Factors influencing clinical trial site selection in Europe: the Survey of Attitudes towards Trial sites in Europe (the SAT-EU Study).

This is the final version of the article. Available from the publisher via the DOI in this record.OBJECTIVES: Applications to run clinical trials in Europe fell 25% between 2007 and 2011. Costs, speed of approvals and shortcomings of European Clinical Trial Directive are commonly invoked to explain this unsatisfactory performance. However, no hard evidence is available on the actual weight of these factors or has it been previously investigated whether other criteria may also impact clinical trial site selection. DESIGN: The Survey of Attitudes towards Trial sites in Europe (SAT-EU Study) was an anonymous, cross-sectional web-based survey that systematically assessed factors impacting European clinical trial site selection. It explored 19 factors across investigator-driven, hospital-driven and environment-driven criteria, and costs. It also surveyed perceptions of the European trial environment. SETTING AND PARTICIPANTS: Clinical research organisations (CROs), academic clinical trial units (CTUs) and industry invited to respond. OUTCOME MEASURES: PRIMARY OUTCOME: weight assigned to each factor hypothesised to impact trial site selection and trial incidence. Secondary outcome: desirability of European countries to run clinical trials. RESULTS: Responses were obtained from 485 professionals in 34 countries: 49% from BioPharma, 40% from CTUs or CROs. Investigator-dependent, environment-dependent and hospital-dependent factors were rated highly important, costs being less important (p<0.0001). Within environment-driven criteria, pool of eligible patients, speed of approvals and presence of disease-management networks were significantly more important than costs or government financial incentives (p<0.0001). The pattern of response was consistent across respondent groupings (CTU vs CRO vs industry). Considerable variability was demonstrated in the perceived receptivity of countries to undertake clinical trials, with Germany, the UK and the Netherlands rated the best trial markets (p<0.0001). CONCLUSIONS: Investigator-dependent factors and ease of approval dominate trial site selection, while costs appear less important. Fostering competitiveness of European clinical research may not require additional government spending/incentives. Rather, harmonisation of approval processes, greater visibility of centres of excellence and reduction of 'hidden' indirect costs, may bring significantly more clinical trials to Europe

Peptide location fingerprinting reveals modification‐associated biomarker candidates of ageing in human tissue proteomes

From Wiley via Jisc Publications RouterHistory: received 2020-10-08, rev-recd 2021-02-18, accepted 2021-03-15, pub-electronic 2021-04-08, pub-print 2021-05Article version: VoRPublication status: PublishedFunder: Walgreens Boots AllianceAbstract: Although dysfunctional protein homeostasis (proteostasis) is a key factor in many age‐related diseases, the untargeted identification of structurally modified proteins remains challenging. Peptide location fingerprinting is a proteomic analysis technique capable of identifying structural modification‐associated differences in mass spectrometry (MS) data sets of complex biological samples. A new webtool (Manchester Peptide Location Fingerprinter), applied to photoaged and intrinsically aged skin proteomes, can relatively quantify peptides and map statistically significant differences to regions within protein structures. New photoageing biomarker candidates were identified in multiple pathways including extracellular matrix organisation (collagens and proteoglycans), protein synthesis and folding (ribosomal proteins and TRiC complex subunits), cornification (keratins) and hemidesmosome assembly (plectin and integrin α6β4). Crucially, peptide location fingerprinting uniquely identified 120 protein biomarker candidates in the dermis and 71 in the epidermis which were modified as a consequence of photoageing but did not differ significantly in relative abundance (measured by MS1 ion intensity). By applying peptide location fingerprinting to published MS data sets, (identifying biomarker candidates including collagen V and versican in ageing tendon) we demonstrate the potential of the MPLF webtool for biomarker discovery

Les jeunes peu qualifiés : une diversité de positions sur le marché du travail

Le parcours de jeunes sortis depuis plusieurs années et sans diplôme du système scolaire fait l’objet d’une enquête qualitative et longitudinale. Prenant appui sur une typologie, cet article met en exergue la diversité des positions des jeunes par rapport au marché du travail secondaire. Il s’agit de mieux comprendre comment et pourquoi ces positions sont plus ou moins contraignantes et intégratives pour ces jeunes.The results of this qualitative and longitudinal research that we have to present in this paper are about the process of young people, without diploma, who has left scholar system few years ago. Bulding on a typology, this article compare their positions to understand how and why these same positions seem to be more or less expensive and integrative fort those young.Die Laufbahn junger Menschen, die seit mehreren Jahren ohne Abschluss das Schulsystem verlassen haben, ist Gegenstand einer qualitativen und einer Längsschnittstudie. Gestützt auf eine Typologie werden in diesem Artikel die vielfältigen Positionen in Bezug auf den sekundären Arbeitsmarkt herausgestellt. Es soll herausgefunden werden, wie und warum diese Positionen für die jungen Menschen mehr oder weniger zwingend und integrativ sind.El itinerario de jóvenes que salieron del sistema escolar hace algunos años sin título es el objeto de una investigación cualitativa y longitudinal. Sobre la base de una tipología, este artículo pone de relieve la diversidad de posiciones respecto del mercado de trabajo secundario. Se trata de comprender mejor cómo y por qué estas posiciones son más o menos restrictivas e integradoras para estos jóvenes