WHAT SHOULD I THINK WHEN ASKED TO BE IN A CLINICAL TRIAL?

Robert L Page II, PharmD, MSPHProfessor

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