Pioneers in Radiation Oncology for 37 Years
Exploring New Cancer Care Strategies
The Study Team:
Clinical Trials and Research Associates, Inc. (CTRA) led by John Thropay, M.D., President, Medical Director and Maribelle Sunga, Site Director, is a freestanding clinical research facility to serve as a clinical trial management resource to its parent company, Beverly Oncology and the surrounding medical community. Dr. Thropay regularly engages in clinical research studies, collaborates with sponsor-pharmaceutical/biotech companies and plays an active role in conveying in-study ideas to enhance study outcomes. His clinical research studies with Biotechnology Corporation were published and presented at the American Cancer Society of Clinical Oncologists meetings in Orlando, Florida and Berlin, Germany in 2002. He is currently a member of the Institutional Review Board at the University of California, Los Angeles (UCLA). Maribelle Sunga is a certified clinical research professional through the Society of Clinical Research Associates. While serving as the first Chairperson for the Society of Clinical Research Associates (SoCRA) in Orange County, California, she contributes to providing a forum for continuing education and training among clinical research professionals. (www.SoCRA.org). She also serves on the advisory committee for Clinical Trials: Medical Device and Drug Development Program at the University of California, Irvine (UCI). (www.extension.uci.edu)
Investigators, clinical research coordinators and ancillary staff offer the expertise needed to make clinical trials a success for patients and the sponsors. CTRA employs clinical research coordinators with strong clinical and allied medical backgrounds and with a solid record of clinical research experience across various therapeutic areas.
Facility Description:
CTRA is a cancer-focused facility with a capability to conduct studies in other therapeutic areas. The main office is located next to Beverly Hospital and within the densely populated multi-cultural Los Angeles population. The office space is comprised of a spacious patient waiting room, a large and comfortable infusion area, a separate examination room, a common physician-investigator office and a study coordinator work area. There is also a storage room for case report forms and study charts, secure ambient and refrigerated study drug storage and laboratory area for specimen processing. CTRA has direct access to a state-of-the-art imaging center conveniently located within the building. (www.beverlyoncology.com)The easy access to the imaging center makes patient scheduling and reporting efficient and timely.
Please contact CTRA at (323) 271-1330 or via email at ctra120@aol.com
What Are Clinical Trials?
Clinical trials, also called cancer treatment or research studies, test new treatments in people with cancer. The goal of this research is to find better ways to treat cancer and help cancer patients. Clinical Trials test many types of treatments such as new medications and drugs, new approaches to surgery or radiation therapy, new combination of treatments, or new methods. A clinical trial is one of the final stages of a long and careful cancer research process. This process begins with scientists developing and testing new ideas in a lab. If an approach they have tested seems potentially effective, they may move to a next step of testing the treatment on an animal. However, a treatment that works well on an animal may not always work well for people. This is why human participation in a study is crucial in order to determine whether or not the new method is viable.
Why Are Clinical Trials Important?
First, cancer affects us all, whether we have it, care about someone who does, or worry about getting it in the future. Clinical trials contribute to knowledge and progress against cancer. If a new treatment proves effective in a study, it may become a new standard treatment that can help many patients. Many of today’s most effective standard treatments are based on previous study results. Examples include treatments for breast, colon, rectal, and childhood cancers. Clinical trials may also answer important scientific questions and suggest future research directions. Because of progress made through clinical trials, many people treated for cancer are now living longer.
Second, the patients who take part may be helped personally by the treatment(s) they receive. They get up-to-date care from cancer experts, and they receive either a new treatment being tested or the best available standard treatment for their cancer. There is no guarantee that a new treatment being tested or a standard treatment will produce good results. New treatments also may have unknown risks. But if a new treatment proves effective or more effective than standard treatment, study patients who receive it may be among the first to benefit. Some patients receive only standard treatment and benefit from it.
In the past, clinical trials were sometimes seen as a last resort for people who had no other treatment choices. Today, patients with common cancers often choose to receive their first treatment in a clinical trial.
What Happens in a Clinical Trial?
In a clinical trial, patients receive treatment and doctors carry out research on how the treatment affects the patients. While clinical trials have risks for the people who take part, each study also takes steps to protect patients.
What Is It Like To Receive Treatment in a Clinical Trial?
When you take part in a clinical trial, you receive your treatment in a cancer center, hospital, clinic, and/or doctor’s office. A team of doctors, nurses, social workers, and other health professionals may be part of a treatment team that will keep track of your progress. You may need to attend more doctor visits and undergo more testing than if you were not participating in a trial. Your doctor will prescribe a treatment plan, and you may be tasked with keeping a log of your symptoms to help inform the research. In some studies, doctors will continue to check in on you even after the treatment has ended to see if anything has changed.
How is the Research Carried Out? How Are Patients Protected?
Those who conduct clinical trials are concerned with both the integrity of the research as well as a patient's well-being. In order to protect patients during the trial, researchers must adhere to strict scientific and ethical principles.
- Each clinical trial has an action plan (protocol) that will explain the process and what exactly will go on during the study.
- Each trial will recruit participants who meet their eligibility criteria.
Cancer clinical trials include research at three different phases:
Phase I. In Phase I, researchers consider the most effective delivery method for the new treatment. They will consider whether the treatment should be delivered orally, with an IV, or with an injection. They will also consider how frequently the treatment should be administered and at what dosage. Because the new treatment is still in its early phase of research, not much is known about potential side effects. This is why there will typically be a small and limited number of people who participate, so as to minimize the number of people who may be harmed. Usually the individuals who participate in a Phase I trial are those who cannot be helped by any known treatments.
Phase II trials focus on learning whether the new treatment has an anticancer effect (e.g., Does it shrink a tumor? Improve blood test results?) As in Phase I, only a small number of people take part because of the risks and unknowns involved.
Phase III trials compare the results of people taking the new treatment with results of people taking standard treatment (e.g. Which group has better survival rates? Fewer side effects?). In most cases, studies move into Phase III testing only after a treatment shows promise in Phases I and II. Phase III trials may include hundreds of people around the country. In Phase III trials, people are assigned at random to receive either the new treatment or standard treatment.
Should I Take Part in a Clinical Trial?
Possible Benefits
- Clinical trials offer high-quality cancer care.
- Typically, a research sponsor will fund the treatment. You may receive the treatments at little or no cost to you, since you are volunteering for a study.
- If you are in a study and are not selected to receive the new treatment type, you will receive the best standard treatment. This may be as good as, or better than, the new approach.
- If you are selected to try the new treatment approach, it may end up being effective for combating your cancer.
- Your participation helps advance cancer research and make a difference for other cancer patients.
Possible Drawbacks
- New treatment under study may have unforeseen side effects that may even be worse than those of standard treatment.
- The treatment you receive, whether it's the one under study or the standard, may not work for you.
- Although study-related procedures are usually paid for by the research sponsor, other costs of care that are independent of study participation may not be covered but may be paid for by third-party health insurance. To find out in advance what costs are likely to be paid in your case, talk to a doctor or healthcare professional from the study.
Questions You Should Ask
- What is the purpose of the study?
- Who sponsors the study, and who has reviewed and approved it?
- How are the study data and patient safety being checked?
Possible Risks and Benefits
- What are the possible short and long-term risks, side effects, and benefits to me?
- Are there standard treatments for my type of cancer?
Your care
- What kinds of treatments, medical tests, or procedures will I have during the study?
- How often and for how long will I receive the treatment and how long will I need to remain in the study?
- Where will my treatment take place and will I be able to see my own doctor?
Cost Issues
- Will I have to pay for any treatment, tests, or other charges?
- What is my health insurance likely to cover?
Beverly Oncology, through Clinical Trials and Research Associates, Inc., offers clinical trials that are currently accruing for the following disease indication:
- Breast Cancer
- Breast Cancer with bone metastasis
- Lung Cancer
- Prostate cancer with bone metastasis
- Cancer-related pain
- You or a loved one may qualify for a clinical trial
Reference: NIH Publication No. 98-4250. December 1998
For detailed information, please contact: John Thropay, MD or Maribelle Sunga, BS, CCRP at 323 271-1330
Informative websites:
www.clinicaltrials.gov
www.cancer.gov
www.oncologytrials.com
www.cancer.org
Websites of Cancer Patients:
www.cancer.gov (National Cancer Institute)
www.cancer.gov/espanol (Spanish Version of National Cancer Institute)
www.cancer.org (American Cancer Society)
Breast and Gynecologic Cancer Websites:
www.wen.org (Women's Cancer Network)
www.wcn.org/espanol/ (Spanish Version of Women's Cancer Network)
Cervical Cancer Websites:
www.NCCC-online.org (National Cervical Cancer Coalition)
www.ncc-online.org/espanol.html (Spanish Version of National Cervical Cancer Coalition)
www.asccp.org/patient_edu.shtml (American Society for Colposcopy and Cervical Pathology with Patient info in Spanish and Vietnamese)
Ovarian Cancer Website:
www.ovarian.org (National Ovarian Cancer Coalition)
www.ovariancancer.org (Ovarian Cancer National Alliance)