What is a clinical trial?
- A carefully designed, systematic study of the safety and/or effectiveness
of new, often innovative, healthcare options. A clinical trial is sometimes called a clinical research study. Clinical research studies often
try to determine whether new medicines, procedures, equipment or therapies are
safe or will help in treating, diagnosing, preventing or caring for people
with specific illnesses or conditions.
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Why are clinical trials important?
- To find new advances in medicine
- To find new ideas or approaches for treatment
- To identify safe and effectiveness of treatments
- To receive FDA approval for use of new drugs or
devices
- To find out which existing treatments might be better for certain
patients, which might be the most cost-effective, or which ones might be
easier to give
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Why might I want to participate in a clinical trial?
There are many reasons why people participate in clinical trials, but here are a few reasons:
- To help others
- To help advance science or knowledge about a particular disease or treatment
- To possibly improve their own health
- To benefit from having a research team involved in their care
- To receive treatment options that might not otherwise have been available to them or a physician outside the research facility
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How do I participate in a clinical trial?
Either search trials locally or nationally to find a trial (for instance for a specific disease of interest). You should find the appropriate contact info there.
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How are clinical trials conducted?
Study Protocol
- The entire plan of the research study
- Answers any questions you may have about the study
- Safeguards medical and mental health of patients
Types of Studies
- Testing one treatment in a group of patients
- Testing two or more very similar groups who each receive a different treatment option such as:
- Treatment of interest
- Standard treatment for the disease (active control)
- Inactive substance (placebo control)
- No treatment at all
- Randomized
Where the patient is assigned to either a treatment or a control group by chance
- Single-blinded
Where the patient(s) are unaware of the treatment they are given, but the researchers know what treatment each patient is being given
- Double-blinded
Where both the patient(s) and researchers are unaware of which treatment they are given
What else goes into conducting a clinical trial?
- Doctor can remove you at any point from the study if the study treatment is not helping the patient
- The patient can decide to withdraw at anytime
- If the treatment is harmful or ineffective, or if one
treatment is considerably better than the other the study will come to a halt
earlier than anticipated
- Results of a study are generally published in medical
journals or on clinicaltrials.gov
- Throughout the entire study the patient's personal doctor is kept up to
date about their progress in the study
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Why are clinical trials divided into phases?
The four phases for clinical trials were designed because each phase has a
special purpose in helping scientists answer different questions about the drug
or therapy being tested.
What are the four phases of a clinical trial?
Phase I
- New treatment given to a small group (20-100)
- Determine the safety of the drug therapy by:
- How much is given (dosage)
- What side effects occured, if any
- Volunteers in Phase I trials are generally healthy volunteers
Phase II
- Medium size group (100-300)
- Determine if the treatment has an effect on a
particular disease state
- Volunteers in a Phase II trial are typically those
who have the disease or disorder of interest
- If the treatment was determined to be effective in Phase II then it will
move into Phase III
Phase III
- Larger group (1000-10,000)
- Compare the treatment with a placebo or with standard
treatment(s) to determine which is more effective or if it is equivalent to
the existing treatment
- Phase III trials can last many years and involve
thousands of volunteers
- Once Phase III has been completed, the drug or device company will go to
the FDA to request approval to sell the drug or device in the U.S. as a
treatment for a particular disease
Phase IV
- In Phase IV, the treatment has already been approved
by the FDA and is ready for post-marketing
- What do they look for during post-marketing?
- To look at the treatment after it has been given to
the general population to assess any side effects and safety issues that may
not have been recognized in a Phase III trial
- Continue to monitor the effects of the drug in a
population of 3 million people in a Phase IV trial versus 3,000 people in a
Phase III trial
- Test to see if the drug may be useful to treat other diseases
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For more questions about clinical trials
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