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Objective To examine the association between the presence of individual principal investigators’ financial ties to the manufacturer of the study drug and the trial’s outcomes after accounting for source of research funding.Design Cross sectional study of randomized controlled trials (RCTs).Setting Studies published in “core clinical” journals, as identified by Medline, between 1 January 2013 and 31 December 2013.Participants Random sample of RCTs focused on drug efficacy.Main outcome measure Association between financial ties of principal investigators and study outcome.Results A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers’ fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1.4 to 7.9).Conclusions Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base.

Background Conducting research can be time consuming, difficult and challenging. Guidance and pragmatic advice focussing on randomised controlled trial conduct are available but do not necessarily constitute comprehensive guidance. A successful trial is one that recruits to time and target and collects high-quality data within the originally agreed budget. Standardised trial management tools have outlined key project management elements for a successful trial as a method of ensuring good practice in research trials: initiation, planning, execution, monitoring and closure. Lessons are also frequently learnt during the development and conduct of trials but rarely shared for the benefit of others. For the wider research team, the key focus will always be on the execution and delivery of a study. The aim of this study was to evaluate the acceptability of clinical trials management methods, focussing on study execution and monitoring, as implemented in the National Institute for Health Research Health Technology Assessment Programme-funded Obsessive Compulsive Treatment Efficacy Trial (OCTET). Methods Workshops, questionnaires and semi-structured interviews were used to explore acceptability of trial management methods with members of the OCTET Trial research team. Nine members participated in the focus group, 10 completed a questionnaire and 20 were interviewed as part of qualitative work for the main OCTET study. Data was collected and analysed using thematic analysis. Results Six key themes were identified: support; communication; processes; resources; training and ethos. Clear and open communication, enthusiasm and accessibility of the trial managers and chief investigator were consistently noted as an important facet of the successful running of the trial. Clear resources and training materials were also found to be crucial in helping staff to work within the trial setting. Constructive suggestions were also made for improvement of these resources; for example, including both checklists and flowcharts within trial processes. Conclusion Organisation, openness and positivity are crucial for executing a trial successfully, whilst clear and focussed processes and resources are essential in monitoring and controlling the trial progress. Although derived from a single study, these findings are likely to be applicable to the successful conduct of all trials. Trial managers should consider developing these elements when setting up a study. Trial registration Clinical Trial Registry, ID: ISRCTN73535163 . Registered prospectively on 5 April 2011.

Nature ’s survey of more than 6,000 graduate students reveals the turbulent nature of doctoral research. Nature’s survey of more than 6,000 graduate students reveals the turbulent nature of doctoral research.

Scientists and inventors set the direction of their work amid evolving questions, opportunities and challenges, yet the understanding of pivots between research areas and their outcomes remains limited 1 , 2 , 3 , 4 – 5 . Theories of creative search highlight the potential benefits of exploration but also emphasize difficulties in moving beyond one’s expertise 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 – 14 . Here we introduce a measurement framework to quantify how far researchers move from their existing work, and apply it to millions of papers and patents. We find a pervasive ‘pivot penalty’, in which the impact of new research steeply declines the further a researcher moves from their previous work. The pivot penalty applies nearly universally across science and patenting, and has been growing in magnitude over the past five decades. Larger pivots further exhibit weak engagement with established mixtures of prior knowledge, lower publication success rates and less market impact. Unexpected shocks to the research landscape, which may push researchers away from existing areas or pull them into new ones, further demonstrate substantial pivot penalties, including in the context of the COVID-19 pandemic. The pivot penalty generalizes across fields, career stage, productivity, collaboration and funding contexts, highlighting both the breadth and depth of the adaptive challenge. Overall, the findings point to large and increasing challenges in effectively adapting to new opportunities and threats, with implications for individual researchers, research organizations, science policy and the capacity of science and society as a whole to confront emergent demands. An analysis of millions of scientific papers and patents reveals a ‘pivot penalty’ when researchers shift direction, with the impact of studies decreasing rapidly the further they move from their previous work.

Thousands of academic journals do not aspire to quality. They exist primarily to extract fees from authors. These 'predatory' journals exhibit questionable marketing schemes, follow lax or nonexistent peer-review procedures and fail to provide scientific rigour or transparency1-3. The open-access movement, although noble in its intent, has been an unwitting host to these parasitic publishers. Bogus journals can imitate legitimate ones that also collect fees from authors. Researchers, eager to publish (lest they perish), may submit their papers with or without verifying a journal's reputability.

Little is known about the effects of investigators' financial disclosures on potential research participants. We conducted a vignette trial in which 470 participants in a telephone survey were randomly assigned to receive a simulated informed consent document that contained 1 of 2 financial disclosures (per capita payments to the research institution or equity ownership by the investigator) or no disclosure. The main outcome measures were trust in medical research and willingness to participate in a hypothetical clinical trial. Participants in the equity group reported less willingness to participate than participants in the per capita payments group ( P = .01) and the no disclosure group ( P = .03). Trust in the investigator was highest in the per capita payments group and lowest in the equity group ( P < .001). Trust among participants who received no disclosure was also greater than trust among participants in the equity group ( P = .04) but did not differ significantly from trust among participants in the per capita payments group ( P = .15). Participants in the equity group made 3 times as many negative comments as participants in the per capita payments group; and 10 participants in the equity group spontaneously said they would not participate in the hypothetical trial because of the financial interest, compared with only 1 such participant from the other groups. Although investigators' financial disclosures in research do not substantially affect willingness to participate, potential research participants are more troubled by equity interests than by per capita payments.

Later, after the paper is accepted and published, the authors are invoiced for the fees, typically US$1,800. Because the scientists are often asked to sign over their copyright to the work as part of the submission process (against the spirit of open access) they feel unable to withdraw the paper and send it elsewhere. The research community needs to use scholarly social networks such as Connotea and Mendeley to identify and share information on publishers that deceive, lack transparency or otherwise fail to follow industry standards.

A new analysis of biomedical awards over five decades shows men receive more cash and more respect for their research than women do, report Brian Uzzi and colleagues. A new analysis of biomedical awards over five decades shows men receive more cash and more respect for their research than women do, report Brian Uzzi and colleagues.

Despite improvements, female scientists continue to face discrimination, unequal pay and funding disparities.