Alter-Standardizing Clinical Trials: The Gold Standard in the Crossfire

ABSTRACT

The international landscape of medical research is in the midst of a process of diversification and change. The randomized controlled trial (RCT), long considered the global gold standard for clinical research, has become increasingly contested and is partly replaced by alternative methodologies, standards and forms of evidence. The contours of mainstream medical research are changing as a result. Regulatory paradigms and standards are, literally, being rewritten, at a global level. The evidence-based medicine (EBM) hierarchy of evidence is redefined. This special issue explores these developments through the concept of ‘alter-standardization’. The term refers to the processes, controversies and negotiations through which multiphase RCTs and the EBM system are challenged and gradually superseded by alternative methodological and regulatory forms and standards. This special issue examines the conceptual, practical and theoretical implications of these changes, and the ways in which these transformations influence the situation and possibilities of patients, knowledge producers, physicians, large pharmaceutical corporations, smaller biotech companies, as well as regulatory bodies, civil societal organizations and national health care systems. The articles in this special issue make use of comparative and historical perspectives that focus on scientific, social, economic and regulatory developments in the European Union, China, India, Japan, Argentina, the UK and the USA. They show that the alter-standardizing of clinical trials arises in a pluralistic way, that is driven by a variety of often conflicting factors, developments and expectations. These changes reflect a broad transformation in the culture and politics of biomedicine today, with implications for the ways in which new medicinal products, devices, procedures and technologies are developed, approved for clinical use, sold to consumers, and licensed by health care systems.     

Ferenczi and Freud – From psychoanalysis as a “professional and personal home” to the creation of a “psychoanalytic home” for the patient1

Abstract

The author explores the relationship between Sándor Ferenczi and Sigmund Freud in the light of their correspondence. This allows us to see how Freud was able to offer and create for Ferenczi a “professional and personal home” that enabled the latter to find a much more meaningful and creative contact with himself. According to the author, this experience played an important role in Ferenczi’s later readiness to offer to and create with his patients a similar “psychoanalytic home.” As Freud was not able to share such clinical research work with Ferenczi, a conflict developed between them whose nature has occupied psychoanalysts ever since, and whose seeds can be found in the 1246 letters that they exchanged between January 1908 and May 1933. From this point of view, Ferenczi’s Clinical diary (written in 1932 and published only in 1985) can be seen as the continuation of the dialogue they had entertained for so many years, as well as Ferenczi’s attempt not to give up the “professional and personal home” that they had created together.