Tuesday, March 5, 2013

A Clinical Trials System for the 21st Century

By Samantha Mayberry, Program Assistant at FasterCures

Last month, a host of clinical trial and oncology experts at the Institute of Medicine's (IOM) “Implementing a National Cancer Clinical Trials System for the 21st Century” workshop discussed the great strides that have recently been made in the clinical trials space. The workshop, co-sponsored by the Institute of Medicine and the American Society of Clinical Oncology (ASCO), examined how the National Cancer Institute (NCI) has implemented the recommendations put forth in IOM’s 2010 report “A National Cancer Clinical Trials System for the 21st Century” with the goal of both evaluating progress against these recommendations, and identifying any outstanding gaps.

A January 2012 ASCO report details much of the progress discussed at the workshop, including the development of a centralized patient registration system amd a clinical trials data management system, as well as advancement in gaining coverage for trials through the Affordable Care Act.  However, the issues that remain clearly demonstrate that the current system is still being built to accommodate science as it was, not as it will be.

Specific issues include the fact that many NCI-run trials are not currently equipped for the rapidly-advancing science available in cancer therapeutics, particularly precision medicine, and the need for a clinical trials system run and regulated on an international scale rather than national systems for individual countries.

The NCI cooperative group program promotes and supports clinical trials for cancer therapies by coordinating researchers, cancer centers, and physicians to identify crucial issues in cancer research and design trials to answer these issues. Their goal is to make clinical trials more coordinated and efficient.

More than 30 experts from across NCI, academia, major pharmaceutical companies, cancer research institutes and biotech participated in the workshop. In a presentation to the group, FasterCures Executive Director Margaret Anderson pointed to the many innovative solutions being applied by the venture philanthropy community -- nonprofit disease research organizations that are moving away from the more conventional public charity model and instead are adopting the tools and techniques of venture capital finance, and the strategies and tactics of high-technology business management. One prime example is the Leukemia and Lymphoma Society’s Therapy Acceleration Program (TAP), which targets therapies in areas of high unmet medical need, specifically funding investigators who are performing research in those areas at all stages of clinical investigation.
Another trend prevalent among these organizations is the prominence of clinical trial matching tools and trial databases. Many provide opportunities for patients to register their data and/or run complete registries for trials within the disease they focus on, helping to alleviate some of the stress that academia and industry often face with patient enrollment. Finally, another unique ability of these organizations is the capacity to run clinical centers for research.

As NCI, industry, and academia seek out new models to help improve and accelerate the system, these venture philanthropies – many of whom are members of The Research Acceleration and Innovation Network (TRAIN) at FasterCures – provide a fertile nesting ground of ideas.

We look forward to seeing the official outcomes from the workshop and continuing to work with IOM and ASCO on this important issue.

Relevant Links:
• The webcast and presentations from the workshop can be found here.

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