Frequently Asked Questions

 

What are clinical trials?

Clinical trials are research studies that are conducted in humans. They are usually medical- or health-related, and follow a detailed study plan, known as a protocol. In general, clinical trials investigate the use of a particular intervention (such as surgery, medication, or a behavior change), and then measure the impact of that intervention on a specific outcome or outcomes. Some trials simply observe research subjects without an intervention and then measure various outcomes at the end of the trial.

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Why are clinical trials performed?

Clinical trials are conducted for a variety of reasons. They can be used to test the safety and effectiveness of a new drug, or to compare existing drugs (or other treatments) to determine which is safer or more effective. In addition, clinical trials can also be used to determine different ways to use common treatments in ways that will make them more effective, easier to use, or decrease their side effects.

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Who performs clinical trials?

Researchers usually perform clinical trials once they have tested their therapies in a laboratory and in animal studies. Researchers can be affiliated with any number of different institutions, organizations, or agencies. Some researchers conduct research for government health agencies, whereas others are affiliated with a major hospital or university. In addition, some researchers may be independent (unaffiliated), or work for private companies, such as private research institutions or drug companies.

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Who regulates clinical trials?

Clinical trials are regulated on several levels. On the national level, the U.S. government has strict rules and regulations for clinical research, all of which are designed to protect the people who choose to participate in clinical trials. In addition, the U.S. Food and Drug Administration (FDA) monitors all serious side effects that are associated with a clinical trial as an additional safeguard.

On the local level, to ensure that potential risks to participants do not outweigh the potential benefits, every clinical trial in the U.S. must be reviewed, approved, and monitored by a local Institutional Review Board (IRB). An IRB is an independent committee comprised of doctors, statisticians, community advocates, and other individuals who ensure that a clinical trial is ethical to conduct and that the rights of trial participants are protected during the trial.

In addition to the federal government, the FDA, and individual IRBs, some clinical trials may also be monitored by the sponsors who fund them (such as a drug company), as well as other committees within the institution or agency conducting the research.

A list of the individual committees and agencies that will monitor a clinical trial, as well as those that will have access to the trial’s data, will be clearly listed in the informed consent document.

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What is ‘”informed consent?”

Informed consent refers to the process by with potential clinical trial participants are informed of the details of the clinical trial, including the possible risks and benefits, as well as their rights and responsibilities.

An “informed consent document” is given to each potential participant for them to review and discuss with their doctor, their friends and family, and the research team.

During this process, a member of the research team will also discuss the clinical trial with the individual and answer any questions they may have, so that they can make an informed decision regarding whether or not to participate in the clinical trial.

Each participant must read and sign prior to joining the clinical trial, and they will also receive a copy of the document for their records and reference.

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What questions should I ask before joining a trial?

In general, you should ask any question that you feel is important, and you should also feel able to ask questions at any time during the clinical trial. It is also important to ask any questions you may have about information contained in the informed consent document that is not clear to you.

Examples of ideas to help generate potential questions for your doctor or the research team include:

    • What is the purpose of the clinical trial?
    • Why do researchers think the treatment may be effective?
    • How long will I be in the clinical trial?

    • What will be required of me if I choose to participate in the clinical trial?
    • What kinds of therapies and tests are involved in the clinical trial?
    • Who has reviewed and approved the clinical trial?
    • What are the potential risks and benefits of participating in the clinical trial?
    • Are there any other options for treatment besides participation in the clinical trial?
    • What are the potential risks and benefits of those options?
    • Where will I receive my medical care?
    • Will participating in this clinical trial affect my daily life? If so, how?
    • Am I allowed to talk to other participants in the clinical trial?
    • How is the clinical trial funded?
    • How much will it cost me to participate in the clinical trial?
    • Will my insurance pay for any or all of the associated costs?

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Will my information be shared or sold?

Any information that you provide for the purposes of the clinical trial will not be sold or distributed in any way. Certain information will be shared with agencies and research institutions that are participating in the clinical trial; however, only the information that is related to, and necessary for, the clinical trial will be shared.

The informed consent document will clearly list information about the use, disclosure, and confidentiality of your personal information. In addition, you can also ask your doctor or the research team any questions you have related to the safety of your personal information.

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Are volunteers required to sign a confidentiality statement or are they prohibited from discussing the clinical trial?

No. Clinical trials participants can discuss the trial with anyone they wish. 

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What are the different types of clinical trials?

There are several different types of clinical trials, including:

    • Treatment trials:  Treatment trials are used to evaluate experimental treatments or drug combinations, as well as new surgical methods or approaches to radiation therapy.
    • Prevention trials:  Prevention trials investigate new and improved ways to prevent diseases in healthy individuals, as well as to prevent a disease from recurring. Prevention trials may use drugs, vaccinations, dietary supplements, or changes in behavior and lifestyle.
    • Diagnostic trials:  These trials are used to discover improved tests or procedures for the diagnosis of various illnesses and diseases.
    • Screening trials:  Screening trials evaluate the best method to detect the presence of certain diseases or conditions.
    • Quality of life trials:  Also referred to as supportive care trials, these trials investigate ways to improve the comfort and quality of life for patients who have a chronic or terminal illness.

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What are the different phases of clinical trials?

Treatment trials are always assigned one of the following phases:  Phase 0, Phase I, Phase II, Phase III, or Phase IV. 

    • Phase 0:  These clinical trials are used to determine if an investigational drug acts the same way in humans that it did in laboratory animal studies. During these trials, a very small dose of the investigational drug or agent is given to a small group of participants (usually 15 or fewer). The researchers then observe how the body processes the drug and how the drug works in the body.

    • Phase I:  Phase I clinical trials test a new treatment for the first time in human subjects. These trials help to determine the safest dose, route of administration (e.g., pill, injection, skin patch), how often the treatment should be given, and identify side effects. Phase I trials involve a small number of participants (usually between 20 and 80) who are divided into groups called cohorts. Each cohort receives a different dose of the drug or treatment and is monitored for side effects.  The purpose of Phase I trials are to determine highest dose that can be given with an acceptable number of side effects.

    • Phase II:  These clinical trials build on the information obtained from Phase I trials and continue to evaluate the safety and effectiveness of a new treatment in a larger group of participants (usually between 100 and 300).

    • Phase III:  Phase III clinical trials evaluate the effectiveness and safety of a new drug or treatment in very large groups of participants (usually 1,000 or more). In addition, Phase III trials may also be used to compare a new treatment to an existing standard treatment, or to investigate a new use for an existing standard treatment. In those cases, trials are usually randomized, which means participants are randomly assigned by a computer to receive the new treatment, the existing standard treatment, or sometimes a placebo. 

      A placebo is an inactive pill, capsule, liquid, or powder that is indistinguishable from the active treatment being investigated. Experimental treatments are frequently compared with placebos to determine the effectiveness of the experimental therapy. Often, those who receive the placebo are referred to as being in the control group. It is important to note, however, that during a trial which involves the use of placebo, participants will not know if they are receiving the active treatment or the placebo, and sometimes the researchers will not know as well until the trial has been completed.

At the end of phase III trials, the results are compared between groups of patients to determine which treatment (new or investigational) was the most effective. Phase III trials may include hundreds of patients and be conducted across multiple research sites across the country, or around the world.

      • Phase IV:  Phase IV clinical trials are often referred to as postmarketing studies, as they are conducted after a drug as received approval by the U.S. Food and Drug Administration (FDA) and is sold on the market. These trials study the side effects of the treatment or drug, and focus primarily on identifying those side effects that were not observed during Phase I – III studies.

In addition to the different phases of treatment trials, there is also a type of research study known as a pilot study, or feasibility study. These are smaller studies designed to help researchers test study logistics and gather information before starting a larger study. 

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Will I qualify for a clinical trial?

This depends on whether or not you meet certain criteria that are set forth in the protocol. These criteria are known as inclusion and exclusion criteria. Inclusion criteria are a list of factors and characteristics that allow someone to participate in a particular trial, whereas exclusion criteria list those factors and characteristics that disallow participation.

These criteria ensure the integrity of the research by identifying participants who are appropriate for the particular illness or intervention being studied. Inclusion and exclusion criteria do not disqualify individuals from a personal perspective, but rather for reasons such as age, disease type and state, prior treatments, or the presence of other medical conditions that might interfere with the individual’s ability to participate in the trial.

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How long do clinical trials last?

The length of a clinical trial depends on the type of trial being conducted. Some may last for only a few hours whereas others can take years to complete. The length of time required to complete a particular trial will always be detailed in the informed consent document.

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What are the benefits of participation?

There are a number of benefits to participating in a clinical trial. First, clinical trials enable people to be active decision-makers in their own healthcare. Second, clinical trial participation provides people access to new medications and other treatments before they are available to the public.

Additionally, clinical trials also provide people the opportunity to receive expert medical care at premiere healthcare facilities. Finally, although some clinical trials may provide no direct benefit to the participant, the information learned from the clinical trial will contribute to medical research and possibility help others in the future.

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Are clinical trials safe?

There are many Federal rules and regulations in place that are designed to protect individuals from unnecessary risks while participating in a clinical trial. In addition, clinical trials are also designed to control risks to trial participants; however, some risk may still exist due to the uncertainty that comes along with studying a new medical treatment.

Nevertheless, researchers are required to provide potential trial participants with accurate and detailed information about what they will experience during the clinical trial, as well as any potential risks to their safety.

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What are the possible side effects and other risks of participating in a trial?

The potential side effects will vary depending on the nature of the clinical trial. Some trials may involve a high risk of unpleasant, serious, or potentially life-threatening side effects related to the treatments, tests, or screening procedures.  In addition, sometimes an experimental treatment may not be effective for any or all participants.

Other potential risks are associated with participation in a clinical trial. For example, participants may be required to devote considerable amounts of time to the clinical trial (e.g., more treatments, additional hospital stays, or complicated medication dosing requirements).

Some clinical trials may expose participants to increased levels of radiation above what they would normally experience. Regardless of the number and type of risks involved with a particular trial, all risks associated with the clinical trial will be described in detail in the informed consent document.

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What happens after the trial?

After a clinical trial is completed, the researchers analyze the data they gathered during the trial and then carefully consider the meaning of their findings. After completion of a phase I or phase II trial, the researchers will decide if they should continue testing the treatment in a phase III trial.

If data from the completed trial showed that the drug was unsafe or ineffective, the researchers would likely stop further research, so as not to expose other research participants to unnecessary side effects and risks.  After completion of a phase III trial, the researchers will review their data and determine if the results are medically important.

If they are determined to be medically important, the research is usually published in a peer-reviewed scientific journal. During peer-review, experts review the researchers’ report before it is published to be certain that the data analysis and conclusions are accurate. In some instances, clinical trial findings may be reported on by the news media or discussed at scientific meetings.

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How does clinical trial participation work with my health insurance?

This will vary depending on the particular clinical trial and your health insurance provider. In general terms, most health insurance plans cover the costs associated with routine care associated with a particular diagnosis, such as doctor visits, laboratory testing, and x-rays.

During a clinical trial, the costs associated with tests, procedures, treatments, medications, additional doctor visits, and other research-related needs will usually be covered by the sponsor of the clinical trial. However, some health insurance companies may classify the care of a clinical trial subject as experimental or investigational.

In such instances, health insurance will often not cover routine care costs (such as doctor visits, tests, and treatments) that the individual would have required even if they had not participated in the clinical trial.

Currently, many states have laws that require health insurance companies to cover routine care for clinical trial participants; however, more than a dozen states do not.

Fortunately, beginning in 2014, all health insurance companies will be required to pay for routine costs of care for patients who are participating in clinical trials. This requirement is part of the Patient Protection and Affordable Care Act approved by Congress in 2010.

Regardless, be sure and ask your doctor or the research team if you have any questions regarding your health insurance and coverage for clinical trials participation.

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What if I don’t have health insurance, does that exclude me from joining a clinical trial?

No, it does not; however, if there are any costs that are not covered by the research sponsor, it will be your responsibility to pay for them. This can be a barrier to clinical trial participation for uninsured individuals.

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Will I be paid for participating in the clinical trial?

Some clinical trials reimburse participants while others do not.  Reimbursement is frequently determined by the amount of money available to fund the clinical trial, the amount of money/loans given by institutions like the The Southern Institute, as well as the type of research that is being conducted.

For example, payment to participants is common in early stage research that tests the safety and efficacy of a new drug or medical device. Additionally, reimbursement is often used as an incentive to recruit participants to clinical trials that have unknown or nonexistent health benefits to the participants.  

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How can I find out if it is a paid clinical trial?

Reimbursement information will always be discussed with potential clinical trial participants during the informed consent process. In addition, some advertisements for clinical trials may also indicate that the trial offers reimbursement for participation.

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How do I get paid? Will it be before, during, or after the trial?

The amount, method, and schedule of payments will be discussed during the informed consent process, and will be stated clearly in the informed consent document. In addition, any costs that the participant may incur as a result of their participation in the clinical trial will also be discussed and stated in the informed consent document.

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If I leave the trial before it ends, do I still get paid?

This depends on the clinical trial. For example, a trial that lasts for only a day or two may reimburse participants in a single payment at the end, even patients who withdrew prior to that time.

Longer trials are often designed to pay participants in increments as the trial progresses. Participants who withdraw may only be reimbursed for particular trial-related milestones that they complete as they complete them. Or, participants who withdraw early may receive payment for uncompleted milestones, but not until the time at which they would have completed them.

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