Clinical Trials Frequently Asked Questions
1- What is a clinical trial?
A clinical trial is a research study that evaluates a new way to prevent, diagnose or treat a disease. Clinical trials need the participation of volunteer patients to try these new or modified treatments that involve new or known drugs or procedures that have been thoroughly researched in successful laboratory studies.
A clinical trials program helps physicians and researchers determine the safety and effectiveness of new therapies on people. Clinical trials are important to develop new treatments for diseases, like cancer. Many of today’s typical cancer treatments – treatments that are accepted and widely used by medical experts – are the results of previous clinical trials.
2- What kind of clinical trials are available at NVCI?
Phase I, II and III clinical trials.
Phase I trials are first-time tests of new drugs or treatments on human patients. Although the new drug or treatment has not yet been tested on people, researchers have reason to believe that it will be beneficial. At this point, however, researchers do not know how effective the drug will be, the best dose to administer or what side effects could occur. All NVCI patients involved in Phase I clinical trials receive a form of treatment for their cancer; none are given placebos for a control group.
Phase II trials begin once an appropriate dosage of a drug is determined through Phase I trials. In Phase II, researchers will verify the drug’s effectiveness and safety in treating a certain type and stage of cancer. As in Phase I clinical trials, all patients involved in Phase II receive active treatment, none are in a control group given placebos.
Phase III trials test agents that have been effective in the first two stages of testing. Phase III clinical trials put the new (investigational) therapy in focus. For example, a Phase III trial may compare the current standard therapy against the new investigational therapy. Or it may compare patients given the investigational therapy and standard therapy with those who are administered only the standard therapy.
3- Why should I be interested in participating in a clinical trial?
Besides offering you a new treatment and new hope for defeating your cancer, it is an opportunity to contribute to a research effort that could help other cancer patients now and in the future.
If the clinical trial proves that this new cancer therapy is more effective than the current treatment, patients in the clinical trial will receive the benefit of the new treatment before it becomes available to the world.
Additionally, you would be playing an important role in helping to find new and better treatments for cancer for humanity.
4- How can I qualify for a clinical trial?
Each of the clinical trial studies lists the specific requirements, called the inclusion criteria (as well as exclusion criteria), necessary to be a participant. Additionally the physician conducting each trail is listed by name and phone number on the page for additional information.
5- Are there risks in participating in a clinical trial?
New treatments, like clinical trials, may cause side effects. Some side effects are known in advance and expected, but others may not be. NVCI researchers make every possible effort to discover and explain to patients what side effects may occur from trial cancer treatments, varying side effects are a possible outcome.
Please understand that a patient’s well-being and health are the most important part of any clinical trial. If you are involved in one, you will be closely monitored to see how well you are responding to treatment and to check on your overall well-being. If the treatment becomes detrimental to you, it will be stopped. Of course, you, hopefully in consultation with your physician, can withdraw from the clinical trial at any time you wish.
6- Are clinical trials covered by healthcare insurance?
Because nearly every clinical trial includes administering some standard treatment to the patient, some costs are billed to the insurance company and/or the patient (any “standard” treatment charges are billed to the insurance provider). In special cases some of the standard of care cost is paid by the study sponsor, usually a drug company. All procedures that are not considered as part of the standard treatment are covered by the sponsor. Before you enroll in a clinical trial, you need to understand completely what costs will be paid by the insurance company, by the study sponsor and what may be billed to you.
7- How can I find out what clinical trials are available and open at NVCI?
Click on the ‘Science & Research’ button, and then open the ‘Clinical Trials’ dropdown which will offer you the ‘Available Clinical Trials’ link.
8- Who can I contact if I have questions about a clinical trial?
Contact Erin Pennington, technical director, at (702) 822-5346.
