CLINICAL STUDIES FAQS

Q: What is a clinical trial?
A clinical trial is a research study to answer specific questions about vaccines, new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the safest and most reliable way to find treatments that work in people.

Q: What is a protocol?
A protocol is a study design on which all clinical trials follow. The design is carefully followed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

Q: What are the different types of clinical trials?
-Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
-Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
-Screening trials test the best way to detect certain diseases or health conditions.

Q: What are the phases of clinical trials?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer questions:
In Phase I trials, researchers test a new drug or treatment 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 study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to evaluate its safety.
In Phase III trials, the study drug or treatment is given to large groups of people (1000-3000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and to collect information that will allow the drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

Q: Who can participate in a clinical trial?
Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria".

These criteria are based on such factors 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 for the study.

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 are used to identify appropriate participants and a group of people with similar characteristics and keep them safe.
The criteria help ensure that researchers will be able to answer the questions they plan to study.

Q: What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other health care professionals.

They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

Some clinical trials involve more tests and doctor's visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

Q: What is informed consent?
Consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants.

To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document.

The participant then decides whether or not to participate in the study and indicates his/her decision by signing or not. Informed consent is a contract; which is non-binding, and the participant may withdraw from the trial at any time.

Q: What should people consider before participating in a trial?
Participants or subjects should know as much as possible about the clinical trial. They should feel comfortable asking the members of the healthcare team questions about the study, the care provided while in a trial, and the cost of the trial.

The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the new treatment being tested may be effective?
- Has it been tested before?
- What kinds of tests and treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- What type of long -term follow up care is required?
- Who will pay for the treatment?
- Will I be reimbursed for other expenses?
- How will I know that the treatment is working?
- Will results of the trial be provided to me?
- Who will be in charge of my care?

Q: What are the benefits and risks of participating in a clinical trial?

Benefits:
Clinical trials that are well-designed and well-executed are the best treatment approach for eligible participants to:

Play an active role in their own health care.
Gain access to new research treatments before they are widely available.
Obtain expert medical care at leading health care facilities during the trial.
Help others by contributing to medical research.

Risks:
There are risks to clinical trials.
There may be unpleasant, serious or even life-threatening side effects to treatment.The treatment may not be effective for the participant.

The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

Q: Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from a trial, the participant should let the research team know about it, and the reasons for leaving the study.

*Source: U.S. National Library of Medicine