Expanding Public-Private Collaborations to Enhance Cancer Drug Development: A Report of the Institute of Medicine's Workshop Series, “Implementing a National Cancer Clinical Trials System for the 21st Century”

Abstract

Since their inception in the 1950s, the National Cancer Institute‐funded cancer cooperative groups have been important contributors to cancer clinical and translational research. In 2010, a committee appointed by the Institute of Medicine (IOM) of the National Academy of Sciences completed a consensus review on the status of the U.S. publicly funded cancer clinical trials system. This report identified a need to reinvigorate the cooperative groups and provided recommendations for improving their effectiveness. Follow‐up workshops to monitor progress were conducted by the IOM's National Cancer Policy Forum and the American Society of Clinical Oncology (ASCO) in 2011 and 2013. One of the key recommendations of the IOM report was a call for greater collaboration among stakeholders in cancer research. In particular, more active engagement and better alignment of incentives among the cooperative groups, the National Cancer Institute, the U.S. Food and Drug Administration, and the biopharmaceutical industry were identified as essential to achieving the promise of oncology drug development. This review, based on presentations and discussion during the IOM‐ASCO workshops, outlines the progress and remaining challenges of these collaborations.

Institutional Collaboration in Plastic Surgery Research: A Solution to Resource Limitations

“… 29 For example, the NIH experience with large clinical trials is now heavily reliant on industry support as private enterprise can harness their existing global network of diverse clinical trial sites instead of laboriously developing their own. 30 There are also drawbacks to this sort of partnership, particularly in the form of conflicts of interest. 31 It is, therefore, crucial that any conflict of interest is declared and that research is conducted with full transparency.…”

Conducting clinical trials—costs, impacts, and the value of clinical trials networks: A scoping review

“…13,69 Patients are also a scarce resource, with the number of patients treated in US National Cancer Institute (NCI)funded cancer cooperative group trials having declined from 29,000 in 2008 to 17,000 in 2015. 1 As Stensland et al 13 highlight, incomplete trials leave promising therapies untested and shift valuable patients and finances away from addressing other critical questions.…”

“…Industry can contribute resources-like new biological agents, finances, and trained personnel-to support trial operations. 1 Recent studies also show that industry can run efficient trials, 17,72 although its promptness may be motivated by the desire to market a successful therapy. 17…”

Defining a New Role for the National Cancer Institute Cooperative Groups: More Science, Fewer Trials

“…A funding increase for high-accruing sites is being implemented. The next step in the restructuring of the groups, as detailed in the report on IOM workshops elsewhere in this issue [3], will be to bring the groups into the mainstream of targeted cancer drug development.…”

“…The report of the IOM's Workshop Series on "Implementing a Cancer Clinical Trials System for the 21st Century," found elsewhere in this issue [3], offers a number of possibilities for new directions: comparison of multiple different agents for a given tumor subset; "basket" trials for a selected mutation (e.g., b-RAF or RET) and its targeted drug across multiple tumor histologies; trials in often neglected patient populations, such as children or the elderly; adjuvant trials in rare patient subsets; and combinations of drugs (with chemotherapy or with other targeted agents from different firms). Examples are provided of three new NCI group trials (L-MAP, MATCH, and ALCHEMIST) that require screening of extremely large patient populations (e.g., up to 8,000 in the L-MAP trial) to identify those with uncommon mutations and then assign appropriate patients to the logical new drug.…”