Industry Assessment of Risk-Based Quality Management Emphasizes Value of Adoption


A study conducted by the Tufts CSDD in collaboration with CluePoints and PwC revealed that slightly more than half of sponsors and contract research organizations have adopted risk-based quality management approaches.

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The Tufts Center for the Study of Drug Development (Tufts CSDD), in collaboration with CluePoints and PwC, has released a study assessing the adoption of risk-based quality management (RBQM), according to a press release.1

“The value of RBQM-approaches has been recognized at a regulatory level for more than a decade and reinforced with the pending publication of ICH E6 (R3),” Steve Young, chief scientific officer of CluePoints and Applied Clinical Trials (ACT) editorial advisory board (EAB) member said in the press release. “Yet this research reveals we still have remaining work to promote cross-industry and cross-functional awareness and adoption. Education will be key to ensuring that RBQM principles become fully embraced across organizations and become “business as usual” for the industry.”1

Study results showed that that slightly more than half of sponsors and contract research organizations (CROs) have adopted RBQM approaches. Some other more specific findings included:

  • Overall, 57% of sponsors and CROs have adopted RBQM. The highest levels of adoption were found among sponsor bio-pharmaceutical companies, particularly those conducting high volumes of trials (100 trials plus annually). Higher levels of RBQM adoption were also observed in Europe.
  • Implementation of RBQM components was lowest at companies conducting fewer than 25 trials annually (48%)​.
  • The survey also revealed different levels of adoption at different stages of trial design and implementation. Adoption of RBQM components was lowest during execution (52%) and slightly higher during planning and documentation/resolution stages (56% and 60% respectively).1

“Although earlier studies observed increased use of select RBQM components during the pandemic, our recent study suggests that this increase was only temporary,” said Ken Getz, professor and executive director, Tufts CSDD and ACT EAB member, said in the press release. “Our results also highlight resistance to adoption associated with mixed perceptions of RBQM’s value proposition and the need for more effective change management practices to drive routine use of RBQM approaches enterprise-wide.”1

The full study was published in the March 2024 issue of Therapeutic Innovation and Regulatory Science. Results were gathered by method of an online survey conducted by the Tufts CSDD among pharmaceutical, biotechnology, and CROs. It produced 206 responses on 32 distinct RBQM practices.2

“Risk-based monitoring and RBQM offer a compelling approach to increase efficiency, speed and quality in clinical trials by prioritizing and mitigating risks related to essential safety and efficacy data,” the study authors wrote. “Since 2013, the FDA and EMA have encouraged the use of RBM/RBQM, however adoption has been slow with limited understanding of the barriers to adoption.”2

Although the results showed slightly more than half of sponsors and CROs have adopted RBQM approaches, the authors noted that barriers and resistance to adoption were most prominent in clinical development and clinical operations. The primary perceptions on barriers to adoption mainly came from a lack of knowledge and/or awareness. Respondents noted the importance of better training and organizational skills would aid in increasing the trust of adopting RBQM practices.2

“Although most organizations are committed to supporting RBQM, current levels of adoption are explained in part by mixed views on the value proposition of RBQM—specifically its ability to deliver efficiency, lower cost and faster clinical trials—and limited and insufficient change management practices,” the authors concluded.2


1. Scope Of Industry Risk-Based Quality Management (RBQM) Adoption Revealed. News release. April 2, 2024. Accessed April 4, 2024.

2. Dirks, A., Florez, M., Torche, F. et al. Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials. Ther Innov Regul Sci (2024).

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