ArticleTrials2017
Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study.
Article in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed.
- Effectiveness of remote risk-based monitoring and potential benefits for combination with direct data capture.Trials · 2024Trial
- Review
- Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical Trials.Therapeutic innovation & regulatory science · 2024Article
- A risk-based monitoring approach to source data monitoring and documenting monitoring findings.Contemporary clinical trials · 2024Article
- Assessing the impact of risk-based data monitoring on outcomes for a paediatric multicentre randomised controlled trial.Clinical trials (London, England) · 2024Article
- Source Data Verification (SDV) quality in clinical research: A scoping review.Journal of clinical and translational science · 2024Article
- Navigating the challenges of clinical trial professionals in the healthcare sector.Frontiers in medicine · 2024Review
- Risk Management in Clinical Trials: Assessment of Current Practices at Portuguese Clinical Trial Sites.Risk management and healthcare policy · 2023Article
- Research monitoring practices in critical care research: a survey of current state and attitudes.BMC medical research methodology · 2022Article
- Clinical researchers' lived experiences with data quality monitoring in clinical trials: a qualitative study.BMC medical research methodology · 2021Article
- Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: A scoping review.Clinical trials (London, England) · 2021Article
- Leveraging analytics to assure quality during the Covid-19 pandemic - The COVACTA clinical study example.Contemporary clinical trials communications · 2020Article
- Harnessing the Power of Quality Assurance Data: Can We Use Statistical Modeling for Quality Risk Assessment of Clinical Trials?Therapeutic innovation & regulatory science · 2020Article
- An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units.Trials · 2019Article
- Enabling Data-Driven Clinical Quality Assurance: Predicting Adverse Event Reporting in Clinical Trials Using Machine Learning.Drug safety · 2019Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.