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Towards implementation of an evidence-based approach in clinical research

English title Towards implementation of an evidence-based approach in clinical research
Applicant Briel Matthias
Number 198082
Funding scheme COST (European Cooperation in Science and Technology)
Research institution Institut für klinische Epidemiologie und Biostatistik Universitätsspital Basel
Institution of higher education University of Basel - BS
Main discipline Methods of Epidemiology and Preventive Medicine
Start/End 01.02.2021 - 31.01.2024
Approved amount 189'810.00
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Keywords (6)

research context; clinical research; stakeholder involvement; research-on-research; systematic reviews; waste reduction

Lay Summary (German)

Lead
Systematisch die bestehende Evidenz zu einer klinischen Forschungsfrage zusammenzufassen und kritisch zu prüfen, ist wichtig bevor eine neue Studie zur selben oder ähnlichen Fragestellung begonnen wird. Es ist jedoch eher die Ausnahme als die Regel, dass solche systematische Übersichtsarbeiten zur Rechtfertigung und optimierten Planung einer klinischen Studie durchgeführt werden. Das vorliegende Projekt will Hürden und Förderfaktoren identifizieren, um in einem Stakeholderkonsensus einen Evidenz-basierten Ansatz in der schweizerischen klinischen Forschung zu etablieren.
Lay summary

Systematische Zusammenfassungen der vorhandenen Evidenz zu einer klinischen Forschungsfrage und deren kritischer Prüfung erlauben es, konkrete Wissenslücken aufzuzeigen und das Design von neuen Studien zu optimieren, welche die Lücken verlässlich schliessen können. Ein solcher Evidenz-basierter Ansatz wird jedoch noch unzureichend in der klinischen Forschungspraxis angewandt. Forschungsförderern und Ethikkommissionen kommt bei der Implementierung eines Evidenz-basierten Ansatzes eine Schlüsselrolle zu.

In Teilprojekt A planen wir Interviews mit Forschungsförderern, Ethikkommissionen, Clinical Trial Units und Forschenden zu führen, um Sichtweisen der verschiedenen Stakeholder sowie Hürden und Förderfaktoren für die Implementierung eines Evidenz-basierten Ansatzes in der Schweiz zu eruieren. In Teilprojekt B werden wir die Methodik von «Rapid Reviews» und praktische Anleitungen für Forschende dazu weiterentwickeln, um die Durchführung von systematischen Übersichtsarbeiten zu erleichtern. Teilprojekt C sieht zwei Stakeholder Workshops mit Vertretern von schweizerischen Forschungsförderern, Ethikkommissionen, Clinical Trial Units und klinischen Forschern vor, um die Ergebnisse der Projekte A & B zu diskutieren und eine konkrete Implementierungsstrategie für einen Evidenz-basierten Ansatz in der Schweiz zu entwickeln.

Die Ergebnisse des Projektes werden die laufenden Aktivitäten der EU-COST Action CA17117 zu Evidenz-basierter klinischer Forschung ergänzen und die Implementierung eines Evidenz-basierten Ansatzes über die Schweiz hinaus beschleunigen.

Direct link to Lay Summary Last update: 13.11.2020

Responsible applicant and co-applicants

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Associated projects

Number Title Start Funding scheme
188675 Generalizability, applicability and pragmatism of clinical trials and their impact on treatment effect estimates: a meta-epidemiological study 01.11.2019 Project funding
183427 INSPIRE: Implementation of an integrated community-based care program for home-dwelling senior citizens 01.02.2019 NRP 74 Smarter Health Care
188802 Making clinical trials more affordable - systematic investigation of trial costs and tool development 01.11.2019 Project funding

Abstract

Systematically reviewing prior evidence is of paramount importance before starting a new clinical study. Failure to acknowledge existing evidence can result in unnecessary, unethical, and costly research, puts patients at risk, limits the available resources for necessary and well-designed research, and diminishes the public’s trust in science. Systematic reviews ensure that clinical studies are warranted and optimally designed. A recent scoping review of meta-research studies found that (i) systematic reviews are insufficiently used to justify and design a new clinical trial, (ii) qualitative research on what different stakeholders view to be barriers and facilitators of systematic reviews is lacking, and (iii) stakeholder policies, in particular of funding agencies, can be key to successfully implement an evidence-based research approach.The overall objective of this project is to improve clinical research practice when justifying and designing a new clinical trial. Specific aims are (1) to identify barriers and facilitators for systematically reviewing the prior evidence from the perspective of multiple stakeholders, (2) to develop rapid review methods and user-tested guidance tailored to evidence-based research, and (3) to directly engage with Swiss funding agencies and research ethics committees to devise a roadmap on how to concretely implement an evidence-based approach in the Swiss clinical research arena. To achieve these aims, we propose three interlinked projects. In project A, we will conduct approximately 55 semi-structured qualitative interviews with funders of clinical trials, that already require systematic reviews in funding applications (all outside of Switzerland), all Swiss funders of clinical trials that do not require systematic reviews in applications, the Swiss research ethics committees and clinical trial units, and a random sample of Swiss trial investigators to identify barriers and facilitators for the use or conduct of systematic reviews when planning a new trial and placing its results in context. In project B, we will integrate preliminary work from the Cochrane Rapid Reviews Methods Group, findings from project A, and results from Working Groups 1 and 3 of COST Action CA17117 to develop rapid review methods and practical guidance for their use tailored to clinical researchers and the context of evidence-based research. We will formally user-test the developed methods and guidance and disseminate it through multiple networks. In project C, we will hold two stakeholder workshops with mainly Swiss funding agencies and ethics committees, but also clinical researchers and members of clinical trial units, to share the findings of projects A and B and to develop and agree on a concrete implementation strategy in Switzerland. The proposed project follows key principles of implementation science, such as stakeholder involvement, user orientation, and context consideration. It will complement ongoing activities of COST Action CA17117 and is fully supported by the chair and all working group leads. Finally, the proposed project and lessons learned may facilitate the international implementation of an evidence-based approach to improve clinical research and, ultimately, patient care.
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