melanoma face unique challenges. Addressing the rising incidence and unique
biology of human melanoma will require a well-defined process to access and provide
input to existing NCI drug development programs such as the Cancer Therapy
Evaluation Program (CTEP) and the Rapid Access to Intervention Development
(RAID) program. The procedures followed by CTEP for identifying new agents for
evaluation and introducing them into clinical trials should be streamlined, and
interactions between CTEP and RAID should be expedited. Currently, the
Investigational Drug Steering Committee (IDSC) is designed to provide NCI with
broad external scientific and clinical input for the design and prioritization of phase I
and phase II trials with agents. IDSC membership has included principal
investigators, representatives from the NCI Cooperative Groups, NCI staff members,
and additional representatives as ad hoc members for consideration of specific agents.
• To facilitate rational clinical trials of therapies for advanced melanoma, researchers
need improved access to new drugs and orphan drugs. Testing of combinations of
drugs from multiple sources, including pharmaceutical companies and academia, will
accelerate progress in melanoma research. This is currently hindered by legal liability
and intellectual property issues. Regulatory support, and the additional funding
required, should be provided to facilitate access to promising drugs for preclinical and
clinical studies relevant to melanoma, even if their application is limited to this
disease, in order to address legal and IP issues. Drug companies should be
indemnified against the risks of allowing their drugs to be combined in innovative
strategies to encourage participation in melanoma clinical trials.
• Lost-opportunity drugs should be identified, and funds should be devoted to
production, validation, and quality control for drugs that private industry is unwilling
or unable to develop due to the perception that the market is limited. This is
particularly relevant when the investigational agent is not expected to have single
agent activity, but could be essential as an adjuvant to a vaccine or supplement one of
the important, existing immunologic approaches in melanoma.
• The melanoma research community needs dedicated support for the efficient study of
scientific opportunities within timelines expected in the more common tumors.
Funding for innovative new trials, especially those using agents from CTEP or
prepared by the RAID program, should be increased. This can be accomplished by
leveraging existing programs and creating partnerships.
• Biological discoveries in trials of patients with advanced disease may inform the
research in premalignant and early-stage disease, as well as predict which patients will
respond to immunologic therapies such as interleukin, interferon, T-cell antibodies, or
other signaling pathways. The government has a unique opportunity to stimulate
scientific research simultaneously with federally-supported treatment trials. Funding
should be designated for bench-to-bedside translational research through those clinical
trials that have the greatest potential to improve melanoma survival.
• A high-priority should be to enhance infrastructure that supports clinical trials in rare
diseases. Rare diseases require a focused national accrual effort for early drug
development trials in addition to large, randomized Phase III trials. Single-institution
funding is not sufficient to coordinate a national infrastructure. Existing structures
such as the NCI Cancer Trials Support Unit (CTSU) could provide regulatory
coordination and access on a national scale for Phase II trials, allowing the pace of
scientific inquiry to approach that of trials in common tumors."
Source: Final Melanoma Action Plan of 2007 NCI
Final Melanoma Action Plan of 2007 NCI
“You Can’t Start a Fire Without a Spark!!”
We need everyone to work together and drop the GREED.
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Take Care,
Jimmy B
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