THE EVOLUTION OF CLINICAL DATA MANAGEMENT TO CLINICAL DATA SCIENCE: A REFLECTION PAPER ON THE IMPACT OF THE CLINICAL RESEARCH INDUSTRY TRENDS ON CLINICAL DATA MANAGEMENT
As SCDM is celebrating its 25th year anniversary, the SCDM Innovation Committee seeks to raise awareness on the upcoming industry trends affecting Clinical Data Management (CDM) and prepare for its evolution toward Clinical Data Science. In the context of this reflection paper, Clinical Data Science is defined as the strategic discipline enabling data driven Clinical Research approaches and ensuring subject protection as well as the reliability and credibility of trial results. Clinical Data Science encompasses processes, domain expertise, technologies, data analytics and Good Clinical Data Management Practices essential to prompt decision making throughout the life cycle of Clinical Research.
The target audience for this reflection paper is broad‐based clinical data management professionals ‐ from Subject Matter Experts (SMEs) executing CDM activities for their clinical studies to CDM Leaders setting the direction for their organizations.
The main objective of this paper is to provide a forward‐looking and pragmatic view on why and how emerging study designs, regulations and technology innovations are reshaping the role and profile of CDM. This paper particularly examines the industry drivers and trends in Clinical Research and their direct impact on CDM. The paper concludes by providing organizations, leaders and SMEs initial insights on the evolution of the CDM role and associated best practices in our journey from traditional Clinical Data Management to Clinical Data Science.
The SCDM Innovation Committee intends to release subsequent papers and/or articles which will provide deeper insights on specific areas of change summarized or introduced in this paper such as technology enablers and the CDM role evolution.