Tilting the Playing Field in Clinical Development

Recent discussions with a large sponsor were a pleasant reminder that big doesn’t have to mean backward. This progressive company has made a start at adaptive (risk-based) monitoring. The goal of the clinical team is to achieve equal or better data quality at lower cost while prioritizing critical data and reducing timelines.

One reason that the sponsor is open to risk-based monitoring is that 100% SDV is failing to produce data as clean as the senior clinical team would like. They view 100% SDV not as a gold standard that adaptive monitoring should approach as a limit, but as a baseline that adaptive monitoring should at least match and preferably surpass. It is heartening that they are not thinking of adaptive monitoring as a cost-savings measure based on an arbitrary reduction in % SDV.

Furthermore, the sponsor shows an even more progressive mindset in recognizing that surrogate measures for data quality have an important role in adaptive monitoring. The senior clinical team accepts this idea based on hard-won experience. They know that sites with other performance issues are likely to submit data of poor quality. It’s just that current systems limit their ability to detect and correct problems before the damage is done.

While this large sponsor sees the potential benefits of adaptive monitoring and has an open mind and ambitious goals, one thing prevents rapid implementation of the type of adaptive monitoring systems that they would like: large-scale deployment of a CTMS and EDC system that lack the required capabilities. This problem is common if not universal among big pharma companies. Sheer scale substantially delays desperately needed operational improvements. Progressive thinking doesn’t guarantee progress.

No matter how insightful and progressive the clinical leadership is at large companies, they can embrace innovation primarily through pilot projects that don’t use their current systems. It will take years for them to implement the improvements that they want across all their development programs. These companies face a difficult choice: they can wait for their current vendors to develop sound approaches to adaptive monitoring or start building their own system based on licensed or internally developed intellectual property. Risks are high either way.

Small and midsize biopharma, take heart! Fewer barriers stand between you and an adaptive monitoring approach that provides greater efficiency, higher data quality and shorter timelines. If you have the expertise, you can upgrade your systems more quickly than your larger counterparts can. Better yet, you can identify an outsourcing partner with the adaptive monitoring capabilities you need.

The advent of a new generation of monitoring technology changes the competitive balance. Small and midsize pharma has an excellent chance to bring products to market ahead of large competitors hamstrung by their own infrastructure and inertia.

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