farmaecFARMAKOEKONOMIKA. Modern Pharmacoeconomics and PharmacoepidemiologyФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология2070-49092070-4933IRBIS LLC10.17749/2070-4909/farmakoekonomika.2021.062farmaec-558Research ArticleREVIEW ARTICLESОБЗОРНЫЕ ПУБЛИКАЦИИHistory of controlled trials in medicine: real priorities are little-known. Report 2. From early experiments to the present day: without alternation and randomizationИстория контролируемых испытаний в медицине: реальные приоритеты малоизвестны. Сообщение 2. От ранних экспериментов до наших дней: без чередования и рандомизацииhttps://orcid.org/0000-0001-8700-7624КотеровА. Н.KoterovA. N.

Котеров Алексей Николаевич – д.б.н., заведующий лабораторией отдела радиационной эпидемиологии

РИНЦ SPIN-код: 1493-2530

ул. Живописная, д. 46, Москва 123182, Россия

Aleksey N. Koterov – Dr. Biol. Sc., Head of Laboratory, Department of Radiation Epidemiology

RSCI SPIN-code: 1493-2530

46 Zhivopisnaya Str., Moscow 123182, Russia 

govorilga@inbox.ruТихоноваО. А.TikhonovaO. A.

Тихонова Ольга Александровна – к.м.н., заведующая лабораторией мультидисциплинарных клинических исследований

РИНЦ SPIN-код: 5904-4013 

ул. Живописная, д. 46, Москва 123182, Россия

Olga A. Tikhonova – MD, PhD, Head of Laboratory of Multidisciplinary Clinical Studies

RSCI SPIN-code: 5904-4013

46 Zhivopisnaya Str., Moscow 123182, Russia 

УшенковаЛ. Н.UshenkovaL. N.

Ушенкова Лилия Николаевна – к.б.н., ведущий научный сотрудник отдела радиационной эпидемиологии

РИНЦ SPIN-код: 1289-9679 

ул. Живописная, д. 46, Москва 123182, Россия

Liliya N. Ushenkova – PhD (Biol.), Leading Researcher, Department of Radiation Epidemiology

RSCI SPIN-code: 1289-9679

46 Zhivopisnaya Str., Moscow 123182, Russia 

https://orcid.org/0000-0003-2165-6984БирюковА. П.BiryukovA. P.

Бирюков Александр Петрович – д.м.н., профессор, заведующий отделом радиационной эпидемиологии

РИНЦ SPIN-код: 5690-5212

ул. Живописная, д. 46, Москва 123182, Россия

Aleksander P. Biryukov – Dr. Med. Sc., Professor, Head of Department of Radiation Epidemiology 

RSCI SPIN-code: 5690-5212

46 Zhivopisnaya Str., Moscow 123182, Russia 

Федеральное государственное бюджетное учреждение «Государственный научный центр Российской Федерации – Федеральный медицинский биофизический центр им. А.И. Бурназяна» Федерального медико-биологического агентства РоссииРоссияRussian State Research Center – Burnasyan Federal Medical Biophysical Center, Federal Medical Biological AgencyRussian Federation202108102021143423444Copyright © Koterov A.N., Tikhonova O.A., Ushenkova L.N., Biryukov A.P., 20212021Котеров А.Н., Тихонова О.А., Ушенкова Л.Н., Бирюков А.П.Koterov A.N., Tikhonova O.A., Ushenkova L.N., Biryukov A.P.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmacoeconomics.ru/jour/article/view/558

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).

Обзор из трех сообщений посвящен историческому развитию клинических испытаний, контролируемых испытаний (англ. controlled trials, CT) и рандомизированных контролируемых испытаний (англ. randomized controlled trials, RCT), а также включению этих подходов в дисциплины, связанные со здоровьем (медицина и эпидемиология). В Сообщении 2 представлена характеристика известной библиотеки James Lind Library (JLL) и сформированной базы источников по теме. Отмечена интернациональность JLL, хотя большинство работ и принадлежит авторам из Великобритании. Многие исследования по теме истории CT и RCT отражены в публикациях JLL, но остаются невостребованными, не меняя общепринятых вех и приоритетов. Кроме того, в сформированную базу работ вошли 9 исследований, не отраженных в JLL, из которых 3 принципиальны. Шесть из них приведены в Сообщении 2.

Половина исторических вех по теме (всего 168) принадлежит Великобритании, 23% – США, 4% – Италии. Остальные 19 стран (древних, средневековых и современных) вносят вклады в 0,6–3,6% (Россия – 1,2% к XX в.). Самым ранним источником по теме истории CT является диссертация J.P. Bull (1951 г.). В сформированной базе на июль 2020 г. находилось более 260 публикаций, и только 9 из них – русскоязычные (2005–2018 гг.). В базу вошли 7 западных диссертаций по истории CT.

Объектом исследования Сообщения 2 являлись CT как таковые, без попыток рандомизации и даже квазирандомизации путем чередования (англ. alternate allocation). Сформирована наиболее полная тематическая таблица по нерандомизированным CT, включившая исследования от китайского императора Shen Nung (2373 г. до н.э.) и пророка Даниила (VI в. до н.э.) до прививки БЦЖ детям канадских индейцев (1941–1949 гг.). Выполнен поиск в PubMed на ‘non-randomized controlled trial’. Для периода 1990–2020 гг. обнаружено 303 публикации (до 32 статей в 2020 г.). Сравнительно с RCT число таких исследований мало (оценено в 0,08%), но важно наличие соответствующей конъюнктуры в современный период. Поскольку большинство используемых ныне препаратов и средств терапии разработаны без RCT, выявленная «бессмертность» CT даже без квазирандомизации может иметь социальное значение в тех случаях, когда ни RCT, ни даже квази-RCT провести невозможно, однако общественно-социальная необходимость требует получения хотя бы приблизительного ответа на острые вопросы из области здравоохранения (например, в 2020 г.).

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The authors declare that there are no conflicts of interest present.