The Merck Oncology Collaborative Trials Network, newsworthy for many reasons, also is a classic technology symbiosis. In it, drug development technology and information technology pair for mutual benefit.
The network represents a breakthrough strategy for speeding the company's cancer drug development efforts. It joins the pharma giant with 15 clinical sites around the world. They will collectively create and access a cancer drug data infrastructure that will aid researchers in coordinated investigations of clinical hypotheses in cancer research.
"IT is critical to the success of clinical trial programs," says Eliav Barr, VP at Merck Research Laboratories, in a phone interview with FierceBiotechIT. "We want to help sites standardize. When we looked around, each site had a separate database and procedures. That reduces their ability to share data and collaborate on trials."
One goal is to facilitate sites' ability to develop common databases. "We're looking at various models now," Barr says.
He adds that Merck has been looking at its own drug development processes over the past few years and asking investigators around the world for their ideas on how to streamline processes and enhance collaboration. He says he found an imbalance in how researchers spend their time--heavy on administration, light on scientific time. That finding has led to an early focus in the development of the trials network on such tasks as contract negotiations and intellectual property ownership agreements.
Drug sponsors have enormous requirements surrounding their data, says Barr. But the proof-of-concept studies of interest to investigators don't require the same level of administrative rigor required in most other big pharma work. "For research sites, we're facilitating the creation of a network--an easy-to-assemble network that will let them use our tools to increase the scope of research."
Early IT efforts in the development of the trials network will encompass standardization of data management and review processes, Barr says. He notes "unnecessary variability" in how clinicians ask questions, collect data, enter data and validate it. "It's often just a matter of the flavor the day," he says. More standard case report forms, for example, can do much to aid collaboration among sites.
"We're proactive in reducing variability and workload," says Barr, "and in giving researchers a deeper opportunity to see our data." - George Miller