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Shared Expectations, Data Help Can Improve Site, Sponsor Collaborations

Clinical trial sponsors and research sites—citing the need for better communication and realistic expectations—are seeking to turn their sometimes adversarial relationship into one more focused on collaboration, representatives from across the research community said.

To that end, researchers are urging trial sponsors to curtail unnecessary communications and consider streamlining data collection, the representatives said during a webinar sponsored by WIRB-Copernicus Group.[1] At the same time, trial sponsors are providing technical assistance to sites that may be struggling with some aspects of a trial’s requirements, they said.

This shift in mindset means researchers and trial sponsors are working together more and no longer perceive themselves to be at odds with each other, explained MaryLou Watson, chief clinical research operations director, clinical trials office, the State University of New York (SUNY) Upstate Medical University.

“I think what we have seen at Upstate is a definite evolution of the relationship between sponsors and our site,” Watson said. “I think we were much more siloed and we didn’t communicate well with each other.” This relationship has changed, she said: “We currently are seeing much more of a collaboration and a back-and-forth relationship.”

This leads to more effective management of every aspect of the relationship, ranging from protocol input to having a master clinical trial agreement, Watson said. Also, she said, having a preferred site relationship with a trial sponsor “just expedites everything exponentially to get clinical trials up and running.”

Manny Lazaro, senior vice president of clinical development operations, Jounce Therapeutics, said that establishing two-way communication is critical to a trial’s success. He cited figures provided by WCG that showed a top site may have up to 214 trials underway at the same time. “So, setting realistic expectations and setting priorities [are] critical,” he said.

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