Conditional approval: discussion points from the PSI conditional approval expert group

The European Agency for the Evaluation of Medicinal Products has recently completed the consultation of a draft guidance on how to implement conditional approval. This route of application is available for orphan drugs, emergency situations and serious debilitating or life-threatening diseases. Although there has been limited experience in implementing conditional approval to date, PSI (Statisticians in the Pharmaceutical Industry) sponsored a meeting of pharmaceutical statisticians with an interest in the area to discuss potential issues. This article outlines the issues raised and resulting discussions, based on the group's interpretation of the legislation. Conditional approval seems to fit well with the accepted regulatory strategy in HIV. In oncology, conditional approval may be most likely when (a) compelling phase II data are available using accepted clinical outcomes (e.g. progression/recurrence-free survival or overall survival) and Phase III has been planned or started, or (b) when data are available using a surrogate endpoint for clinical outcome (e.g. response rate or biochemical measures) from a single-arm study in rare tumours with high response, compared with historical data. The use of interim analyses in Phase III for supporting conditional approval raises some challenging issues regarding dissemination of information, maintenance of blinding, potential introduction of bias, ethics, switching, etc.     

Staying well. Factors contributing to successful community adaptation

1. Friends were rated as the most important factor in assisting former psychiatric patients to avoid rehospitalization. 2. When respondents were asked to comment on rehospitalization in their own words, the most frequent responses dealt with factors related to keeping active, developing a healthy lifestyle and positive self-image, and accepting their illness. 3. Self-help groups, community health workers, and community nurses were rated as the least beneficial in preventing rehospitalization.     

The Family Life Cycle and Clinical Intervention*

With an aim toward encouraging more precise identification and treatment of familial dysfunction, the authors suggest combining the principles of first and second order change (Watzlawick, Weakland, and Fisch, 1974) with the concept of the family life cycle (Duvall, 1971). A theoretical discussion is followed by clinical case examples.     

Talking about sexual identity with older men

How do social workers begin to talk about sexual identity when conducting assessments with older men? This paper focuses on work with older gay men and highlights the importance of talking about sexual identity in order to prevent it being rendered invisible. While there may be some risks associated with openly identifying as gay, such as homophobic violence, being open about one's sexuality is important for maintaining self-esteem and mental health. Despite the obstacles facing social workers in talking to older men about their sexual identity, it is essential that they do not ignore this aspect of people's lives. Therefore it is important that social workers open themselves up to the possibility that an older man might be gay or bisexual and help construct environments that enable the disclosure of this aspect of his identity.     

A National Survey of Graduate Education in Psychopharmacology: Advancing the Social Work Perspective on Psychiatric Medication

ABSTRACT

Social workers’ unique skills and professional perspective can contribute to improved practices in psychopharmacology, yet it is unclear how social work programs prepare students for this area of practice. This study examined instruction of psychopharmacology through a national Web-based survey of MSW program directors and instructors of psychopharmacology content (n = 171). Nearly two-thirds (63.7%) reported their program integrates psychopharmacology usually into one or two existing courses, whereas 20.5% indicated their program offers a stand-alone course. Lack of faculty expertise and having no room in the current curriculum structure were identified as the top barriers for programs not offering any psychopharmacology content. The profession’s critical, social justice, empowerment, client-centered, and systems perspective appears to ground the teaching of psychopharmacology in social work programs.     

Critical Perspectives on Hate Speech: The Centrality of ‘Dialogic Listening’

This article examines the study of listening as a cognitive process tied to memory and information processing. In examining the study of listening as a cognitive process, the authors discuss creating a theory of listening and the progress of that endeavor. Finally, they address whether or not researchers can create a theory about any concept as abstract as cognitive process or listening.     

A Factor Analytic Study of Four Listening Tests

This paper describes the nature and assessment of an interactive videodisc instructional program on listening. The program is available to other educational institutions seeking to expand cost-effective listening instruction to students. Formative evaluations indicate that students enjoyed the Level III interactive multimedia instruction (IMI). Results of a dummy variable regression analysis indicate that students receiving IMI in listening achieved significantly higher immediate cognitive test scores and listening gain scores than did students in the control group. Regression analysis indicated no significant effect of reported GPA, year in school, previous listening instruction, or time-on-task on listening test gain scores of the IMI treatment group. However, significant effects on cognitive test scores were found for reported GPA, previous listening instruction, time-on-task, and senior versus non-senior standing.