Transcript What should I think when asked to be in a Clinical Trial?

WHAT SHOULD I THINK WHEN
ASKED TO BE IN A CLINICAL TRIAL?
Robert L Page II, PharmD, MSPH
Professor
University of Colorado Schools of
Pharmacy and Medicine
What Happens Before a Clinical
Trial Starts
• Pre-clinical or laboratory studies
• Completion of an Investigational New Drug
Application
 Pre-clinical studies
 Manufacturing information
 Clinical protocols and investigator information
Facts About Clinical Trials To Keep in Mind
•
Taking part in any trial is voluntary (you can leave a study at any
time).
•
You must give your consent to be a part of a study. Sign a consent
form.
•
Not all clinical trials study treatments.
•
Even those trials that study treatments, not all are study drugs.
When trials look at drugs not all of them are new drugs.
•
Some trials may use a placebo
What are the Phases of Clinical Trials
Broad Questions to Think About
• Why do I want to take part in a clinical trial?
• What are my goals and expectations? Are they realistic?
• Have I considered the chance of benefits and risks?
• Have I considered other possible factors, such as travel,
time, and money?
Questions to Ask the Investigator?
• Why is this study being done?
• How is sponsoring this study?
• What’s likely to happen if I decide to take part or
decide not to?
• How much experience do you have with this
treatment?
• What kind of treatments and tests would I need to
have in this study?
Questions to Ask the Investigator?
• Will this study require extra time or travel on my
part?
• Could this study treatment affect my daily life?
• What side effects might I expect? Are their other
short or long term risks?
• How will we know if this treatment is working?
• Will I have to be in the hospital? If so, who is going
to pay for it?
Questions to Ask the Investigator?
• Will I have costs? Will the treatment be for free?
Will my insurance cover any of this?
• If I am harmed as a result, what treatment will I be
entitled?
• How long is the study going to last?
• If this treatment works, can I stay on the therapy?
• Will my information remain confidential? How?
Activity: Consent Form
• Take a minute and look at the consent form
provided to you.
• Think about: What is included? Is it readable?
Do you understand the risks and benefits?
Does it answer your questions?
Questions