Artikel
The quality of clinical research is often discussed but rarely defined – a systematic survey and proposal for a comprehensive framework of clinical research quality
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Autoren
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Belinda von Niederhäusern
- Clinical Trial Unit, Department of Clinical Research, University and University Hospital Basel, Basel, Schweiz
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Lars G. Hemkens
- Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University and University Hospital Basel, Basel, Schweiz
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Marie Mi Bonde
- Clinical Trial Unit, Department of Clinical Research, University and University Hospital Basel, Basel, Schweiz
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Nicole Brunner
- Clinical Trial Unit, Department of Clinical Research, University and University Hospital Basel, Basel, Schweiz
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Marielle Rutquist
- Clinical Trial Unit, Department of Clinical Research, University and University Hospital Basel, Basel, Schweiz
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Gordon H. Guyatt
- Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Kanada
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Matthias Briel
- Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University and University Hospital Basel, Basel, Schweiz
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Christiane Pauli-Magnus
- Clinical Trial Unit, Department of Clinical Research, University and University Hospital Basel, Basel, Schweiz
| Veröffentlicht: | 23. Februar 2017 |
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Gliederung
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Background: While the quality of clinical research is often criticized, there is no underlying consensus on a definition of the term “quality” yet.
Objectives: (1) To systematically survey definitions of quality in clinical research; and (2) to develop a conceptual framework of criteria allowing for the comprehensive assessment of clinical research quality.
Methods: We systematically and in duplicate searched definitions and concepts of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic research initiatives, contract research organizations, ethics committees, patient organizations and funding agencies from 12 countries. Based on the qualitative framework analysis, we systematically developed a concept for a comprehensive framework for clinical research quality. The framework was circulated among 8 stakeholder groups from 12 countries until consensus on structure and content was reached.
Results: In our systematic survey we found that stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We did not find one definition or concept comprehensively considering a range of quality dimensions, different phases or types of clinical research, and stakeholder perspectives. Our proposed framework therefore synthesizes criteria that were identified from different stakeholder groups and study settings, and spans all phases of clinical research. It includes the following dimensions: (1) ethical conduct and protection of participants’ safety and rights, (2) internal validity, (3) precision, (4) external validity, (5) relevance, and (6) transparency/public access to data. These dimensions are embedded in and interacting with an environment that a) consists of an established infrastructure including well-trained personnel and functional facilities, and b) uses ongoing clinical research efficiently for training purposes in order to ensure sustainability of an effective infrastructure.
Conclusions: The quality of clinical research is often discussed, but remains rarely defined. We propose a comprehensive framework of criteria which may be used as the basis to develop measurement tools of clinical research quality for various settings
