Reporting adverse events in randomized controlled trials in periodontology: a systematic review.

BACKGROUND/AIMS: Reporting of adverse events is of paramount importance in randomized controlled trials (RCTs) to guide the implementation of new therapeutic approaches in clinical practice. The aim of this study was to assess the quality of adverse events reporting in RCTs published in the periodontal literature. MATERIALS AND METHODS: Two authors (CMF and NNG) searched the PubMed and LILACS electronic databases independently and in duplicate to identify RCTs published in periodontology from 2002 to 2003 and from 2011 to 2012. Reporting quality in RCTs was assessed with reference to the 2004 CONSORT Extension for Harms checklist. Differences in adverse events reporting between industry- and non-industry-funded RCTs were also determined. Cohen's kappa statistic was used to determine the extent of inter-reviewer agreement. Fischer's exact test was used to assess differences in reporting between the two samples. RESULTS: The analysis included 246 publications. One hundred twenty-four of 990 (13%) items and 223 of 1460 (15%) items were adequately reported in publications from 2002 to 2003 and from 2011 to 2012 respectively. Three checklist topics were significantly better reported in the 2011-2012 sample; two recommendations were better reported in non-industry-funded trials in publications from both periods. CONCLUSION: Improvement and standardization of adverse events reporting in periodontology are needed.

How much are we spending? The estimation of research expenditures on cardiovascular disease in Canada.

BACKGROUND: Cardiovascular disease (CVD) is a leading cause of death in Canada and is a priority area for medical research. The research funding landscape in Canada has changed quite a bit over the last few decades, as have funding levels. Our objective was to estimate the magnitude of expenditures on CVD research for the public and charitable (not-for profit) sectors in Canada between 1975 and 2005. METHODS: To estimate research expenditures for the public and charitable sectors, we compiled a complete list of granting agencies in Canada, contacted each agency and the Canadian Institutes of Health Research (CIHR), and extracted data from the organizations' annual reports and the Reference Lists of health research in Canada. Two independent reviewers scanned all grant and fellowship/scholarship titles (and summary/key words, when available) of all research projects funded to determine their inclusion in our analysis; only grants and fellowships/scholarships that focused on heart and peripheral vascular diseases were selected. RESULTS: Public/charitable sector funding increased 7.5 times, from close to $13 million (in constant dollars) in 1975 to almost $96 million (in constant dollars) in 2005 (base year). The Medical Research Council of Canada (MRCC)/CIHR and the Heart & Stroke Foundation of Canada have been the main founders of this type of research during our analysis period; the Alberta Heritage Foundation for Medical Research and the Fonds de la recherche en santé du Quebec have played major roles at the provincial level. The Indirect Costs Research Program and Canada Foundation for Innovation have played major roles in terms of funding in the last years of our analysis. CONCLUSION: Public/charitable-funded research expenditures devoted to CVD have increased substantially over the last three decades. By international standards, the evidence suggests Canada spends less on health-related research than the UK and the US, at least in absolute terms. However, this may not be too problematic as Canada is likely to free-ride from research undertaken elsewhere. Understanding these past trends in research funding may provide decision makers with important information for planning future research efforts. Future work in this area should include the use of our coding methods to obtain estimates of funded research for other diseases in Canada.

Authorship, collaboration, and funding trends in implantology literature: analysis of five journals from 2005 to 2009.

PURPOSE: To identify the trend of authorship in dental implant by exploring the prevalence of coauthored articles and to investigate the collaboration efforts, trends in funding involved in original articles, and their relationships. MATERIALS: Articles published in the Clinical Oral Implants Research, International Journal of Oral & Maxillofacial Implants, Clinical Implant Dentistry and Related Research, Implant Dentistry, and Journal of Oral Implantology from 2005 to 2009 were reviewed. Nonoriginal articles were excluded. For each included articles, number of authors, collaboration efforts, and extramural funding were recorded. Descriptive and analytical statistics (α = 0.05), including logistic regression analysis and χ² test, were used. RESULTS: From a total of 2085 articles, 1503 met the inclusion criteria. Publications with 5 or more authors increased over time (P = 0.813). The amount of collaboration among different disciplines, institutions, and countries all increased. The greatest increase of collaboration was seen among institutions (P = 0.09). Nonfunding studies decreased over time (P = 0.031). There was a strong association between collaboration and funding for the manuscripts during the years studied (OR, 1.5). CONCLUSION: The number of authors per articles and collaborative studies increased over time in implant-related journals. Collaborative studies were more likely to be funded.

[Public financing of health research in Chile]. / El financiamiento público de la investigación en salud en Chile.

BACKGROUND: In Chile, researchers can apply to public research funds through specific research projects and must compete with other professionals of other disciplines. AIM: To perform a critical assessment of the allocation of public funds for health research in Chile by a public institution called CONICYT. MATERIAL AND METHODS: A database was constructed with health projects financed by CONICYT, between 2002 and 2006. Projects were classified (according to their titles) in three methodological categories and nine topics. Age, gender and region where the main researcher is based, were also recorded. RESULTS: 768 research projects were analyzed. Biomedical, clinical and public health research projects accounted for 66, 24 and 10% of allocated funds, respectively. Main researchers were female in 31 % of projects, their mean age was 52 years and 76% worked in the Metropolitan region. CONCLUSIONS: These results show that some objectives of the National Research System lead by CONICYT, such as using research as a tool for regional development and allocating funds for conditions with a large burden, are not been met.

El financiamiento público de la investigación en salud en Chile / Public financing of health research in Chile

Background: In Chile, researchers can apply to public research funds through specific research projects and must compete with other professionals of other disciplines. Aim: To perform a critical assessment of the allocation of public funds for health research in Chile by a public institution called CONICYT. Material and Methods: A database was constructed with health projects financed by CONICYT, between 2002 and 2006. Projects were classified (according to their titles) in three methodological categories and nine topics. Age, gender and region where the main researcher is based, were also recorded. Results: 768 research projects were analyzed. Biomedical, clinical and public health research projects accounted for 66, 24 and 10 percent of allocated funds, respectively. Main researchers were female in 31 percent of projects, their mean age was 52 years and 76 percent worked in the Metropolitan region. Conclusions: These results show that some objectives of the National Research System lead by CONICYT, such as using research as a tool for regional development and allocating funds for conditions with a large burden, are not been met.

A best-fit model for concept vectors in biomedical research grants.

The Research, Condition, and Disease Categorization (RCDC) project was created to standardize budget reporting by research topic. Text mining techniques have been implemented to classify NIH grant applications into proper research and disease categories. A best-fit model is shown to achieve classification performance rivaling that of concept vectors produced by human experts.

Randomized controlled trials in otolaryngology journals.

OBJECTIVE: To identify trends in randomized controlled trials (RCTs) in leading otolaryngology journals. STUDY DESIGN AND SETTING: We reviewed all RCTs of treatment efficacy from 2000 through 2005 in 4 major otolaryngology journals. Data included study quality, author's conclusions, adverse events, and study support/funding. RESULTS: Of 5467 total articles, 202 (3.7%) were RCTs of treatment efficacy. Slightly more than half of the trials were supported by for-profit organizations (25%), not-for-profit groups (21%), or both (7%). Intent-to-treat analysis was used in 58 percent of trials, P values in 88 percent, and confidence intervals in 11 percent. Conclusions favoring the experimental group were unrelated to presence or absence of industry funding, and conclusions suggesting equivalence were unrelated to sample size. CONCLUSIONS: RCTs are uncommon in otolaryngology journals, but they demonstrate frequent use of intent-to-treat analysis, no evidence of publication bias for funded studies, and no evidence of low power in studies suggesting equivalence. SIGNIFICANCE: This study has implications for both the otolaryngology researcher designing studies and the practicing clinician interpreting them.

Current priorities in health research funding and lack of impact on the number of child deaths per year.

We determined the proportion of research on childhood mortality directed toward better medical technology (i.e., by improving old technology or creating new technology) compared with research on technology delivery and utilization. We also estimated mortality reductions from a research-funding strategy focusing primarily on developing technology compared with one that also focused on delivery and utilization. Ninety-seven percent of grants were for developing new technologies, which could reduce child mortality by 22%. This reduction is one third of what could be achieved if existing technologies were fully utilized. There is a serious discrepancy between current research and the research needed to save children's lives. In addition to increased research on the efficacy of treatment, there is an even greater need for increased research on delivery and use of technology.

Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000-2005.

CONTEXT: In surveys based on data available prior to 2000, clinical trials funded by for-profit organizations appeared more likely to report positive findings than those funded by not-for-profit organizations. Whether this situation has changed over the past 5 years or whether similar effects are present among jointly funded trials is unknown. OBJECTIVE: To determine in contemporary randomized cardiovascular trials the association between funding source and the likelihood of reporting positive findings. DESIGN: We reviewed 324 consecutive superiority trials of cardiovascular medicine published between January 1, 2000, and July 30, 2005, in JAMA, The Lancet, and the New England Journal of Medicine. MAIN OUTCOME MEASURE: The proportion of trials favoring newer treatments over the standard of care was evaluated by funding source. RESULTS: Of the 324 superiority trials, 21 cited no funding source. Of the 104 trials funded solely by not-for-profit organizations, 51 (49%) reported evidence significantly favoring newer treatments over the standard of care, whereas 53 (51%) did not (P = .80). By contrast, 92 (67.2%) of 137 trials funded solely by for-profit organizations favored newer treatments over standard of care (P<.001). Among 62 jointly funded trials, 35 (56.5%), an intermediate proportion, favored newer treatments. For 205 randomized trials evaluating drugs, the proportions favoring newer treatments were 39.5%, not-for-profit; 54.4%, jointly funded; and 65.5%, for-profit trials (P for trend across groups = .002). For the 39 randomized trials evaluating cardiovascular devices, the proportions favoring newer treatments were 50.0%, not-for-profit; 69.2%, jointly funded; and 82.4%, for-profit trials (P for trend across groups = .07). Regardless of funding source, trials using surrogate end points, such as quantitative angiography, intravascular ultrasound, plasma biomarkers, and functional measures were more likely to report positive findings (67%) than trials using clinical end points (54.1%; P = .02). CONCLUSIONS: Recent cardiovascular trials funded by for-profit organizations are more likely to report positive findings than trials funded by not-for-profit organizations, as are trials using surrogate rather than clinical end points. Trials jointly funded by not-for-profit and for-profit organizations appear to report positive findings at a rate approximately midway between rates observed in trials supported solely by one or the other of these entities.

Data withholding and the next generation of scientists: results of a national survey.

PURPOSE: To provide the first national data on the nature, extent, and consequences of withholding among life science trainees. METHOD: In 2003, the authors surveyed 1,077 second-year doctoral students and postdoctoral fellows in life sciences at 50 U.S. universities, with a comparison group of trainees in computer science and chemical engineering. The study variables examined trainees' exposure to and the consequences of data withholding. RESULTS: Two hundred forty-six trainees (23.0%) reported that they had asked for and been denied access to information, data, materials, or programming associated with published research and 221 (20.6%) to unpublished research. Eighty-five trainees (7.9%) reported that they had denied another academic scientist's request(s) related to their own published research. Five hundred thirty-three trainees (50.8%) reported that withholding had had a negative effect on the progress of their research, 508 (48.5%) on the rate of discovery in their lab/research group, 472 (45.0%) on the quality of their relationships with academic scientists, 346 (33.0%) on the quality of their education, and 299 (28.5%) on the level of communication in their lab/research group. Trainees denied access to research were significantly more likely to report that data withholding had had a negative effect on several aspects of the educational experience. CONCLUSIONS: Data withholding had demonstrated negative effects on trainees. The life sciences, more so than chemical engineering or computer science, will have to address this issue among its trainees. Failure to do so could result in delayed research, inefficient training, and a culture of withholding among future life scientists.

Medical research. Fools' gold.

London, Oxford and Cambridge receive an unequal share of research and development funds. Eight other cities are working with the government to raise their own status generally. New regional centres of excellence would reduce the disparities.

Funding source, trial outcome and reporting quality: are they related? Results of a pilot study.

BACKGROUND: There has been increasing concern regarding the potential effects of the commercialization of research. METHODS: In order to examine the relationships between funding source, trial outcome and reporting quality, recent issues of five peer-reviewed, high impact factor, general medical journals were hand-searched to identify a sample of 100 randomized controlled trials (20 trials/journal). Relevant data, including funding source (industry/not-for-profit/mixed/not reported) and statistical significance of primary outcome (favouring new treatment/favouring conventional treatment/neutral/unclear), were abstracted. Quality scores were assigned using the Jadad scale and the adequacy of allocation concealment. RESULTS: Sixty-six percent of trials received some industry funding. Trial outcome was not associated with funding source (p=.461). There was a preponderance of favourable statistical conclusions among published trials with 67% reporting results that favored a new treatment whereas 6% favoured the conventional treatment. Quality scores were not associated with funding source or trial outcome. CONCLUSIONS: It is not known whether the absence of significant associations between funding source, trial outcome and reporting quality reflects a true absence of an association or is an artefact of inadequate statistical power, reliance on voluntary disclosure of funding information, a focus on trials recently published in the top medical journals, or some combination thereof. Continued and expanded monitoring of potential conflicts is recommended, particularly in light of new guidelines for disclosure that have been endorsed by the ICMJE.