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What is a clinical trial?
- 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?
- 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
- 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?
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?
Can a participant leave a clinical trial after it has begun?
Who sponsors clinical trials?
- individuals such as physicians
- medical institutions
- volunteer or community groups
- private companies such as:
- 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)