What is a clinical trial?
A clinical trial (also called a clinical study or clinical research) is conducted with the participation of human volunteers. Carefully conducted clinical trials are the fastest and safest way to find potential new treatments and possibly improve existing treatments for a variety of diseases and disorders. The ultimate goal is improve public health.
Clinical trials are conducted in phases, depending on their specific purpose.
In Phase I trials, researchers test an investigational medication or procedure in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range and identify side effects.
In Phase II trials, the investigational medication or procedure is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the investigational medication or procedure is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, researchers seek additional information including the benefits, risks and best use of the investigational medication or procedure.
Why should I consider participating in a clinical trial?
Participants in clinical trials can play a more active role in their own healthcare, gain access to potential new treatments before they are widely available, and help others by contributing to medical research.
What are the risks of participating in a clinical trial?
As with any medication, there are potential risks associated with clinical trials. For example, you may experience side effects (unwanted or unintended results) from the investigational medication. Additionally, the investigational medication may not be effective for you.
Who will ensure my safety during participation?
The ethical and legal codes that govern medical practice also apply to clinical studies. To ensure participants’ safety and well-being, clinical studies are heavily regulated by the government. In turn, the government empowers Institutional Review Boards (in North America) and Ethics Committees (in other countries) to monitor the study process and enforce regulations. Each trial follows a carefully controlled protocol, a study plan which details what researchers will do. As a trial progresses, researchers report the results at scientific meetings, to medical journals and to various government agencies. The names of study participants are closely guarded and are never revealed to these third parties.
A process called informed consent ensures you know the facts regarding the study, the investigational drug and your care in particular. The research team will detail the purpose and duration of the study, required procedures, key contacts and any known benefits and risks associated with the investigational medication. Translation assistance will be provided for those who do not speak English. If you decide to participate in the study, you will sign an informed consent document. This document is not a contract, and you may withdraw your participation at any time.
How do researchers determine who will be a good candidate for trial participation?
All clinical trials have guidelines about who can participate. Inclusion and exclusion criteria help to produce reliable results. The factors that allow someone to participate in a clinical trial are called inclusion criteria and those that restrict someone from participating are called exclusion criteria. These criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Before joining a clinical trial, a participant must qualify. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria help identify appropriate participants and ensure researchers can answer the questions they plan to study.
What happens during a clinical trial?
As a study participant you will work closely with the research team, which includes doctors and nurses as well as other healthcare professionals. They will assess your health at the beginning of the study, give specific instructions for participation, monitor you closely during the study, and stay in touch after the study is completed. Clinical trials require you to undergo more tests and doctor’s visits than you would normally have for health maintenance, an illness or condition.
May I leave the trial after it has begun?
Yes, you may leave the trial at any time. As a courtesy, let the research team know of your decision and your reasons for leaving.
How should I prepare to meet a research coordinator or doctor to discuss trial participation?
Plan ahead and write down possible questions. Ask a friend or relative to come for support and to help you remember responses to questions. You may also want to bring a tape recorder to reference later.
What questions should I ask the research team?
The following questions might be helpful for the participant to discuss with the healthcare team. Some of the answers to these questions are found in the informed consent document.
- What is the purpose of the study?
- Why do researchers believe the investigational medication may be effective?
- Has it been tested before?
- What kinds of tests are involved?
- How do the possible risks, side effects and benefits in the study compare with standard treatment?
- How might this trial affect my daily life? How long will the trial last?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow-up care is part of this study?
- How will I know that the experimental treatment is working?
- Will results of the trial be provided to me?
- Who will be in charge of my care?
May I continue to see my primary healthcare provider while I’m in the trial?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition but do not provide extended or complete primary healthcare. In addition, by having the healthcare provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
If interested, contact our clinical trial coordinator, Mikki Sells, LVN, at MSells@ntlsc.com or the office at (817) 731-0230, ext. 113.