Clinical development advancements continue to evolve the plethora of processes included in executing clinical trials – yet costs continue to rise, timelines get extended, and patients wait longer for potentially life-changing treatments.
Technology and the breadth and depth of curated healthcare data sources continues to grow. Advanced analytics, artificial intelligence, and predictive analytics provide faster, more precise decision-making – yet adoption of these advancements continues to lag.
As clinical development evolves to a new age of trial conduct models, there is an increasing awareness of the need for practices that enable closer engagement with patients and for increased adoption of the rapidly changing technology landscape.
At IQVIA, we’re delivering on a clinical development strategy aligned towards more effective process and providing technology solutions that can adapt and leverage the change in trial designs, data sources and the fast-paced world of digital transformation. Technology is pushing the envelope for clinical trials toward digitization and virtualization. Both consumer and medical grade devices are seeing new entrants like wearables, sensors, connected devices, telemedicine, eConsent, etc. that imply an essential change to the approach of how clinical trial data is collected and monitored. And that has a definite impact on how we are managing the clinical monitoring workforce across the industry.
Currently, access to patients and monitoring of clinical investigator sites are the biggest factors driving costs higher and delaying completion of clinical trials. The increasing complexity of clinical trial systems and protocol designs needs novel and robust approaches to provide better patient safety, data quality and operational efficiency. This evolution highlights the value of models like risk-based monitoring (RBM) and centralized monitoring, and how these can further facilitate the digital trial to reduce study monitoring costs and improve the ability for monitoring and managing data quality and subject safety.
This paper will discuss specifically the component of clinical monitoring and the transforming role of Clinical Research Associates (CRA/site monitor) as part of the future of clinical trials. The scope of this discussion includes aspects of innovative and emerging clinical trial models, the changing technology landscape, digitization and virtualization of trials including, but not limited to, site monitoring activities, and, in summary, the impact to CRA as a role, their required skill-sets and changing responsibilities.