A Primer on Clinical Trials

NEWPORT BEACH, CA (thehealthchannel.com) - Clinical trials are research studies conducted with people. Many trials try to find better ways to prevent or treat diseases, while others test new ways to detect or diagnose a disease. They have been responsible for virtually all major advances in cancer treatment.

Participants take part in clinical trials for many reasons. Usually, they hope for a cure and for a way to contribute to a research effort that may help others. Also, participants in a clinical trial are among the first to receive the new treatments before they are widely available. The care they receive is always the best available.

There are three main phases of clinical trials:

Before a treatment is tested in a phased clinical trial, it has been studied in a laboratory where treatments are tested on animals. But treatments that seem to work well on animals in the lab do not always work as well for people. That is why clinical trials are needed-to determine the safety and effectiveness of a treatment in human patients.

To protect patients and to provide consistent testing procedures, clinical trials must follow a strict plan called a protocol. The protocol follows medical, ethical and legal guidelines to ensure patient safety. It specifies the doses, frequency and duration of treatment. It also specifies what lab work, scans or other tests are needed, as well as their optimal frequency.

As part of the protocol, patients may be randomly assigned to one of two study groups-one group that receives the treatment being researched and one that receives the standard treatment.

Research protocols for clinical trials have to go through an extensive, independent, peer review process by a separate board of scientists, doctors, nurses, and laypersons not connected with the trial before they are approved. These boards are called Institutional Review Boards or IRBs. In addition, these boards review the progress of the trials on a yearly basis. These reviews provide additional assurance to women entering breast cancer research trials that the trials are properly designed and monitored.

Participation in clinical trials is tightly controlled and patients must meet specific criteria before they can participate. Also, it is important to note that any standard treatments you receive could affect your eventual eligibility in a particular trial. Therefore, you may want to discuss clinical trial options with your oncologist prior to initiating treatment.

Studies may have one, two, three, or even four different treatment plans. Participants in studies with more than one treatment plan are randomized (chosen by a flip of a coin) to receive one of the plans. One plan may be the standard treatment, while the other plan(s) may have different therapies, treatment schedules, or higher doses. All participants are monitored closely.

If your treatment does not seem to be helping, the medical doctor can decide to take you off the trial. Also, you can personally decide to leave the trial at any time. If you leave the trial for any reason, your continued care will not be jeopardized.

Lack of Awareness

Unfortunately, the vast majority of cancer patients do not take part in clinical trials. In a presentation to delegates at the recent annual meeting of the American Society for Clinical Oncology, Dr. Robert Comis of the MCP Hahnemann University Clinical Trials Research Center in Philadelphia said that 84 percent of cancer patients are simply unaware of clinical trials or not sure that they would be an option for them. The findings were based on a survey of 6,000 cancer patients by Harris Interactive.

Only 4 percent of the cancer patients interviewed by Harris Interactive said they had participated in clinical trials, and the majority of them heard about the possibility through their physician. About 58 percent of the respondents said they would never participate in a clinical trial; fear of getting insurance coverage for the trial costs was mentioned as a concern by a majority of these respondents. They also cited worries that they would not get the best treatment or that they would get a placebo instead of a real drug. More than 20 percent said they would feel like a “guinea pig.”

Yet, in the same survey 97 percent of the patients who had participated in clinical trials said they received excellent or good quality care and that they were treated with dignity. And the vast majority said they would recommend participating in clinical trials to others. Eighty-six percent of the patients also said they were able to secure insurance coverage for their participation.

Is a Clinical Trial For You?

Before you decide to take part in a clinical trial, you should know as much as possible. Ask your medical doctor for more details on the trial, such as:

What is the purpose of the study?
How many people will be included in the trial?
What does the study involve? What kinds of tests and treatments will I have?
How are treatments given and what side effects should I expect?
What are the risks and benefits of each protocol?
How long will the study last? What type of long-term follow-up care is provided?
Will I have any costs? Will any of the treatments be free? What does my insurance cover? Is financial aid available?

If you want additional information regarding ovarian cancer clinical trials, ask your doctor what trials may be open to you. And the following organizations may also be helpful:

CancerNet - National Cancer Institute
900 Rockville Pike
Building #31, HSV2580, Room 10A046
Bethesda, MD 20892

CenterWatch Clinical Trials Listing Service
581 Boylston Street, Suite 200
Boston, MA 02116


The National Cancer Institute Web Site
Written by Richard A. Zmuda, thehealthchannel.com Editorial Team