Frequently Asked Questions

What is a clinical trial?

A clinical trial is a research study in human volunteers that seeks to answer very specific health questions. A major component of clinical research is the process of testing and evaluating the safety and effectiveness of potential treatments. Carefully conducted clinical trials and drug studies are the fastest and safest way to find treatments that work and that may improve your health.

How are clinical trials conducted?


Clinical trials are conducted in phases. The clinical trials at each phase have a different purpose and help scientists answer different 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 possible 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 further evaluate its safety.
  • In Phase III trials, 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 continue to collect information that will allow the drug or treatment to be used safely.
  • In Phase IV trials, after the drug is licensed by the Food and Drug Administration and is on the market, studies provide additional information including the drug’s risks, benefits, and the best ways to use it in combination with other medications.
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What happens during a clinical trial?

The clinical trial experience depends on the type of trial being conducted. The clinical trial or research team includes doctors, nurses, and other health care professionals, and this team works closely with the participant’s primary care provider so that there is continuity of care and good exchange of important information throughout the trial. The research team checks the health of the participant at the beginning of the clinical trial, gives specific instructions for participation, monitors the participant carefully during the trial, and, if you wish, will stay in touch with you after the clinical trial is completed.

Who can participate in a clinical trial?


All clinical trials have guidelines about who can participate. The factors, or rules, that allow someone to participate in a clinical trial are called "inclusion criteria," and those factors that prevent others from participating are called "exclusion criteria". These criteria are based on such things as age, gender, the type and stage of the disease being studied, previous treatment history, and other medical conditions and laboratory test results. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable and unbiased results. It is important to note that inclusion and exclusion criteria are not used to "reject" people in the usual sense of the word. Rather, the criteria are technical necessities to identify participants who are similar enough to be compared to one another so that the study will not produce misleading or false results. Another reason for these criteria is to protect the safety of participants by excluding those with, for example, blood test abnormalities that might put an individual at undue risk. In summary, these criteria help ensure that researchers will be able to answer the questions reliably and at the same time protect the study participants.

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Why should I participate in a clinical trial?

  • You can play a more active role in your health care.
  • You may gain access to new treatments before they are widely available.
  • You can help others by contributing to medical research.
  • You will receive, at a minimum, the best available treatment.
  • The research team can be a great resource for your questions about HIV.
  • Some studies reimburse participants to defray costs for travel and time spent.

What should I consider before participating in a trial?

You should know as much as possible about the clinical trial before signing the informed consent document, and you should feel comfortable asking the members of the research team any questions you may have. You will be given time to think about your decision, and you will be able to take the document home to talk it over with the important people in your life.

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How is my safety protected?


Clinical research is federally regulated and has built-in safeguards to protect all participants. In addition, the ethical and legal codes that govern medical practice also apply to clinical trials. One of the ways that the safety of participants is protected is with the oversight of an Institutional Review Board (IRB). Every clinical trial in the U.S. must be approved and monitored by an IRB to make sure the risks are as low as possible and are balanced by any potential benefits. The IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. All institutions that conduct or support medical research must, by federal regulations, have an IRB that initially approves and periodically reviews all research projects involving humans. As a clinical trial progresses, researchers will report the results of the trial at scientific meetings, to medical journals, and to various governmental agencies. All patient information, including the identifying factors used on laboratory specimens, is transmitted by code numbers. Therefore, individual participants’ names will always remain secret and are never mentioned in any reports. Another way that the rights of study participants are protected is through a process known as "informed consent".

What is Informed Consent?

Informed consent is the process of learning the key facts about a clinical trial in order to make an intelligent and informed decision about whether or not to participate. It is also a continuing process throughout the study for the research team to provide updates and information to participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial will explain the details of the study in everyday language. If the participant’s native language is not English, translation assistance will be provided. The study coordinator will review an informed consent document and a research authorization form with you. These documents include all of the details about the study, such as its purpose, duration, required procedures, and key contacts. All known risks and potential benefits are explained in the informed consent document. After reading them through and talking to your family or members of your health care team, you can then decide whether or not to sign the documents. If you decide to sign these forms, this will be to give your permission to proceed with the screening evaluations. Only after you sign the informed consent and research authorization documents can blood be drawn or other tests performed to see if you are definitely eligible to participate. Informed consent is not a contract, and you may withdraw from the trial at any time without fear of a change in your healthcare or benefits.

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What are some of the questions I should ask?


The following questions might be helpful for you to discuss with the research team. Most 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?
  • Will I be paid for my time?
  • What type of long-term follow up care is part of this study?
  • How will I know that the treatment is working?
  • Will results of the trials be provided to me?
  • Who will be in charge of my care?


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How should I prepare for my appointment with the research coordinator or doctor?

Plan ahead and write down your questions. If you would like, ask a friend or relative to come along. If possible, bring a copy of your medical records with your medication history, a list of any drugs that you are allergic to or intolerant of, and your recent blood test results such as T-cells and viral load.

What happens at my first research appointment?


Your first appointment in the research clinic will be a learning experience for both you and the study team. At this first appointment, also known as a screening visit, the study coordinator will review the available studies with you in detail and will encourage you to ask questions. At the same time, the coordinator will try to get to know you and help you decide if you could possibly benefit from participation in any of the studies that you seem to qualify for. For the next step, the study coordinator will review the informed consent document and a research authorization form with you. The evaluations done during the screening visit are to determine whether you meet the full inclusion/exclusion (eligibility) criteria. In most cases, blood samples will be drawn for laboratory tests, and the study coordinator will conduct a physical examination. The screening visit will take about one hour. Some studies require you to return to the research clinic for a second screening (pre-entry) visit before actually entering the study.

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Do I continue to work with my primary health care provider while I am in a trial?


Yes, in fact, the study team works closely with the primary care provider that is required of all study volunteers. The reason for this requirement is that most clinical trials provide relatively short-term treatments related to a specific illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can be assured that other medications or treatments will not conflict with the study treatments, and can also be assured of a more comprehensive level of care than if limited to either one or the other component. For people who do not have a primary care provider, the ACTU can refer you to someone.

Can I leave a clinical trial after it has begun?


Yes. You can leave a clinical trial at any time without it affecting your health care or benefits. If you decide you want to withdraw from the trial after you have entered, you should let the research team know of your wishes, and talk to them about your reasons for wanting to leave the study.

How do I participate in a clinical trial?


To determine if there is a study that would be appropriate for you, speak to your health care provider or call the Beth Israel AIDS Clinical Trials Unit at 800-483-7339 from 9:00am to 5:00pm Monday through Friday. When you call, it would be helpful to have your recent blood test results such as T-cells and viral load available, and, if possible, a record of your medications. The study coordinator will answer your questions about general study requirements and help determine if there is a specific study for which you may be eligible. Your conversation will be entirely confidential. You do not need to give your name or telephone number unless you want to make an appointment.

What drugs are currently approved for the treatment of HIV?

View a list of currently-approved drugs.

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Call toll free: 800.483.7339

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Clinical trials update