Learning from Principles of Evidence-Based Medicine to Optimize Nonclinical Research Practices

Lefevre, Isabel A.; Balice-Gordon, Rita J.

doi:10.1007/164_2019_276

Cited by 2 publications

(2 citation statements)

References 36 publications

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“…Besides lack of funding, expertise, and a dearth of suitable systems, the prospect of auditing may be among the chief reasons why academia has so far shunned QM systems altogether. In our own experience with ISO 9001 [ 21 ], the audits performed by the certification agency were disappointing: Research specific deficiencies in our quality management remained undetected by the auditors untrained in preclinical research, and targeted advice how to improve research quality was consequently very limited.…”

Section: Introductionmentioning

confidence: 99%

Improving quality of preclinical academic research through auditing: A feasibility study

et al. 2020

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How much can we rely on whether what was reported in a study was actually done? Systematic and independent examination of records, documents and processes through audits are a central element of quality management systems. In the context of current concerns about the robustness and reproducibility of experimental biomedical research audits have been suggested as a remedy a number of times. However, audits are resource intense and time consuming, and due to their very nature may be perceived as inquisition. Consequently, there is very little experience or literature on auditing and assessments in the complex preclinical biomedical research environment. To gain some insight into which audit approaches might best suit biomedical research in academia, in this study we have applied a number of them in a typical academic neuroscience environment consisting of twelve research groups with about 100 researchers, students and technicians, utilizing the full gamut of state-of-the-art methodology. Several types of assessments and internal as well as external audits (including the novel format of a peer audit) were systematically explored by a team of quality management specialists. An experimental design template was developed (and is provided here) that takes into account and mitigates difficulties, risks and systematic errors that may occur during the course of a study. All audits were performed according to a pre-defined workflow developed by us. Outcomes were assessed qualitatively. We asked for feedback from participating employees in every final discussion of an audit and documented this in the audit reports. Based on these reports follow-up audits were improved. We conclude that several realistic options for auditing exist which have the potential to improve preclinical biomedical research in academia, and have listed specific recommendations regarding their benefits and provided practical resources for their implementation (e.g. study design and audit templates, audit workflow).

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Section: Introductionmentioning

confidence: 99%

Improving quality of preclinical academic research through auditing: A feasibility study

et al. 2020

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“…Structured quality management systems (QMS) [16] [17], and more relevant to biomedicine, Good Clinical Practice (GCP) methodology [18] require auditing to avoid discrepancies between reporting and what was actually done in a study. Audits of academic non-clinical research have been suggested a number of times [19] [20] [21]. A recent computer simulation suggests that random auditing of research groups can improve research quality, and is highly cost effective [6].…”

Section: Introductionmentioning

confidence: 99%

Improving quality of preclinical academic research through auditing:

Kurreck¹,

Castaños‐Vélez²,

Freyer³

et al. 2020

Preprint

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How much can we rely on whether what was reported in a study was actually done? Systematic and independent examination of records, documents and processes through audits are a central element of quality management systems. In the context of current concerns about the robustness and reproducibility of experimental biomedical research audits have been suggested as a remedy a number of times. However, audits are resource intense and time consuming, and due to their very nature may be perceived as inquisition. Consequently, there is very little experience or literature on auditing and assessments in the complex preclinical biomedical research environment. To gain some insight into which audit approaches might best suit biomedical research in academia, in this study we have applied a number of them in a typical academic neuroscience environment consisting of twelve research groups with about 100 researchers, students and technicians, utilizing the full gamut of state of the art methodology. Several types of assessments and internal as well as external audits (including the novel format of a peer audit) were systematically explored by a team of quality management specialists. An experimental design template was developed (and is provided here) that takes into account and mitigates difficulties, risks and systematic errors that may occur during the course of a study. All audits were performed according to a pre-defined workflow developed by us. Outcomes were assessed qualitatively. We asked for feedback from participating employees in every final discussion of an audit and documented this in the audit reports. Based on these reports follow-up audits were improved. We conclude that several realistic options for auditing exist which have the potential to improve preclinical biomedical research in academia, and have listed specific recommendations regarding their benefits and provided practical resources for their implementation (e.g. study design and audit templates, audit workflow).

show abstract

Learning from Principles of Evidence-Based Medicine to Optimize Nonclinical Research Practices

Cited by 2 publications

References 36 publications

Improving quality of preclinical academic research through auditing: A feasibility study

Improving quality of preclinical academic research through auditing: A feasibility study

Improving quality of preclinical academic research through auditing:

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