Cancer Clinical Trials Questions and Answers

August 15, 2016

New Hanover Regional Medical Center is pleased to be able to offer clinical trials for some of our cancer patients. Clinical trials are one way cancer patients can access the latest medications. The hope is always that the medication or course of treatment being trialed is a better way to treat cancer.

At NHRMC, we develop a treatment plan tailored to each patient. Sometimes, that plan includes a clinical trial, and a patient can choose whether or not to enroll. Taking part in a clinical trial may or may not mean better results. While doctors hope patients’ participation in the study will be better, there is no proof of this yet. We do know that the information from the clinical trial will help doctors learn more about cancer treatment and may be of benefit to future patients with the same condition.

But there's still some mystery surrounding clinical trials, so I'll try to answer some anticipated questions here:

Does every patient qualify for a trial?

Every patient does not qualify for a trial. There are typically specific criteria for eligibility. Trials generally seek to answer a specific question. Thus, patients need to be appropriately screened to be sure that the question will apply to the patient's specific case.


What are the chances that a trial will lead to a better outcome? Will I live longer, recover sooner?

Clinical trials are one way that we make progress in cancer treatment. In Phase I trials, the purpose is to test whether the new treatment is safe. These are the riskiest trials. These trials do not seek to answer the question as to whether the treatment improves outcomes. In Phase II trials, the drug has already been established as relatively safe. These trials seek to determine whether the treatment has any measurable effect on the cancer. In Phase III trials, the new treatment is usually compared to the current method of care. There are also Phase III "non-inferiority" trials where we try to prove that one treatment is equivalent to the standard of care, but may become the preferred treatment because it may be cheaper, easier to administer, or reduces side effects.


In trials in which the new treatment is superior to the standard of care, the patient may have better outcomes or fewer side effects.


Will a trial reduce the side effects I feel?

This depends upon the purpose of the trial. In some cases the treatment could have more significant side effects, but at the benefit of a longer survival rate. Everyone taking part in a clinical trial is watched very closely and may be given medicine to reduce side effects, if necessary. In a non-inferiority trial, fewer side effects for same outcome may be the question being answered.


If I participate in a trial, will I have more paperwork, more appointments?

This may be the case. This is a good question to ask the study coordinator. In general, investigators try to minimize any excess burden on trial participants, both in expense and time.


Is there a chance I would receive a placebo?

This depends on the trial design. Patients usually get standard of care therapy in addition to the investigational drug or placebo. Placebo may be an option when compared to an investigational drug if there is no current standard of care treatment available.


Will a trial reduce my costs of treatment?

The cost of participating in a clinical trial may or may not cost patients or their insurance company any more than the cost of getting regular treatment. Usually, any treatment or test that will be done as part of regular therapy will be paid by patients or their insurance company; whereas, any treatment or test that is considered investigational, or performed only for the purpose of the clinical trial, will be done at no cost to patients or their insurance.


Will I receive more care if I'm in a trial?

Trials generally have "heightened" oversight, as study participants are monitored more closely to assess side effects of the investigational drug.


If I start a trial, can I withdraw?

Trial participation is entirely voluntary and patients may withdraw at any time. We prefer that patients commit or decline up front, but the option to withdraw exists. Not participating, or withdrawing from study participation at any time, will not affect patients' quality of care; in that case, patients and their physicians agree on the best course of treatment.

 Still have questions about Clinical Trials? Learn more from our Research Department.



Categories: Your Health
Topics: Cancer

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