
What would I like to get out of participating?
What amount of risk am I willing to take? Do the possible benefits outweigh the risks?
Do I have enough time to participate?
Would I need to arrange for child care or for the care of another family member if I participate?

Questions to Ask a Healthcare Professional

What are the possible risks and benefits of participating?
How would the risks and benefits of a trial treatment compare with my current treatment?
How might participating affect my daily life?
Would I have to pay for any part of a clinical trial? Will my insurance cover these costs?
What are the current treatment options for my condition?
Are there any clinical trials that would be a good option for treatment?
Can I get the materials in a language I want? Can I get a translator?
Will you be part of my care team if I participate in a clinical trial?

Questions to Ask Family, Friends, and Others You Trust

Can you attend doctor visits with me to help make sure I understand everything?
Can you take notes and help me organize the information I get during doctor visits?
Would you be able to watch my kids, pets, or house while I go to appointments?
Would you be able to give me a ride if I need it?
What do you think about me participating in a clinical trial?
What do you think about clinical trials in general?

Ask questions until you feel comfortable. Once you have asked all your questions and have all the information you need, you might want to make a list of pros and cons. This can help you make an informed decision about participating in clinical research.

What are some of the risks and benefits of being in a clinical trial?

Some potential risks if you participate are:

The treatment in the trial may not help you.
You may have side effects from the trial treatment.
You may have frequent testing or blood draws.
You may need to set aside time for participation.

Some potential benefits if you participate are:

You will help researchers learn more about how a treatment affects your community.
You may have early access to advanced treatments for your condition.
You may have access to treatment when no approved treatment exists.
Your health will be watched by the trial doctors and nurses.

Do I get paid?

Some trials pay for travel costs, time, and commitment. But not all do. Each trial will have its own guidelines that tell you if you will be paid and what costs will be covered. Check with your trial doctor and the research team to confirm.

Payments in trials are made for your time and possible inconvenience of participating in the trial. These payments are also called compensation or stipends. The amount is usually based on the trial length, number of visits, the types of procedures, and other factors.

Will my insurance cover any costs?

What if I want a language other than English?