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processes, controversies and negotiations through which multiphase RCTs and the EBM system are challenged and gradually superseded by alternative methodological and regulatory forms and standards.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.

Ethical Considerations in Conducting Clinical Trials

“…Accordingly, the results can be interpreted [9][10][11] because the researcher can re-evaluate them based on the parameters obtained during the study [12]. Also, in pragmatic clinical trial studies performed in real environments, it is crucial to design research questions and topics.…”

Dealing with Ethical Issues in Clinical Trials: The ussr in the Global Context

“…25 In 1977, Viacheslav V. Zharkov published an entire study on the social and economic aspects of the globalizing Western pharmaceutical business, denouncing what he perceived as amoral behavior on the part of 'transnational pharmaceutical monopolies' .26 In many ways, Zharkov's critique anticipates the contemporary concerns about the potentially ominous role of 'Big Pharma'27 and the search for alternatives to the randomized controlled trial. 28 The Soviet model was also supposed to discourage the duplication of research by numerous independent actors which was perceived as a quite common occurrence in capitalist countries. 29 It is not coincidental that many critiques of the brief Soviet experiment with a decentralized system of expert review in 1958-1963 (as part of larger policy experiments tried out during the 'Thaw' under Nikita Khrushchev) centered around the fact that it allowed the unwarranted duplication of research on similar drugs to be carried out simultaneously at multiple sites across the Soviet Union.30 The system of central planning, executed by the Ministry of Health and the Pharmacological Committee in coordination with the Ministry of Medical Industry and other healthcare institutions, was thought to streamline the process of drug development and to make it more efficient and economical.31…”

Feasibility of a Noninterventional Decentralized Clinical Trial Model in Adults with Major Depressive Disorder

“…Randomized controlled clinical trials are the gold-standard scientific and regulatory approach to gain health authority approval for new therapies or technologies [1]. Challenges persist with multisite clinical trials, including failure to reach accrual goals, which can prolong trial timelines and increase study costs [2,3].…”