• You receive quality care from Shenandoah Oncology physicians and other healthcare providers, 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 and less toxic than standard treatments.
• You may help future cancer patients by bringing new therapies to market and by contributing to the greater knowledge of cancer.

Possible risks:

• New treatments being studied are not always more effective than standard therapy. 
• Even when a new treatment or prevention approach has benefits, not every patient who receives the treatment will experience them.
• New treatments or prevention approaches may have unknown side effects or risks.
• You may be required to make more visits to our office than you would if you were not on the clinical trial.

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.

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.

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.

Clinical trials are conducted in phases. The trials in each phase have a different purpose and help researchers answer different questions: 

• Phase I trials test an experimental drug, vaccine, or device in a small group of participants (about 20-100 people) to evaluate the safety, identify side effects, and determine how the drug should be used or delivered 
• Phase II trials involve larger groups of participants than Phase I (about 100-300 people) and they are designed to assess whether an experimental treatment is safe and whether it works 
• Phase III trials evaluate the safety and effectiveness in a greater group of participants (about 300-3000 people), often in comparison to a placebo or standard treatment 
• Phase IV trials are performed once a drug or vaccine has been approved for use and has reached the market, to seek more information about its risks, benefits, and optimal use 

This varies from trial to trial. Some can last as little as one day, and others are more involved and can last for several years.

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 in which you are interested.

There are two types of costs associated with a clinical trial: patient care costs and research costs.

1. Patient care costs are those costs related to treating your cancer, whether you are in a cancer research trial or receiving standard therapy. These costs are often covered by health insurance and usual copays and coinsurance would apply. Doctor visits, hospital stays, standard cancer treatment, lab tests, and imaging tests are considered patient care costs.
2. Research costs are those related to taking part in the trial. Often these costs are not covered by health insurance but are usually covered by the research trial’s sponsor. Study drugs, as well as, additional lab and/or imaging tests performed solely for the trial are examples of research costs.

When you take part in a clinical trial, you may have extra doctor visits that you would not have with standard treatment. During these visits, your cancer care team carefully watches for side effects and your safety in the study. These extra visits can add costs for transportation and child care.

Yes, you are a volunteer and can choose to withdraw from the clinical trial at any time.