Projects & Collaborations 2 foundShow per page10 10 20 50 Increasing value of health research: development of a new methodological decision support system to assist researchers in study design, conduct, and analysis Research Project | 1 Project MembersMethods applied in health research are often uninformed and inappropriate. One important reason is that methodological guidance has limitations regarding access, presentation, and veracity. AIM: We propose to develop a new online methodological decision support system that provides health researchers with access to up-to-date, trustworthy, and user-friendly methodological recommendations. If feasible, the new system could become the key reference for those seeking methodological guidance. METHODS: We have formulated an overall development plan in which we identified key features and processes. To inform the feasibility of the overall initiative, we will start with pilot studies addressing key features of the proposed system: We will explore existing approaches for systematically reviewing and monitoring the methodological literature for a specific methodological question. We will test candidate approaches by applying them to a specific topic (e.g. adaptive designs for randomized trials). Based on the test results, we will draft a standard process for reviewing a methodological topic. In addition, we will explore ways to develop methodological recommendations together with experts. Specifically, we are interested in the extent to which we can adapt guideline processes from the medical context (e.g. the GRADE approach). We will draft processes for transparently selecting, evaluating, and integrating methodological evidence (i.e. results of research on research and simulation studies) in methodological practice recommendations. Learning from failure - Understanding the mechanisms of trial discontinuation Research Project | 6 Project MembersOne out of four randomized controlled trials (RCTs) is discontinued; insufficient recruitment of participants is the most frequent reason, in particular in investigator-initiated RCTs. Trials initiated by commercial sponsors are less likely to be discontinued suggesting that professional planning and conduct as well as sufficient funding of RCTs help complete recruitment as planned. Currently, the mechanisms and specific root causes of trial discontinuation remain unclear. Evidence-based guidance for trialists and other stakeholders on how to plan and assess recruitment in RCTs is lacking. In most cases, participants and research ethics committees (RECs) are not informed about discontinuation or publication of trial results. Accounts of the work done so far are not disseminated to the scientific community in up to 60% of discontinued RCTs. This entails ethical problems: The patients' and the public's trust in clinical research is undermined, and finite research resources are wasted. It is unknown to what extent trialists are aware of the ethical implications with trial discontinuation and what their attitudes and views are. We propose three complementary projects that will use both qualitative and quantitative methods to better understand the mechanisms that lead to RCT discontinuation, find ways to meet the associated ethical challenges, and develop guiding principles for involved stakeholders. In Project A we will conduct semi-structured interviews with principal investigators of RCTs discontinued for insufficient recruitment and with key stakeholders of clinical research in Switzerland representing Clinical Trial Units, RECs, the Swiss National Science Foundation (SNSF), the pharmaceutical industry, and Swissmedic. Project B will empirically examine all health-care RCTs funded by the SNSF to explore whether a rigorous selection of trials for funding and monitoring decreases the risk of trial discontinuation including potential effects of full versus partial funding. In Project C we will perform a comprehensive analysis of recruitment patterns from about 500 completed and discontinued RCTs conducted in different countries and settings. It will explore whether insufficient recruitment can reliably be identified at an early stage and determine optimal time points and criteria for the assessment of recruitment progress in RCTs. Using a mixed methods approach, this study will further our understanding of the complex mechanisms leading to failure in trial recruitment and identify potential lever points for targeted interventions. Following on the successfully completed DISCO study it will continue a line of methodological research that is of high relevance to clinical researchers and trial participants in Switzerland and abroad. At a time in which the legal framework of research involving humans is being revised, the study will provide a most needed empirical base for the elaboration of guidance documents to be used by trialists and other stakeholders. 1 1
Increasing value of health research: development of a new methodological decision support system to assist researchers in study design, conduct, and analysis Research Project | 1 Project MembersMethods applied in health research are often uninformed and inappropriate. One important reason is that methodological guidance has limitations regarding access, presentation, and veracity. AIM: We propose to develop a new online methodological decision support system that provides health researchers with access to up-to-date, trustworthy, and user-friendly methodological recommendations. If feasible, the new system could become the key reference for those seeking methodological guidance. METHODS: We have formulated an overall development plan in which we identified key features and processes. To inform the feasibility of the overall initiative, we will start with pilot studies addressing key features of the proposed system: We will explore existing approaches for systematically reviewing and monitoring the methodological literature for a specific methodological question. We will test candidate approaches by applying them to a specific topic (e.g. adaptive designs for randomized trials). Based on the test results, we will draft a standard process for reviewing a methodological topic. In addition, we will explore ways to develop methodological recommendations together with experts. Specifically, we are interested in the extent to which we can adapt guideline processes from the medical context (e.g. the GRADE approach). We will draft processes for transparently selecting, evaluating, and integrating methodological evidence (i.e. results of research on research and simulation studies) in methodological practice recommendations.
Learning from failure - Understanding the mechanisms of trial discontinuation Research Project | 6 Project MembersOne out of four randomized controlled trials (RCTs) is discontinued; insufficient recruitment of participants is the most frequent reason, in particular in investigator-initiated RCTs. Trials initiated by commercial sponsors are less likely to be discontinued suggesting that professional planning and conduct as well as sufficient funding of RCTs help complete recruitment as planned. Currently, the mechanisms and specific root causes of trial discontinuation remain unclear. Evidence-based guidance for trialists and other stakeholders on how to plan and assess recruitment in RCTs is lacking. In most cases, participants and research ethics committees (RECs) are not informed about discontinuation or publication of trial results. Accounts of the work done so far are not disseminated to the scientific community in up to 60% of discontinued RCTs. This entails ethical problems: The patients' and the public's trust in clinical research is undermined, and finite research resources are wasted. It is unknown to what extent trialists are aware of the ethical implications with trial discontinuation and what their attitudes and views are. We propose three complementary projects that will use both qualitative and quantitative methods to better understand the mechanisms that lead to RCT discontinuation, find ways to meet the associated ethical challenges, and develop guiding principles for involved stakeholders. In Project A we will conduct semi-structured interviews with principal investigators of RCTs discontinued for insufficient recruitment and with key stakeholders of clinical research in Switzerland representing Clinical Trial Units, RECs, the Swiss National Science Foundation (SNSF), the pharmaceutical industry, and Swissmedic. Project B will empirically examine all health-care RCTs funded by the SNSF to explore whether a rigorous selection of trials for funding and monitoring decreases the risk of trial discontinuation including potential effects of full versus partial funding. In Project C we will perform a comprehensive analysis of recruitment patterns from about 500 completed and discontinued RCTs conducted in different countries and settings. It will explore whether insufficient recruitment can reliably be identified at an early stage and determine optimal time points and criteria for the assessment of recruitment progress in RCTs. Using a mixed methods approach, this study will further our understanding of the complex mechanisms leading to failure in trial recruitment and identify potential lever points for targeted interventions. Following on the successfully completed DISCO study it will continue a line of methodological research that is of high relevance to clinical researchers and trial participants in Switzerland and abroad. At a time in which the legal framework of research involving humans is being revised, the study will provide a most needed empirical base for the elaboration of guidance documents to be used by trialists and other stakeholders.
