• developed a science course designed to educate advocates in the basic science, medical language, and concepts of breast cancer, as well as in the breast cancer research decision-making structure;
  • developed a program to educate members of Congress and their staffs on the science, health care, and medical practices that are important for implementation of policies related to breast cancer;
  • launched a breast cancer political campaign;
  • brought together more than 250 breast cancer activists from 43 countries to help create or expand networks and collaboration, as well as to share information, ideas, and strategies in the fight against the disease;
  • developed a program to educate and train the media in the tools essential for critical analysis of information on breast cancer before relaying that information to the public; and
  • initiated the Clinical Trials Project, which educates NBCC members on the importance of clinical trials and trains them to work in partnership with industry and the scientific community to expedite the conduct of clinical trials. Such trials provide an opportunity to involve consumers in the search for answers to research questions that may subsequently result in important new advances in the field.

Among the many reasons why NBCC has been successful in achieving its mission and has realized many accomplishments since its inception has been its persistent focus on three goals:

  • research—increasing appropriations for peer-reviewed research and working within the scientific community to concentrate research efforts on breast cancer prevention and finding a cure;
  • access—increasing access for all women to high-quality treatment and care and to clinical trials to treat breast cancer; and
  • influence increasing the influence of women who live with breast cancer as well as other breast cancer activists in the decision-making process.

An industry representative found it encouraging that FDA reviewers were discussing the probability of collecting fewer data and asked when it would be most appropriate to hold such discussions in the review process. FDA personnel suggested that such discussion should be integrated into meetings on protocol design, before the clinical trial is actually launched. Although a regulatory agency may never have a concrete answer to what is considered sufficient data or sufficient quality, it is best for sponsors to discuss such questions early in the development process.



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