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Clinical Trials Services

Innovation today to benefit health care tomorrow

Fairview Clinical Trials Services (CTS) brings together people and resources to make drug-related clinical trials run smoothly. It moves research into the community and closer to our patients.

We ensure successfully completed trials in a responsible, timely and ethical manner.

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We work behind the scenes to locate patients and process the paperwork so that Fairview-affiliated investigators and trial sponsors can concentrate on the research at hand.

Why are clinical drug trials done?
  • To improve patient care
  • To get innovative drugs and therapies approved by the Food and Drug Administration
  • To ensure these drugs and therapies are safe and effective
  • To have physicians on the "cutting edge" of clinical medicine

Services
  • Protocol consultation
  • Site recruitment and qualification
  • Trial management
  • Regulatory management
  • Data management
  • Quality assurance

A strong network of resources
Fairview Health Services - the parent company of CTS, Fairview Pharmacy Services and Fairview Research Administration - is a leader in health care delivery, from prevention and disease management to the most complex, life-threatening injuries and illnesses.

Fairview is home to the Minnesota Heart, Vascular and Stroke Clinic, the Brain Tumor Center of Minnesota and a Robert Wood Johnson Foundation-designated Palliative Care Leadership Center with services extending throughout Minnesota.

In partnership with the University of Minnesota Academic Health Center and University of Minnesota Physicians, Fairview educates and trains two-thirds of Minnesota's health care professionals and provides medical services to residents across the state.

Participating in a research project

Research in medicine and health care is at the core of all advances in treatments and cures. Without research leading to new knowledge, many of the procedures so common today would not exist.

Today's research will fuel tomorrow's treatments and cures.

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Seeking volunteers, including men and women of all ages.

We need volunteers to make research work
You can help develop new knowledge by participating in research. In carefully controlled research protocols, our physicians and scientists work to find out what works best, whether it's a new medication or a better way to educate patients about diabetes.

Fairview and its partners, including the University of Minnesota, support research that improves health care for patients.

Who should participate?
Researchers who work with Fairview are actively seeking a wide range of research volunteers, including men and women, children and the elderly, from a variety of ethnic backgrounds and regions.

Research is most successful when we can learn how various treatments or therapies work with various types of people.

What do you need to know?
Before taking part in any type of health care or medical research, there are a number of questions you should ask to ensure you fully understand and are comfortable with the project and your role.

Following are a list of issues to address:

Make certain all information about the research is clear to you
Researchers should clearly explain to you the purpose of the research. Make certain you understand:
  • The background for the study
  • Any previous testing done
  • Who is sponsoring the research
  • Details about your participation

Understand the oversight and review committees in place
There are a number of federal and local organizations that review research practices and protocols, including the National Institutes of Health, Food and Drug Administration and the Office of Human Research Protection (OHRP).

Fairview and its partners have received permission from the OHRP to conduct research, because we've demonstrated our commitment to protect participants. This commitment includes the review of all research by a local committee called an Institutional Review Board, which includes health professionals as well as non-medical representatives. The IRB ensures there are appropriate protections for those who participate in research and the research doesn't create unnecessary risk for the participants. The IRB has the authority to require changes to the research or to stop the research if necessary.

What a researcher will tell you
Researchers will explain all anticipated benefits and risks associated with the research, as well as any potential for discomfort. In addition, you will receive information about what to do and who to contact if you become ill or have any concerns resulting from the research.

You also will receive the names and phone numbers for the researchers in charge of the study. You are welcome to contact them at any time with questions or concerns. In addition, you will receive contact information for the Patient Relations Department in the event you would like to talk to someone other than the researchers about your participation in the study.

Participation is always voluntary
After learning about a research study, you may choose to participate or refuse. Signing a consent form for a research study does not commit you to participate. You are free to change your mind at any time and leave the study. Your relationship with your regular doctor, Fairview Health Services and its partners will not be affected by your decision to withdraw from a research study.

Any financial costs will be explained up front
The researchers will inform you of any costs associated with participating in the study. They will explain how these charges are billed and who is responsible for them. You will receive information about who to contact with research billing questions.

You are entitled to know how the research data will be used and who has access to the information
Researchers generally keep study records for a minimum of two years and will explain exactly how they track your participation and how it is documented.

Information about your research participation may be included in your medical record. Research records are kept confidential; however, there are circumstances when these records may be reviewed.

Data that researchers collect from you are coded to assure that no identifying information about you is part of the study. The researcher or research sponsor collects the data, analyzes it and often publishes the results. No research subjects are identified in any research publications.

To obtain information about research projects, ask your doctor if there is a clinical trial that might be right for you.

Principal investigator

CTS provides infrastructure that enables Fairview Physician Associate physicians to participate in drug-related clinical trials. We give them direct assistance in conducting clinical trials and a framework for working with trial sponsors.

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The CTS Approach

Protocol evaluation
  • Solicits and reviews protocols from trial sponsors
  • Sends trial abstracts to prospective principal investigators for review
  • Secures site participation

Bring protocols to physicians that:
  • Are of interest to the physician
  • Are appropriate for their patient populations
  • Have scientific merit

Study start-up and ongoing support (in collaboration with principal investigator)
  • Prepares and submits IRB (Investigational Review Board) application
  • Develops and negotiates budget with sponsor
  • Signs agreements with sponsor
  • Begins protocol implementation
  • Assists in patient recruitment and scheduling
  • Has on-site trial coordinators for patient visits
  • Provides all legal and regulatory support
 
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