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?     

Development and Validation of the Workplace Age Discrimination Scale

Purpose

Workplace age discrimination research is proliferating, but researchers lack a valid measure with which to capture targets’ discriminatory experiences. We developed a measure of perceived workplace age discrimination that assesses overt and covert forms of discrimination and then compared older, middle-aged, and younger workers’ experiences.

Design/Methodology

In Study 1, we developed the Workplace Age Discrimination Scale (WADS) based on older workers’ experiences using a deductive approach, a qualitative study, and two quantitative surveys. In Study 2, we validated the measure among young employees using a qualitative and two quantitative surveys. In Study 3, we tested the WADS among middle-aged workers and tested models of invariance between age groups.

Findings

Participants frequently endorsed covert discriminatory experiences, which the WADS reflects. The WADS contains convergent and discriminant validity, high reliability, and a unidimensional structure across age groups. It demonstrates criterion-related validity among older and younger workers but not middle-aged workers, given their low experiences of age discrimination. Age discrimination frequency follows a U-shaped pattern across age groups.

Implications

Researchers can use the WADS to identify long-term outcomes of age discrimination and to further compare workers’ discriminatory experiences. Practitioners and policymakers can use the measure to develop interventions to ameliorate workplace age discrimination and inform policymaking.

Originality/Value

The WADS is the first validated measure of targets’ perspectives of workplace age discrimination. Our results challenge assumptions that only older workers experience age discrimination (younger workers’ means were highest) and that age discrimination is usually overt in nature (it is often covert).

     

The Relationship Between Parenting Style and Children's Adjustment: The Parents' Perspective

We examined the relationship between authoritative and authoritarian parenting styles and socio-emotional adjustment in elementary school children as reported from the parents' perspective. Mothers of first through fifth graders provided information about parenting style as well as children's competencies and problem behaviors. Teachers provided ratings of children's adjustment for a subset of the participants. Results indicated that authoritative parenting was associated negatively with parent- and teacher-rated maladaptive behavior, and positively with indicators of healthy adjustment. Correlations between authoritarian parenting and adjustment were either small or non-significant. Regression analyses indicated that authoritative parenting was more predictive of children's competence than maladaptation (22% versus 10% of variance). The effects of parenting style on adjustment were not moderated by demographic variables, such as the child's gender, grade level, ethnicity, and family income.     

Remembering the Grocery Shopping List: a Study on Metacognitive Biases

Three experiments examined the influence on memory monitoring and memory control of typicality and frequency of purchase of grocery items. On the basis of normative data, food items were divided into three categories: T+F+ (items typically bought in an Italian food store, and of frequent purchase for university students), T+F− (items typical but not frequently purchased) and T−F− (items low in both characteristics). Experiment 1 revealed that despite an equal recall of the three categories of items, ease of learning judgments were significantly lower for T−F− items. In Experiments 2 and 3, T−F− items were also treated differently than the two other types, when subjects had to decide which items to select for an additional check, and when they had to apportion their study time. Overall, data show that biases independent of the memory state of an item can influence memory monitoring. In addition, the same biases appear to influence the cognitive behaviour, suggesting that monitoring can have an impact on subsequent cognitive behaviour independent of the memorization processes. © 1997 by John Wiley & Sons, Ltd.     

Identifying pre-service teachers’ profiles of conceptions of learning: a cluster analysis

Social Psychology of Education - This study was conducted to track conceptions of learning among pre-service teachers and to verify whether they can be grouped in profiles. A sample of 232...     

Perceived Parenting,Self-Esteem,and Depressive Symptoms in Immigrant and Non-Immigrant Adolescents in Italy: A Multigroup Path Analysis

Previous research has shown that a warm and caring parental style is associated with better psychological adjustment in adolescents from diverse cultural contexts. Yet, the differential role of mothers and fathers in adolescents’ depressive symptoms is still understudied, especially among immigrant populations. This study examined the relationship between perceived care from both mother and father and depressive symptoms among adolescents with and without a migration background, postulating mediation by self-esteem. Participants were 686 first-generation immigrant (44?% girls) and 1295 non-immigrant (46?% girls) Italian adolescents aged 14–20 years, who completed a questionnaire survey. Multigroup path analyses controlling for age, gender, and SES showed that (a) perceived maternal and paternal care and self-esteem were negatively related to depressive symptoms in both groups; (b) self-esteem mediated the link between perceived parenting and youth depressive symptoms in both groups; (c) the direct and indirect effects were invariant across the two groups. Results suggest that involved fathers, just as much as mothers, contribute to adolescents’ positive adjustment irrespective of immigrant status. Interventions may focus on the enhancement of self-esteem as well as the perceived quality of attachment to both mother and father, shifting away from risk models towards more positive youth development models.     

Asymmetrical number-space mapping in the avian brain

When trained to peck a selected position in a sagittally-oriented series of identical food containers, and then required to generalize to an identical series rotated by 90°, chicks identify as correct only the target position from the left end, while choosing the right one at chance. Here we show that when accustomed to systematic changes in inter-elements distances during training or faced with similar spatial changes at test, chicks identify as correct both the target positions from left and right ends. However, ordinal position is spontaneously encoded even when inter-element distances are kept fixed during training (in spite of the fact that distances between elements suffice for target identification without any numerical computation). We explain these findings in terms of intra-hemispheric coupling of bilateral numerical (ordinal) representation and unilateral (right hemispheric) spatial representation of the number line, producing differential allocation of attention in the left and right visual hemifields.     

Discrimination of small numerosities in young chicks

Chicks were trained to discriminate small sets of identical elements. They were then tested for choices (unrewarded) between sets of similar numerosities, when continuous physical variables such as spatial distribution, contour length, and overall surface were equalized. In all conditions chicks discriminated one versus two and two versus three stimulus sets. Similar results were obtained when elements were presented under conditions of partial occlusion. In contrast, with sets of four versus five, four versus six, and three versus four elements chicks seemed unable to discriminate on the basis of number, although nonnumerical discrimination based on perceptual cues was observed. This adds to increasing evidence for discrimination of small numerosities of up to three elements in human infants and nonhuman animals.