Article type
Year
Abstract
Background: Clinical research is a prerequisite for advancing our understanding and treatment of disease. While there are factors that some understand as indicators of clinical research quality (e.g. impact factors or whether good clinical practice guidelines were followed), a comprehensive definition considering various stakeholders’ perspectives remains elusive.
Objectives: To: 1) systematically review definitions of quality in clinical research; and 2) to create a conceptual framework of indicators allowing for a comprehensive assessment of clinical research quality.
Methods: Systematically we searched for definitions of quality in clinical research by screening websites (and any linked information) of various stakeholders involved in clinical research. Stakeholders included governmental bodies, regulatory agencies, pharmaceutical industry, academic and commercial contract research organizations, research ethics committees, patient organizations and funding agencies from 12 countries. In addition, we systematically searched MEDLINE with support from an information specialist. Data synthesis will involve a structured summary of quality definitions. The summary will inform a conceptual framework that we will circulate among methodological experts and experienced clinical researchers until no further ideas emerge using the Delphi method.
Results: At the time of the Colloquium, we will present how different stakeholders from different countries conceptualize clinical research quality. We will further provide a framework of indicators of clinical research quality that will span all phases of clinical research (i.e. planning to dissemination) and include at least the following dimensions: 1) absence of bias; 2) precision; 3) external validity; 4) innovation/relevance; 5) transparency/public access to data; and 6) well-trained personnel/number of trainees involved.
Conclusions: A holistic definition of clinical research quality is still missing. Based on a systematic review we propose a comprehensive framework of quality indicators that may be used as the basis to develop a measurement tool of clinical research quality.
Objectives: To: 1) systematically review definitions of quality in clinical research; and 2) to create a conceptual framework of indicators allowing for a comprehensive assessment of clinical research quality.
Methods: Systematically we searched for definitions of quality in clinical research by screening websites (and any linked information) of various stakeholders involved in clinical research. Stakeholders included governmental bodies, regulatory agencies, pharmaceutical industry, academic and commercial contract research organizations, research ethics committees, patient organizations and funding agencies from 12 countries. In addition, we systematically searched MEDLINE with support from an information specialist. Data synthesis will involve a structured summary of quality definitions. The summary will inform a conceptual framework that we will circulate among methodological experts and experienced clinical researchers until no further ideas emerge using the Delphi method.
Results: At the time of the Colloquium, we will present how different stakeholders from different countries conceptualize clinical research quality. We will further provide a framework of indicators of clinical research quality that will span all phases of clinical research (i.e. planning to dissemination) and include at least the following dimensions: 1) absence of bias; 2) precision; 3) external validity; 4) innovation/relevance; 5) transparency/public access to data; and 6) well-trained personnel/number of trainees involved.
Conclusions: A holistic definition of clinical research quality is still missing. Based on a systematic review we propose a comprehensive framework of quality indicators that may be used as the basis to develop a measurement tool of clinical research quality.