If you are considering participating in a clinical trial for cancer, you probably have lots of questions. To help you answer them and understand what a clinical trial entails, every trial has a protocol – a detailed, written action plan, which specifies the objectives and design of the trial, and its eligibility criteria.
Be sure to get a copy of the protocol summary to help answer the following questions:
- What is the scientific rational for conducting the trial?
- What are the objectives of the trial?
- In what phase is the trial? How many participants will there be?
- What are the eligibility requirements?
- What is the intervention, and what is its duration and schedule?
- What are the possible risks, side effects and benefits?
- What medical tests and follow-up tests will participants undergo? How often?
- What are the endpoints (measurable outcomes that indicate an intervention’s effectiveness)?
- Who is sponsoring the trial?
- What is the contact information to inquire about the trial?