Academic response to improving value and reducing waste: A comprehensive framework for INcreasing QUality In patient-oriented academic clinical REsearch (INQUIRE)

<div><p>Background</p><p>Compelling evidence has demonstrated that a large proportion of investment in biomedical research is wasted; this waste is avoidable. Academic institutions have, thus far, shown limited response to recommendations for increasing value and reducing waste. We formulated an academic response by (i) achieving consensus across a wide range of stakeholder groups on a comprehensive framework for quality of patient-oriented clinical research and (ii) highlighting first successful examples of its operationalization to facilitate waste-reducing strategies at academic institutions.</p><p>Methods and findings</p><p>Based on a systematic review of quality definitions, concepts, and criteria in the medical literature (systematic MEDLINE search up to February 15, 2015, with independent and in duplicate article selection) and on stakeholder websites from 13 countries (Australia, Austria, Canada, France, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland, United Kingdom, and United States), we systematically developed a comprehensive framework for the quality of clinical research. We identified websites through personal contacts with experts in clinical research or public health who also suggested, for each country, websites of the following 7 stakeholder groups: patient organizations; academic research infrastructures; governmental bodies; regulatory agencies; ethics committees; the pharmaceutical industry; and funding agencies. In addition, we searched websites of inter- or supranational bodies involved in clinical research until no further insights emerged. After consolidation of the identified definitions, concepts, and criteria of quality in a basic framework structure, we conducted 4 rounds of an adapted online Delphi process among the same 7 stakeholder groups from 16 countries. The Delphi process ultimately achieved consensus on structure and content. The framework addresses 5 study stages (concept, planning and feasibility, conduct, analysis and interpretation, and reporting and knowledge translation) and includes the following dimensions: (i) protection of patient safety and rights, (ii) relevance/patient centeredness and involvement, (iii) minimization of bias (internal validity), (iv) precision, (v) transparency/access to data, and (vi) generalizability (external validity) of study results. These dimensions interact with 2 promoters—infrastructure and sustainability through education—that include a set of factors that may enhance all listed quality dimensions. Each quality dimension contains specific questions and explanatory items that guide quality assessment at each research stage from conceptualization of the research question through reporting and knowledge translation of study results. In the last survey round, Delphi participants from 9 countries (Austria, Australia, Canada, Germany, Italy, the Netherlands, Switzerland, UK, and US) agreed on the structure, content, and wording of the research stages, quality dimensions, specific questions, and descriptive examples of the final framework. In Switzerland, INQUIRE has resulted in a roadmap that guides initiatives to increase value within the Swiss Clinical Trial Organization network and through affiliated researchers.</p><p>Conclusions</p><p>We present a framework based on a consensus of different stakeholder groups guiding the practical assessment of clinical research quality at all stages of a research project. Operationalization of this common structure will support the increase of value by guiding academic institutions and researchers in developing quality enhancement initiatives, from posing the right research question to the transparent publication of results.</p></div

SCTO roadmap on how to increase value in Swiss academic clinical research.

<p>¹The CTU Network and SCTO actively support the design, planning, and conduct of investigator-initiated studies that apply for the Swiss National Science Foundation’s call for investigator-initiated clinical trials (<a href="http://www.snf.ch/en/funding/programmes/iict/Pages/default.aspx" target="_blank">http://www.snf.ch/en/funding/programmes/iict/Pages/default.aspx</a>). The Swiss National Science Foundation has earmarked CHF 10 million for the 2017 funding period. Performance measures would allow assessing the SCTO network’s impact on the success of supported studies. ²SCTO platforms are excellence clusters for specific support units, e.g., data management, statistics, training, and education, located at different CTUs. CTU, Clinical Trial Unit; REWARD, Reduce Research Waste and Reward Diligence.</p

INQUIRE’s specific quality questions (and descriptive examples for Stage I) by quality dimension and research stage, and promoters.

<p>INQUIRE’s specific quality questions (and descriptive examples for Stage I) by quality dimension and research stage, and promoters.</p

Response rates by stakeholder group for Delphi rounds 1 and 2.

<p>Response rates by stakeholder group for Delphi rounds 1 and 2.</p

Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality

<div><p>Objective</p><p>To 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.</p><p>Study design and setting</p><p>We 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.</p><p>Results</p><p>Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no <i>a priori</i> 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.</p><p>Conclusion</p><p>Clinical 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.</p></div

Characteristics of articles providing an explicit definition of clinical research quality; by author (n = 8).

<p>Characteristics of articles providing an explicit definition of clinical research quality; by author (n = 8).</p

Article flow diagram.

<p>Article flow diagram.</p

Qualitative analysis of common and stakeholder-specific quality themes in the context of clinical research.

<p>Qualitative analysis of common and stakeholder-specific quality themes in the context of clinical research.</p