Insights

Data integrity issues continue to be uncovered by U.S. Food and Drug Administration (FDA) investigators, leading to a range of regulatory actions. Between 2017 and 2022, FDA issued more than 160 Warning Letters citing data integrity deficiencies,¹ which relate to the completeness, consistency and accuracy of data.²

We need to have open conversations about all elements of medical product development that are currently in flux and what these changes mean to clinical trial stakeholders

Continued progress in modernizing clinical trials is essential. This should include evaluating appropriate use of technology and the potential of non-traditional sites, such as retail pharmacies, as well as offering at-home services to study participants.

If “being more mindful” isn’t already among your New Year’s resolutions for 2024, an expert on the negative consequences of having a “busy brain” thinks it should be, and that intellectual, stress-driven professionals like those who are often drawn to clinical research will benefit from pausing to process their thoughts and emotions more methodically. 

Today, large academic research centers receive the vast majority of trial opportunities, leaving countless other sites constrained by studies that don't align with their strengths. It’s not uncommon for experienced and motivated sites to accept the majority of opportunities that come their way, even when it's not the best match for their team and patients. This results in highly qualified sites underperforming across trials – not because they lack the ability to deliver results, but because they lack the power to be strategic and selective in choosing trials.