Clinical Trials

Many people are interested in learning about clinical trials and many people are volunteering to participate in them. Research is a scientific and systematic way to look at the outcomes of a particular drug, device or other process to see how well it works including how safe it is.  Participating in research is a voluntary process.  The investigators designing and conducting the research, the institutions where the research may be conducted, the sponsors of the research and the federal government are all interested in minimizing the risks to participants involved in research.

As a patient undergoing a treatment plan that is part of research or standard therapy, there is a certain amount of risk involved.  As a participant in a clinical trial, you are always exposing yourself to some risk.  You need to decide if the risk is acceptable to you or not. You need to be sure you understand the research and ask as many questions as you can to make an informed choice.  Talk over what you have learned with your family, friends and health care providers. Learn as much as you can before you decide to participate.
This site will help link you to other resources and will tell you what trials Cape Cod Healthcare is participating in.

Clinical Trials at CCHC

Medical Oncology at Cape Cod Hospital and Radiation Oncology at both Falmouth and Cape Cod Hospitals participate in national and regional clinical research trials. If you are interested in speaking with someone at CCHC about clinical trials in Oncology, please call Rebecca Buscanera, RN, BSN, Certified in Oncology & Research at 508-862-5799.

Policies and Forms

This web page is designed for investigators who are interested in performing research at any Cape Cod Healthcare entity.
The policies and forms have been reviewed by the Cape Cod Healthcare Institutional Review Board (IRB) and the Office of Research Compliance. Please be certain to review the policies and forms that are listed as “Required.”

Any research including human subjects must be submitted to the Office of Research Compliance, who will confer with the CCHC IRB Chairman. The IRB Co-Chairman will determine if the research requires review by the IRB.

That decision may not be made by an investigator alone. This includes students or staff of a CCHC entity who may want to pursue a research project.

Other links provide forms that may assist you with your application.  If you have any questions about the process please e-mail LShields@capecodhealth.org

• CCHC Institutional Review Board
• Required Policies
• Required and Optional Forms

CCHC Institutional Review Board

The federal regulations dictate that a group called an Institutional Review Board (IRB) must approve and oversee the research being conducted. The IRB at Cape Cod Healthcare is composed of physicians, nurses, pharmacists and community members. The community members are critical to an IRB to review the research from the point of view of the patient. They often bring up issues that clinicians are not aware of, because they think from the patient’s point of view. The IRB plays a critical role in safeguarding subjects’ rights and welfare during the recruitment process, informed consent process and the conduct of the clinical trial.

Federal Agencies Involved in Clinical Trials

Federal Agencies that have the primary responsibility of helping to ensure the rights and welfare of human subjects participating in the clinical research:

DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS)

The Office for Human Research Protections (OHRP)
OHRP is an office of the DHHS.  OHRP ensures the rights and welfare of human subjects, establishes standards for the organizations review of research through the Institutional Review Board process.  The OHRP provides guidance and training to help IRBs. Sponsors of trials and Physicians must meet the Federal requirements.

Food and Drug Administration (FDA)
An office of the DHHS that regulates research in the products it oversees. In clinical trials, those are usually a new drug or new medical device. The FDA requires evidence of drug and product safety in the form of an application process and has rules about reporting of safety issues during clinical trials.

The Office of Good Clinical Practice
The Office of Good Clinical Practice is part of the FDA.  Its mission is to establish consistency in policy. They are charged with ensuring FDA’s protective role in clinical research, from the design of a trial through how the trial is conducted and overseen.

Who to Contact at CCHC about Clinical Trials

The most critical person to speak with is your doctor.
Others at Cape Cod Healthcare who are involved with clinical trials and who will be able to assist you are:
Director of Research Compliance    508-862-5812
Co-Chair of the CCHC IRB    508-846-9076
Co-Chair of the CCHC IRB    508-778-8835
Cancer Clinical Research Nurse    508-862-5799