Evidence map›Paper›PMID 28637515›Full record

ArticleTrials2017

Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011-2013.

Sohyun Jeong, Minji Sohn, Jae Hyun Kim, Minoh Ko, Hee-Won Seo, Yun-Kyoung Song, Boyoon Choi, Nayoung Han, Han-Sung Na, Jong Gu Lee and 3 more

Abstract readComparative Study
In one paragraph

Article in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Patient Benefit of Clinical Research in Diversely Advanced African Developing Countries.Current therapeutic research, clinical and experimental · 2022
    Article
  11. Article
  12. Review
  13. Article
  14. [Globalization in medical research].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2018
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Sohyun JeongCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Korea.
Minji SohnCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Korea.
Jae Hyun KimCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Korea.
Minoh KoCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Korea.
Hee-Won SeoCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Korea.
Yun-Kyoung SongCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Korea.
Boyoon ChoiCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Korea.
Nayoung HanCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Korea.
Han-Sung NaClinical Research Division, Toxicology Evaluation and Research Department, National Institute of Food and Drug Evaluation, Chungcheongbuk-do, Korea.
Jong Gu LeeClinical Research Division, Toxicology Evaluation and Research Department, National Institute of Food and Drug Evaluation, Chungcheongbuk-do, Korea.
In-Wha KimCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Korea.
Jung Mi OhCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Korea.
Euni LeeCollege of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Korea. eunilee@snu.ac.kr.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical trial globalization is a major trend for industry-sponsored clinical trials. There has been a shift in clinical trial sites towards emerging regions of Eastern Europe, Latin America, Asia, the Middle East, and Africa. Our study objectives were to evaluate the current characteristics of clinical trials and to find out the associated multiple factors which could explain clinical trial globalization and its implications for clinical trial globalization in 2011-2013.

methodsThe data elements of "phase," "recruitment status," "type of sponsor," "age groups," and "design of trial" from 30 countries were extracted from the ClinicalTrials.gov website. Ten continental representative countries including the USA were selected and the design elements were compared to those of the USA. Factors associated with trial site distribution were chosen for a multilinear regression analysis.

resultsThe USA, Germany, France, Canada, and United Kingdom were the "top five" countries which frequently held clinical trials. The design elements from nine continental representative countries were quite different from those of the USA; phase 1 trials were more prevalent in India (OR 1.517, p < 0.001) while phase 3 trials were much more prevalent in all nine representative countries than in the USA. A larger number of "child" age group trials was performed in Poland (OR 1.852, p < 0.001), Israel (OR 1.546, p = 0.005), and South Africa (OR 1.963, p < 0.001) than in the USA. Multivariate analysis showed that health care expenditure per capita, Economic Freedom Index, Human Capital Index, and Intellectual Property Rights Index could explain the variance of regional distribution of clinical trials by 63.6%.

conclusionsThe globalization of clinical trials in the emerging regions of Asia, South Africa, and Eastern Europe developed in parallel with the factors of economic drive, population for recruitment, and regulatory constraints.

Indexed as

Drug TherapyInternationalityResearch DesignAge FactorsChi-Square DistributionClinical Trials as TopicDrug CostsHealth ExpendituresHumansIntellectual PropertyInternational CooperationLinear ModelsMulticenter Studies as TopicMultivariate AnalysisOdds RatioPatient SelectionClinical trialsEconomic freedom indexHealth care expenditure per capitaHuman capital indexIntellectual property rights index

Identifiers

PMID28637515
PMCPMC5480138

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.