ASCO Shares Concerns Over the Future of Cancer Research

Colin Gittens

November/December 2010, Vol 1, No 6 - Clinical Research

George W. Sledge, Jr,  MDConcerns about the future of cancer research exist among the spectrum of researchers and regulators, and in remarks prepared for the President’s Cancer Panel: The Future of Cancer Research—Accelerating Scientific Innovation (held September 22, 2010, in Boston), American Society of Clinical Oncology (ASCO) President George W. Sledge, Jr, MD, outlined some of the organization’s concerns regarding new biological therapies and the future of cancer research.

The pace of trials has slowed even as the amount of targeted therapies has increased, he noted, and it is essential to have adequate funding and an adequately trained national research capability to maintain a comprehensive and effective clinical trials program. In addition, given new therapeutic approaches, it may be necessary to consider newways of conducting trials.

Among the challenges faced by researchers is inadequate existing infrastructure for biomarker analysis and the need to screen high numbers of patients to determine trial eligibility. In addition, understanding of cancer biology and the drivers of cancer development in multiple patients (with different patients having different drivers) is still emerging. Recruiting patients into clinical trials can be done at the community level, but not unless the current low payment levels are increased.

ASCO calls for a doubling of National Cancer Institute–funded cooperative clinical research to reinvigorate that system and ensure its future. In addition, the group emphasizes the importance of electronic health records to help drive clinical research.

The regulatory schema also needs simplifying, Dr Sledge wrote. Processes concerning institutional review boards (IRBs), informed consent, privacy rules, regulations surrounding the conduct of clinical trials, and the evaluation of efficacy end points need to be overhauled. Echoing the proposals of others, he suggests a centralized IRB review, a standard case report form, and a single approach across all sites.

Trials should also change with new technological developments, he argued, writing that “the incorporation of bioinformatic principles into clinical trial methodology is in its infancy, but [this] represents a clear requirement for future progress in the genomic era.” To ensure that investigators capable of conducting these types of trials are trained, Dr Sledge argued the necessity of a “trained, incentivized clinicaltranslational workforce.”