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What is a clinical trial?

A clinical trial or clinical study are carefully designed and conducted interventional or observational studies in human volunteers to answer precise health questions.

  • Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments
  • Observational trials monitor the health of large groups of volunteers through their normal activities over a set timeframe without an investigational therapy being administered

Clinical trials is the backbone of medical innovation and is considered one of the fastest and safest ways to realize new treatments that improve health and save lives.

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

Benefits:

  • Receive cutting edge treatments not normally delivered as “standard of care”
  • May receive new treatments or care at no cost
  • Access new treatments to combat the most challenging of conditions
  • Access to new treatment pipelines not readily available to the public
  • Possess greater control over healthcare options and decisions
  • Help others and save lives by being an integral part of medical research and innovation

Risks:

  • The treatment may not be effective for the participant.
  • Potential side effect may occur that can be unpleasant, serious or even life-threatening
  • May be assigned to control group and/or receive placebo in blinded studies
  • Trials may demand more of a patient’s time and attention in comparison to conventional clinics or physicians. Examples of this include but are not limited to:
    • Multiple trips to the study site
    • Additional treatments
    • Hospital stays
    • Complex dosage requirements
    • Daily/Weekly/Monthly journal charting
    • Use of remoting monitoring devices (i.e. wearable)

What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?

  • Plan ahead and write down possible questions to ask.
  • Ask a friend or relative to come along for support and to hear the responses to the questions.
  • Record the discussion to replay later
  • Bring a list of medications, vitamins and supplements you currently take. You can also bring your medications with you, if easier.
  • Write down a list of all past major medical events, including hospitalizations and surgeries that includes dates and related conditions

Who oversees a clinical trial?

An Institutional Review Board or IRB is an administrative body that reviews all components of a human clinical trial in order to protect the rights and wellbeing of human research participants. An IRB is usually composed of doctors, scientists, advocates, researchers, and specialized community members. An IRB is also known as an ethical review board (ERB), research ethics board (REB) or independent ethics committee (IEC). All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that approves and regularly reviews the research effort.

In addition, each trial or study has a Principal Investigator or PI that oversees the conduct and safety of the trial at a specific clinical site. A PI is usually a leading physician specializing in the disease or condition being studied, and is supported by a staff of additional physicians, nurses, and scientists.

Can a participant continue to work with a primary health care provider while in a trial?

Yes, and is even encourage to do so! Most clinical trials provide short-term treatments related to a designated 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 ensure that other medications or treatments will not conflict with the protocol or cause adverse reactions to the patient.

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 the trial, the participant should let the research team know about it, and the reasons for leaving the study.

Who sponsors clinical trials?

A sponsor is a company, institution, organization, or person who oversees or pays for the administration, data collection, and analysis of a clinical trial. Examples of sponsors include but are not limited to:

  • individuals such as physicians
  • medical institutions
  • foundations
  • volunteer or community groups
  • private companies such as:
    • pharmaceutical
    • biotechnology
    • or medical device companies
  • federal agencies such as:
    • the National Institutes of Health (NIH)
    • Department of Defense (DOD)
    • the Department of Veteran’s Affairs (VA)

Where do trials take place?

Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.

Where do the ideas for trials come from?

Ideas for clinical trials usually come from researchers like scientists or physicians themselves. After researchers test new therapies or procedures in laboratory and/or animal studies, the treatments with the most promising early results advance into Phase I clinical trials. As trials advance, a greater picture is given into how well new treatments are working, the side effects, and what dosage work best or worst.

Will insurance cover clinical trials?

Clinical trial sponsorships cover trial costs if participants do not have insurance, and even the majority of the time that they do have insurance. In fact, most studies even pay a modest amount to the patients for their time and willingness to volunteer.