How Has Clinical Trial Monitoring Adapted to Today’s Complex Trials and Decentralized Trials? Hear From the Industry

Clinical trials continue to increase in complexity. They rely on an expanding array of high-volume and high-velocity data from various sources and increasingly rely upon decentralized and adaptive designs. 

Consequently, the paradigm for clinical trial monitoring has permanently changed. It has shifted towards remote and risk-based approaches to monitor patient safety and data quality proactively and reduce reliance on manual review of data unlikely to impact the outcome of the trial. Risk-based quality management (RBQM) includes elements such as central monitoring, reduced or targeted source data verification (SDV)/source document review (SDR), and remote SDR.

Medidata commissioned a quantitative survey in spring 2022 to better understand the current landscape for clinical monitoring modalities and expectations for the future. The survey included 70 patients involved in clinical monitoring within pharmaceutical, biopharma, biotech, or contract research organizations (CROs). Patients were asked about the usage of clinical monitoring features, benefits and barriers of adopting newer elements, and perceptions of these elements in decentralized clinical trials (DCTs)/hybrid trials. Below are the key results.

Key Takeaways 

RBQM Utilization Will Increase as On-Site Presence Decreases

Patients reported still using on-site monitoring in most trials (80% on average). But they expect this proportion to decrease over the next two years. Respondents also indicated that an average of 54%, 51%, and 42% of current trials use central monitoring, reduced or targeted SDV/SDR, and remote SDR, respectively. New clinical monitoring elements are expected to increase across the board. Central monitoring and remote SDR are predicted to increase the most over the next two years, by 16% and 15%, respectively.

RBQM Offers Many Benefits, but Perceived Challenges Exist

Respondents selected a variety of benefits, including reduced monitoring costs, higher clinical trial data quality, more frequent data oversight, higher efficiency for on-site monitoring activities, and higher sustainability due to reduced travel. Perceived barriers included disconnected processes and systems, lack of organizational structure to implement, decreased data quality, and regulatory and compliance issues. Reduced clinical trial monitoring costs were frequently selected as a top benefit. But being too expensive was not commonly selected as a top barrier. Overall, more than 99% of respondents saw at least some benefit for each clinical monitoring practice. 

Attitudes are Positive Towards Adopting RBQM

Approximately 75% of respondents expressed a positive impression toward adopting newer clinical monitoring elements. None had a very negative impression. More than 30% of respondents selected each of the following positive impacts: lower costs, improved monitoring team satisfaction, improved clinical site satisfaction, shortened trial timelines, and higher-quality data. 

Adoption of RBQM is Expanding

Nearly two-thirds of respondents expected their companies to increase adoption of remote SDR in the next 36 months. That result is consistent with the increase across ~15% of trials that respondents predict in the next two years. 

Two RBQM Elements are Most Highly Valued for DCTs

Among the 50% of survey respondents that are running decentralized/hybrid trials, “risk assessments” (i.e., determining critical quality factors, risks, and associated mitigation strategies) and “central monitoring” were valued by most as very or extremely important in such trials.

Summary

The main results of this survey confirm that in today’s ever more complex clinical trial landscape—with exponential data growth arising from a wider array of sources—the industry is increasingly looking to leverage remote and risk-based capabilities, including central monitoring, reduced or targeted SDV/SDR, and remote SDR. 

Medidata provides holistic RBQM solutions that support excellence in clinical trial execution and lets companies achieve true digital oversight, which Medidata sees as the future of clinical trial operations.

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