Envisioning the site of the future
The drug development world has been notoriously slow to adopt change, but industry leaders and visionaries expect the clinical research enterprise to change dramatically.
Integration of healthcare data, the power of data and analytics, a rapid move toward more targeted therapies and customized treatments, along with the desire for a lower cost R&D model are among the forces driving transformation in the way the research environment will function in the future. As CenterWatch looks toward the decades ahead, we asked a team of experts, which included top-level executives and active investigators, to describe their vision of what clinical trials will look like in the year 2050. Many common elements emerged. The visionaries interviewed described a research environment where the traditional physical investigative site may not exist and one where clinical research and healthcare data become more integrated.
Preparing for the ICH E6 Revisions
In November 2016, the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued Step 4 of the new Good Clinical Practice (GCP) E6 (R2) guideline. A core principle of E6 (R2) is the integration of quality management (QM) and risk-based approaches to span the entire clinical trial process. The addendum embodies the concept of proactive planning for quality, oversight, preventive action and documentation.
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