Clinical Trials Research (CTRC)
1. Center Structure:a. Center Description
The clinical trials research center objective is to evaluate in a multidisciplinary fashion evaluate the new forms of diagnosis or therapy of human diseases. Thus, at the core of the clinical research center is the Clinical Trials Initiative and the training of health providers in clinical research
b. Research Members
c. Active Trials
d. IRB web page
2. General information about clinical trials:
a. What is a clinical trial?
A clinical trial is a research study to answer specific questions about vaccines or 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 fastest and safest way to find treatments that work. Ideas for clinical trials usually come from researchers. Once researchers test new therapies or procedures in the laboratory and get promising results, they begin planning Phase I clinical trials. New therapies are tested on people only after laboratory and animal studies show promising results.
b. What is a clinical trial protocol?
All clinical trials are based on a set of rules called a protocol. 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 are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
c. What are clinical trial phases?
Clinical trials proceed through four phases:
Phase 1
In the phase I of clinical trials, researchers test a new drug, treatment or diagnostic method in a small group of people (20-80) to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2
In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to evaluate it is clinical effectiveness and to further evaluate its safety.
Phase 3
In Phase III studies, the study drug or treatment 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 drug or treatment to be used safely.
Phase 4
Phase IV studies are done after the drug or treatment has been marketed (post-marketing evaluation). These studies continue testing the study drug or treatment to collect information about their effect in various populations and any side effects associated with long-term use.
d. What protections are there for people who participate in clinical trials?
The government has strict guidelines and safeguards to protect people who choose to participate in clinical trials. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
e. What is informed consent?
Informed consent is the process of by which the volunteer clinical trial participant is informed about the key facts about a clinical trial before he/she decide whether or not to participate. Informed consent must be signed by parents or legal guardians in minors and individuals without the legal ability to sign for participation. These facts include:
i. Why the research is being done.
ii. What the researchers want to accomplish.
iii. What will be done during the trial and for how long.
iv. What risks are involved in the trial.
v. How participants are informed of complications and the final result of the study
vi. What benefits can be expected from the trial.
vii. What other alternatives are available.
viii. Your right to leave the trial at any time without any negative consequences or disruption of your regular care.
The research staff is required to give all volunteers a series of informed consent documents that include the details about the study. These forms are overseen and approved by an Institution review committee or IRB and should be given to you in the lenguaje that you understand the best or feel comfortable with. If English is not your native language, you can ask for the consent documents in languages other than English.
Since joining a clinical trial is an important decision, you should ask the research team any questions you may have about the study and the consent forms before you make a decision. It is also a good idea to take the consent documents home and discuss them with family members and friends. Talking about your options can help you to feel comfortable with your decision. If you decide to join the clinical trial, be sure to ask for a copy of the informed consent documents so you can review them at any time. Remember informed consent is more than signing a form. It is a process that continues through your participation on the study. You should feel free to ask the research team Informed consent questions before, during, and even after the study is completed.
f. Who can participate in a clinical trial?
All clinical trials have guidelines about who can get into the program. Guidelines are based on such factors as age, type of disease, medical history, and current medical condition. Before you join a clinical trial, you must qualify for the study. Some research studies seek volunteers with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers. Healthy volunteers participate in Phase I trials, vaccine studies, and trials on research on preventive care for children or adults. The factors that allow you to participate in a clinical trial are called inclusion criteria and the factors that keep you from participating are called exclusion criteria. 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 keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
g. Who sponsors clinical trials?
Clinical trials are sponsored by government agencies: such as the National Institutes of Health (NIH); pharmaceutical companies; individual physician- investigators; health care institutions such as health maintenance organizations (HMOs); and organizations that develop medical devices or equipment. Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.
h. What happens to me during a clinical trial?
The clinical trial process depends on the kind of trial you participate in. The team will include doctors and nurses as well as social workers and other health care professionals. They will check your health at the beginning of the trial, give you specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch with you after the study. Some clinical trials involve more tests and doctor visits than you would normally have for your illness or condition. For all types of trials, you will work with a research team. Your participation will be most successful if you follow the protocol carefully and stay in contact with the research staff. Some terms that will help you understand what happens in a trial are defined below.
i. What is a placebo?
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.
j. What is a control or control group?
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
k. What is a “ blinded” or masked study?
A blinded or masked study is one in which participants do not know whether they are in the experimental or control group in a research study. Those in the experimental group get the medications or treatments being tested, while those in the control group get a standard treatment or no treatment.
l. What is a “double-blind” or double-masked study?
A double-blind or double-masked study is one in which neither the participants nor the study staff know which participants are receiving the experimental treatment and which ones are getting either a standard treatment or a placebo. These studies are performed so neither the patients' nor the doctors' expectations about the experimental drug can influence the outcome.
m. What are side effects and adverse reactions?
Side effects are any undesired actions or effects of drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
n. What are the benefits associated with clinical trials?
There are both benefits and risks associated with clinical trials. By participating in a clinical trial, you can:
i. Take an active role in your own health care.
ii. Gain access to new treatments that are not available to the public.
iii. Obtain expert medical care at leading health care facilities during the trial.
iv. Help others by contributing to medical research.
o. What are the risks associated with clinical trials?
Clinical trials have risks:
i. There may be side effects or adverse reactions to medications or treatments.
ii. The treatment may not be effective for you.
iii. The protocol may require a lot of your time for trips to the study site, treatments, hospital stays, or complex dosage requirements.
p. What should I know before I join a clinical trial?
You should know as much as possible about the research study. It is important for you to feel very comfortable asking questions and the staff should answer them in a way you can understand. A list of sample questions appears below.
q. How should I prepare for meeting with the research coordinator or doctor?
i. Plan ahead and write down the questions you want to ask.
ii. Ask a friend or relative to come with you for support and to hear the responses to your questions.
iii. Bring a tape recorder so you can replay the discussion after you get home.
r. What questions should I ask?
Some questions you might ask about the research include:
About the study:
• What is the purpose of the study?
• Who is sponsoring the study?
• Who has reviewed and approved this study?
• Why does the research team think the treatment, drug, or medical device will work?
• Where is the study site?
• What kinds of therapies, procedures, and/or tests will I have during the trial?
• Will they hurt? If so, for how long?
• How much blood and how frequently do I have to give samples?
• How will the tests in the study compare to tests I regularly have outside the study?
• How long will the study last?
• How often will I have to go to the study site, whop will pay for transportation?
• Will I be able to take my regular medications during the trial?
• What medications, procedures, or treatments must I avoid while in the study?
• Will I have to be in the hospital during the study?
About my participation
• What are my responsibilities during the study?
• Will the study researchers work with my doctor while I am in the study?
• Who will provide my medical care during the study and after the study ends?
• Can anyone find out that I am participating in a study?
• Can I talk to other people in the study?
• Can I tell my doctor and others that I am participating in the study
• Will I be able to find out the final results of the clinical trial?
• Is my and my family confidentiality protected?
• How do the possible risks and benefits of the study compare with approved treatments for me?
• What are the possible immediate and long-term side effects?
Other questions include:
• What other treatment options do I have?
• Will I have to pay anything to participate in the study?
• If I incur harm as result of the study who will cover my medical and other expenses
• What are the charges likely to be?
• Is my insurance likely to cover those expenses?
s. Should I continue working with my primary health care provider if I participate in a trial?
Most clinical trials provide short-term treatments related to a designated illness or condition, but not extended or complete primary health care. In addition, by having your health care provider work with the research team, you can ensure that your other medications or treatments will not conflict with the clinical trial protocol.
t. Can I leave a clinical trial after it has begun?
Yes. You can leave a clinical trial at any time. If you plan to stop participating, let the research team know why you are leaving the study.
u. Will I be paid for participating in a clinical trial?
Some clinical trials will pay you for joining the trial, while others will not. In some programs, researchers will reimburse you for expenses associated with participating in the research. Such expenses may include transportation costs, child care, meals, and accommodations.
v. What is the institutional review board (IRB)
1. research members
2. Ongoing Clinical Trials
3. Useful Links
a. TTUHSC-El Paso IRB