Clinical Trials

FAQs

Listed below are several common questions asked by patients and their family members.  Click the question and the answer will appear.  Or you can click "Expand All" and all of the answers will appear at once.  If you have other questions, write them down for your next appointment or, if they're more urgent, please contact your physician's office and we'll be happy to assist you.

What are the benefits of being in a clinical trial?

  • You receive quality care from Shenandoah Oncology physicans and research staff, and your overall health is closely monitored.
  • You have access to promising new therapies that are not yet available to patients outside of the clinical trial and that may be more effective than standard treatments.
  • You may help future cancer patients by bringing new therapies to market and by contributing to the greater knowledge of cancer.

What are the risks of being in a clinical trial?

  • Side effects of the new therapy may be different or  worse than those of the standard therapy.
  • The new therapy may not be more effective than the standard therapy.
  • You may be required to make more visits to our office than you would if you were not on the clinical trial.

What is the informed consent process?

The informed consent process is intended to protect the patient.  This document lists all of the information that will help you decide whether a clinical trial is right for you.  It also lists any known side effects of the drugs being tested and explains that a patient may withdraw from the clinical trial at any time.  The informed consent form will include such information as the reason for the clinical trial (what doctors hope to learn), who is eligible to take part in the clinical trial, what is known about the treatment being studied, possible risks and benefits, and a statement about privacy protection.

What is a protocol?

A protocol is the map used by your research team to conduct a clinical trial.  The protocol explains the treatment plan, describes the medical tests patients will receive, includes how many patients will take part in the clinical trial, describes rigid guidelines for patients involved with the clinical trial and explains safety information.

How will my cancer be evaluated if I am on a clinical trial?

Patients are closely monitored during a clinical trial.  Methods of evaluation vary from study to study, but patient safety is always the primary goal.  Decisions about patient care during a clinical trial are made according to evidence-based guidelines provided in the protocol standards of care practiced by the treating physician.

What is a Phase I clinical trial?

Phase I trials are used to assess an experimental drug in humans for the first time.  Generally, Phase I trials typically include a small group (20-100 people) that is monitored closely.  The purposes of a Phase I trial are to determine the safety of the drug, to establish safe dose levels, to see how the drug interacts in the body on a molecular level, and to evaluate any side effects of the drug.  Once the minimum and maximum dose is established and the drug is considered safe, the trial moves to Phase II.

What is a Phase II clinical trial?

In a Phase II trial, only people with the specific disease are able to enroll, and it typically includes a study population of 100-400 people.  The main objectives are to determine the effectiveness of the drug and to continue safety evaluations.  After Phase II, the therapy moves to an even larger patient population in a Phase III trial.

What is a Phase III clinical trial?

The purpose of a Phase III clinical trial is to determine the long-term efficacy of the drug and to compare it to standard-of-care therapy.  If the experimental drug provides a better outcome than a standard-of-care therapy, the sponsor applies for approval by the FDA.  Once the FDA has approved the drug for its specific indication, the drug can be prescribed for its intended use.

How long are clinical trials?

Clinical trials involve a long, careful process that may take a few months to many years.

Would there be any follow-up after the clinical trial?

Yes, you would continue to see your doctor for treatment and follow-up care.  Each clinical trial is different, so please ask your research team what the requirements are for the specific trial for which you are interested.

Who pays for the clinical trial?

Every clinical research trial is different.  The sponsor of a clinical trial may pay for the treatment, extra tests and extra doctor visits, as part of the trial.  The clinical trial sponsor may be:

US Oncology

The National Cancer Institute

A drug company

A non-profit organization

Will my health insurance pay for it?

Your health insurance typically will pay for the components of the clinical trial that are considered standard therapy, while the sponsor will pay for the non-standard components of the trial.

Would I be allowed to quit the clinical trial?

All patients included in clinical trials are volunteers.  You can choose to quit a clinical trial at any time, but you should speak with your doctor and research nurse first.  They can tell you how quitting the trial might affect your health, and if there are other treatment options.

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