Merck launches global network of cancer centers to accelerate cancer trials and improve collaborative research effor

Called the Merck Oncology Collaborative Trials Network, the partners in this initiative will work together to develop innovative treatments for different types of cancer

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CHICAGO—Seeking to improve collaborative research approaches to developing oncology treatments, Merck & Co. Inc. recently announced the launch of a pioneering clinical trial network of leading cancer research centers that will work with the company to develop its oncology drug and vaccine candidates.

Called the Merck Oncology Collaborative Trials Network, the partners in this initiative will work together to develop innovative treatments for different types of cancer, which according to the World Health Organization, kills 7.4 million people worldwide every year—making it the leading cause of death globally.

In announcing the network's launch June 3 at the 2010 American Society of Clinical Oncology (ASCO) Meeting in Chicago, Dr. Malcolm Moore, head of Medical and Hematological Oncology at Princess Margaret Hospital, noted Merck's commitment to advancing all aspects of cancer care, from prevention to treatment to supportive care. The company's oncology pipeline includes candidates that target key pathways and processes involved in the growth and progression of cancer, including PI3 kinase and other signaling pathways; DNA damage repair, cell-cycle and checkpoint pathways; developmental pathways; and novel cancer vaccines.  

Yet despite recent advances, there remains an urgent need for effective treatments for cancer, and the pace of traditional drug development often lags far behind the latest science, said Moore, who is also a scientist at the Ontario Cancer Institute. During its announcement at ASCO, Merck highlighted a recent Institute of Medicine report which found that about half of collaborative cancer studies are never completed due to cumbersome procedures, bureaucracy and poor coordination. The report suggested that collaborative research approaches could be improved by reducing the number of sites, properly funding research efforts, setting strict deadlines and prioritizing studies based on potential.

Those sobering statistics are what inspired Merck to form this network, Moore says.

"We are proud to participate in this unique network, which will create the access and the infrastructure for coordinated investigation of the latest clinical hypotheses in cancer research," Moore says. "The Merck Oncology Collaborative Trials Network could serve as a blueprint for how industry and research institutions can work together more efficiently and effectively to expedite the delivery of innovative cancer therapies to patients."  

The network is currently comprised of 15 sites in North America, South America,
Europe and Asia, and Merck is considering adding more, says Noreen Verbrugge, a spokeswoman for the company. Verbrugge adds that Merck sees value and opportunity in each of those regions.

"For example, Asia Pacific faces a growing cancer burden and different cancer types; Europe has high experience, high-quality sites and annotated tumor banks; North America has high experience and high-quality sites; and South America faces a growing cancer burden," she points out.

Current participants abroad are: The National Cancer Institute of Brazil (INCA) in Rio de Janeiro; Instituto do Cancer do Estado de São Paulo, Faculdade de Medicina da Universidade de São Paulo in São Paulo, Brazil; Princess Margaret Hospital and the Ontario Cancer Institute in Toronto; Institut Gustave Roussy in Villejuif, France; Chaim Sheba Medical Center in Tel Hashomer, Israel; Seoul National University Hospital and the Yonsei Cancer Center at Severance Hospital in Seoul, Korea; the Netherlands Cancer Institute in Amsterdam; Oslo University Hospital in Norway; and the National Taiwan University Hospital in Taipei, Taiwan.

American participants include the Mayo Clinic Cancer Center in Rochester, Minn., Scottsdale, Ariz., and Jacksonville, Fl.; the University of Texas MD Anderson Cancer Center in Houston; Memorial Sloan Kettering Cancer Center in New York City; the START Center for Cancer Care in San Antonio, Texas; and the University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center in San Francisco.

Partners were selected based on their capacity and track record for novel, early-phase trials, will enter into a pipeline-based, longitudinal relationship with Merck and will focus on streamlines administrative processes to reduce delays, Verbrugge says.

Through a rigorous proposal and feedback process, the research sites will lead the design and conduct of clinical studies up to Phase IIa of Merck's investigational oncology candidates. Every year, the network will enroll approximately 1,200 patients in 30 to 40 clinical trials. These studies will include investigator and company-sponsored trials.

Infrastructure to consolidate data, specimen testing results, imaging testing results, and patient outcomes is being developed. This goal of the network is to lead to more informed, data-driven, and rapid decision-making regarding the efficacy and safety profile of compounds and the utility of biomarkers developed by Merck or its collaborators, says Verbrugge says.

"The development timelines to bring new medicines to market to address to growing burden of cancer is too long," she adds. "Companies and institutions face different processes, multiple competing studies ongoing in same indications, different complex processes and systems. This network, focused on Phase 0 to IIa, will maximize efficiencies through long-term relationships. For example, we are focused on mutual prioritization and commitment (pipeline view, not protocol view), less administrative time, more science time, the standardization of protocols, start-up procedures, data capture, guidelines and dedicated site resource talking to dedicated MRL field staff."

Dr. Gary Gilliland, senior vice president of Merck Research Laboratories and head of the company's oncology franchise, says the network is a cornerstone of the company's strategy of accelerating drug and vaccine development for people with cancer.

"By partnering at an early stage with global centers of excellence and combining our strengths in key areas such as biomarkers, information technology and adaptive clinical trial design, we are fundamentally changing the way we evaluate and advance our oncology pipeline," Gilliland says.

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