scholarly journals Clinical Trial Subject

2020 ◽  
Author(s):  
Keyword(s):  
2021 ◽  
Vol 27 (1) ◽  
pp. 146045822198939
Author(s):  
Euisung Jung ◽  
Hemant Jain ◽  
Atish P Sinha ◽  
Carmelo Gaudioso

A natural language processing (NLP) application requires sophisticated lexical resources to support its processing goals. Different solutions, such as dictionary lookup and MetaMap, have been proposed in the healthcare informatics literature to identify disease terms with more than one word (multi-gram disease named entities). Although a lot of work has been done in the identification of protein- and gene-named entities in the biomedical field, not much research has been done on the recognition and resolution of terminologies in the clinical trial subject eligibility analysis. In this study, we develop a specialized lexicon for improving NLP and text mining analysis in the breast cancer domain, and evaluate it by comparing it with the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT). We use a hybrid methodology, which combines the knowledge of domain experts, terms from multiple online dictionaries, and the mining of text from sample clinical trials. Use of our methodology introduces 4243 unique lexicon items, which increase bigram entity match by 38.6% and trigram entity match by 41%. Our lexicon, which adds a significant number of new terms, is very useful for matching patients to clinical trials automatically based on eligibility matching. Beyond clinical trial matching, the specialized lexicon developed in this study could serve as a foundation for future healthcare text mining applications.


Author(s):  
Wendy A. Kennedy ◽  
Claudine Laurier ◽  
Jean-Luc Malo ◽  
Heberto Ghezzo ◽  
Jocelyne L'archevêque ◽  
...  

Objectives: To explore one aspect of the external validity of the randomized controlled trial (RCT), specifically how being selected for inclusion in a trial and having participated has influenced the use and cost of asthma-related health services.Methods: Services used by asthmatic users of inhaled corticosteroids (iCSTs) having previously participated in an RCT (TS, n = 46) were compared with individuals who had never participated (NS, n = 51).Results: TS were more likely to use higher (≥400 μg) daily doses of iCSTs than NS (OR, 3.3; 95% CI, 1.1–8.3) but less likely to visit emergency departments (OR, 0.3; 95% CI, 0.1–0.7). Total asthma-related costs did not differ significantly.Conclusions: Subject differences may impede generalizing from RCTs to real life.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lauren A. Marcath ◽  
Colin M. Finley ◽  
Siu Fun Wong ◽  
Daniel L. Hertz

Abstract Background Patients with cancer are at increased risk of drug-drug interactions (DDI), which can increase treatment toxicity or decrease efficacy. It is especially important to thoroughly screen DDI in oncology clinical trial subjects to ensure trial subject safety and data accuracy. This study determined the prevalence of potential DDI involving oral anti-cancer trial agents in subjects enrolled in two SWOG clinical trials. Methods Completed SWOG clinical trials of commercially available agents with possible DDI that had complete concomitant medication information available at enrollment were included. Screening for DDI was conducted through three methods: protocol-guided screening, Lexicomp® screening, and pharmacist determination of clinical relevance. Descriptive statistics were calculated. Results SWOG trials S0711 (dasatinib, n = 83) and S0528 (everolimus/lapatinib, n = 84) were included. Subjects received an average of 6.6 medications (standard deviation = 4.9, range 0–29) at enrollment. Based on the clinical trial protocols, at enrollment 18.6% (31/167) of subjects had a DDI and 12.0% (20/167) had a DDI that violated a protocol exclusion criterion. According to Lexicomp®, 28.7% of subjects (48/167) had a DDI classified as moderate or worse, whereas pharmacist review indicated that 7.2% of subjects (12/167) had a clinically relevant interaction. The majority of clinically relevant DDI identified were due to the coadministration of acid suppression therapies with dasatinib (83.3%, 10/12). Conclusions The high DDI prevalence in subjects enrolled on SWOG clinical trials, including a high prevalence that violate trial exclusion criteria, support the need for improved processes for DDI screening to ensure trial subject safety and trial data accuracy.


Author(s):  
H. W. Dalrymple

AbstractAlthough a number of authors have commented upon the impact of the GDPR on clinical trial conduct, few have examined the specific setting of paediatric trials. Whilst the general principles are the same as those for adults, some additional considerations arise. The ages of consent relating to data privacy and clinical trial participation are different in a number of countries, but the distinction is often not recognised in non-drug trials. Accidental pregnancies in clinical trials always raise complexities, but these are amplified when the trial subject is a minor, and the processes described in clinical trial protocols rarely take account of GDPR requirements. This paper describes approaches which can be taken to ensure the rights of children are respected.Conclusion: The conduct of paediatric clinical trials within GDPR requirements is quite possible provided authors think carefully when drafting protocols. What is Known:•GDPR is applicable to clinical trials, including paediatric trials.•A number of challenges at the interface between the GDPR and CTR have been described. What is New:•The application of the GDPR to certain specific situations in paediatric trials does not appear to have been explored.•Three such situations are described and solutions offered.


1980 ◽  
Vol 8 (4) ◽  
pp. 286-292 ◽  
Author(s):  
T Dorman

A double-blind between-group trial was undertaken in fifty depressed patients to compare the efficacy of a sustained release form of amitriptyline (Lentizol®) with dothiepin (Prothiaden®) over a 5-week period. Patients fulfilling defined admission criteria were randomly allocated to treatment with evening dosage of either 50 mg of the sustained release preparation or 75 mg of dothiepin for the first week of the trial. Subject to review as necessary, these dosages were doubled at the end of the first week. Both drugs effected significant and appreciable improvement over the 5-week period, with the mean responses at the end of the trial retaining the same relative positions as at the beginning.


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