Publication and non-publication of clinical trials: longitudinal study of applications submitted to a research ethics committee

BACKGROUND: Not all clinical trials are published, which may distort the evidence that is available in the literature. We studied the publication rate of a cohort of clinical trials and identified factors associated with publication and nonpublication of results. METHODS: We analysed the protocols of randomized clinical trials of drug interventions submitted to the research ethics committee of University Hospital (Inselspital) Bern, Switzerland from 1988 to 1998. We identified full articles published up to 2006 by searching the Cochrane CENTRAL database (issue 02/2006) and by contacting investigators. We analyzed factors associated with the publication of trials using descriptive statistics and logistic regression models. RESULTS: 451 study protocols and 375 corresponding articles were analyzed. 233 protocols resulted in at least one publication, a publication rate of 52%. A total of 366 (81%) trials were commercially funded, 47 (10%) had non-commercial funding. 346 trials (77%) were multi-centre studies and 272 of these (79%) were international collaborations. In the adjusted logistic regression model non-commercial funding (Odds Ratio [OR] 2.42, 95% CI 1.14-5.17), multi-centre status (OR 2.09, 95% CI 1.03-4.24), international collaboration (OR 1.87, 95% CI 0.99-3.55) and a sample size above the median of 236 participants (OR 2.04, 95% CI 1.23-3.39) were associated with full publication. CONCLUSIONS: In this cohort of applications to an ethics committee in Switzerland, only about half of clinical drug trials were published. Large multi-centre trials with non-commercial funding were more likely to be published than other trials, but most trials were funded by industry.

Clinical research projects at a German medical faculty: follow-up from ethical approval to publication and citation by others

BACKGROUND: Only data of published study results are available to the scientific community for further use such as informing future research and synthesis of available evidence. If study results are reported selectively, reporting bias and distortion of summarised estimates of effect or harm of treatments can occur. The publication and citation of results of clinical research conducted in Germany was studied. METHODS: The protocols of clinical research projects submitted to the research ethics committee of the University of Freiburg (Germany) in 2000 were analysed. Published full articles in several databases were searched and investigators contacted. Data on study and publication characteristics were extracted from protocols and corresponding publications. RESULTS: 299 study protocols were included. The most frequent study design was randomised controlled trial (141; 47%), followed by uncontrolled studies (61; 20%), laboratory studies (30; 10%) and non-randomised studies (29; 10%). 182 (61%) were multicentre studies including 97 (53%) international collaborations. 152 of 299 (51%) had commercial (co-)funding and 46 (15%) non-commercial funding. 109 of the 225 completed protocols corresponded to at least one full publication (total 210 articles); the publication rate was 48%. 168 of 210 identified publications (80%) were cited in articles indexed in the ISI Web of Science. The median was 11 citations per publication (range 0-1151). CONCLUSIONS: Results of German clinical research projects conducted are largely underreported. Barriers to successful publication need to be identified and appropriate measures taken. Close monitoring of projects until publication and adequate support provided to investigators may help remedy the prevailing underreporting of research.

Genetic engineering and the world trade system

While the WTO agreements do not regulate the use of biotechnology per se, their rules can have a profound impact on the use of the technology for both commercial and non-commercial purposes. This book seeks to identify the challenges to international trade regulation that arise from biotechnology. The contributions examine whether existing international obligations of WTO Members are appropriate to deal with the issues arising for the use of biotechnology and whether there is a need for new international legal instruments, including a potential WTO Agreement on Biotechnology. They combine various perspectives on and topics relating to genetic engineering and trade, including human rights and gender; intellectual property rights; traditional knowledge and access and benefit sharing; food security, trade and agricultural production and food safety; and medical research, cloning and international trade.

Lake sediments as natural seismographs: A compiled record of Late Quaternary earthquakes in Central Switzerland and its implication for Alpine deformation

Central Switzerland lies tectonically in an intraplate area and recurrence rates of strong earthquakes exceed the time span covered by historic chronicles. However, many lakes are present in the area that act as natural seismographs: their continuous, datable and high-resolution sediment succession allows extension of the earthquake catalogue to pre-historic times. This study reviews and compiles available data sets and results from more than 10 years of lacustrine palaeoseismological research in lakes of northern and Central Switzerland. The concept of using lacustrine mass-movement event stratigraphy to identify palaeo-earthquakes is showcased by presenting new data and results from Lake Zurich. The Late Glacial to Holocene mass-movement units in this lake document a complex history of varying tectonic and environmental impacts. Results include sedimentary evidence of three major and three minor, simultaneously triggered basin-wide lateral slope failure events interpreted as the fingerprints of palaeoseismic activity. A refined earthquake catalogue, which includes results from previous lake studies, reveals a non-uniform temporal distribution of earthquakes in northern and Central Switzerland. A higher frequency of earthquakes in the Late Glacial and Late Holocene period documents two different phases of neotectonic activity; they are interpreted to be related to isostatic post-glacial rebound and relatively recent (re-)activation of seismogenic zones, respectively. Magnitudes and epicentre reconstructions for the largest identified earthquakes provide evidence for two possible earthquake sources: (i) a source area in the region of the Alpine or Sub-Alpine Front due to release of accumulated north-west/south-east compressional stress related to an active basal thrust beneath the Aar massif; and (ii) a source area beneath the Alpine foreland due to reactivation of deep-seated strike-slip faults. Such activity has been repeatedly observed instrumentally, for example, during the most recent magnitude 4.2 and 3.5 earthquakes of February 2012, near Zug. The combined lacustrine record from northern and Central Switzerland indicates that at least one of these potential sources has been capable of producing magnitude 6.2 to 6.7 events in the past.

Misunderstanding Creativity : User Created Content in Virtual Worlds and its Constraints by Code and Law

Virtual worlds have moved from being a geek topic to one of mainstream academic interest. This transition is contingent not only on the augmented economic, societal and cultural value of these virtual realities and their effect upon real life but also on their convenience as fields for experimentation, for testing models and paradigms. User creation is however not something that has been transplanted from the real to the virtual world but a phenomenon and a dynamic process that happens from within and is defined through complex relationships between commercial and non-commercial, commodified and not commodified, individual and of the community, amateur and professional, art and not art. Accounting for this complex environment, the present paper explores user created content in virtual worlds, its dimensions and value and above all, its constraints by code and law. It puts forward suggestions for better understanding and harnessing this creativity.

Three “Bali Deliverables” for more Food Security

As the clock is ticking for a positive outcome at the Ninth WTO Ministerial Conference to be held in Bali in December 2013, agricultural negotiators are scrambling to find solutions to issues such as tariff-rate quota (TRQ) administration and export competition in order to improve trade flows. The main issue seems to be whether WTO rules applying to public stockpiles in developing countries need to be changed or temporarily suspended as a means to enhance national food security. This paper is based on a note submitted to the ICTSD-IPC Expert Group “Meeting on Agriculture and Food Security – Policy Options for MC9 and beyond” (Geneva, June 2013). It lists the policy instruments impacting on global, national and (urban and rural) household food security – “The Food Security Tool Box” – and asks which immediate decisions the WTO Ministers might take in this field despite the political difficulties such as continued agro-dumping practices or the “land grab” issue. Three such “deliverables” are outlined: (i) regional and “virtual” food security schemes could be allowed to provide reserves to other countries without violating the obligation to “form an integral part of a food security programme identified in national legislation” (Agreement on Agriculture, Annex II, para 3); (ii) TRQ under-fills could be improved by mandatory enquiries into low fill rate situations; and (iii) World Food Program (WFP) and other non-commercial food purchases could be exempted from export restrictions and prohibitions. High ambitions for Bali seem to be misplaced. A more realistic yet real progress could restore the dwindling credibility of the WTO as a forum for trade negotiations.