Challenges and solutions for clinical development of new antibacterial agents: results of a survey among pharmaceutical industry professionals.
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ABSTRACT:
SUBMITTER: Bettiol E
PROVIDER: S-EPMC4468719 | biostudies-literature | 2015 Jul
REPOSITORIES: biostudies-literature
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Project description:PurposeTo qualitatively explore Australian healthcare professionals' perspectives on how to improve the care and management of cancer-related financial toxicity, including relevant practices, services, and unmet needs.MethodsWe invited healthcare professionals (HCP) who currently provide care to people with cancer within their role to complete an online survey, which was distributed via the networks of Australian clinical oncology professional associations/organisations. The survey was developed by the Clinical Oncology Society of Australia's Financial Toxicity Working Group and contained 12 open-ended items which we analysed using descriptive content analysis and NVivo software.ResultsHCPs (n = 277) believed that identifying and addressing financial concerns within routine cancer care was important and most believed this to be the responsibility of all HCP involved in the patient's care. However, financial toxicity was viewed as a "blind spot" within a medical model of healthcare, with a lack of services, resources, and training identified as barriers to care. Social workers reported assessment and advocacy were part of their role, but many reported lacking formal training and understanding of financial complexities/laws. HCPs reported positive attitudes towards transparent discussions of costs and actioning cost-reduction strategies within their control, but feelings of helplessness when they perceived no solution was available.ConclusionIdentifying financial needs and providing transparent information about cancer-related costs was viewed as a cross-disciplinary responsibility, however, a lack of training and services limited the provision of support. Increased cancer-specific financial counselling and advocacy, via dedicated roles or developing HCPs' skills, is urgently needed within the healthcare system.
| S-EPMC10319649 | biostudies-literature
Project description:In 2007 the Association of Research-Based Pharmaceutical Companies (vfa) published recommendations to improve the quality and transparency of non-interventional studies. These recommendations include quality assurance measures, in particular with respect to transparency as well as for the verification of the data collected in these studies. This publication presents the results of a survey on fees in non-interventional studies which was conducted within the member companies of the vfa in June 2011. These results demonstrate a consistent adherence to the statutory requirements and the implementation of the recommendations concerning the remuneration of the study centers. Depending on the indication, the number of routine doctor/patient contacts is different and associated with that number the documentation efforts vary. Accordingly, the fee varies based on the fee schedule for physicians (German: Gebührenordnung für Ärzte) by taking into account the actual efforts at the study center.
| S-EPMC3278977 | biostudies-other
Project description:The number of antibacterial agents in clinical and preclinical development possessing activity against a narrow spectrum of bacterial pathogens is increasing, with many of them being nontraditional products. The key value proposition hinges on sparing antibiotic use and curtailing the emergence of resistance, as well as preventing the destruction of a beneficial microbiome, versus the immediate need for effective treatment of an active infection with a high risk of mortality. The clinical use of a targeted spectrum agent, most likely in combination with a rapid and robust diagnostic test, is a commendable goal with significant healthcare benefits if executed correctly. However, the path to achieving this will come with several challenges, and many scientific and clinical development disciplines will need to align their efforts to successfully change the treatment paradigm.
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Project description:ObjectivesTo analyse patterns and characteristics of pharmaceutical industry sponsorship of events for Australian health professionals and to understand the implications of recent changes in transparency provisions that no longer require reporting of payments for food and beverages.DesignCross-sectional analysis.Participants and setting301 publicly available company transparency reports downloaded from the website of Medicines Australia, the pharmaceutical industry trade association, covering the period from October 2011 to September 2015.ResultsForty-two companies sponsored 116 845 events for health professionals, on average 608 per week with 30 attendees per event. Events typically included a broad range of health professionals: 82.0% included medical doctors, including specialists and primary care doctors, and 38.3% trainees. Oncology, surgery and endocrinology were the most frequent clinical areas of focus. Most events (64.2%) were held in a clinical setting. The median cost per event was $A263 (IQR $A153-1195) and over 90% included food and beverages.ConclusionsOver this 4-year period, industry-sponsored events were widespread and pharmaceutical companies maintained a high frequency of contact with health professionals. Most events were held in clinical settings, suggesting a pervasive commercial presence in everyday clinical practice. Food and beverages, known to be associated with changes to prescribing practice, were almost always provided. New Australian transparency provisions explicitly exclude meals from the reporting requirements; thus, a large proportion of potentially influential payments from pharmaceutical companies to health professionals will disappear from public view.
| S-EPMC5726125 | biostudies-literature
Project description:BackgroundIncreasingly, medical school policies limit pharmaceutical representatives' access to students and gifts from drugmakers, but little is known about how these policies affect student attitudes toward industry.ObjectiveTo assess interactions between trainees and the pharmaceutical industry, and to determine whether learning environment characteristics influence students' practices and attitudes.Design, participantsWe conducted a cross-sectional survey with a nationally-representative sample of first- and fourth-year medical students and third-year residents, stratified by medical school, including ? 14 randomly selected trainees at each level per school.Main measuresWe measured frequency of industry interactions and attitudes regarding how such interactions affect medical training and the profession. Chi-squared tests assessed bivariate linear trend, and hierarchical logistic regression models were fitted to assess associations between trainees' attitudes and their schools' National Institutes of Health (NIH) funding levels and American Medical Student Association (AMSA) PharmFree Scorecard grades reflecting industry-related conflict of interest policies.Key resultsAmong 1,610 student (49.3 % response rate) and 739 resident (43.1 %) respondents, industry-sponsored gifts were common, rising from 33.0 % (first-year students) to 56.8 % (fourth-year students) and 54 % (residents) (p?<?0.001). These gifts included meals outside the hospital (reported by 5 % first-year students, 13.4 % fourth-year students, 27.5 % residents (p?<?0.001)) and free drug samples (reported by 7.4 % first-year students, 14.1 % fourth-year students, 14.3 % residents (p?<?0.001)). The perception that industry interactions lead to bias was prevalent, but the belief that physicians receive valuable education through these interactions increased (64.1 % to 67.5 % to 79.8 %, p?<?0.001). Students in schools receiving more NIH funding reported industry gifts less often (OR?=?0.51, 95 % CI: 0.38-0.68, p?<?0.001), but the strength of institutional conflict of interest policies was not associated with this variable.ConclusionsDespite recent policy changes, a substantial number of trainees continue to receive gifts from pharmaceutical representatives. We found no relation between these outcomes and a school's policies concerning interactions with industry.
| S-EPMC3710396 | biostudies-literature
Project description:Interaction of medical students with the pharmaceutical industry is common. However, students are thought to be vulnerable to the influence of this interaction, and regulations to limit such interactions are required. The Japan Pharmaceutical Manufacturers Association revised its promotion code in 2013 and specified upper limits for promotional aids. We aimed to investigate whether Japanese medical students' interactions with the pharmaceutical industry changed from 2012 to 2016. This study solicited the participation of all medical schools in Japan. An anonymous cross-sectional survey was administered to medical students from May 2016 to March 2017 to investigate their interactions with the pharmaceutical industry. The results were compared with those of a previous study conducted in 2012. Forty of the 80 medical schools in Japan participated. The student response rate was 74.1%, with 6771 (3395 preclinical, 3376 clinical) evaluable responses. More than 98% of clinical students had previously accepted stationery, a brochure, or a lunch, and significantly higher percentages of clinical students had accepted these items in 2016 than in 2012 (p < .001). The interactions between clinical students and pharmaceutical companies increased slightly between 2012 and 2016. This study will hopefully promote discussion regarding the regulation of student-industry interactions.
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Project description:Activated sludge from Pharmaceutical industry Metagenome
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Project description:Chloramphenicol (CAM) is the D-threo isomer of a small molecule, consisting of a p-nitrobenzene ring connected to a dichloroacetyl tail through a 2-amino-1,3-propanediol moiety. CAM displays a broad-spectrum bacteriostatic activity by specifically inhibiting the bacterial protein synthesis. In certain but important cases, it also exhibits bactericidal activity, namely against the three most common causes of meningitis, Haemophilus influenzae, Streptococcus pneumoniae and Neisseria meningitidis. Resistance to CAM has been frequently reported and ascribed to a variety of mechanisms. However, the most important concerns that limit its clinical utility relate to side effects such as neurotoxicity and hematologic disorders. In this review, we present previous and current efforts to synthesize CAM derivatives with improved pharmacological properties. In addition, we highlight potentially broader roles of these derivatives in investigating the plasticity of the ribosomal catalytic center, the main target of CAM.
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Project description:A cross-industry survey was conducted to assess the landscape of preclinical quantitative systems pharmacology (QSP) modeling within pharmaceutical companies. This article presents the survey results, which provide insights on the current state of preclinical QSP modeling in addition to future opportunities. Our results call attention to the need for an aligned definition and consistent terminology around QSP, yet highlight the broad applicability and benefits preclinical QSP modeling is currently delivering.
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