Article ID: CBB107905760

Alter-Standardizing Clinical Trials: The Gold Standard in the Crossfire (2019)

unapi

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controversies and negotiations through which multiphase RCTs and the EBM system are challenged and gradually superseded by alternative methodological and regulatory forms and standards.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

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Includes Series Articles

Article Achim Rosemann; Federico Vasen; Gabriela Bortz (2019) Global Diversification in Medicine Regulation: Insights from Regenerative Stem Cell Medicine. Science as Culture (pp. 223-249). unapi

Article Salla Sariola; Roger Jeffery; Amar Jesani; Gerard Porter (2019) How Civil Society Organisations Changed the Regulation of Clinical Trials in India. Science as Culture (pp. 200-222). unapi

Article Christine Hauskeller; Nicole Baur; Jean Harrington (2019) Standards, Harmonization and Cultural Differences: Examining the Implementation of a European Stem Cell Clinical Trial. Science as Culture (pp. 174-199). unapi

Article Alex Faulkner (2019) Special Treatment? Flexibilities in the Politics of Regenerative Medicine’s Gatekeeping Regimes in the UK. Science as Culture (pp. 149-173). unapi

Citation URI
https://data.isiscb.org/isis/citation/CBB107905760/

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Authors & Contributors
Halverson, Colin Michael Egenberger
Rayzberg, Margarita S.
Pinto, Manuela Fernández
Devanesan, Arjun
Hauskeller, Christine
Brives, Charlotte
Concepts
Clinical trials
Medicine
Research
Technoscience; science and technology studies
Standards and standardization
Methodology
Time Periods
21st century
20th century, late
20th century, early
Places
United States
Europe
Thailand
Uganda
Kenya
South Africa
Institutions
American Public Health Association
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