Innovation in protocol design showing signs of success

“New approaches to protocol designs are already yielding positive results,” was the take-home message from Ken Getz, associate professor and director of sponsored research at Tufts Center for the Study of Drug Development, at a round-table discussion with leaders from across the research-based drug industry.

Growing protocol complexity, which causes longer clinical study times, greater difficulty in recruiting volunteers, and rising drug development costs, is spurring new approaches to optimizing protocol design.

“Drug developers are making headway in changing and streamlining protocol design that will have a major downstream impact on clinical trials performance and success,” said Getz after the meeting. Among these improvements are the establishment of internal governance mechanisms that promote cross-functional collaboration and ensure higher levels of clinical trial efficiency and feasibility.

Key points of the discussion are summarized in the April Tufts CSDD R&D Management Report.