Article type
Abstract
Background: A 2014 Lancet series suggested that 85% of biomedical research is avoidably wasted. So far, academic institutions have paid little attention to the recommendations on how to increase value and reduce waste.
Objectives: To develop a conceptual framework guiding the comprehensive assessment of clinical research quality at academic institutions, and Swiss university hospitals in particular.
Methods: We systematically, and in duplicate, searched definitions and concepts of clinical research quality on websites of international stakeholders and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic research initiatives, contract research organisations, ethics committees, patient organisations and funding agencies from 12 countries. Using qualitative-framework analysis, we systematically developed a comprehensive framework for clinical research quality. In a Delphi process, a framework draft was circulated among representatives of the 8 international stakeholder groups and all 6 Swiss Clinical Trial Units, until consensus on structure and content was reached.
Results: Our proposed framework synthesises criteria that were identified from different stakeholders and settings, and spans 5 study stages. It includes the following dimensions: (1) ethical conduct and protection of participants’ safety and rights; (2) relevance and patient centredness; (3) minimisation of bias/internal validity; (4) precision; (5) transparency/public access to data; and, (6) generalisability of study results. These dimensions are embedded in an environment that a) consists of an established infrastructure including well-trained personnel and functional facilities; and, b) uses ongoing research efficiently for training purposes to ensure sustainability of an effective infrastructure. Each dimension contains main quality questions and explanatory items guiding the quality assessment of each study stage.
Conclusions:We propose a consensus-based framework guiding the assessment of quality of clinical research, which aims to increase value at Swiss university hospitals.
Objectives: To develop a conceptual framework guiding the comprehensive assessment of clinical research quality at academic institutions, and Swiss university hospitals in particular.
Methods: We systematically, and in duplicate, searched definitions and concepts of clinical research quality on websites of international stakeholders and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic research initiatives, contract research organisations, ethics committees, patient organisations and funding agencies from 12 countries. Using qualitative-framework analysis, we systematically developed a comprehensive framework for clinical research quality. In a Delphi process, a framework draft was circulated among representatives of the 8 international stakeholder groups and all 6 Swiss Clinical Trial Units, until consensus on structure and content was reached.
Results: Our proposed framework synthesises criteria that were identified from different stakeholders and settings, and spans 5 study stages. It includes the following dimensions: (1) ethical conduct and protection of participants’ safety and rights; (2) relevance and patient centredness; (3) minimisation of bias/internal validity; (4) precision; (5) transparency/public access to data; and, (6) generalisability of study results. These dimensions are embedded in an environment that a) consists of an established infrastructure including well-trained personnel and functional facilities; and, b) uses ongoing research efficiently for training purposes to ensure sustainability of an effective infrastructure. Each dimension contains main quality questions and explanatory items guiding the quality assessment of each study stage.
Conclusions:We propose a consensus-based framework guiding the assessment of quality of clinical research, which aims to increase value at Swiss university hospitals.