Trends in clinical trials for stroke by cell therapy: data mining ClinicalTrials.gov and the ICTRP portal site

Negoro, Takaharu; Okura, Hanayuki; Maehata, Midori; Hayashi, Shigekazu; Yoshida, Shigeo; Takada, Nozomi; Matsuyama, Akifumi

doi:10.1038/s41536-019-0082-7

Cited by 20 publications

(12 citation statements)

References 24 publications

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“…ClinicalTrials.gov data mining has been used to analyze the characteristics of oncology clinical trials [ 8 ], trends in clinical trials for stroke treatment [ 24 ], disparities in racial and ethnic representation in stem cell clinical trials [ 25 ], nonpublication rates of registered digital health trials [ 26 ], and relationships between mutations and phenotypes [ 27 ]. With regard to outcomes and other CDEs, Huser et al [ 19 , 20 ] examined the use of CDEs in real data sets and showed how the CDEs identified change by changing the threshold of commonness.…”

Section: Introductionmentioning

confidence: 99%

Automated Identification of Common Disease-Specific Outcomes for Comparative Effectiveness Research Using ClinicalTrials.gov: Algorithm Development and Validation Study

Elghafari¹,

Finkelstein²

2021

JMIR Med Inform

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Background Common disease-specific outcomes are vital for ensuring comparability of clinical trial data and enabling meta analyses and interstudy comparisons. Traditionally, the process of deciding which outcomes should be recommended as common for a particular disease relied on assembling and surveying panels of subject-matter experts. This is usually a time-consuming and laborious process. Objective The objectives of this work were to develop and evaluate a generalized pipeline that can automatically identify common outcomes specific to any given disease by finding, downloading, and analyzing data of previous clinical trials relevant to that disease. Methods An automated pipeline to interface with ClinicalTrials.gov’s application programming interface and download the relevant trials for the input condition was designed. The primary and secondary outcomes of those trials were parsed and grouped based on text similarity and ranked based on frequency. The quality and usefulness of the pipeline’s output were assessed by comparing the top outcomes identified by it for chronic obstructive pulmonary disease (COPD) to a list of 80 outcomes manually abstracted from the most frequently cited and comprehensive reviews delineating clinical outcomes for COPD. Results The common disease-specific outcome pipeline successfully downloaded and processed 3876 studies related to COPD. Manual verification indicated that the pipeline was downloading and processing the same number of trials as were obtained from the self-service ClinicalTrials.gov portal. Evaluating the automatically identified outcomes against the manually abstracted ones showed that the pipeline achieved a recall of 92% and precision of 79%. The precision number indicated that the pipeline was identifying many outcomes that were not covered in the literature reviews. Assessment of those outcomes indicated that they are relevant to COPD and could be considered in future research. Conclusions An automated evidence-based pipeline can identify common clinical trial outcomes of comparable breadth and quality as the outcomes identified in comprehensive literature reviews. Moreover, such an approach can highlight relevant outcomes for further consideration.

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Section: Introductionmentioning

confidence: 99%

Automated Identification of Common Disease-Specific Outcomes for Comparative Effectiveness Research Using ClinicalTrials.gov: Algorithm Development and Validation Study

Elghafari¹,

Finkelstein²

2021

JMIR Med Inform

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“…Even though “ClinicalTrials.gov” is the largest database for clinical trials and represented in more than 200 countries around the globe, a search query in this database does not guarantee completeness. Alternative meta-databases collecting data from even more countries and databases, such as the ICTRP database from the WHO, have not been included in several studies 45 , which implies that some trials may have been missed.…”

Section: Discussionmentioning

confidence: 99%

Global trends in clinical trials involving pluripotent stem cells: a systematic multi-database analysis

2020

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Pluripotent stem cells (PSCs) hold great potential for novel therapeutic approaches to regenerate or replace functionally impaired tissues. Since the introduction of the induced pluripotent stem cell technology in 2006, the number of scientific publications on this topic has constantly been increasing. However, so far no therapy based on PSCs has found its way into routine clinical use. In this study, we examined research trends related to clinical trials involving PSCs based on data obtained from ClinicalTrials.gov, the ICTRP database from the World Health Organization, as well as from a search of all individual databases that are included in the ICTRP using a multistep search algorithm. Following a stringent inclusion/exclusion procedure 131 studies remained that could be classified as clinical trials involving PSCs. The magnitude of these studies (77.1%) was observational, which implies that no cells were transplanted into patients, and only a minority of studies (22.9%) were of an interventional study type. The number of clinical trials involving induced pluripotent stem cells (iPSCs, 74.8%) was substantially higher than the one involving embryonic stem cells (ESCs, 25.2%). However, the picture changes completely when focusing on interventional studies, where in the majority (73.3%) of cases ESCs were used. Interestingly, also the study duration was significantly shorter for interventional versus observational trials (p = 0.002). When focusing on the geographical study regions, it became obvious that the greatest part of all observational trials was performed in the USA (41.6%) and in France (16.8%), while the magnitude of interventional studies was performed in Asian countries (China 36.7%, Japan 13.3%, South Korea 10.0%) and in the field of ophthalmology. In summary, these results indicate that only a limited number of trials were focusing on the actual transplantation of PSCs into patients in a rather narrow field of diagnoses. The future will tell us, if the iPSC technology will ultimately overcome the current challenges and will finally make its way into routine clinical use.

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“…Even though "ClinicalTrials.gov" is the largest database for clinical trials and represented in more than 200 countries around the globe, a search query in this database does not guarantee completeness. Alternative meta-databases collecting data from even more countries and databases, such as the ICTRP database from the WHO, have not been included in several studies (46), which implies that some trials may have been missed.…”

Section: Discussionmentioning

confidence: 99%

Global trends in clinical trials involving pluripotent stem cells: A systematic multi-database analysis

Deinsberger

Reisinger

Weber

2020

Preprint

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Background: Pluripotent stem cells (PSCs) hold great potential for novel therapeutic approaches to regenerate or replace functionally impaired tissues. Since the introduction of the induced pluripotent stem cell technology in 2006, the number of scientific publications on this topic has constantly been increasing. However, so far no therapy based on PSCs has found its way into routine clinical use. Methods: In this study, we examined research trends related to clinical trials involving PSCs based on data obtained from ClinicalTrial.gov, the ICTRP database from the World Health Organization, as well as from a search of all individual databases that are included in the ICTRP using a multistep search algorithm. Results: 131 studies could be classified as clinical trials involving PSCs and were included into further analyses. The magnitude of these studies (77.1%) was observational, which implies that no cells were transplanted into patients, and only a minority of studies (22.9%) had an interventional character. The number of clinical trials involving induced pluripotent stem cells (iPSCs, 74.8%) was substantially higher than the one involving embryonic stem cells (ESCs, 25.2%). However, the picture changes when focusing on interventional studies, where in the majority (73.3%) of cases ESCs were used. Interestingly, the study duration was significantly shorter for interventional versus observational trials (p=0.002). When focusing on the geographical study regions, it became obvious that the greatest part of all observational trials was performed in the USA (41.6%) and in France (16.8%), while the magnitude of interventional studies was performed in Asian countries (China 36.7%, Japan 13.3%, South Korea 10.0%) and in the field of ophthalmology. Conclusions: These results indicate that only a limited number of trials were focusing on the actual transplantation of PSCs into patients in a rather narrow field of diagnoses. The majority of interventional trials involving PSCs took place in Asian countries and in the field of ophthalmology. The future will tell us, if the iPSC technology will ultimately overcome the current challenges and will finally make its way into routine clinical use.

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Trends in clinical trials for stroke by cell therapy: data mining ClinicalTrials.gov and the ICTRP portal site

Cited by 20 publications

References 24 publications

Automated Identification of Common Disease-Specific Outcomes for Comparative Effectiveness Research Using ClinicalTrials.gov: Algorithm Development and Validation Study

Automated Identification of Common Disease-Specific Outcomes for Comparative Effectiveness Research Using ClinicalTrials.gov: Algorithm Development and Validation Study

Global trends in clinical trials involving pluripotent stem cells: a systematic multi-database analysis

Global trends in clinical trials involving pluripotent stem cells: A systematic multi-database analysis

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