CHICAGO—Seeking to improvecollaborative research approaches to developing oncology treatments,Merck & Co. Inc. recently announced the launch of a pioneeringclinical trial network of leading cancer research centers that willwork with the company to develop its oncology drug and vaccinecandidates.
Called the Merck Oncology CollaborativeTrials Network, the partners in this initiative will work together todevelop innovative treatments for different types of cancer, whichaccording to the World Health Organization, kills 7.4 million peopleworldwide every year—making it the leading cause of death globally.
In announcing the network's launchJune 3 at the 2010 American Society of Clinical Oncology (ASCO)Meeting in Chicago, Dr. Malcolm Moore, head of Medical andHematological Oncology at Princess Margaret Hospital, noted Merck'scommitment to advancing all aspects of cancer care, from preventionto treatment to supportive care. The company's oncology pipelineincludes candidates that target key pathways and processes involvedin the growth and progression of cancer, including PI3 kinase andother signaling pathways; DNA damage repair, cell-cycle andcheckpoint pathways; developmental pathways; and novel cancervaccines.
Yet despite recent advances, thereremains an urgent need for effective treatments for cancer, and thepace of traditional drug development often lags far behind the latestscience, said Moore, who is also a scientist at the Ontario CancerInstitute. During its announcement at ASCO, Merck highlighted arecent Institute of Medicine report which found that about half ofcollaborative cancer studies are never completed due to cumbersomeprocedures, bureaucracy and poor coordination. The report suggestedthat collaborative research approaches could be improved by reducingthe number of sites, properly funding research efforts, settingstrict deadlines and prioritizing studies based on potential.
Those sobering statistics are whatinspired Merck to form this network, Moore says.
"We are proud to participate in thisunique network, which will create the access and the infrastructurefor coordinated investigation of the latest clinical hypotheses incancer research," Moore says. "The Merck Oncology CollaborativeTrials Network could serve as a blueprint for how industry andresearch institutions can work together more efficiently andeffectively to expedite the delivery of innovative cancer therapiesto patients."
The network is currently comprised of15 sites in North America, South America, Europe and Asia, and Merckis considering adding more, says Noreen Verbrugge, a spokeswoman forthe company. Verbrugge adds that Merck sees opportunity in eachregion.
"For example, Asia Pacific faces agrowing cancer burden and different cancer types; Europe has highexperience, high-quality sites and annotated tumor banks; NorthAmerica has high experience and high-quality sites; and South Americafaces a growing cancer burden," she points out.
Current participants abroadare: The National Cancer Institute of Brazil (INCA) in Rio de Janeiro;Instituto do Cancer do Estado de São Paulo,Faculdade de Medicina daUniversidade de São Paulo in São Paulo, Brazil; Princess Margaret Hospital andthe Ontario Cancer Institute in Toronto; Institut Gustave Roussy in Villejuif,France; Chaim Sheba Medical Center in Tel Hashomer, Israel; Seoul NationalUniversity Hospital and the Yonsei Cancer Center at Severance Hospital inSeoul, Korea; the Netherlands Cancer Institute in Amsterdam; Oslo UniversityHospital in Norway; and the National Taiwan University Hospital in Taipei,Taiwan.
American participants includethe Mayo Clinic Cancer Center in Rochester, Minn., Scottsdale, Ariz., andJacksonville, Fla.; the University of Texas MD Anderson Cancer Center inHouston; Memorial Sloan Kettering Cancer Center in New York City; the STARTCenter for Cancer Care in San Antonio, Texas; and the University of California,San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center in SanFrancisco.
Partners were selected based on theircapacity and track record for novel, early-phase trials, will enterinto a pipeline-based, longitudinal relationship with Merck and willfocus on streamlines administrative processes to reduce delays,Verbrugge says.
Through a rigorous proposal andfeedback process, the research sites will lead the design and conductof clinical studies up to Phase IIa of Merck's investigationaloncology candidates. Every year, the network will enrollapproximately 1,200 patients in 30 to 40 clinical trials. Thesestudies will include investigator and company-sponsored trials.
Infrastructure to consolidate data,specimen testing results, imaging testing results, and patientoutcomes is being developed. This goal of the network is to lead tomore informed, data-driven, and rapid decision-making regarding theefficacy and safety profile of compounds and the utility ofbiomarkers developed by Merck or its collaborators, says Verbruggesays.
"The development timelines to bringnew medicines to market to address to growing burden of cancer is toolong," she adds. "Companies and institutions face differentprocesses, multiple competing studies ongoing in same indications,different complex processes and systems. This network, focused onPhase 0 to IIa, will maximize efficiencies through long-termrelationships. For example, we are focused on mutual prioritizationand commitment (pipeline view), less administrative time, morescience time, the standardization of protocols, start-up procedures,data capture, guidelines and dedicated site resource talking todedicated MRL field staff."
Dr. Gary Gilliland, senior vicepresident of Merck Research Laboratories and head of the company'soncology franchise, says the network is a cornerstone of thecompany's strategy of accelerating drug and vaccine development forpeople with cancer.
"By partnering at an early stage withglobal centers of excellence and combining our strengths in key areassuch as biomarkers, information technology and adaptive clinicaltrial design, we are fundamentally changing the way we evaluate andadvance our oncology pipeline," Gilliland says.
