Nicole Baur

Travelling cells: harmonized European regulation and the BAMI stem cell trial

Harmonized regulation of clinical trials seems necessary in order to speed up approval processes and the time from bench to bedside for novel stem cell treatments. Europe is comprised of countries with diverse regulatory and health-care systems, and the regulators’ aim to unify practice across them provides an opportunity to study the effects of harmonization through regulation and novel institutions. We report findings from a long-term study alongside the first multinational European stem cell clinical trial that applied the harmonized approval procedures and follows the regulations in stem cell clinical trial practice standards introduced over the past decade. Adapting to this regulatory environment was costly in terms of trial implementation and caused delays in patient recruitment. That the stem cells for autologous use had to be transported all over Europe for processing in licensed centres stands out among the costly complications the teams had to address. We conclude that academic trials with little industry support are currently hampered by harmonized regulation. Such trials depend on complex cross-area expertise for implementation. The academic and public sectors have insufficient access to such information. In order to facilitate all promising routes towards a future stem cell medicine, a central support institution bundling expertise in handling the technicalities of implementing multinational trials in Europe is needed.

Standards, Harmonization and Cultural Differences: Examining the Implementation of a European Stem Cell Clinical Trial

ABSTRACT A complex set of European regulations aims to facilitate regenerative medicine, harmonizing good clinical and manufacturing standards and streamlining ethical approval procedures. The sociology of standardization has elaborated some of the effects of regulation but little is known about how such implementation works in practice across institutions and countries in regenerative medicine. The effects of transnational harmonization of clinical trial conduct are complex. A long-term ethnographic study alongside a multinational clinical trial finds a range of obstacles. Harmonization standardizes at one level, but implementing the standards brings to the fore new layers of difference between countries. Europe-wide harmonization of regulations currently disadvantages low-cost clinician-lead research in comparison to industry-sponsored clinical trials. Moreover, harmonized standards must be aligned with the cultural variations in everyday practice across European countries. Each clinical team must find its own way of bridging harmonized compulsory practice with how things are done where they are, respecting expectations from both patients and the local hospital ethics committee. Established ways of working must further be adapted to a range of institutional and cultural conventions that affect the clinical trial such as insurance practices and understandings of patient autonomy. An additional finding is that the specific practical roles of team members in the trial affect their evaluation of the importance of these challenges. Our findings lead to conclusions of wider significance for the sociology of standards concerning how regulation works and for medical sociology about how trial funding and research directions in stem cell medicine intersect.

Dressing and Addressing the Mental Patient: The Uses of Clothing in the Admission, Care and Employment of Residents in English Provincial Mental Hospitals, c. 1860–1960

Abstract Scholars of insanity and its historical antecedents have paid very little attention to personal and institutional clothing. Such dress, distributed to patients in mental institutions, has always been inscribed with the conflicting narratives of the period in which it was made and worn. The language of civil and medical authority is more evident than personal choice in the shape and address of the attire. This article examines clothing worn by patients in three Devon mental hospitals during the century before 1960. We consider the ways in which institutional clothing formed part of a hospital regimen of overt control, as well as suiting considerations of economy and employment that figured in these institutions.

Family influence and psychiatric care: physical treatments in Devon mental hospitals, c. 1920 to the 1970s.

Highlights • In the 20th century a variety of short-lived treatments were trialled at the DCLA.• Therapeutic regimes depended on institutional, legislative and social factors.• The 20th century witnessed an increase in the medicalisation of mental illness.• The 1930 Mental Treatment Act granted patients slightly greater agency.• Deinstitutionalisation did not eliminate coercion in psychiatric treatment.