Aligning research funding and the production of useful evidence to reduce research waste.

Considering the substantial increase in research funding in the field of urology, minimizing research wasteshould be a top priority. Systematic reviews (SRs) compile available evidence regarding a clinical question into a single critical resource. If properly utilized, SRs can help minimize redundant studies, focus attention to unsubstantiated treatments, and reduce research waste. To appraise the use of SRs as justification for conducting randomized controlled trials (RCTs) published in high impact urology journals, and to report the ways SRs were incorporated into RCT manuscripts published in the top four urology journals by h5 index. On December 13, 2019, a PubMed search was conducted for RCTs published in the top four urology journals according to the Google Scholar h5-index: European Urology, BJU International, The Journal of Urology, and Urology. For an article to be eligible for inclusion in this study, it must have been a full length RCT, published between November 30, 2014, and November 30, 2019 in one of the identified journals, reported only human subjects, and been accessible in English. The following data points were extracted independently by select investigators from each included RCT: manuscript title, year of publication, journal title, type of intervention (drug, medical device, procedure, other), funding source (government, hospital/university, industry, mixed) type of trial (parallel groups, crossover, cluster), and total number of participants reported in each RCT. The included RCTs were searched for reference to an SR, which was then recorded as "yes- verbatim," "yes- inferred," or "not used as justification" and the location in the manuscript where the SR was cited was recorded. Of the 566 articles retrieved, 276 were included. Overall, 150 (54.3%) RCTs cited an SR as either verbatim (108; 39.1%) or inferred (42; 15.2%) trial justification, while 126 (45.7%) did not use an SR for RCT justification. Of those 126, 107 (84.9%) RCTs did not cite an SR to any extent. A significant association was noted between verbatim justification and type of intervention (x 2=20.23, p=0.017), with 18 of 31 (58.1%) "other" interventions (i.e. psychosocial intervention, exercise programs, and online therapy) having an SR cited as verbatim justification. Only 39 of 118 (33.1%) pharmaceutical trials referenced an SR as verbatim justification. Of 403 systematic review citations, 205 (50.8%) appeared in the Discussion section, while 15 (3.7%) were in the Methods section. We found that RCTs published in four high impact urology journals inconsistently referenced an SR as justification and 39.1% of our entire sample did not reference an SR at all. These findings indicate that a divide exists between the instruction and implementation of evidence based medicine in the field of urology concerning RCTs published in the top four journals. Educating clinicians and researchers on the use of SR as justification for RCTs in urology may reduce research waste and increase the quality of RCTs in the field.

Research funders can reduce research waste and publication bias by requiring their grantees to register and report clinical trials. To determine the extent to which 21 major European research funders' efforts to reduce research waste and publication bias in clinical trials meet World Health Organization (WHO) best practice benchmarks and to investigate areas for improvement. This cross-sectional study was based on 2 to 3 independent assessments of each funder's publicly available documentation and validation of results with funders during 2021. Included funders were the 21 largest nonmultilateral public and philanthropic medical research funders in Europe, with a combined budget of more than US $22 billion. Scoring of funders using an 11-item assessment tool based on WHO best practice benchmarks, grouped into 4 broad categories: trial registries, academic publication, monitoring, and sanctions. Funder references to reporting standards were captured. The primary outcome was funder adoption or nonadoption of 11 policy and monitoring measures to reduce research waste and publication bias as set out by WHO best practices. The secondary outcomes were whether and how funder policies referred to reporting standards. Outcomes were preregistered after a pilot phase that used the same outcome measures. Among 21 of the largest nonmultilateral public and philanthropic funders in Europe, some best practices were more widely adopted than others, with 14 funders (66.7%) mandating prospective trial registration and 6 funders (28.6%) requiring that trial results be made public on trial registries within 12 months of trial completion. Less than half of funders actively monitored whether trials were registered (9 funders [42.9%]) or whether results were made public (8 funders [38.1%]). Funders implemented a mean of 4 of 11 best practices in clinical trial transparency (36.4%) set out by WHO. The extent to which funders adopted WHO best practice items varied widely, ranging from 0 practices for the French Centre National de la Recherche Scientifique and the ministries of health of Germany and Italy to 10 practices (90.9%) for the UK National Institute of Health Research. Overall, 9 funders referred to reporting standards in their policies. This study found that many European medical research funder policy and monitoring measures fell short of WHO best practices. These findings suggest that funders worldwide may need to identify and address gaps in policies and processes.

ObjectivesClinicians, patients, and policy makers rely on published results from clinical trials to help inform evidence-based decision-making. To be able to critically evaluate and use the results of trials, readers...

ObjectivesClinicians, patients, and policy makers rely on published results from clinical trials to help inform evidence-based decision-making. To be able to critically evaluate and use the results of trials, readers...

Background: When health-related research funding agencies choose to fund research, they balance a number of competing issues: costs, stakeholder views and potential benefits. The REWARD Alliance, and the related Lancet-REWARD Campaign, question whether those decisions are yielding all the value they could. Methods: A group of health-related research funding agencies, organisations that represent health-related research funding agencies and those that inform and set health-related-research funding policy from around the world have come together since 2016 to share, learn, collaborate and influence emerging practice. This group meets under the name of the Ensuring Value in Research Funders’ Forum (EViR Funders’ Forum). The EViR Funders’ Forum worked together to develop a set of ten Guiding Principles, that if funders adhered to would reduce research waste and ensure value in research. Results: The EViR Funders’ Forum has previously agreed and published a Consensus Statement. The Forum has agreed on a set of ten Guiding Principles to help health-research funders to maximise the value of research by ensuring that: research priorities are justifiable; the design, conduct and analysis of research minimise bias; regulation and management are proportionate to risks; methods and findings are accessible in full; and findings are appropriately and effectively disseminated and used. Conclusions: When setting research funding policy, we must balance multiple stakeholders’ needs and expectations. When funders do this well, they maximise the probability of benefits to society from the research they support - when funders do this badly, they passively allow or actively contribute to research waste. These challenges must be resolved by funders either working together or in conjunction with other actors in the research ecosystem.

Background: When health-related research funding agencies choose to fund research, they balance a number of competing issues: costs, stakeholder views and potential benefits. The REWARD Alliance, and the related Lancet-REWARD Campaign, question whether those decisions are yielding all the value they could. Methods: A group of health-related research funding agencies, organisations that represent health-related research funding agencies and those that inform and set health-related-research funding policy from around the world have come together since 2016 to share, learn, collaborate and influence emerging practice. This group meets under the name of the Ensuring Value in Research Funders' Forum (EViR Funders' Forum). The EViR Funders' Forum worked together to develop a set of ten Guiding Principles, that if funders adhered to would reduce research waste and ensure value in research. Results: The EViR Funders' Forum has previously agreed and published a Consensus Statement. The Forum has agreed on a set of ten Guiding Principles to help health-research funders to maximise the value of research by ensuring that: research priorities are justifiable; the design, conduct and analysis of research minimise bias; regulation and management are proportionate to risks; methods and findings are accessible in full; and findings are appropriately and effectively disseminated and used. Conclusions: When setting research funding policy, we must balance multiple stakeholders' needs and expectations. When funders do this well, they maximise the probability of benefits to society from the research they support - when funders do this badly, they passively allow or actively contribute to research waste. These challenges must be resolved by funders either working together or in conjunction with other actors in the research ecosystem.

ObjectiveThere are many uncertainties surrounding the aetiology, treatment and sequelae of hyperemesis gravidarum (HG). Prioritising research questions could reduce research waste, helping researchers and funders direct attention to those questions...

Objective There are many uncertainties surrounding the aetiology, treatment and sequelae of hyperemesis gravidarum (HG). Prioritising research questions could reduce research waste, helping researchers and funders direct attention to those questions which most urgently need addressing. The HG priority setting partnership (PSP) was established to identify and rank the top 25 priority research questions important to both patients and clinicians. Methods Following the James Lind Alliance (JLA) methodology, an HG PSP steering group was established. Stakeholders representing patients, carers and multidisciplinary professionals completed an online survey to gather uncertainties. Eligible uncertainties related to HG. Uncertainties on nausea and vomiting of pregnancy and those on complementary treatments were not eligible. Questions were verified against the evidence. Two rounds of prioritisation included an online ranking survey and a 1-hour consensus workshop. Results 1009 participants (938 patients/carers, 118 professionals with overlap between categories) submitted 2899 questions. Questions originated from participants in 26 different countries, and people from 32 countries took part in the first prioritisation stage. 66 unique questions emerged, which were evidence checked according to the agreed protocol. 65 true uncertainties were narrowed via an online ranking survey to 26 unranked uncertainties. The consensus workshop was attended by 19 international patients and clinicians who reached consensus on the top 10 questions for international researchers to address. More patients than professionals took part in the surveys but were equally distributed during the consensus workshop. Participants from low-income and middle-income countries noted that the priorities may be different in their settings. Conclusions By following the JLA method, a prioritised list of uncertainties relevant to both HG patients and their clinicians has been identified which can inform the international HG research agenda, funders and policy-makers. While it is possible to conduct an international PSP, results from developed countries may not be as relevant in low-income and middle-income countries.

Increasing value and reducing waste in biomedical research: librarians are listening and are part of the answer.

Ethics of research methodology requires a methodology of research ethics

Background: Data sharing enables researchers to conduct novel research with previously collected data sets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing anonymised data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to data sharing remain, there are additional challenges for qualitative data. Qualitative data including videos, interviews, and observations are often more readily identifiable than quantitative data. Existing guidance from UK Economic and Social Research Council applies to sharing qualitative data but does not address the additional challenges related to sharing qualitative data collected within trials, including the need to incorporate the necessary information and consent into already complex recruitment processes, with the additional sensitive nature of health-related data. Methods: Work package 1 will involve separate focus group interviews with members of each stakeholder group: trial managers, clinical trialists, qualitative researchers, members of research funding bodies and trial participants who have been involved in qualitative research. Data will be analysed using thematic analysis and managed within QSR NVivo to enhance transparency. Work package 2 will involve a documentary analysis of current consent procedures for qualitative data collected as part of the conduct of clinical trials. We will include documents such as participant information leaflets and consent forms for the qualitative components in trials. We will extract data such as whether specific clauses for data sharing are included in the consent form. Content analysis will be used to analyse whether and how consent is being obtained for qualitative data sharing. Conclusions: This study will provide insight into the existing practice of sharing of qualitative data in clinical trials and the current issues and opportunities, to help shape future research and development of guidance to encourage maximum learning to be gained from this valuable data.

Background There is increasing evidence on the value of PPI reporting (patient public involvement) in all research. GRIPP2 (Guidance for Reporting Involvement of Patients and the Public) is the first international guidance for reporting of patient and public involvement in health and social care research. Associations with improved relevance and applicability may reduce research waste and target research funds more appropriately. The aim of this study was to review the reporting of PPI amongst all oesophago-gastric clinical trials undertaken between 2015 and 2021. Methods An electronic search in databases Medline, Embase and the Cochrane Library was conducted to identify all clinical trials pertaining to oesophagogastric cancer from 2015 to 2021(with the exception of reviews, case reports and conference abstracts). Articles were scanned by two authors to identify if reporting of PPI had taken place. Results A total of 334 studies were found, of which 285 met the inclusion and exclusion criteria.Only 4 studies had reported on PPI. Two of which reported positive involvement and two reported negatively. None of the studies reported using the GRIPP 2 checklist and when reported by this study, none achieved all points on the GRIPP2 SF checklist. An analysis on the extent of PPI involvement in these studies was carried out. Conclusions PPI is poorly reported across oesophago-gastric research trials.

Background: Data sharing enables researchers to conduct novel research with previously collected data sets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing anonymised data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to data sharing remain, there are additional challenges for qualitative data. Qualitative data including videos, interviews, and observations are often more readily identifiable than quantitative data. Existing guidance from UK Economic and Social Research Council applies to sharing qualitative data but does not address the additional challenges related to sharing qualitative data collected within trials, including the need to incorporate the necessary information and consent into already complex recruitment processes, with the additional sensitive nature of health-related data. Methods: Work package 1 will involve separate focus group interviews with members of each stakeholder group: trial managers, clinical trialists, qualitative researchers, members of research funding bodies and trial participants who have been involved in qualitative research. Data will be analysed using thematic analysis and managed within QSR NVivo to enhance transparency. Work package 2 will involve a documentary analysis of current consent procedures for qualitative data collected as part of the conduct of clinical trials. We will include documents such as participant information leaflets and consent forms for the qualitative components in trials. We will extract data such as whether specific clauses for data sharing are included in the consent form. Content analysis will be used to analyse whether and how consent is being obtained for qualitative data sharing. Conclusions: This study will provide insight into the existing practice of sharing of qualitative data in clinical trials and the current issues and opportunities, to help shape future research and development of guidance to encourage maximum learning to be gained from this valuable data.

Background: Data sharing enables researchers to conduct novel research with previously collected datasets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing, even de-identified, quantitative data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to sharing quantitative data remain, there are additional challenges for sharing qualitative data in trials. Incorporating the necessary information about how qualitative data will be shared into already complex trial recruitment and consent processes proves challenging. The aim of this study was to explore whether and how trial teams share qualitative data collected as part of the design, conduct, analysis, or delivery of clinical trials.Methods: Phase 1 involved semi-structured, in-depth qualitative interviews and focus groups with key trial stakeholder groups including trial managers and clinical trialists (n=3), qualitative researchers in trials (n=9), members of research funding bodies (n=2) and trial participants (n=1). Data were analysed using thematic analysis. In Phase 2, we conducted a content analysis of 16 participant information leaflets (PIL) and consent forms (CF) for trials that collected qualitative data.Results: Three key themes were identified from our Phase 1 findings: ‘Understanding and experiences of the potential benefits of sharing qualitative data from trials’, ‘Concerns about qualitative data sharing’, and ‘Future guidance and funding’. In phase 2, the PILs and CFs received revealed that the benefits of data sharing for participants were only explained in two of the study documents.Conclusions: The value of sharing qualitative data was acknowledged, but there are many uncertainties as to how, when, and where to share this data. In addition, there were ethical concerns in relation to the consent process required for qualitative data sharing in trials. This study provides insight into the existing practice of qualitative data sharing in trials.

Background: Data sharing enables researchers to conduct novel research with previously collected data sets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing anonymised data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to data sharing remain, there are additional challenges for qualitative data. Qualitative data including videos, interviews, and observations are often more readily identifiable than quantitative data. Existing guidance from UK Economic and Social Research Council applies to sharing qualitative data but does not address the additional challenges related to sharing qualitative data collected within trials, including the need to incorporate the necessary information and consent into already complex recruitment processes, with the additional sensitive nature of health-related data. Methods: Work package 1 will involve separate focus group interviews with members of each stakeholder group: trial managers, clinical trialists, qualitative researchers, members of research funding bodies and trial participants who have been involved in qualitative research. Data will be analysed using thematic analysis and managed within QSR NVivo to enhance transparency. Work package 2 will involve a documentary analysis of current consent procedures for qualitative data collected as part of the conduct of clinical trials. We will include documents such as participant information leaflets and consent forms for the qualitative components in trials. We will extract data such as whether specific clauses for data sharing are included in the consent form. Content analysis will be used to analyse whether and how consent is being obtained for qualitative data sharing. Conclusions: This study will provide insight into the existing practice of sharing of qualitative data in clinical trials and the current issues and opportunities, to help shape future research and development of guidance to encourage maximum learning to be gained from this valuable data.