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| Clinical Trials Initiative |
In 1996, the National Breast Cancer Coalition launched a new program in the fight against breast cancer - a Clinical Trials Initiative. Because we do not know how to prevent or cure breast cancer, or how best to treat it, we need clinical trials to help find the answers.
Currently, less than three percent of adult cancer patients in the United States participate in clinical trials. Many trials either take too long - or are not long enough - or never accrue a sufficient number of patients. In addition, many trials are not designed to address important patient interests and concerns. The National Breast Cancer Coalition has trained its member organizations so that the issues surrounding clinical trials are high on their agenda. Our members recognize that clinical trials are research questions they must help answer. As activists, we must understand trials from a scientific, political and medical-care perspective, and we must become players in their conception, design, accrual and implementation. That means having the skills and the tools necessary to be at the table when trials are designed and implemented. We must also design public policies that will facilitate quality clinical trials. That means having the knowledge and credibility necessary to get the right laws enacted. The Clinical Trials Initiative addresses all three of NBCC's goals:
Research Partnerships: NBCC works with research organizations to publicize to our membership the existence of particular trials that meet our criteria (NBCC's Criteria to Evaluate Quality Clinical Trials). Activists who have been trained through Project LEAD® will participate in the design and oversight of specific trials. To that end, NBCC will work with pharmaceutical and biotechnology companies, the National Cancer Institute (NCI) and other research institutions to link trial investigators with our activists around the country who have been trained through our programs. This "link" will enable our member organizations to help specific trials accrue patients. Consumer advocates, if involved in research as substantive collaborators, can offer important insights in designing clinical trials and invaluable assistance in increasing awareness and knowledge of clinical trials within the breast cancer community. In 1996, NBCC partnered with the biotechnology company, Genentech, to design and implement a Phase III clinical trial of the drug Herceptin®. Herceptin® improves survival and disease progression rates in women with metastatic breast cancer who overexpress HER2. NBCC helped design an expanded access program for the drug, served on the Data Monitoring Committee and served on the Steering Committee of the trial. Advocates reviewed and revised the trial protocol, and they attended all major principal investigator meetings. Finally, NBCC used its networks in the breast cancer community to raise awareness about the trial and to facilitate patient accrual. In this groundbreaking collaboration, advocates and industry worked together to bring a life-saving breast cancer treatment to market. NBCC has been active in the implementation of the following clinical trials:
NBCC designed the Clinical Trials Initiative to empower and enable its members to make a meaningful contribution to the clinical trials research process. We want to eradicate breast cancer, so we are putting clinical trials high on our agenda. We must make certain that the right questions are asked and that trials accrue enough participants to answer these questions. NBCC hosted a Clinical Trials Summit in 2001, which brought together multi-disciplinary experts in order to discuss ways to improve the scientific, regulatory and economic climate in which clinical trials are conducted. NBCC does not accept any compensation from industry for any of its work in our Clinical Trials Initiative. Clinical Trials Resources on the Internet: Given the rapid growth of web sites attempting to provide consumers with a database of all the clinical trials being conducted, NBCC is developing tools to become a &uqot;watch dog" of clinical trials and tools to guide consumers through this new landscape of databases. Ten things to know when evaluating medical resources on the Web will help inform consumers to find the best available information and understand the strengths and weaknesses of each of these sites, as well as the quality of the trials themselves. Legislative: NBCC worked with members of Congress to pass legislation that will improve the quality of clinical trials and patient access to clinical trials. In June 2000, President Clinton issued an Executive Memorandum requiring Medicare to reimburse all routine patient care costs for those participating in clinical trials. While passage of the Breast and Cervical Cancer Treatment Act will ensure that thousands of low-income women have access to the breast cancer treatment they deserve, that act alone is just one step in ensuring access to quality breast cancer treatment for all women. NBCC is therefore working to ensure access to care for all uninsured and underinsured women. See NBCC's legislative priorities. Education and Training: Project LEAD® and the Annual Advocacy Training Conference train our members to understand and critically analyze clinical trials. In addition, we publish information in our membership newsletter about the importance of clinical trials and about specific trials. Through its Clinical Trials Initiative, NBCCF intends to expand our outreach to educate the community about trials as advocacy. Clinical Trials Project LEAD®, an advanced course for Project LEAD® graduates that is offered every other year, trains its students to participate in all levels of the clinical trials process from evaluating trial design to serving on Institutional Review Boards and Data Safety Monitoring Boards. Clinical Trials Project LEAD® graduates will represent NBCCF in research partnerships. As NBCCF partners with more industry clinical trials, we will need a fleet of advocates who are trained to participate in the trial review process. NBCCF develops Fact Sheets and Analyses that explain the findings of important clinical trials for the public. These publications deliver the results of different clinical trials in lay terms and identify important issues so women can assess research for themselves. NBCCF also develops resources for consumers who are monitoring breast cancer research. One example is the Drug Fact Sheet, an index providing basic information about breast cancer drugs. These resources enable NBCCF and its consumers to evaluate research and advocate for high-quality studies. For more information about the NBCC Clinical Trials Initiative, contact NBCC's Programs Department at (202) 296-7477 |
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