A large amount of biomedical research is not useful and thus wasteful; academic institutions in particular have failed to take responsive measures to reports of research waste. The lack of a common understanding of the key principles of good clinical research and the lack of practical guidance on how to improve the current situation inhibit efforts to increase value within the academic system. Practical guidance on how to improve the current situation, however, may not become effective until consensus on these pillars exist.
Therefore, we aimed to develop a comprehensive framework for quality of patient-oriented clinical research that is based on the consensus of key major stakeholder groups and covers key research stages.
We present INQUIRE (INcreasing QUality In patient-oriented academic clinical REsearch), a consensus-based framework that supports academia in developing quality enhancement initiatives and setting their research agendas to increase efficiency and quality of patient-oriented research at all study stages, i.e. from conceptualization of the research question to reporting of study results and knowledge translation.
The final framework is structured in three main building blocks:
a) Six quality dimensions, with a dimension being defined as an overarching concept containing several individual quality questions:
Protection of patients’ safety and rightsrepresents the cornerstone of clinical research.It assures that researchers, at all times, respect and protect participants’ safety, rights, and well-being.
Relevance of study question and patient centeredness and involvement reflects the extent to which the research question is scientifically and societally beneficial (i.e., leads to improved decision-making in healthcare) and involves patient values and preferences.
Minimization of bias (internal validity reflects the extent to which the research minimizes systematic error (bias) through selecting an appropriate study design and prespecifying analyses.
Precision reflects the extent to which the research minimizes random error (i.e., sufficiently narrow confidence intervals) and to what extent authors present precision to facilitate researcher users’ understanding.
Transparency and access to data reflect the extent to which study planning, conduct, data collection, and presentation of results are transparent and accessible for the scientific community and the public. This dimension includes the registration of the study in a publicly accessible database, publication of the full study protocol, publication of the study results—independent of their effect size or direction—and explicitly encouraging access to the full patient-level dataset (data sharing).
Generalizability (external validity) reflects the extent to which study results are applicable and generalizable to the wider patient population in real-life circumstances.
b) five successive study stages (concept, planning and feasibility, conduct, analysis and interpretation, and reporting and knowledge translation) to which the dimensions apply, and
c) two quality(sustainability through education, and infrastructure), with a promotor being defined as set of factors that may enhance all quality dimensions at a research institution.
In contrast to existing frameworks, seven international stakeholder groups, including patient representatives, have participated in the development of INQUIRE and have agreed on the final product. INQUIRE is therefore based on a common understanding of factors contributing to clinical research quality.
INQUIRE was developed based on the three principles of
integrating empirical evidence on aspects of quality through a systematic review informing a first matrix of quality dimensions (von Niederhäusern, PlosOne 2017),
including the views of a broad range of stakeholder representatives through iterative rounds of a modified online Delphi process,
addressing operationalization of the framework through detailed feedback of stakeholders from the Swiss academic setting.
INQUIRE can support academic institutions and researchers to design quality enhancement initiatives for clinical research. In the future, other stakeholders may adapt INQUIRE for their own environment and specific purposes.
In Switzerland, INQUIRE has triggered major stakeholders to agree on a national roadmap to improve clinical research, and is currently undergoing implementation in academia (e.g. Swiss Clinical Trial Organisation (SCTO)).
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Do you have questions about INQUIRE or its application in practice? Would you like to use INQUIRE for your institution or your study? Please do not hesitate to contact us! We are available at firstname.lastname@example.org