Monitoring clinical trials: a practical guide

Molloy, Síle F.; Henley, Patricia

doi:10.1111/tmi.12781

Cited by 13 publications

(17 citation statements)

References 6 publications

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“…SDV is the process by which the data collected for a trial are compared with the original source of information. More recently, there has been a shift toward increased remote monitoring conducted by the trial sponsor or coordinating trials unit or both [3]. Central checks can be carried out on electronic records, consent forms and overall performance of participating sites [3], highlighted by the recent development of metrics in this area [4].…”

Section: Introductionmentioning

confidence: 99%

“…More recently, there has been a shift toward increased remote monitoring conducted by the trial sponsor or coordinating trials unit or both [3]. Central checks can be carried out on electronic records, consent forms and overall performance of participating sites [3], highlighted by the recent development of metrics in this area [4]. Although this may reduce the number or duration of visits, central monitoring has its own limitations, including access to the source data and reliance on sites maintaining data collection records.…”

Section: Introductionmentioning

confidence: 99%

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An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units

Beever

Swaby

2019

Trials

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Background Good Clinical Practice guidelines issued in 2016 encourage risk-based approaches to monitoring clinical trials. This study compared current risk assessment and monitoring approaches in UK Clinical Trials Units (CTUs) with the published guidance and makes recommendations for risk-based monitoring in pragmatic trials. Methods An online survey of UK Clinical Research Collaboration registered CTUs was administered via email invitation. Forty-nine units were invited, and 23 responded. Respondents were also invited to share copies of risk assessment templates. Results Most CTUs reported using remote combined with on-site monitoring. All reported undertaking a risk assessment for Clinical Trials of Investigational Medicinal Products (CTIMPs) and 21 units did so for non-CTIMPs. Most CTIMP risk assessments used MHRA (Medicines and Healthcare products Regulatory Agency) classifications, although some also employed staff judgement. Almost all units based their monitoring on perceived risk level; this number was higher for CTIMPs (n = 22) than for non-CTIMPs (n = 19). In most cases, monitoring plans were produced. More CTUs revisited risk assessments during trials in CTIMPs (n = 21) than in non-CTIMPs (n = 18). Small numbers of units reviewed the monitoring approach always (n = 4) or sometimes (n = 9) and few used the reflection to guide future monitoring. Conclusions A high proportion of UK CTUs are using risk-based monitoring in the UK, as recommended by guidelines, for both CTIMPs and non-CTIMPs. This has the potential to make trials more efficient and reduce costs. However, there appears to be a lack of reflection on the value of these revised approaches. There may be a benefit in CTUs collaborating nationally to improve processes for reflection and making changes during the life course of a trial.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units

Beever

Swaby

2019

Trials

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“…Study completion: The final stage is the completion of the study with the last monitoring visit, the so-called close out visit (COV) [ 29 ]. The end of the study must be reported to the ethics committee, the responsible national competent authority and the hospital management.…”

Section: Resultsmentioning

confidence: 99%

Implementing a Clinical Research Department to Support Pediatric Studies: A SWOT Analysis

Thajer

Sommersguter-Reichmann

Löffler‐Stastka

2020

IJERPH

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The safety, tolerability, pharmacokinetics and efficacy of most drugs used in pediatrics have not been studied in different age groups and are administered “off-label use”. Clinical pediatric drug trials require specific and stringent compliance with laws, regulations, guidelines, and patient/parent/public involvement, which in turn increases resource use and makes support useful from a medical, qualitative, economic, and system perspective. We examined the strengths, weaknesses, opportunities and threats of implementing a Research Department for the Support of Pediatric Studies (RDPS) in Vienna. We used the SWOT (“strengths”, “weaknesses”, “opportunities”, and “threats”) analysis to collect comprehensive data and facts on the internal strengths, weaknesses (company analysis), and external opportunities and threats (environmental analysis). The company analysis revealed a productivity gain, due to a highly specialized team and standardized processes. The environmental analysis outlined a considerable 360-degree potential for a qualitative and quantitative medical- and social-scientific expansion of the service portfolio. The establishment of a RDPS leads to the centralization of pediatric studies by bundling tasks and concentration of specialist knowledge, which enables the exploitation of synergies, the standardization of processes, the promotion of professionalism, flexibility, innovations and the reduction of inefficiencies in the form of duplication of tasks. RDPS offers tailored advice and support for different types of pediatric studies.

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“…The CRA draws up a schedule with the investigator which may relate to telephone contacts but is essentially concerned with future visits. The CRA provides the investigator with the products necessary for conducting the trial, consisting of the drug packages and the materials necessary for performing biological assays [3]. The CRA must ensure that the communication of information between analytic laboratories and/or the different specialists is performed correctly (e.g.…”

Section: Training and Informing Investigatorsmentioning

confidence: 99%

Monitoring the Clinical Trial

Bourin¹

2018

SOJPPS

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The monitoring of clinical trials is an essential function for the smooth running of studies. The monitor or the clinical research assistant, in charge of this activity and a real link between the investigator and the sponsor, will have to ensure the respect of the subjects' rights, the reliability and the traceability of the data generated, and to verify that the study is conducted in accordance with the protocol, good clinical practice (GCP) and applicable clinical regulation. Beyond these control objectives, monitoring is also a prevention tool to minimize or avoid potential problems during the study and to anticipate their too late identification, which could lead to more critical consequenceson the conformity of the study. The objective of this paper is to review the various stages of the monitoring and then to give practical tools that can be used at each of these stages.

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Monitoring clinical trials: a practical guide

Abstract: SummaryThis paper describes the processes and procedures involved in planning, conducting and reporting monitoring activities for large clinical trials of investigational medicinal products, focusing on those conducted in resource-limited settings.

Cited by 13 publications

References 6 publications

An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units

An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units

Implementing a Clinical Research Department to Support Pediatric Studies: A SWOT Analysis

Monitoring the Clinical Trial

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