The Information Collected During a Clinical Trial
The Information Collected During a Clinical Trial

What information will the researchers collect before I can go on a clinical trial?

  • Your age, overall health, any other illness (diabetes, heart disease), medications you take
  • Your insurance, general finances, transportation, family
  • Current symptoms related to your cancer
  • Any treatment you may have had for your cancer before
  • Childbearing status and protection (use of condoms, birth control pills) if of childbearing age
  • Studies on your blood such as:
    • Red and white blood cell levels, number of platelets
    • Tests to see how your liver and kidneys are working

  • Review of tumor pathology to verify type and size of the tumor, as well as other information about the how the tumor may grow or spread
  • X-rays and other scans (PET, MRI, CT) to show if there is any spread of the tumor to another place
  • If the tumor has spread, where and how much it has spread
  • May look at your current quality of life by asking you questions
  • Your ability to follow the requirements of the study
    • To travel to the treatment site
    • To report symptoms

  • Your current knowledge about your cancer and treatment
  • The type of information you will need to take part in the study such as
    • Keep a study diary
    • Eat special foods
    • Record important information to tell your provider

What type of information will the researchers be collecting during a clinical trial?

  • Side effects
    • Upset stomach (mild, moderate, severe?)
    • Occasional vomiting or vomiting every hour
  • Blood counts, such as
    • how many white cells
  • white blood cells help you fight infection
    • how many red cells
  • red blood cells carry oxygen for your body to work
    • how is your liver working
  • Appearance (cosmetic outcome, like a lot of scarring on the breasts)
  • How easy or difficult it is for
    • You to do what is required for the treatment.
    • Your provider and the clinic to do what is required in the study.
  • Your overall quality of life while you are going through treatment.
  • Whether there were any delays in you getting your treatment
    • Maybe you had a low white blood cell count and they decided to wait a week to treat you so that your white blood cell count would be higher
    • Maybe you had low white blood cell counts and the dose of your drug had to be reduced
  • Are you getting the dosages of medicine you are supposed to receive according to the study?
  • Whether you have any other or unexpected problems
  • How your cancer is responding to the treatment
  • You responses to any special things you need to do while on the treatment such as eating a special diet.
  • Any changes in other diseases, finances, ability to take part.

What information will the researchers collect after I have finished the clinical trial?

  • Your overall quality of life after you have finished your treatment.
  • Delayed side effects (not being able to get pregnant)
  • Whether or not you have a recurrence of your cancer or your cancer has spread
  • Have you had appropriate follow-up (to schedule and keep your appointments)
  • What new medical conditions have you been diagnosed with since your treatment was completed?
  • Appearance (cosmetic outcome, like a lot of scarring on the breasts)

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