In an effort to streamline its cancer research, Merck has launched the Merck Oncology Collaborative Trials Network, a collection of key oncology-focused investigative sites around the world with which Merck will work exclusively on promising compounds during early phases.
Eliav Barr, vice president of projects and pipeline management for Merck, said the point is to create a brain trust with top investigators in the therapeutic area, getting them involved very early in a compound’s life—something that’s not typical in drug development now.
“It’s not Merck dictating to the sites: ‘Here’s what the study is, here’s the protocol,’” Barr said. “Rather, we’ll say, ‘Here’s a Merck compound, it targets this and this receptor, how would you explore this molecule?
Where do you see an interesting way of figuring out if this has efficacy or not?’ The notion is: give investigators complete insight (to the compound) and intellectual freedom to say to us, ‘This is how we think you should do this.’ They can look at our pipeline and work through all of the issues related to a compound’s efficacy, and match drugs to their patient population.”
The plan is to enroll approximately 1,200 patients in 30 to 40 clinical trials each year. This is good news for the 15 sites Merck has chosen for inclusion in the network, and for the five more that are in the final stages of negotiation for inclusion now. For all other sites Merck had been working with on phase I and IIa research in oncology, it is bad news for now.
But the many sites working with Merck on later-stage cancer trials need not fear. “It’s not like we’re breaking our relationship with everybody,” Barr said. “Later-stage trials of 250 patients at lots of sites are still needed.”
Barr established a similar collaboration within Merck in the area of vaccines, and one of the results was Merck’s blockbuster human papillomavirus vaccine Gardasil. Barr said he hatched the idea for a Merck oncology network in 2008 and spent all of 2009 meeting with sites, explaining the concept to them and hammering out master contracts to reduce delays at study start up.
Now, each of the 15 chosen sites are at work on at least one study with Merck. Barr said most have had a long relationship with the company, but some haven’t, and were chosen instead because they’re in an up-and-coming part of the world for research, they have “a dynamic physician,” or are known for elegant late-stage research in oncology and are eager to get into early phase. The vast majority are academic medical centers.
The sites that are new to the sponsor include National Cancer Institute of Brazil in Rio de Janeiro; Instituto do Cancer do Estado de São Paulo, Brazil; Faculdade de Medicina da Universidade de São Paulo, Brazil; and Chaim Sheba Medical Center in Tel Hashomer, Israel. The other sites are: Princess Margaret Hospital and Ontario Cancer Institute in Toronto, Canada; Institut Gustave Roussy in Villejuif, France; Seoul National University Hospital in Seoul, Korea; Yonsei Cancer Center, Severance Hospital, Yonsei University Health System in Seoul; Netherlands Cancer Institute in Amsterdam; Oslo University Hospital in Norway; National Taiwan University Hospital in Taipei; the Mayo Clinic Cancer Center sites in Rochester, Minn., Scottsdale, Ariz., and Jacksonville, Fla.; the University of Texas MD Anderson Cancer Center in Houston; Memorial Sloan Kettering Cancer Center, New York City; START Clinic in San Antonio, Texas; and University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.
The network is essentially a five-year experiment. After that, Barr said Merck will reevaluate it. But he’s not worried. “Everyone’s trying to create new models, more efficiency, ways to break out of the lull in productivity in the research labs. I’m very optimistic this is the right way to go,” he said.