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Designing clinical trials to improve care for brain tumor patients

December 14, 2011
Dr. Mark Linskey

UC Irvine surgical oncologist Dr. Mark E. Linskey, along with colleague Dr. Susan Chang from UC San Francisco, have led the first-ever course for brain tumor specialists on the basics of designing and running brain tumor clinical trials during November’s annual meeting of the Society of Neuro-Oncology in Orange County, Calif.

Nearly 400 physicians and PhD researchers from disciplines including neurosurgery, medical neuro-oncology, general oncology, radiation oncology, neuropathology, and neuroradiology participated.

The course was so successful that the society, the world’s largest multidisciplinary professional group for physicians that treat and research brain tumors, is now considering offering a three- to five-day intensive course on brain tumor methodology, based on Linskey and Chang’s model.          

The event included lectures on Phase 0, I, II and III clinical trial design, defining optimal imaging and clinical endpoints, regulatory responsibilities and compliance, as well as a sharing of personal experiences running brain tumor clinical trials.

“Advancing the care and improving outcomes for patients with brain tumors can only come about through the development of and participation in brain tumor clinical trials,” Linskey said. “For these trials to have maximum benefit, they must be designed with the most rigorous methodology. Our course was an important first step in expanding this potential.”

Linskey has long been a leader in improving neurosurgery practices in the U.S.

In October, he received the Congress of Neurological Surgeons’ Distinguished Service Award for outstanding contributions to the field of neurosurgery.

As chairman of the joint CNS/American Association of Neurological Surgeons guidelines committee in 2008 and 2009, Linskey led the development of new treatment guidelines to improve the quality of care for patients with brain metastases. Such cancers travel to the brain from other parts of the body and account for nearly 500,000 new cases each year.

He also received the Trauma Intervention Program of Orange County’s 2011 Heroes with Heart award in October for his commitment to compassionate care.

Linskey is co-director, with neuro-oncologist Dr. Daniela Bota, of UC Irvine’s Comprehensive Brain Tumor Program at the Chao Family Comprehensive Cancer Center, the only National Cancer Institute-designated comprehensive cancer center in Orange County.