The Life Saved by Participation in a Clinical Trial Could be Your Own

by Jenny Johnson, Rex Healthcare
July 2010

AA diagnosis of cancer or heart and vascular disease is often overwhelming, frightening and often places a patient on an emotional roller coaster with a lot of questions. Is it curable? How will my life have to change now that I have this? What are my treatment options? What side effects will I have from the treatment? Will I be able to work? And the list goes on and on.

Unfortunately, all too often questions about participation in a clinical trial are not asked or even explored. While the results from clinical trials provide vital information towards determining whether new advances and products are safe and effective prior to being placed on the market, very few adults and even fewer minorities participate in clinical trials.

Why is participation important?
Almost all medications and medical devices available today have gone through a clinical trial. In fact, everything we know about treatment options today are based on the results from past clinical trials or research studies. These current medical therapies and technologies are constantly being evaluated for areas of improvement.

At Rex Healthcare, oncology, heart and vascular diagnostic trials are available to patients who want to participate. “By offering patients the chance to join in a clinical trial program, we can actively contribute to improvements in medical science while providing our patients the opportunity to help advance more effective cancer treatments for future patients,” said Vickie Byler, Director of Rex Cancer Center/Clinical Research. “Today, there are successful treatments for hundreds of diseases directly due to participation in clinical trials similar to those offered at Rex, and as a result, more patients are surviving and living longer, healthier lives.”

Nancy Burns, Clinical Research Nurse at Rex Cancer Center believes strongly in the role clinical trials play in oncology. “Clinical Trials are the foundation in the fight against cancer,” explained Burns. “They are a key component in the research process. Doctors test the value of new treatment ideas with the help of cancer patients who take part in treatment studies or clinical trials. In return, the knowledge gained from these trials has led to increase survival for many childhood cancers, Hodgkin’s disease, breast, uterine, testicular, and bladder cancers and certain leukemias.”

One size doesn’t fit all
“A common misconception,” said Burns, “is that clinical trials are only offered as a last resort. Clinical trials are often thought of as a last chance for patients who have no other good treatment choices. Of course there are clinical trial options in this setting, but actually, there are many clinical trials available in the United States for an individual whose disease has not spread and even trials for those who have no evidence of disease at all.”

There are a variety of different types of clinical trials and research studies. Some trials involve medications or drugs while others focus on medical devices and their use and impact on a patient’s treatment and/or recovery. Clinical trials and research studies available today include:

Early Detection/Screening Trials
Diagnostic Trials
Quality of Life/Supportive Care Trials
Treatment Trials
Prevention Trials that include healthy participants who may be at risk for the disease.

Unlike prevention trials, cancer treatment trials do involve people who have been diagnosed with cancer. Breast cancer survivor, Dr. Delores A. Parker was diagnosed in November 2008. After recovering from surgery in December and following ten radiation treatments, Dr. Parker met with Dr. Susan Moore at Rex Hematology Oncology Associates, who introduced her to the idea of participating in a clinical trial. As an educator who understands the importance of research, Dr. Parker decided to enroll in a clinical trial sponsored by the National Cancer Institute and began treatments at Rex Cancer Center with Dr. Moore.

“I felt compelled to participate so I could help others who have had breast cancer,“ said Dr. Parker, “and I’d heard that very few African Americans participate in clinical trials, so I felt that it was really important that I join. Luckily for me, I haven’t had any side effects from the medication I’m taking. Dr Moore and the nurses made sure I knew exactly what I was getting into and gave me material in writing that explained everything. I was able to take that with me and discuss the trial with my other physicians and my family. This all helped me to decide to participate in the program,“ explained Parker.

Although participating in the trial has been the right choice for Dr. Parker, joining a clinical trial is a very important personal decision. Even when participants qualify for clinical trials, every situation and every patient is unique. “I would most definitely recommend participation in clinical trials to others, but they should learn as much as they can about what is involved and then take some time to reflect on whether it is right for them. This particular trial that I’m participating in is researching the advantages of taking a particular medication to determine whether or not it will help prevent cancer survivors from later developing breast cancer recurrence in the bone.” Dr. Parker will complete her treatments in February 2012.

It’s a long road
Therapeutic trials evaluate the effectiveness of a new drug or treatment, or a new way of using a standard treatment. Clinical trials take years to complete from start to finish and follow strict scientific guidelines and patient safety always comes first, explained Burns.

Every trial has a doctor in charge and each one follows the exact same protocol to treat patients in the study ensuring safety guidelines are met no matter where treatment is received. Information from all the sites is combined and compared. In addition, the law requires that all participants learn about the study protocol through a process called informed consent. This process helps patients decide whether participation in a clinical trial is right for them.

As a clinical treatment trial volunteer, you may be asked to regularly visit a healthcare provider; take study medication; have laboratory and diagnostic tests; or even change your diet and exercise habits.

Phase I, II, III, or IV—What does it all mean?
The primary purpose of phase I trials is to find the safest dose of a new agent, but researchers also consider whether the new agent benefits patients.

Phase II trials continue to test the safety of the new agent and begin to evaluate how well it works against a specific type of disease. Participation in phase II trials is often restricted based on the previous treatment received.

Phase III trials focus on learning how a new treatment compares to the standard or most widely accepted treatment.

After a treatment plan or medication has been made available by prescription, information is gathered in a Phase IV trial to further assess the drug’s risks, benefits and optimal use.

The reality—the goal
At sometime or another, everyone alive will be effected by either cancer or heart and vascular disease, through personal experience or that of someone close.

The good news is—with the help of research gathered through clinical trials and many new targeted therapies, there have been dramatic improvements in the diagnosis and treatment of diseases.

Clinical trial opportunities close to home
Oncology, heart and vascular diagnostic trials are currently underway at Rex Healthcare, with Rex Cancer Center in Raleigh, Rex Cancer Center of Wakefield and Rex Health & Vascular Services. To learn more about all of the IRB/Clinical Trials available at Rex Healthcare, visit rexhealth.com.

Rex Healthcare is part of the UNC Health Care System and is affiliated with the Lineberger Comprehensive Cancer Center in Chapel Hill.