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Clinical Trials

At the Karmanos Cancer institute (KCI), patients may be offered several treatment options for their type and stage of cancer.  One of these options may include an offer to participate in a clinical trial.  These are studies widely-believed to be among the best options for most cancer patients.  They seek to answer questions that we hope and expect will lead to better ways of preventing, diagnosing, and treating cancer, while improving quality of life.

Karmanos offers more than 400 clinical trials developed and sponsored by our own physicians and researchers, major pharmaceutical companies or national cooperative group programs which are funded by the National Cancer Institute (NCI). 
Choosing to participate in a clinical trial is an important personal decision and one that only the patient can make with the help of physicians, family members and friends.

What is a Clinical Trial?

A clinical trial is defined as a research study that evaluates new approaches to the prevention, diagnosis and treatment of cancer.  These trials can also include the study of patient quality of life/comfort, behavioral, psychosocial (the impact of cancer) and genetic questions that researchers would like to answer.  They involve human participation and can also be referred to as “clinical studies”, “research protocols”, and “medical research”.  

What are the Different Types of Clinical Trials?

Karmanos offers many different types of clinical trials including: 
  • Treatment- tests new cancer treatments, new combinations of drugs, or new approaches to surgery or radiation therapy
  • Prevention- exploring better ways to prevent cancer in people who have never had the disease or to prevent a cancer from recurring. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes
  • Diagnostic- conducted to find better tests or procedures for diagnosing a cancer
  • Screening- test the best way to detect certain cancers
  • Quality of Life (or Supportive Care) - explore ways to improve comfort and quality of life for individuals with cancer

What are the Phases of Clinical Trials?

  • Phase I- researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects
  • Phase II- the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety
  • Phase III- the experimental study drug or treatment is given to large groups of people (1000-3000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely

Why Are Clinical Trials Important?

The purpose of clinical trials is to develop improved treatments that cure or control cancer, while providing an improved quality of life. They are necessary to identify more effective interventions before they can be considered standard of care and offered to other patients.   Standard of care is defined as the best treatment we have at this time, based on previous research.  Today’s standard of care was yesterday’s clinical trial.  Today’s clinical trials will lead to tomorrow’s standard of care.  

Who Can Participate in a Clinical Trial?

Every study has specific eligibility requirements designed to recruit patients that will best answer the research question.  These requirements help make sure that patients in a trial are similar to each other in terms of specific factors such as age, type and stage of cancer, general health, and previous treatment. When all participants meet the same eligibility criteria, it gives researchers greater confidence that results of the study are caused by the intervention being tested and not by other factors.

Are Clinical Trials Safe?

Risks and side effects exist with standard care or a clinical trial.  Many safeguards are in place to make clinical trials as safe as possible and protect patients.  Before a human subject receives a new therapy, it is carefully studied in the laboratory.  Laboratory research determines how best to use the new methods with people safely and effectively.  Any research involving patients at the Karmanos Cancer Institute must be approved by the Institutional Review Board (IRB).  The IRB is made up of doctors from different specialties, ethicists (often a chaplain), administrators, and members of the community.  An IRB is required by the U.S. Food and Drug Administration (FDA) to ensure protection of the rights and welfare of patients who are enrolled in clinical trials.  Therefore, the IRB is authorized to review, require changes to, approve, or disapprove research studies.

Through a process called informed consent, the patient is given ample time and opportunity to inquire about details of the trial before making a decision to participate.  Once registered to the clinical trial and treatment begins, the patients are carefully monitored by the physicians, Research Nurses and clinical staff.  Blood tests, x-rays, and other procedures are performed regularly to detect and record any changes, good or bad, in the patient’s condition. This monitoring provides valuable data for making patient care decisions and documenting research results.

For More Information

  1. Speak with your physician.
  2. Call (800) KARMANOS (1-800-527-6266) and speak with one of our information specialists.
  3. E-mail info@karmanos.org
  4. Visit the Institute's clinical trials website.
  5. Call (800) 4-CANCER (1-800-422-6237), the National Cancer Institute's Cancer Information Service, or visit its website: www.cancer.gov
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The Barbara Ann Karmanos Cancer Center is accredited by The Joint Commission.
If members of the public have any quality-of-care or safety concerns, they may notify The Joint Commission at 630-792-5800.