When the pandemic hit, it reshaped almost every sector of the global economy in a matter of months. Clinical trials were particularly impacted by immediate and long-lasting disruptions, with a global decline of 20% in new patients entering trials per study-site as compared to the pre-COVID baseline.¹
In contrast, the organizations that had already implemented robust processes using RBQM practices including centralized monitoring, flexible on-site interactions, remote data collection, and document review were agile in adjusting to the complex new environment brought on by the pandemic.
A firm grasp of the RBQM approach, its terminology, and how to leverage and implement it is essential to realizing the value it brings to sponsors, CROs, sites, and ultimately patients during COVID and beyond.
Understanding Risk-Based Quality Management (RBQM)
RBQM is a holistic, systems-based approach to trial management that focuses sponsor resources and oversight on the biggest risks to a clinical study. It supports the historical misallocation of limited resources, focusing on areas of top priority rather than trying to cover all risks and monitor all data.
But due to confusion around terminology and scope, early adopters took a haphazard approach, focusing only on source data verification (SDV) and source data review (SDR) without conducting a comprehensive risk assessment first.
Adopting a Common Language
Differences over the meaning of key terminology has been an ongoing source of confusion and an obstacle to more widespread adoption of RBQM protocols. It is critical to clarify terms and establish a common vocabulary.
For example, the term "virtual" (aka "decentralized") has been widely applied to clinical trials when referring to patient participation outside of a traditional trial site using virtual solutions. But trial virtualization also applies to clinical trial oversight, which includes all the monitoring and oversight activities required to ensure patient safety and protect data quality during trial execution.
The universal understanding of key terms that are imperative to successful adoption of RBQM is exhaustive and complex. It can be found in the White Paper Virtualizing Clinical Trial Oversight: The COVID-19 Effect.
The COVID-19 Effect and Leveraging RBQM
In response to the rapid realization of benefits of remote monitoring during the pandemic, many clinical trial sponsors and CROs adopted it in a provisional way in 2020 — but most have not formalized risk-based protocols or processes for clinical trial quality management. Regulatory authorities responded to pandemic-driven risks by amping up their calls for implementation of risk-based approaches to data monitoring and quality control. In March of last year, for example, the FDA issued nonbinding recommendations that supported risk-based approaches to clinical trial oversight activities.²
Even without the disruptions of a global pandemic, the benefits of RBQM and remote monitoring are clear and far reaching and include increased overall trial quality, greater efficiency, improved patient safety, and better overall value. Because so many activities can be conducted off-site, monitoring is ongoing and more effective, allowing for the detection of potential adverse events sooner. This in turn improves patient safety, a benefit for both patients and sponsors.
The Expertise Required to Successfully Integrate RBQM
The fundamental first step in RBQM is development of a risk management plan through an end-to-end risk assessment. This risk-assessment should: 1) support protocol development, 2) prioritize trial participant safety and data validity, 3) take into account key stakeholder input and mitigation strategies, and 4) be reviewed and adjusted on an ongoing basis.
For companies that do not already have quality management systems in place, an experienced strategic consulting team can provide the professional support needed to develop formalized risk-based protocols and processes for clinical trial quality management. These experts not only guide organizations through new compliance demands, but can also educate them on the processes and tools needed for efficient monitoring.
By allowing these consulting strategists to perform risk assessments and help determine the Critical to Quality (CtQ) Factors, KRIs, and Quality Tolerance Limits (QTLs), the path to the adoption of RBQM can be significantly accelerated. In addition, they can provide value metrics gained through working with industry partners and regulators to implement industry-wide surveys.
To support industry-wide adoption of RBQM principles and move toward RBQM as a standard business process, some challenges must be overcome. Supporting RBQM as a best practice begins with educating key internal and external stakeholders on RBQM implementation and the regulatory landscape, as well as managing expectations about compliant and efficient monitoring.
To learn more, download your free White Paper Virtualizing Clinical Trial Oversight: The COVID-19 Effect.
¹ Medidata. COVID-19 and Clinical Trials: The Medidata Perspective. Release 9.0 https://www.medidata.com/wp-content/uploads/2020/09/COVID19-Response9.0_Clinical-Trials_2020921_v2.pdf. Published September 21, 2020. Accessed January 2021.
² U.S. Food and Drug Administration. Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency. Guidance for Industry, Investigators, and Institutional Review Boards. https://www.fda.gov/media/136238/download. Published March 2020. Updated January 21, 2021. Accessed January 2021.