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Therapeutic Misconception In Clinical Trials - Maribelle Sunga


 


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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 drugs, new approaches to surgery or radiation therapy, new combination of treatments, or new methods such as gene therapy.

A clinical trial is one of the final stages of a long and careful cancer research process. The search for new treatments begins in the laboratory, where scientists first develop and test new ideas. If an approach seems promising, the next step may be testing a treatment in animals to see how it affects cancer in a living being and whether it has harmful effects. Of course, treatments that work well in the lab or in animals do not always work well in people. Studies are done with cancer patients to find out whether promising treatments are safe and effective.

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. Doctors, nurses, social workers, and other health professionals may be part of your treatment team. They will follow your progress closely. You may have more tests and doctor visits that you would if you were not taking part in a study. You will follow a treatment plan your doctor prescribes, and you may also have other responsibilities such as keeping a log or filling our forms about your health. Some studies continue to check on patients even after their treatment is over.

How is the Research Carried Out? How Are Patients Protected?

In clinical trials, both research concerns and patient well-being are important. To help protect patients and produce sound results, research with people is carried out according to strict scientific and ethical principles.

Each clinical trial has an action plan (protocol) that explains how it will work.

Each study enrolls people who are alike in key ways (eligibility criteria)

Cancer clinical trials include research at three different phases:

Phase I trials are the first step in testing a new treatment in humans. In these studies, researchers look for the best way to give a new treatment (e.g., by mouth, IV drip, or injection? How many times a day?) They also try to find out if and how the treatment can be given safely (e.g. best dose?) and they watch for any harmful side effects. Because less is known about the possible risks and benefits in Phase I, these studies usually include only a limited number of patients who would not be helped by other 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?

While a clinical trial is a good choice for some people, this treatment option has possible benefits and drawbacks.

Possible benefits:

  • Clinical trials offer high-quality cancer care. If you are in a study and do not receive the new treatment being tested, you will receive the best standard treatment. This may be as good as, or better than, the new approach.
  • If a new treatment approach is proven to work and you are taking it, you may be among the first to benefit.
  • By looking at the pros and cons of clinical trials and your other treatment choices, you are taking an active role in a decision that affects your life.
  • You have the chance to help others and improve cancer treatment.

Possible Drawbacks:

  • New treatment under study are not always better than, or even as good as, standard care. They may have side effects that doctors do not expect or that are worse than those of standard treatment.
  • Even if a new treatment has benefits, it may not work for you. Even standard treatments, proven effective for many people, do not help everyone.
  • If you receive standard treatment instead of the new treatment being tested, it may not be as effective as the new approach.
  • Study-related procedures are usually paid for by the researc h sponsor.  However, 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 Institutue)
www.cancer.gov/espanol (Spanish Version of National Cancer Institutue)
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)


   
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