Clinical Trial Application in Europe: What Will Change with the New Regulation?

The European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout the different steps including the registration of the trial in the European database; the preparation of documents to be submitted and their contents; the preparation of documents related to the information and consent process; the submission to competent bodies. Specific issues related to paediatric research and trials involving non EU/EEA countries have been addressed as well. Results reveal that the European legislation offers a well defined set of European rules covering different aspects of a Clinical Trial Application. However, these are not suitable to meet the challenges from multicentre and multinational clinical studies. A stronger set of rules, such as is available in a composite European Regulation has been adopted and is expected to harmonise practices and enable sponsors to carry out well conducted trials. But will the new regulation overcome the existing criticisms of Directive 2001/20/EC?     

Effects of self-generated versus experimenter-provided cues on the representation of future events

Most experimental studies of prospection focused on episodic forms of future events prompted by means of verbal cues. However, there is evidence suggesting that future events differ considerably according to whether they are produced in response to external, experimenter-provided verbal cues or they are self-generated. In the present study, we compared the quality, the phenomenal characteristics, the temporal distribution, and the content of imagined events prompted by experimenter-provided cues (i.e., cue-words and short verbal sentences) or elicited by means of verbal cues that were self-generated in an autobiographical fluency task. The results showed that future events prompted by means of self-generated cues contained fewer event-specific details than future events prompted by experimenter-provided cues. However, future events elicited by means of self-generated and by experimenter-provided cues did not differ with respect to their phenomenal characteristics. The temporal distribution and the thematic content of future representations were also affected by the type of cue used to elicit prospection. These results offer a holistic view of the properties of future thinking and suggest that the content and the characteristics of envisioned future events may be affected by the method used to elicit prospection.     

Goal programming with dynamic goals

The aim of this paper is to present a dynamic goal programming scheme. Throughout the revised literature, most of the dynamic goal programming approaches use target values on the final value of the objective functionals. In this paper, dynamic target values are assumed, so that they control not only the final values of the corresponding functionals, but their evolution along the planning period. As a result, the scalar problems are also dynamic ones, where the evolution of the deviation variables is minimized. A lexicographic dynamic goal programming algorithm is developed on these basis, and some considerations are made on the efficiency of the final solutions. © 1998 John Wiley & Sons, Ltd.     

A semistructured interview with parents-to-be used during pregnancy: Preliminary data

The aim of this paper is to describe The Clinical Interview for Parents during Pregnancy (CGG—Colloquio per Genitori in Gravidanza). The interview was developed in the context of a longitudinal research study, carried out in the first 2 years of the child's life. The study was aimed at investigating fathers' attitudes and behavior toward child care and the possible influence of these attitudes and behavior on the child's current and future development. This was also compared with mothers' attitudes and behaviors. This work provides the background rationale for the content of the CGG and the discussion of the interview. The CGG was administered to 90 middle-class Italian couples expecting their first baby, who were recruited from childbirth classes to participate in the study. The sample did not include women at risk during pregnancy. We chose to investigate three areas: couples' ability to foresee their own function after the child's birth; the activities they expected to share with their baby; their capacity to anticipate their child's physical and psychological characteristics. Responses were subjected to quantitative content analysis. We describe the utility of such analysis. Finally, we review clinical and research meanings and applications of the CGG. © 1997 Michigan Association for Infant Mental Health     

Incivility at work,upset at home? Testing the cross‐level moderation effect of emotional dysregulation among female nurses from primary health care

Workplace incivility is a growing problem in nursing. However, most studies that explore this psychosocial risk and its consequences do so considering a single level and a between‐person perspective. The aims of the study were to explore whether the effects of experiencing incivility during work‐time could explain the daily levels of well‐being of nurses at home; and to analyze if that relationship could be moderated by their levels of emotional dysregulation as a trait. This is a multilevel study with diary methodology. The study was carried out in 18 primary health‐care centers belonging to Madrid and the Basque Country, in Spain. Ninety‐four nurses completed a general questionnaire and 54 of them a diary booklet over five consecutive working days in two different moments, immediately after work and at bedtime. The results showed that nurses’ emotional dysregulation moderated the relationship between daily workplace incivility and daily fatigue, and positive affect at night at home. However, there were no direct effects of daily incivility on these outcome variables. In conclusion, the presence of difficulties in emotional regulation among nurses can increase the negative effects of daily workplace incivility on their health and well‐being.     

Modes of Introspective Access: a Pluralist Approach

Philosophia - Several contemporary philosophical theories of introspection have been offered, yet each faces a number of difficulties in providing an explanation of the exact nature of...     

Psychopathology and behavior problems in children and adolescents with Williams syndrome: Distinctive relationships with cognition

Several studies have documented the high prevalence of psychopathology and behavior problems in Williams syndrome (WS). However, the links between cognitive development and such symptoms need further clarification. Our study aims to expand current knowledge on levels of behavior problems and its links to cognition in a sample of Brazilian individuals with WS. A total of 25 children and adolescents with WS and their parents participated in this study. The participants’ IQs were assessed with the Wechsler Scales of Intelligence (for children or adults) and parental reports of psychopathology/behavior problems were collected using the Child Behavior Checklist (CBCL). The presence of clinically significant attention problems was a main feature in our sample of children and adolescents with WS. In the children, higher IQ scores were found to be significantly associated with less externalizing problems, while in the adolescents cognitive abilities were found to be associated with less internalizing symptoms. These results provide further insight into the links between psychopathology and behavior problems and cognitive abilities in WS, and suggest the need to take age into consideration when analyzing such relationships.