Abstract
ObjectiveTo systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research.Study design and settingWe systematically and in duplicate searched definitions, concepts and criteria 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 and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes.ResultsStakeholder 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 identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives.ConclusionClinical research quality is often discussed but rarely defined. A framework defining clinical research quality across stakeholders’ individual perspectives is desirable to facilitate discussion, assessment, and improvement of quality at all stages of clinical research.
Highlights
Clinical research is necessary to advance our knowledge and practice of diagnosing and preventing diseases and treating patients
We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process
Concepts of how to assure quality of clinical research or quality criteria were commonly reported among most stakeholder groups (66.4% (103/155); i.e. in 86.1% (31/36) of pharmaceutical companies or contract research organizations (CROs), 72% (18/25) of academic research organizations or initiatives, 63.6% (14/22) of international and governmental organizations, 61.9% (13/21) of regulatory agencies, 57.9% (11/19) of ethics committees, and 63.2% (12/19) of funding agencies, respectively), but this was relatively uncommon for patient organizations (31%; 4/13)
Summary
Clinical research is necessary to advance our knowledge and practice of diagnosing and preventing diseases and treating patients. Low quality research may result in misleading findings [9], but may compromise safety and rights of patients. The regulatory international “ethical and scientific quality standard for designing, conducting, recording and reporting trials”–the Good Clinical Practice (GCP) guideline developed by the International Conference on Harmonisation (ICH) aims to ensure that safety and rights of participants are protected and that trial data are credible [10, 11]. The GCP guideline is a widely disseminated and applied standard for the broad concept of clinical research quality. Its limitations include development as an agreement between industry and regulatory experts and its focus on data accuracy and extensive formal requirements has been criticized as an unsuitable standard for investigator-initiated clinical research [12, 13]. The GCP guidelines lack a broad stakeholder consensus and a sound evidence-base [14, 15]
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