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Home > Publications > Cancer Program Guidelines > Chapter 5

Cancer Program Guidelines

Chapter 5: Clinical Research

Guideline I
Cancer patients are provided access to clinical research programs.

Rationale
The great majority of cancer patients receive their care from community oncologists and community cancer centers.  All cancer patients and their physicians should have access to clinical trials, which often provide the most advanced and promising new therapeutic options.  In many cases, the best treatment plan for a cancer patient is a well-designed clinical study.  Clinical trials typically address important clinical questions and bring the latest basic science discoveries to the patient.  They frequently represent the best pathway for advancement of knowledge while protecting the safety, prerogatives, and confidentiality of the patient.

Research by community oncologists and community cancer centers also involves treatment, prevention, diagnostic, screening, and quality of life (supportive care) trials, all of which should be available to patients with cancer or those at high risk for cancer.

The mechanism for providing information to patients in the community setting regarding the availability of appropriate clinical trials should be established and documented.

Characteristics

  1. The research conducted is in the best interest of the patient. Providers in the community setting should demonstrate an understanding of the scientific research process before engaging in clinical research.
  2. An Institutional Review Board (IRB) is responsible for the review and approval of all protocols involving human subject participation.
  3. Information on the availability of clinical trials, in general, and nformation on specific clinical trials, in particular, should be offered to patients as appropriate.
  4. Participation in clinical trials may include:
    1. Participation in National Cancer Institute-sponsored programs such as the Community Clinical Oncology Program (CCOP) or Clinical Trials Support Unit (CTSU)
    2. Participation in cooperative trials groups
    3. Participation in comprehensive cancer center or university-related research
    4. Participation in industry-sponsored pharmaceutical or biotechnological research
    5. Development and participation in locally generated, peer-reviewed, scientifically sound, and rigorously managed research studies.
  5. Cancer research may include, but is not limited to:
    1. Treatment-related clinical trials
    2. Quality-of-life evaluation and recommendations
    3. Symptoms management
    4. Economics of cancer care
    5. Survivorship issues
    6. Outcome evaluation of all research efforts
    7. Effectiveness of psychosocial interventions
    8. Hospice and terminal care
    9. Diagnostic trials
    10. Screening trials.
  6. The Cancer Committee is responsible for assuring accrual to clinical trials of the minimum percentage of annual analytic cases, as defined by the cancer program category of the American College of Surgeons Commission on Cancer. In lieu of an active research program, the Cancer Committee assures that patients have information about and access to other avenues for accessing clinical trials.

REFERENCES

Please note: While every attempt has been made to ensure the accuracy of the publications, addresses, phone numbers, and websites, ACCC cannot ensure that this information has not changed. Web addresses, in particular, change frequently. If you find that a web address has changed, try to locate the publication name through an online search engine.

  1. American College of Surgeons. Commission on Cancer: Cancer Program Standards 2009. www.facs.org/cancer/coc/cocprogramstandards.pdf.
    Pages 65-66. Phone: 312.202.5085.

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