The Evolution of Risk-Based & Remote Monitoring in the Healthcare Industry

Despite a rising trend toward using risk-based monitoring and new technology to enable this alternative to traditional onsite monitoring, there is still resistance to using this strategy. The fundamental reason for this hesitation is an inherent concern of violating regulatory compliance during the execution of a clinical study after discussing remote monitoring capabilities with industry peers. Limitations in inspection capacity, exacerbated by globalization, shift supervision responsibilities from regulators to industry. As a result of this move, the US Food and Drug Administration (FDA) and other authorities will require clinical trial sites and the industry as a whole to mitigate their risks.

Introduction

Regulatory agencies across the globe, notably the United States Food and Drug Administration (US FDA), encountered problems assessing applications near the end of the twentieth and beginning of the twenty-first centuries. The quantity and complexity of clinical trials expanded rapidly, and studies became indeed worldwide, encompassing many nations and hundreds of locations. The issue was to get assurances of appropriate oversight, data integrity, and protection of the trial subjects’ safety, rights, and well-being. The obstacles were the study/ies’ significant geographic dispersion, varied investigator expertise, site infrastructure, variations in the quality of care, and treatment practices. The conventional supervision technique of regular onsite visits by the clinical research associate (CRA) was becoming time-consuming, resource-intensive, and costly. At the same time, technical advancements provided numerous benefits. Technology platforms were now available to gather, compile, and display enormous amounts of data remotely, including site performance tracking. The improvement of statistical evaluation tools allowed for the early detection of trends, hazards, and outliers. This prompted the idea of looking into more effective, alternative ways of oversight. One such technique, risk-based monitoring, was recommended by the US FDA in their guideline document.

FDA approaches

Until recently, recent FDA warning letters have referred to this new strategy. The self-reporting of compliance events will be the next stage in this organic progression. It is generally expected that the FDA will adopt obligatory self-reporting in the not-too-distant future, and firms should have procedures in place before this happens. Thus, companies will distribute resources more efficiently to detect real-time erroneous, potentially fraudulent, or manipulated data.

Internal communication must increase in frequency and concentration since organizations have historically failed to use audit information effectively, partly due to an inability to communicate these findings to top management. Thorough and thorough clinical monitoring is critical for risk reduction. As globalization makes trial monitoring more complex, firms are spending a significant portion of trial money on this issue, with the majority being ineffectively employed. Failure to verify that the trial is being carried out in line with protocol, an underlying assumption of trial conduct, which may be attributable in part to complicated and unrealistic procedures.

Clinical research associates’ perception of risk-based monitoring

Because organizations have traditionally failed to use audit information effectively due to an inability to convey these findings to senior management, internal communication must improve in frequency and intensity. Thorough clinical monitoring is essential for risk minimization. As globalization makes trial monitoring more complex, businesses are allocating more trial funds to this issue, with the vast majority being wasted. Failure to check that the trial is being conducted under the protocol, an underlying assumption of trial conduct that may be due in part to difficult and unrealistic methods

The adoption and execution of RBM have resulted in a paradigm shift in the role of the data management function. Data management will likely play a more significant role beginning with protocol development. This is because RBM depends largely on real-time data review and analysis to discover trends and hazards in the research with less onsite monitoring. As a result, data management inputs are essential throughout the protocol and monitoring plan preparation stages and during the study because they may identify critical data points, possible risk regions, and mitigation measures.

Other simultaneous advances/changes (some of which are noted below) have also made the job of data managers more difficult. During the medication development process, they now manage a significantly more significant amount of data and data from various sources. These are just a few examples of electronic clinical outcome evaluations, real-world data acquired via cellphones and wearable devices, social media, and electronic health/medical records. The additional data areas, including unstructured data, are maintained separately from the core electronic data capture system, which gathers data from sites on electronic case report forms (CRFs).

Conclusion

RBM has just been added to the ICH E6 version as a potentially viable alternative to conventional monitoring. It is gaining traction and may soon become “business as usual.” Why are there still doubts and scepticism among people who put this notion into action? One apparent explanation is that they are growing pains as the model matures. However, the surveys, shared experiences, and opinion articles indicate several holes that must be filled. A site survey revealed that many participants lacked conceptual awareness of RBM despite their involvement in the RBM trial. Many sponsors began to adopt RBM with fewer onsite visits and SDV with real-time data review. They taught project managers, CRAs, and sites about tactical and technical implementation elements, perhaps leaving a gap in comprehension of the idea.

References

1. Christina K, Rollinger Y, Sigmund M, Kunert V, Breuer B. RBM — An Update of Experiences Among European CRAs. Applied Clinical Trials. 2017 Oct 20; [Google Scholar]

Wilkinson M, Getz K. A Critical Juncture for Clinical Trial Data Management. Clinical Leader. 2017 Nov 02; [Google Scholar]