History of controlled trials in medicine: real priorities are little-known. &lt;i&gt;Report 1&lt;/i&gt;. Basic concepts, terms, and disciplines that use medical experiment: historical and philosophical sources

Koterov, A. N.; Тихонова, Олеся Александровна; Ushenkova, L. N.; Biryukov, A.

doi:10.17749/2070-4909/farmakoekonomika.2021.059

Cited by 4 publications

(1 citation statement)

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“…A. Koterov et al (2021) cite a source in 1896 [3]. After 1946, prototypes of clinical trials appeared, consisting of a sponsor, a researcher, and a patient, which were then joined by an ethical component (the Nuremberg Code and the Declaration of Helsinki) [4].…”

Section: Introductionmentioning

confidence: 99%

Clinical Trials Trends of 2023 Year and Visionary to the Future

Milovanov¹

2023

IJCICR

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Introduction: The importance of studying historical changes in the development of human activity is substantiated by the need to systematize such changes and the possibility of predicting them. Historical changes are extended in time and do not have clear boundaries, requiring greater involvement in their study and the prerequisites for their appearance. Clinical research is more than just the practical application of medical changes and discoveries. They make changes in medical practice but are subject to change. Changes in the clinical research industry are tendentious and develop gradually, requiring study and forecasting. According to the generally accepted temporal gradation of the forecast, there is an operational forecast of up to one month, a short-term forecast of up to one year, a medium-term forecast of up to five years, a long-term forecast of up to 20 years and a long-term forecast over long-term, and a short-term forecast is common in the clinical research industry. We analyzed publications in open sources from 1930 to 2023 by keywords in the Russian-language literature trends in the clinical trial industry and the English-language literature trends in the clinical trial industry. Discussion and Conclusion: Trends in the development of clinical trials until the end of 2023 can be divided into two groups, those related to changes in the conduct of clinical trials and changes in the products of clinical trials in nosologies. If in the first group, the trends remain similar to 2022, the ongoing digitalization of operations, the shift of centralized research towards decentralization, and the shift in protocol design towards patient-centricity, then in the second group, the number of expected drugs has decreased, and there is a shift of drugs towards biologics and gene therapy drugs.

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Section: Introductionmentioning

confidence: 99%

Clinical Trials Trends of 2023 Year and Visionary to the Future

Milovanov¹

2023

IJCICR

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History of controlled trials in medicine: real priorities are little-known. Report 2. From early experiments to the present day: without alternation and randomization

et al. 2021

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The aim of the three-report review is the historical development of clinical trials, controlled trials (CT) and randomized controlled trials (RCT), and the inclusion of these approaches in health-related disciplines (Medicine and Epidemiology). Report 2 provides a description of the wellknown James Lind Library (JLL), as well as a formed database of sources on the theme. JLL was internationalized, although most of the papers belong to authors from the UK. Many studies on the history of CT and RCT are reflected in JLL publications, but remain unclaimed without changing on common milestones and priorities. Besides, the formed base of sources included 9 studies not reflected in the JLL, of which three are principled. Six of them are given in Report 2.Half of historical milestones on the theme (168 in total) belong to the United Kingdom, 23% to the United States, and 4% to the Italy. The remaining 19 countries, ancient, medieval and modern, contribute 0.6–4% (Russia – 1.2% by the 20th century). The earliest source on the history of CT is J.P. Bull’s dissertation (1951). The formed database as of July 2020 contained more than 260 publications, and only 9 of them were Russian (2005–2018). The base includes 7 western dissertations on the history of CT.The object of the Report 2 study was CT as such, without any attempts at randomization or even quasi-randomization by alternate allocation. The most comprehensive thematic table on non-randomized CTs has been compiled, including studies from the Chinese emperor Shen Nung (2373 BC) and the prophet Daniel (6th century BC), to BCG vaccination for children of Canadian Indians (1941–1949). PubMed search on ‘non-randomized controlled trial’ was made. For the period of 1990–2020 years, 303 publications were found (up to 32 papers in 2020). Compared to RCT, the number of such studies is small (estimated at 0.08%), but it is important to have an appropriate conjuncture in the modern period. Along with the fact that most of the drugs and therapies currently in use are developed without RCT, the revealed ‘immortality’ of CT, even without quasi-randomization, can have social significance, removing complexes and embarrassment in cases where neither RCT nor even quasi-RCT is possible, but social and public needs require the immediate receipt of at least an approximate answer to hot questions of public health (for example, in 2020).

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History of controlled trials in medicine: real priorities are little-known. Report 3. Quasi-randomized and randomized trials in humans and animals

et al. 2022

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The three-report review is aimed to describe the historical development of clinical trials, controlled trials (CT) and randomized controlled trials (RCT), and the inclusion of these approaches in health-related disciplines (Medicine and Epidemiology). Report 3 summarizes historical milestones (ideas and studies) for quasi-randomized CT (‘alternate allocation’; 88 milestones) and RCT (37 milestones). It was found that although the ideas of both designs are a thing of the past (from A. Lesassier Hamilton (1816) and J.B. Van Helmont (1648), respectively), the bulk of the tests were carried out in the 20th century, when both designs existed in parallel. Overall, the alternate allocation was used nearly three times longer than randomization.Analysis of the sources showed that the first RCT in medicine was the work of D. Colebrook, 1925 (Great Britain), and the first close to the modern RCT, including randomization according to the table of random numbers, was J.A. Bell, 1941 (USA). Often referred to as the ‘new era in CT’ and ‘the origine of RCT’, a study of the effects of streptomycin on tuberculosis in 1946–1948, which was also designed by A.B. Hill is only 13th known RCT, only 9th RCT in medicine and only the 2nd with modern randomization. Other facts of insufficient reflection of the priorities and real history of CT/RCT in West and Russian publications were found, including dozens of Western textbooks on epidemiology and evidence-based medicine of recent decades. True priorities are often omitted, and the most frequent references to the history of CT (progressively) are the experience of the prophet Daniel, the experience of the surgeon J. Lind, and the study on the effect of streptomycin on tuberculosis in 1946–1948.Based on a PubMed/MEDLINE search, a summary of alternate allocation CT, and RCT for the period 1960–1990 to 2020 is provided. In the first case, single publications were found, but the fact that design with alternation survives to this day is important. For RCT, since 1990s, an increase in the number of papers (up to tens of thousands per year) has been revealed. The data are given for the total number of RCTs performed by countries, continents and parts of the world for 2020. According to the calculated index of the ratio of the number of RCTs to the specific number of doctors (per 100,000 population) among 45 countries of Eurasia (from France to Tajikistan), Russia ranks 12th.A three-report review based on the originals of nearly all publications from the late 19th century and including the necessary references and citations can serve as a reference guide to the historical development of CT and related topics.

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History of controlled trials in medicine: real priorities are little-known. <i>Report 1</i>. Basic concepts, terms, and disciplines that use medical experiment: historical and philosophical sources

Cited by 4 publications

References 127 publications

Clinical Trials Trends of 2023 Year and Visionary to the Future

Clinical Trials Trends of 2023 Year and Visionary to the Future

History of controlled trials in medicine: real priorities are little-known. Report 2. From early experiments to the present day: without alternation and randomization

History of controlled trials in medicine: real priorities are little-known. Report 3. Quasi-randomized and randomized trials in humans and animals

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