Point of Failure: How Specialization is Preventing the Advancement of Clinical Data Management (CDM) and What We Can Do About It
Information
Session chaired by Derek Lawrence
Description:
Since the introduction of electronic data capture (EDC) systems, clinical data management (CDM) has been in a 20-year evolution away from broad skill sets toward role specialization. Today’s CDM functional area contains dozens of specialities that span multiple data collection, analysis, and aggregation systems in addition to more operations-focused roles. Recent technology advancements – including diversification of data collection methodologies and solutions equipped with artificial intelligence (AI) and machine learning (ML) – have opened the door to unparalleled advancements in terms of CDM efficiency, performance, and quality.
These advances, while both necessary and welcome, have highlighted two key challenges among early adopters: process misalignment and knowledge fragmentation.
Legacy processes that depend on multiple roles with specialized skill sets are unable to scale and adapt to new technologies that are intended to streamline workflows by incorporating multiple aspects of complex tasks into single roles.
The operational and technical knowledge required to effectively leverage AI and ML features of newer tool sets can be spread across a number of different specialized roles, which further complicates adoption efforts.
The rapid evolution of clinical trial technology combined with recent data trends – including data source diversity, complexity, and volume – suggests not only that the approaches that CDM has historically used to tackle problems will be obsolete within 5 years, but also that many of our processes are ineffective and outdated even today.
Additionally, as CDM evolves into clinical data science (CDS), a broader knowledge across separate tasks and deeper technical knowledge that aligns with the near-future state of both tools and data will be required.
Without a significant change in processes and role responsibilities, CDM as a functional area is bound to fail and CDS will be delayed in its evolution as part of the new drug development paradigm.
This thought-provoking session will cover the current state of the CDM functional area across both pharmaceuticals and contract research organizations (CROs) in terms of resourcing, processes, and methodologies. It will also cover the opportunities presented by modern advances in the tech space and where they fit within established industry technologies, and where we as a functional area should rethink our approaches to data review/surveillance/monitoring, systems design and implementation, and professional development.
