Application of risk-based quality management (RBQM) is still limited in trials, according to new data that show sponsors and CROs use RBQM elements in about half of trials overall and hold varying perceptions of their benefits.

These latest findings come from a 206-respondent survey of sponsors and CROs conducted by the Tufts Center for the Study of Drug Development (CSDD) between November 2022 and February 2023. Specifically, CSDD researchers asked participants about their adoption of 31 individual RBQM components across trial design and planning, trial execution, and risk documentation, verification and resolution. Respondents were also polled on their confidence in the ability of RBQM to improve trial efficiency, speed and quality and the barriers they believe constrain its adoption.

CSDD’s most recent report shows that sponsors and CROs use elements of RBQM in 55 percent of their trials overall. Companies with larger trial workloads showed significantly higher rates of RBQM adoption (58 to 60 percent) compared to those with lower trial volumes (47 percent).

The most widely used early-stage RBQM component was risk assessment and risk control planning, which was employed in 79 percent of trials on average, especially by companies with higher trial volumes and internal central monitoring strategies, CSDD found.

RBQM components to support planning and design were used 56 percent of the time, while identifying critical data/processes, conducting risk assessments for optimal trial design and identifying trial-specific key risk indicators were leveraged in an average 68 percent, 65 percent and 62 percent of trials, respectively.

A significant percentage of trials used RBQM to document, verify and resolve risks and deviations:

• 76 percent used RBQM for detection of risks and validation of source data;
• 72 percent used it for reviewing source data;
• 70 percent used it to evaluate, resolve and follow up on risks; and
• 65 percent used it to report updates to and deviations from monitoring plans.

Components to bolster trial execution, such as key risk indicator tracing, remote site monitoring and review of data visualization, were employed the least — in just 52 percent of trials on average.

The survey also polled respondents on their attitudes toward RBQM and the top implementation challenges they perceive. A strong majority of respondents (83 percent), for instance, reported being either somewhat or very committed to supporting RBQM, with greater dedication seen amongst companies using internal central monitoring, while 78 percent said they trust RBQM will improve the quality of their trials.

Confidence was weaker in other areas. Specifically, 63 percent of respondents felt RBQM would help make trials more efficient and less costly, while just 53 percent were confident that it would help shorten trial timelines. These attitudes hinder the adoption of RBQM methods, according to CSDD.

“A barrier to adoption is apparent in the much lower proportion of respondents who trust that RBQM will deliver efficiency and cost savings and speed for their organization,” the report reads.

The top barriers to RBQM adoption are linked to change management practices, sponsors and CROs say, with 69 percent of respondents naming lack of crossfunctional awareness as a key challenge, followed by a lack of necessary skills (47 percent) and a lack of internal consensus (38 percent).

Nearly half (48 percent) of sponsors and CROs expected time investments to be a key barrier, while only a quarter (26 percent) cited perceived costs as a top hurdle.

Access the full CSDD Impact Report here: https://tinyurl.com/2es3zzd6.