Clinical Trials FAQ


A clinical trial is a strictly controlled research study. Each study is carefully designed to answer specific questions about a new treatment, drug or a medical device, to ascertain safety and efficacy.

Clinical trials develop new therapies and treatments. Many of the standard treatments accepted and used today are based on the success of prior clinical trials.

A protocol is a study plan that is carefully designed to protect the health of participants and address specific research questions. A protocol describes criteria of participation; the schedule of tests, procedures involved, medications and dosages; and the length of the study. While in a clinical trial, participants following a protocol are monitored regularly by the research staff to determine the safety and effectiveness of their treatment.

There are five different types of clinical trials in which you could participate.
  • Treatment trials test experimental treatments, new combinations of drugs or test new and innovative approaches
  • Prevention trials test new approaches to prevent disease or to prevent recurrence. These approaches may include medicines, vaccines, vitamins, minerals or lifestyle changes
  • Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition
  • Screening trials test the best way to detect certain diseases or health conditions in its most nascent stage of development
  • Quality of Life trials explore ways to enhance comfort and quality of life

  • Phase I trials test experimental drugs or treatments in a small group of people (20‒80) for the first time to evaluate its safety, determine a safe dosage range and identify side effects. These studies typically offer little or no benefit to the volunteer participants.
  • Phase II trials test an experimental study drug or treatment in a larger group of people (100‒300) to see if it is effective and to further evaluate safety and learn how it helps the condition under study.
  • Phase III trials test an experimental study drug or treatment in even larger groups of people (1,000‒3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the experimental drug or treatment to be used safely.

Each study is different in the length of time it takes to complete. A study may take a few hours, a few months or even years to finish.

  1. You and the researchers have the opportunity to learn more about your condition or disease
  2. You may receive a new and potentially promising treatment that is not available to the general population just yet
  3. You are provided monitored care at a leading research institution
  4. You are helping move the needle forward for better ways to prevent and treat ovarian cancer
  5. It may offer hope of another chance when current treatments fail or there are no available effective treatments going forward

  1. Your condition may not improve with the experimental treatment.
  2. You may experience more side effects
  3. You may be randomized to the placebo group or the standard of care group vs the control group in which the experimental treatment is being studied
  4. You may have more frequent tests, procedures, and visits vs the standard of care
  5. The commitment may involve more time and resources

Express your interest by reaching out to the study team and understand details carefully, including but not limited to:

  1. The purpose of the study
  2. A description of the study design, such as the use of placebos, controls and whether the study is conducted in a blind or double-blind manner
  3. Why the study is being conducted
  4. Information about the treatment being studied and how the treatment will be administered
  5. What is involved in your participation (tests, procedures, time and overall commitment)
  6. The known risks and benefits
  7. Contact information for the investigator
  8. Contact information for the Institutional Review Board
  9. A confirmation statement that your participation is voluntary and that you may stop or withdraw from the study without any consequences
  10. Time, resources and expectations involved

Here’s a list of 20 questions to ask and add yours to the list:

  1. What is the objective of the study?
  2. How long will the study last?
  3. Who has reviewed and approved the steps?
  4. How will participation in this clinical trial impact my daily life?
  5. If I change my mind how should I withdraw from the clinical trial?
  6. Will I be paid to be in the study?
  7. Will I be reimbursed for any expenses?
  8. Who will know I am taking part in this study?
  9. Who will see my medical record?
  10. Will I be told the results of the study?
  11. Who is my regular contact while enrolled in the trial?
  12. Has the study treatment been tested in humans?
  13. Who is the Principal Investigator of the study?
  14. Will I know what I´m getting? What if I don’t want to be in the placebo group?
  15. What are the possible adverse events I need to be aware of?
  16. Will my health insurance cover any of the costs?
  17. What happens if the clinical trial fails to meet its endpoint?
  18. Can I choose to stay on the treatment after the trial ends?
  19. What else do I need to know that I may have missed?
  20. What other options do I have?