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What are Clinical Trials?
Who takes part in Clinical Trials?
What are the potential risks and benefits of clinical trials?
How can you take part in Clinical Trials at Capital Health?
What happens during a trial?
What is the current Clinical Trial?
Where can you get more more information regarding Clinical Trials at Capital Health?
What are Clinical Trials?
Clinical trials are research studies that look at whether new ways to prevent, diagnose and treat cancer are safe and effective. These clinical trials, also called clinical studies or research protocols, are conducted by physicians with people who volunteer to take part in the studies. Frequently, they give patients access to potentially helpful therapies not widely available elsewhere. Clinical trials can investigate the use of new:
- Drugs
- Devices
- Dietary changes
- Treatment
- Screening methods
- Quality of life studies
Who takes Part in Clinical Trials?
Clinical trials are open to nearly everyone depending on whether or not you fit the criteria of the protocol. When it comes down to it, you are the one who must decide if you should take part. Only you can make the decision about whether or not to participate in a clinical trial. Before you make your decision, you might do the following:
- Learn as much as possible about your disease.
- Go to the American Cancer Society website www.cancer.org for information.
- Visit the National Cancer Institute's (NCI) registry of cancer clinical trials. For guidance, go to www.clinicaltrials.gov.
- Contact physicians or cancer research nurses at Capital Health. They can answer many of your questions about cancer and clinical trials, and guide you to further information. They can be reached at 609-815-7443.
- Talk about this information and how you feel about it with your doctor and health care team, family members, and friends to determine what is right for you.
What are the potential risks and benefits of clinical trials?
Potential benefits include:
- Having health care provided by leading physicians in the field of cancer research.
- Having access to new methods of preventions, drugs and interventions before they are widely available.
- Close monitoring of your health and any potential side effects.
- Taking a more active role in your own health care.
- Being among the first to benefit from a particular therapy.
- Having the opportunity to make a valuable contribution to cancer research.
- New drugs and procedures may have side effects or risks unknown to the doctors
- New drugs and procedures may be ineffective, or less effective, than current approaches
- Even if a new approach has benefits, it may not work for you
How can you take part in Clinical Trials at Capital Health?
Capital Health has numerous protocols underway at both Capital Health Regional Medical Center and the Mercer Campus. We have a long history of providing excellent care for our patients as well as the latest technology and innovative protocols. If you are interested in finding out more about enrolling in a clinical trial, speak to your doctor and find out your options.
What happens during a trial?
If you decide to participate in a clinical trial here at Capital Health, you will work with a research team. Team members may include doctors, nurses, social workers, dieticians, and other health care professionals. They will provide your care, monitor your health carefully, and give you specific instructions about the study. You will participate in an informed consent session, conducted by the research team, in which the protocol will be explained to you in detail. Additionally, information may be distributed to you in the form of brochures, video, CDs. You will be encouraged to take the educational material home to discuss with your family. You can only be enrolled in the protocol following a thorough review and understanding of the procedure and providing your signature acknowledging your permission to proceed. Each protocol that is initiated at Capital goes through our institutional review board (IRB), which is responsible for regulating and monitoring the process and progress of the trials. This board also has the power to terminate the study if they believe that patients may suffer increased risks. The board as well as the research team and a data safety group will monitor your progress throughout the clinical trial and do their utmost to keep your records (data) secure. If there are any unexpected adverse (negative) responses to treatment, the research team will respond immediately and provide corrective medical care.
Please keep in mind that participating in a trial may mean that you might have more tests and doctor visits than you would if you weren't in the study. Also, team members might continue to stay in contact with you after the trial ends. To make the trial results as reliable as possible, it is important for participants to follow the research team's instructions. That means attending all doctor visits and obtaining required tests, taking medicines on time, and completing logs or answering questionnaires. Please also remember that you may withdraw from the trial at anytime and revert to standard treatment.
Current Clinical Trial
Then Capital Health CyberKnife® Center continues to enhance clinical care through research by providing the most current treatment options in radiotherapy and CyberKnife radiosurgery. We currently participate in several clinical trials initiated at leading academic medical centers throughout the country and are in the process of initiating novel investigations involving the use of the CyberKnife with the hope of meeting the needs of our community and improving our patients’ cancer outcomes.
Current Active Clinical Trials:
1) CK Brain Metastases-01 - A Phase II consensus multi-institutional trial of CyberKnife Radiosurgery to the operative cavity in patients with resected brain metastases.
Goal: This trial will look at improving treatment options for patients with cancers that have migrated to the brain from other sites outside the head. It is our hope that treatments with CyberKnife following surgery will prolong the life of the patient.
2) CK Retrospective Study Spine Metastases 01 - Retrospective analysis of patient outcomes following CyberKnife treatments targeting tumor metastases to the spine
Goal: The goal of this study is to look back at patients who have been treated with CyberKnife for tumors that have migrated to regions around the spine and determine if the methods employed were effective at controlling the local tumor growth, improving the patient’s quality of life and reducing pain. We are hoping that the data obtained from this research investigation will help us to improve our CyberKnife treatment methods.
For more information regarding clinical trials please contact:
Our Research Nurses: Susan Wall, RN at (609) 815-7443 or Linda Andrzejewski, RN, at (609) 815-7042
Clinical Doctoral Research Coordinator: Dr. Derrick Grant, PhD at (609) 394-4503