Rebranding Risk-Based Monitoring in Clinical R&D

July 29, 2014
Guest Blogger

Pharmaceutical Executive

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.

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.

Redefining this paradigm may help dispel current misperceptions around RBM and better deliver on the promise of this growing approach, writes Stephen Young in this Applied Clinical Trials article.

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