Barriers, adoption, technology, impact and benefits of risk based monitoring

Shukla, Bharat Kumar; Khan, Mohammed Saleem; Nayak, Veerabhadra Sanekal

doi:10.18203/2349-3259.ijct20160473

Cited by 5 publications

(3 citation statements)

References 1 publication

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“…Accordingly, risk assessment is the cornerstone of RBM [ 9 ]. The emphasis on RBM is due to the assumption that it prevents waste of valuable clinical trial resources, such as study budget and staff time, on unnecessary monitoring activity that does not improve participant safety or data quality [ 10 , 11 ].…”

Section: Introductionmentioning

confidence: 99%

Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study

Hurley

Sinnott

Clarke³

et al. 2017

Trials

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BackgroundIn November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a ‘gold standard’, validated approach to RBM does not exist and it is unclear how sponsors will introduce RBM into their organisations. A first step needed to inform the implementation of RBM is to explore academic trialists’ readiness and ability to perform RBM. The aim of this paper is to identify the attitudes and perceived barriers and facilitators to the implementation of RBM in academic-led clinical trials in Ireland.MethodsThis is a mixed-methods, explanatory sequential design, with quantitative survey followed by semistructured interviews. Academic clinical researchers (N = 132) working in Ireland were surveyed to examine their use and perceptions of RBM. A purposive sample of survey participants (n = 22) were then interviewed to gain greater insight into the quantitative findings. The survey and interview data were merged to generate a list of perceived barriers and facilitators to RBM implementation, with suggestions for, and solutions to, these issues.ResultsSurvey response rate was 49% (132/273). Thirteen percent (n = 18) of responders were not familiar with the term risk-based monitoring and less than a quarter of respondents (21%, n = 28) had performed RBM in a clinical trial. Barriers to RBM implementation included lack of RBM knowledge/training, increased costs caused by greater IT demands, increased workload for trial staff and lack of evidence to support RBM as an effective monitoring approach. Facilitators included participants’ legal obligation to perform RBM under the new ICH-GCP guidelines, availability of RBM guidance and perception of cost savings by performing RBM in future trials.ConclusionThe results of this study demonstrate a need for training and regulatory-endorsed guidelines to support the implementation of RBM in academic-led clinical trials. The study provides valuable insights to inform interventions and strategies by policy-makers and clinical trial regulators to improve RBM uptake.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2148-4) contains supplementary material, which is available to authorized users.

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Section: Introductionmentioning

confidence: 99%

Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study

Hurley

Sinnott

Clarke³

et al. 2017

Trials

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“…Study sites and clinical trials with a high degree of risk are visited for monitoring, and other cases undergo online monitoring with minimal on-site monitoring. 4,7 RBM focuses on supervisory activities of the clinical research associates (CRAs) working at a sponsor’s site to prevent or alleviate important risks related to data quality. Moreover, RBM prioritizes protection of study subjects and safety of trials.…”

Section: Introductionmentioning

confidence: 99%

Clinical Research Coordinators’ Attitude Toward Risk-Based Monitoring

Jeong

Jeong²,

Hwang

et al. 2019

Ther Innov Regul Sci

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Background: Clinical research coordinators (CRCs) are persons who collect, record, and maintain clinical trial data in accordance with the principles of Good Clinical Practice at investigators’ sites. This study was conducted to examine attitudes of clinical research coordinators (CRCs) toward risk-based monitoring (RBM) prior to full-scale implementation of RBM in Korea. Methods: The study subjects were 607 CRCs, and data were collected using a self-reported questionnaire. Collected data were analyzed by frequency, percentage, χ2 test and Fisher exact test. Results: Among CRCs, 42.3% had heard of RBM and 44.6% were found to oppose its implementation. Those opposed believed that implementation of RBM would increase the workload of CRCs and CRAs’ work support for CRCs. In addition, they showed many negative opinions such as poor accuracy of test data input and failure to increase the overall quality of clinical tests. In particular, such attitudes were more noticeable in CRCs with 5 or more years of experience. Conclusion: Before the implementation of RBM, it is necessary to come up with administrative measures such as education for practitioners and recruitment of human resources to help CRCs properly understand RBM.

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“…A customized methodology such as ours has been advocated by clinical trial researchers. 2 BIOTRONIK's RBM process utilizes both on-site and centralized monitors who conduct source data verification based on the study-specific monitoring plan. On-site monitors are responsible for reviewing regulatory documentation, source data for electronic case report forms, investigational device accountability, medical records for unreported subject encounters, and medical records for unreported adverse events.…”

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confidence: 99%

An evaluation of the effectiveness of a risk-based monitoring approach implemented with clinical trials involving implantable cardiac medical devices

Diani¹,

Rock²,

Moll³

2017

Clinical Trials

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Background Risk-based monitoring is a concept endorsed by the Food and Drug Administration to improve clinical trial data quality by focusing monitoring efforts on critical data elements and higher risk investigator sites. BIOTRONIK approached this by implementing a comprehensive strategy that assesses risk and data quality through a combination of operational controls and data surveillance. This publication demonstrates the effectiveness of a data-driven risk assessment methodology when used in conjunction with a tailored monitoring plan. Methods We developed a data-driven risk assessment system to rank 133 investigator sites comprising 3442 subjects and identify those sites that pose a potential risk to the integrity of data collected in implantable cardiac device clinical trials. This included identification of specific risk factors and a weighted scoring mechanism. We conducted trend analyses for risk assessment data collected over 1 year to assess the overall impact of our data surveillance process combined with other operational monitoring efforts. Results Trending analyses of key risk factors revealed an improvement in the quality of data collected during the observation period. The three risk factors follow-up compliance rate, unavailability of critical data, and noncompliance rate correspond closely with Food and Drug Administration's risk-based monitoring guidance document. Among these three risk factors, 100% (12/12) of quantiles analyzed showed an increase in data quality. Of these, 67% (8/12) of the improving trends in worst performing quantiles had p-values less than 0.05, and 17% (2/12) had p-values between 0.05 and 0.06. Among the poorest performing site quantiles, there was a statistically significant decrease in subject follow-up noncompliance rates, protocol noncompliance rates, and incidence of missing critical data. Conclusion One year after implementation of a comprehensive strategy for risk-based monitoring, including a data-driven risk assessment methodology to target on-site monitoring visits, statistically significant improvement was seen in a majority of measurable risk factors at the worst performing site quantiles. For the three risk factors which are most critical to the overall compliance of cardiac rhythm management medical device studies: follow-up compliance rate, unavailability of critical data, and noncompliance rate, we measured significant improvement in data quality. Although the worst performing site quantiles improved but not significantly in some risk factors such as subject attrition, the data-driven risk assessment highlighted key areas on which to continue focusing both on-site and centralized monitoring efforts. Data-driven surveillance of clinical trial performance provides actionable observations that can improve site performance. Clinical trials utilizing risk-based monitoring by leveraging a data-driven quality assessment combined with specific operational procedures may lead to an improvement in data quality and resource efficiencies.

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Barriers, adoption, technology, impact and benefits of risk based monitoring

Cited by 5 publications

References 1 publication

Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study

Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study

Clinical Research Coordinators’ Attitude Toward Risk-Based Monitoring

An evaluation of the effectiveness of a risk-based monitoring approach implemented with clinical trials involving implantable cardiac medical devices

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