American College Of Surgeons - Inspiring Quality: Highest Standards, Better Outcomes

Standard 3.2: Clinical Trial Accrual

Two percent (2%) or more of all eligible breast cancer patients are accrued to treatment-related breast cancer clinical trials and/or research protocols annually.

Definition and Requirements

Clinical research advances science and patient care. The center must demonstrate that efforts to enroll eligible patients in clinical trials are being made and that the center meets or exceeds the two percent annual accrual rate. The National Accreditation Program for Breast Centers (NAPBC) recommends inviting the clinical trials nurse and/or other research leaders to the multidisciplinary breast cancer conference (MBCC).

Eligible patients are those patients:

  • Seen at the center for diagnosis and/or treatment and placed on a clinical trial through the facility
  • Seen at the center for diagnosis and/or treatment and placed on a trial through the office of a staff physician
  • Seen at the center for diagnosis and/or treatment and placed on a trial through another facility
  • Seen at the center for any reason and placed on a prevention or breast cancer control trial

Treatment-related clinical trial groups include, but are not limited to:

  • NCI-sponsored programs such as the Community Clinical Oncology Program (CCOP)
  • Cooperative trial groups such as the Alliance for Clinical Trials in Oncology
  • University-related research
  • Pharmaceutical company-sponsored research
  • Locally developed, investigator initiated trials

In addition to well-established clinical trials, research conducted at the local level offers patients the opportunity to contribute to treatment, prevention, diagnostic, screening, and quality-of-life trials.

Local breast cancer research studies include, but are not limited to:

  • Primary prevention
  • Early detection
  • Quality-of-life evaluation and recommendations
  • Symptom management
  • Economics of care
  • Diagnostic and screening trials
  • Psychosocial interventions
  • Prospective cohort studies (registry)

Process Requirements

Centers must accrue eligible patients to breast cancer-related clinical research at the minimum percentage rate of two percent (2%) annually. Accrual is tracked by the following research study categories:

  • Interventional trials
  • Screening
  • Tissue collection
  • Behavioral
  • Registry
  • Investigator initiated

Centers participating in clinical research show that an independent review mechanism consistent with national standards is in place and used. Research projects involving participation by human subjects must be approved by an internal or external institutional review board (IRB). Patients participating in clinical trials must give their informed consent.

A study coordinator, data manager, or other clinical research professional is available to assist in enrolling patients, monitoring patient accrual, and identifying and providing information/education about new trials.

Patient accrual and compliance is reviewed annually by the Breast Program Leadership Committee (BPLC).

Documentation

Complete all required standard fields in the Survey Application Record (SAR).

Track accrual by research study category.

Document the center’s accrual rate and annual audit by the BPLC in the meeting minutes.

Evaluation

The surveyor will review and discuss the clinical trials program and accrual rate during the site visit.

Rating Compliance

Compliance

  1. Two percent (2%) or more of all eligible breast cancer patients are accrued to treatment-related breast cancer clinical trials and/or research protocols annually.
  2. Compliance is reviewed annually by the BPLC and documented in the meeting minutes.

Noncompliance

The center does not fulfill one or more of the compliance criteria.

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