NBCC’s Criteria for Clinical Trials Collaboration

NBCC Clinical Trials Initiative Research Partnerships

The National Breast Cancer Coalition Fund (NBCC) Clinical Trials Initiative was developed to encourage and improve critical breast cancer clinical trials research, and increase access to high quality clinical trials for all breast cancer patients. A clinical trial is one of the final stages of a long and complex research process that identifies new interventions. It is a study involving individuals, carefully designed to answer a scientific question and find out whether a promising approach to prevention, diagnostic technique or treatment is safe and/or effective. As part of the Clinical Trials Initiative, NBCC works with research organizations to improve trial design and monitoring, increase access and accrual, educate the medical community and consumers, and promote initiation of high quality breast cancer trials.

Criteria for Trial Evaluation

Before forming a partnership with any trial sponsor to participate in one or more clinical trials, NBCC carefully evaluates the proposed clinical trials based on these principles:

1. The study must be designed to answer an important, novel question relevant to breast cancer.
2. The study must be a well-designed clinical trial. It must be scientifically rigorous, and employ appropriate and meaningful outcomes.
3. The study must be conducted in an ethical manner. There must be sufficient data supporting efficacy and safety that reasonable people believe the trial should proceed. Participants must have sufficient information to provide meaningful informed consent, and the study must be approved by an Institutional Review Board (IRB). The trial must employ mechanisms to provide adequate protection for participant privacy and the confidentiality of participant information. There must be a system in place such as a data and safety monitoring committee for evaluating the protocol and patient safety as the trial proceeds.
4. The research agreements between the trial sponsor and any academic/independent investigators must adhere to all of the guidelines for sponsorship, authorship, and accountability outlined by the International Committee of Medical Journal Editors’ “Uniform Requirements for Manuscripts Submitted to Biomedical Journals.” ¹ The academic or independent research institutions participating in the study must be involved in the design, recruitment, and data interpretation for the trial.
5. There must be a mechanism to adequately address NBCC’s concerns about the payment of costs for patient care for the trial’s participants.
6. The trial must adequately address NBCC’s concerns about the inclusion of a diverse population and inappropriate exclusion of specific populations.
7. The trial must meet NBCC’s expectations, which are listed below.

In a partnership between NBCC and a trial sponsor NBCC will contribute the following:

• NBCC will provide formal and informal input from knowledgeable patient advocates on study design and implementation.
• NBCC will assist in designing outreach materials to educate the public and potential trial participants.
• NBCC will assist with participant accrual by publicizing the trial on its website and other outreach methods and through its extensive grassroots network. NBCC will develop a strategy specific to the trial to help with accrual and outreach.
• NBCC will assist in designing an expanded access program, if and when it is deemed that such a program may be necessary.
• NBCC will do all that it can to make certain that ongoing information about the trial is disseminated as soon as possible.
• NBCC will attend meetings with regulators as appropriate.

NBCC expects the trial sponsor to provide the following:

• The sponsor will afford NBCC opportunities for meaningful input into study design and implementation.
• NBCC representatives will sit on study committees and data and safety monitoring committees and other advisory committees and panels
• NBCC representatives will attend investigator meetings.
• The sponsor will provide NBCC with opportunities for meaningful review of and input regarding safety data.
• The trial sponsors will provide NBCC with information about every breast cancer clinical trial they are conducting.
• To the extent feasible the sponsor will provide trial participants and breast cancer advocates with updates on the trial’s progress, status and results, even if the trial is cancelled or ends early.
• The primary results of the study will be published in full form in a respected peer-reviewed journal. The findings will be disseminated regardless of final FDA approval, the strength or direction of the results, or findings of significant adverse events.

Footnotes

¹ International Committee of Medical Journal Editors.  Uniform requirements for manuscripts submitted to biomedical journals: updated April 2010. (Accessible at www.icmje.org)