DCTs: Overrated Or Under-Utilized? Balancing Patient Accessibility With Data Reliability

By Christina Dinger, Senior Director of Product, ThoughtSphere

Navigating the delicate equilibrium between optimizing and diversifying the patient's journey while ensuring the integrity of trial inferences is an ongoing challenge in the industry. Recent years have witnessed substantial efforts to enhance trial accessibility and alleviate patient burden through innovations like digital endpoints and remote care. However, amidst these advancements, there arises a critical question: have commensurate measures been implemented to address the inherent variability introduced by these novel data collection methods?

A more pressing concern emerges — is the pursuit of increased patient centricity inadvertently compromising protocol stringency and the validity of trial outcomes? This article prompts a reflection on whether sponsors, industry experts, and regulators are consistently evaluating the potential trade-offs when embracing novel approaches to support trial accessibility and flexible trial designs. In this dynamic landscape, discover why ongoing dialogue and scrutiny are essential to strike a harmonious balance between patient-centered initiatives and the methodological rigor necessary for credible and reliable clinical trial results.