UNASSIGNED: Medication history errors at hospital admission are common and effective strategies to improve the quality of medication histories are still being researched. However, studies on new approaches regarding medication history taking are often time-consuming and resource-intensive. The gold standard when evaluating the quality of medication histories is the comparison of a Best Possible Medication History to the original. However, this double collection requires significant resources, disrupts clinical procedures, and places an additional burden on patients. Therefore, more efficient study designs need to be explored. We aimed to develop a design for future studies on medication history taking that uses fewer research resources and places less strain on patients and staff.
UNASSIGNED: We first identified shortcomings of the established study designs on medication history taking and subsequently defined requirements for a new design. A pragmatic study with an alternative endpoint was identified in a previous literature search. It served as the starting point from which we developed a new study design to assess the quality of approaches to medication history taking. Instead of taking a second medication history, a patient\'s pre-existing medication document can be used as comparator to determine the quality of the medication history. Furthermore, we defined a new primary endpoint, i.e. the number of updates per patient. Updates are differences between the newly acquired medication history and the comparator. They include discontinued, initiated, and changed medications. To enhance our proposed design, we recommend a preparatory phase to identify a suitable comparator document, and a baseline phase to assess the current process.
UNASSIGNED: We propose a more resource-efficient study design with a new endpoint. We plan to test its feasibility and evaluate whether it could enhance the efficacy of research on medication history taking in a pilot project.

Background and objective Drugs that act on the central nervous system have a high potential to cause drug-related problems (DRPs). A clinical pharmacist aided by collaborative efforts within an interdisciplinary healthcare team can prevent, detect, and resolve DRPs, thereby contributing to the promotion of medication safety and improving the quality of life of individuals under care. This study aimed to assess DRPs identified in the neurology ward of a tertiary hospital from February 2016 to November 2019. Methods This was a descriptive study with a cross-sectional and retrospective design involving secondary data collected from pharmaceutical care (PC) records. Student\'s t-tests, Pearson correlation coefficients, Poisson models, and logistic regression models were used to analyze the associations between age, number and type of medications, duration of hospitalization, and the occurrence of DRPs. Results A total of 130 patients were included in the study, and a total of 266 DRPs were detected, with 93 patients experiencing more than one DRP and 37 not presenting any DRPs. Necessity-related DRPs were the most prevalent (46.6%) type, followed by safety-related DRPs (28.6%). The prevalence of safety-related DRPs was higher in individuals older than 60 years (p<0.001). Conclusions Of note, 84.6% of the interventions suggested by pharmacists to resolve DRPs were accepted by the healthcare team. The high number of DRPs found underscores the importance of the clinical role of the pharmacist and interprofessional collaboration in the care of neurological patients, especially in the pharmaceutical follow-up of elderly individuals.

Real-world data (RWD) can provide intel (real-world evidence, RWE) for research and development, as well as policy and regulatory decision-making along the full spectrum of health care. Despite calls from global regulators for international collaborations to integrate RWE into regulatory decision-making and to bridge knowledge gaps, some challenges remain. In this work, we performed an evaluation of Austrian RWD sources using a multilateral query approach, crosschecked against previously published RWD criteria and conducted direct interviews with representative RWD source samples. This article provides an overview of 73 out of 104 RWD sources in a national legislative setting where major attempts are made to enable secondary use of RWD (e.g. law on the organisation of research, \"Forschungsorganisationsgesetz\"). We were able to detect omnipresent challenges associated with data silos, variable standardisation efforts and governance issues. Our findings suggest a strong need for a national health data strategy and data governance framework, which should inform researchers, as well as policy- and decision-makers, to improve RWD-based research in the healthcare sector to ultimately support actual regulatory decision-making and provide strategic information for governmental health data policies.

This paper examines the events and conditions that led to the creation of the International Clinical Trials Registry Platform (ICTRP) in 2006 by the World Health Organization (WHO), and how the WHO addressed the issue of transparency in global pharmaceutical research. Using historical textual analysis, I trace the scientific debates that advocated for the establishment of official clinical trial registries in medical journals, and the sequence of actions following the GSK Paxil scandal in 2004, identifying the major ethical and scientific arguments that led to the involvement of the WHO as a key actor in trial registration in the context of the Big Pharma business model.
Through the questions \"Why register?\" and \"Why registries?\" as a roadmap, I examine the issues of publication bias and selective reporting by the industry, scrutinizing two ways in which the practice of publication bias damaged transparency in industry-sponsored research. The first involved ethical concerns regarding human subject exploitation and concealing of negative results. The second addresses the deterioration of the certainty of evidence due to incomplete access to trials results. By reviewing the series of events that occurred between 2004 and 2006 -between the Paxil scandal and the launch of the ICTRP-, I analyze the actions taken by the different actors involved: (1) the International Committee of Medical Journal Editors (ICMJE) and the creation of the Ottawa Group; (2) the WHO, beginning with the Ministerial Summit on Health Research held in November of 2004, and (3) the responses of the pharmaceutical industry and specifically GSK to the call for transparency and trial registration.
The history of trial registration through the ICTRP as a dataveillance apparatus shows the difficulty of regulating a health enterprise turned into a global business. Moreover, it shows the challenges of globalization and how easier and faster it is to globalize business compared to good practices, raising the question of why it has been so hard to undo these trends. Indeed, the history of the movement for trial registration is not a history of regulation success, or at least not yet.

Easy-to-understand, stand-alone factual summaries of clinical trial results have the potential to improve public understanding of and engagement with pharmaceutical research. The European Clinical Trial Regulation (EU) No. 536/2014 is a major regulatory initiative that will result in a large number of such plain language summaries (PLSs) posted in the public domain. Today, however, little is known about the extent to which PLSs are written and are available to the general public.
This preliminary study assessed (i) 20 top pharmaceutical companies\' positions on improving transparency and commitment to disclosing trial result summaries in an easy-to-understand format and (ii) the availability of such summaries in the public domain and the ease of locating them via general web searches.
The availability of PLSs in the public domain was estimated based on the number of EudraCT technical result summaries in four disease areas: chronic obstructive pulmonary disease, asthma, meningitis, and influenza. The likelihood of PLSs being easy to find through internet search engine queries by members of the public was assessed using Google.
All 20 sponsors had committed to improve clinical trial transparency, 17 committed to sharing PLSs with trial participants, and 14 had at least one PLS available in the public domain. A total of 99 clinical studies in these four disease areas had technical summaries posted on EudraCT between 1 January 2017 and 30 June 2020. Of these 99, 14 studies had PLSs in the public domain. A total of 12 of 14 PLSs were directly captured by search engine. However, the sponsor trial identifier or EudraCT number had to be included in the search term to locate them. Generic search terms resulted in large volumes of non-relevant results.
Despite the progressive movement towards clinical trial transparency, easily accessible PLSs on clinical trials are currently scarce. The provision of a European mandate and framework for non-technical result summaries by Regulation (EU) 536/2014 will be a major step to bring about positive change.
More patient and public involvement in healthcare research will help to speed the process of making new medicines. This is known by both the regulators and the healthcare industry. The healthcare industry wants to make more information on human research studies available to patients and the public. One way to help achieve this is to write simple summaries of clinical study results. Here, we use the term plain language summary (PLS) to describe them. The PLS allows people to understand human research studies more clearly. A new law will soon make it necessary to write a PLS for every clinical study done in Europe. But, today, is the PLS being used to inform the public about clinical research studies? And what is its potential? We found only  a few researchers have already begun to write PLSs. PLSs on most studies are not available to the public. Even those PLSs on public websites are very hard to find through a Google search. To better understand the potential of PLSs we are doing more research. This research will look at what the public wants to know about these studies and how they will retrieve this information.

BACKGROUND: China has emerged as a powerful platform for global pharmaceutical research and development (R&D) amid the 2014 Ebola outbreak. The research and development impact of developing countries on prevention and control of infectious disease outbreaks has long been underestimated, particularly for emerging economies like China. Here, we studied its research and development progress and government support in response to Ebola outbreak by timeline, input, and output at each research and development stage. This study will contribute to a deeper understanding of the research and development gaps and challenges faced by China, as well as providing evidence-based suggestions on how to accelerate the drug development process to meet urgent needs during future outbreaks.
METHODS: Data were obtained from the National Nature Science Foundation of China database, PubMed database, Patent Search System of the State Intellectual Property Office of China, National Medical Products Administration, national policy reports and literature between Jan 1st, 2006 and Dec 31st, 2017. An overview of research funding, research output, pharmaceutical product patent, and product licensed was described and analyzed by Microsoft Excel. A descriptive analysis with a visualization of plotting charts and graphs was conducted by reporting the mean ± standard deviation.
RESULTS: China has successfully completed the research and development of the Ebola Ad5-EBOV vaccine within 26 months, while the preparation and implementation of clinical trials took relative long time. The National Nature Science Foundation of China funded CNY 44.05 million (USD 6.27 million) for Ebola-related researches and committed strongly to the phase of basic research (87.8%). A proliferation of literature arose between 2014 and 2015, with a 1.7-fold increase in drug research and a 2.5-fold increase in diagnostic research within 1 year. Three years on from the Ebola outbreak, six Ebola-related products in China were approved by the National Medical Products Administration.
CONCLUSIONS: China has started to emphasize the importance of medical product innovation as one of the solutions for tackling emerging infectious diseases. Continuing research on the development of regulatory and market incentives, as well as a multilateral collaboration mechanism that unifies cross-channel supports, would advance the process for China to enter global R&D market more effectively.

Pharmaceuticals play an important role in clinical care. However, in community-based research, medication data are commonly collected as unstructured free-text, which is prohibitively expensive to code for large-scale studies. The ASPirin in Reducing Events in the Elderly (ASPREE) study developed a two-pronged framework to collect structured medication data for 19,114 individuals. ASPREE provides an opportunity to determine whether medication data can be cost-effectively collected and coded, en masse from the community using this framework.
The ASPREE framework of type-to-search box with automated coding and linked free text entry was compared to traditional method of free-text only collection and post hoc coding. Reported medications were classified according to their method of collection and analysed by Anatomical Therapeutic Chemical (ATC) group. Relative cost of collecting medications was determined by calculating the time required for database set up and medication coding.
Overall, 122,910 participant structured medication reports were entered using the type-to-search box and 5,983 were entered as free-text. Free-text data contributed 211 unique medications not present in the type-to-search box. Spelling errors and unnecessary provision of additional information were among the top reasons why medications were reported as free-text. The cost per medication using the ASPREE method was approximately USD $0.03 compared with USD $0.20 per medication for the traditional method.
Implementation of this two-pronged framework is a cost-effective alternative to free-text only data collection in community-based research. Higher initial set-up costs of this combined method are justified by long term cost effectiveness and the scientific potential for analysis and discovery gained through collection of detailed, structured medication data.

The impact of academic journals on scientific activity can be measured using different approaches. The aim of this study was to assess the leading anesthesia journals as springboards for new developments in the field of anesthesia.
The selection of the topics for analysis was based on the degree of increase in the number of articles on a topic that was at the center of specialty interest during 1966-2015. The assessment of a journal\'s response to a new development was made by measuring the number of initial articles on a related topic. Six leading anesthesia journals were assessed collectively and individually as to whether their responses to new developments were prompt and prominent.
The role of the leading specialty journals in presentation of 28 topics related to prominent new developments in anesthesia was found to depend on the nature of topics and the type of articles. Compared with all PubMed journals publishing articles associated with anesthesia in 1966-2015, the six leading anesthesia journals published 43% of drug-related research articles, 30% of technique-related research articles, and 16% of both drug- and technique-related review articles. Regarding initial publications (on new topics), this group of six journals contributed comparably more articles: from 43% to 84% of drug-related research articles, from 30% to 49% of technique-related research articles, from 16% to 33% of drug-related review articles, and from 16% to 25% of technique-related review articles. The approximate doubling of the shares demonstrates the dominance of this group of journals in the swiftness response to new anesthesia developments. The promptness of reaction to new developments in anesthesia of each of the six leading anesthesia journals was assessed (the combination of drug- and technique-related articles) based on the number of articles published among the first (first 5 plus next 30) on all 28 topics. The ranking order of four journals (with the highest number of all 1966-2015 articles) regarding early publications was (from high to low): Anesthesia & Analgesia, British Journal of Anaesthesia, Anesthesiology, and Anaesthesia.
This study assesses six leading anesthesia journals for their function as springboards for new developments in anesthesia over the past 50 years. The dominance of leading journals in initial publications on 28 drug-related and technique-related topics was clearly demonstrated. The results also indicate the possibility of using promptness of response to new advances for quantitative assessment of this aspect of a journal\'s contribution to the specialty.

BACKGROUND: Funders now frequently require that sex and gender be considered in research programmes, but provide little guidance about how this can be accomplished, especially in large research programmes. The purpose of this study is to present and evaluate a model for promoting sex- and gender-based analysis (SGBA) in a large health service research programme, the Ontario Pharmacy Evidence Network (OPEN).
METHODS: A mixed method study incorporating (1) team members\' critical reflection, (2) surveys (n = 37) and interviews (n = 23) at programme midpoint, and (3) an end-of-study survey in 2016 with OPEN research project teams (n = 6).
RESULTS: Incorporating gender and vulnerable populations (GVP) as a cross-cutting theme, with a dedicated team and resources to promote GVP research across the programme, was effective and well received. Team members felt their knowledge was improved, and the programme produced several sex- and gender-related research outputs. Not all resources were well used, however, and better communication of the purposes and roles of the team could increase effectiveness.
CONCLUSIONS: The experience of OPEN suggests that dedicating resources for sex and gender research can be effective in promoting SGBA research, but that research programmes should also focus on communicating the importance of SGBA to their members.

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