Rebranding Risk-Based Monitoring in Clinical R&D

With all of the buzz and excitement around risk-based monitoring (RBM), one might expect that the broad adoption of this emerging clinical research paradigm is well underway. Those familiar with the often painfully slow pace of innovation in the area of clinical R&D, however, will not be surprised by the more sobering reality that only a modest number of clinical trials have adopted a risk-based approach to site monitoring to date. Most organizations engaged in clinical research have been sitting on the edge of the risk-based monitoring pool, anxiously dipping their toes in the water but unwilling to dive in until enough others jump in first and confirm that the water is safe.