FDA Requests Sponsors Flag Remote Assessments In Oncology Trials: What Does It Mean?

ERT |

The FDA Oncology Center of Excellence and the Office of Oncologic Diseases recently announced a formal request for pharma companies running oncology clinical trials to voluntarily flag whether data has been collected remotely or at a clinical trial site. Per the FDA, their particular areas of interest include:

While the use of even partially decentralized clinical trials (DCTs) has been especially rare in oncology, the COVID-19 pandemic forced such modifications during large, ongoing cancer trials to limit exposure. The opportunity now exists to evaluate and learn from the effect of remote assessments on trial data quality and outcomes. These findings can inform the successful use and expansion of DCTs as remote solutions evolve from protocol deviations to permanent changes in the clinical trial landscape. 

As a technology company devoted to endpoint data capture, ERT has a unique perspective on and extensive experience with remote data collection. In fact, while there was certainly great interest prior to, a large portion of our development efforts in remote data collection have also been accelerated due to the COVID-19 pandemic and the subsequent need to stay at home and socially distanced. 

Over time, we have learned firsthand how DCTs can affect patient and sponsor burden while increasing the accrual and retention of more diverse trial populations. A better understanding of the effects of remote assessments on data quality will not only reduce uncertainty for sponsors and regulatory bodies, but enable the identification of potential risk mitigation and optimization strategies for future DCT designs. 

Still, the burden of identifying, segmenting, and flagging remote assessments could be oppressive for pharma companies collecting high-volume, high-velocity data. While there is currently no standard approach to how remote modifications are to be identified in clinical trial datasets submitted to the FDA, we do know that it takes time and effort to, at its simplest, clarify:

  • Which remote modifications were permitted
  • When they were introduced into the process
  • If any abnormalities were present to allow for further study on potential impacts on data when compared to assessments completed at trial site

ERT’s experience and expertise in data collection has equipped us to work with our customers to ideate solutions that ease this additional step of flagging data, and we look forward to continuing to develop technology that facilitates more inclusive, accessible clinical trials into the future.

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