Translational and Clinical Pharmacology最新文献

Clinical pharmacology and therapeutics in South Korea: 30 years with the Korean Society of Clinical Pharmacology and Therapeutics. 韩国的临床药理学和治疗学：韩国临床药理学和治疗学学会 30 年。

IF 1.1

Translational and Clinical Pharmacology Pub Date : 2024-09-01 Epub Date: 2024-09-23 DOI: 10.12793/tcp.2024.32.e12

Tae-Eun Kim, Young-Ran Yoon

引用次数: 0

Advanced clinical symptoms of the antihangover compound HK-GCM-H01 in healthy Koreans. 健康韩国人服用抗宿醉化合物 HK-GCM-H01 后出现的晚期临床症状。

IF 1.1

Translational and Clinical Pharmacology Pub Date : 2024-09-01 Epub Date: 2024-09-23 DOI: 10.12793/tcp.2024.32.e11

Ye Lim Jang, Min Kyu Park

{"title":"Advanced clinical symptoms of the antihangover compound HK-GCM-H01 in healthy Koreans.","authors":"Ye Lim Jang, Min Kyu Park","doi":"10.12793/tcp.2024.32.e11","DOIUrl":"10.12793/tcp.2024.32.e11","url":null,"abstract":"A hangover is a combination of negative mental and physical symptoms, such as headache, diarrhea, and loss of appetite, that occur after alcohol consumption and can vary depending on individual genetic and environmental factors. To quickly relieve these hangover symptoms, a new hangover relief compound called HK-GCM-H01 has been developed. This compound, HK-GCM-H01, consists of fermented rice germ extracts, yeast extract mixtures, cili extract powder, and concentrated nipafam powder, all of which are known to relieve hangover symptoms. The safety and clinical symptoms of HK-GCM-H01 were evaluated, along with the pharmacokinetic properties of alcohol and acetaldehyde after its administration. This study was conducted on 50 healthy Korean men using a randomized, double-blind, placebo-controlled, single-intake, crossover design. To evaluate clinical symptoms, Acute Hangover Scale and Alcohol Hangover Severity Scale were used, and the pharmacokinetic evaluation parameters included the maximum plasma concentration, the time to peak plasma concentration, the terminal half-life, and the area under the plasma concentration-time curve from X hours to Y hours. A significant reduction in clinical symptoms was observed after alcohol consumption in the group that consumed HK-GCM-H01 with added hangover relief compound, as was a significant decrease in blood exposure to acetaldehyde compared to the placebo group. There were no adverse events or significant changes in liver function indicators reported during the safety evaluation. These findings indicate that HK-GCM-H01 is safe and significantly reduces plasma concentrations of acetaldehyde, the main cause of hangover, suggesting that it improves hangover symptoms.","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11458339/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142393599","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Individual pharmacokinetic parameter estimation of gentamicin in an obese hemodialysis patient using non-linear mixed effect model. 利用非线性混合效应模型估算肥胖血液透析患者庆大霉素的个体药代动力学参数。

IF 1.1

Translational and Clinical Pharmacology Pub Date : 2024-09-01 Epub Date: 2024-09-25 DOI: 10.12793/tcp.2024.32.e14

Hyoeun Lee, Seonghae Yoon, Jae Yong Chung

{"title":"Individual pharmacokinetic parameter estimation of gentamicin in an obese hemodialysis patient using non-linear mixed effect model.","authors":"Hyoeun Lee, Seonghae Yoon, Jae Yong Chung","doi":"10.12793/tcp.2024.32.e14","DOIUrl":"10.12793/tcp.2024.32.e14","url":null,"abstract":"This study aimed to estimate individual pharmacokinetic (PK) parameters in an obese hemodialysis (HD) patient receiving gentamicin and to assess the impact of obesity on gentamicin clearance (CL). A 53-year-old obese Korean woman underwent HD and received gentamicin. To estimate individual PK parameters, we employed the POSTHOC option using NONMEM® 7.4.4. A priori model contained HD as a covariate for CL during HD, and creatinine CL (CrCL), normalized by the group mean value from the a priori model, as a covariate for non-HD CL (CLNHD). Individual CLNHD exhibited a substantial reduction from the population CLNHD, with the value corresponding to 36% of the a priori model's population PK (popPK) parameter. The patient's CrCL exceeded the group maximum of the a priori information, suggesting inaccurate renal function representation. After adjusting CrCL to the group mean from the a priori model, the patient's CLNHD was 138% of the population's typical value. The objective function value for each run was 0.53 and -4.49, respectively. The patient's CLNHD was greater than the popPK parameter value but less than the popPK parameter value when estimated using the patient's original CrCL. Meanwhile, another software (Monolix®; version 2024R1) gave similar results. This study shows the importance of individualized PK parameter estimation, particularly in obese HD patients, and highlights the potential impact of factors including obesity on gentamicin CL.","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11458338/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142393603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Determination of a robust headspace GC-MS/MS method for analysis of ethyl alcohol and acetaldehyde: clinical application to pharmacokinetics study. 确定分析乙醇和乙醛的稳健顶空 GC-MS/MS 方法：在药代动力学研究中的临床应用。

IF 1.1

Translational and Clinical Pharmacology Pub Date : 2024-09-01 Epub Date: 2024-09-24 DOI: 10.12793/tcp.2024.32.e13

Hyun-A Oh, Min Kyu Park

{"title":"Determination of a robust headspace GC-MS/MS method for analysis of ethyl alcohol and acetaldehyde: clinical application to pharmacokinetics study.","authors":"Hyun-A Oh, Min Kyu Park","doi":"10.12793/tcp.2024.32.e13","DOIUrl":"10.12793/tcp.2024.32.e13","url":null,"abstract":"Due to the forensic aspects of drinking and exposure to toxic substances, more sophisticated quantitative technology is needed to quantify the concentration of ethyl alcohol and acetaldehyde in the blood. In this study, we developed a headspace gas chromatography tandem mass spectrometry method that could simultaneously detect ethyl alcohol and acetaldehyde in human plasma. Through a simple preparation process, ethyl alcohol and acetaldehyde were quickly detected within 4 min, and a lower limit of quantification (LLOQ) (20 and 0.2 µg/mL) was obtained; these results confirmed the suitability of the system. According to Food and Drug Administration guidelines, the linearity (correlation coefficient > 0.9996), intraday and intraday accuracy, precision, and both short- and long-term stability and freeze-thaw stability satisfied the evaluation criteria (within 100.0 ± 15.0% and 20.0% of the LLOQ). Carryover and batch size assessment for the evaluation of the sample influence during analysis also satisfied the evaluation criteria. A valid method was applied to the pharmacokinetics study, and the plasma from 43 subjects after oral administration of the placebo or HK-GCM-H01 was analyzed. The developed analysis method for ethyl alcohol and acetaldehyde in blood could be used in various fields, such as forensics and those requiring precise quantification.","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11458342/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142393601","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Exploration of pharmacokinetic differences between East Asians and Caucasians: insights from pharmacokinetic studies in healthy subjects. 探索东亚人与白种人的药代动力学差异：健康受试者药代动力学研究的启示。

IF 1.1

Translational and Clinical Pharmacology Pub Date : 2024-09-01 Epub Date: 2024-09-30 DOI: 10.12793/tcp.2024.32.e15

Yoonjin Kim, Sungyeun Bae, Woo Kyung Chung, Jihoon Kwon, Ildae Song, SeungHwan Lee

{"title":"Exploration of pharmacokinetic differences between East Asians and Caucasians: insights from pharmacokinetic studies in healthy subjects.","authors":"Yoonjin Kim, Sungyeun Bae, Woo Kyung Chung, Jihoon Kwon, Ildae Song, SeungHwan Lee","doi":"10.12793/tcp.2024.32.e15","DOIUrl":"10.12793/tcp.2024.32.e15","url":null,"abstract":"Interethnic differences in the pharmacokinetics of drugs result from a complex interplay of environmental, genetic, and demographic factors. Identifying ethnic differences in pharmacokinetics is challenging due to the multifaceted contributions of the underlying factors. To address these challenges, this paper reviews 9 pharmacokinetic studies meeting the following criteria: (A) Conducted at Seoul National University Hospital from 2013 to 2022 as a single-center study. (B) Pharmacokinetic studies involving both East Asians (Korean, Japanese, or Chinese) and Caucasians. (C) Study drugs were administered orally. (D) Raw data was provided for reanalysis. This retrospective analysis aimed to investigate the existence of ethnic differences in drug exposure and understand the possible factors contributing to these variabilities. Pharmacokinetic, demographic, and clinical laboratory test data were analyzed to assess potential pharmacokinetic differences between East Asians and Caucasians. This assessment involved calculating the geometric mean ratio of dose-normalized area under the time-concentration curve (AUC) and dose- and weight-normalized AUC, along with their 90% confidence intervals. Additionally, pharmacological information, including metabolic pathways, was gathered from the investigational brochure or the respective country's drug label. Among 9 studies, 4 studies demonstrated approximately 1.3 to 1.8 times higher drug exposure in East Asians compared to Caucasians. These drugs were primarily eliminated through hepatic metabolism, with less than 5% excreted unchanged in the urine. Two drugs were metabolized by hepatic cytochrome P450 3A4, one by glutathione S-transferase, and specific metabolic pathways for another drug were not identified. Further research is needed to assess the causes of ethnic variability in these drugs.","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11458340/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142393602","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Data science through natural language with ChatGPT's Code Interpreter. 利用 ChatGPT 的代码解释器，通过自然语言实现数据科学。

IF 1.1

Translational and Clinical Pharmacology Pub Date : 2024-06-01 Epub Date: 2024-05-29 DOI: 10.12793/tcp.2024.32.e8

Sangzin Ahn

{"title":"Data science through natural language with ChatGPT's Code Interpreter.","authors":"Sangzin Ahn","doi":"10.12793/tcp.2024.32.e8","DOIUrl":"10.12793/tcp.2024.32.e8","url":null,"abstract":"Large language models (LLMs) have emerged as a powerful tool for biomedical researchers, demonstrating remarkable capabilities in understanding and generating human-like text. ChatGPT with its Code Interpreter functionality, an LLM connected with the ability to write and execute code, streamlines data analysis workflows by enabling natural language interactions. Using materials from a previously published tutorial, similar analyses can be performed through conversational interactions with the chatbot, covering data loading and exploration, model development and comparison, permutation feature importance, partial dependence plots, and additional analyses and recommendations. The findings highlight the significant potential of LLMs in assisting researchers with data analysis tasks, allowing them to focus on higher-level aspects of their work. However, there are limitations and potential concerns associated with the use of LLMs, such as the importance of critical thinking, privacy, security, and equitable access to these tools. As LLMs continue to improve and integrate with available tools, data science may experience a transformation similar to the shift from manual to automatic transmission in driving. The advancements in LLMs call for considering the future directions of data science and its education, ensuring that the benefits of these powerful tools are utilized with proper human supervision and responsibility.","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11224898/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141556495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Development of in-silico drug cardiac toxicity evaluation system with consideration of inter-individual variability. 开发考虑个体间变异性的硅内药物心脏毒性评估系统

IF 1.1

Translational and Clinical Pharmacology Pub Date : 2024-06-01 Epub Date: 2024-05-29 DOI: 10.12793/tcp.2024.32.e7

Ali Ikhsanul Qauli, Rakha Zharfarizqi Danadibrata, Aroli Marcellinus, Ki Moo Lim

{"title":"Development of in-silico drug cardiac toxicity evaluation system with consideration of inter-individual variability.","authors":"Ali Ikhsanul Qauli, Rakha Zharfarizqi Danadibrata, Aroli Marcellinus, Ki Moo Lim","doi":"10.12793/tcp.2024.32.e7","DOIUrl":"10.12793/tcp.2024.32.e7","url":null,"abstract":"Safety pharmacology examines the potential for new drugs to have unusual, rare side effects such as torsade de pointes (TdP). Recently, as a part of the Comprehensive in vitro Proarrhythmia Assay (CiPA) project, techniques for predicting the development of drug-induced TdP through computer simulations have been proposed and verified. However, CiPA assessment generally does not consider the effect of cardiac cell inter-individual variability, especially related to metabolic status. The study aimed to explore whether rare proarrhythmic effects may be linked to the inter-individual variability of cardiac cells and whether incorporating this variability into computational models could alter the prediction of drugs' TdP risks. This study evaluated the contribution of two biological characteristics to the proarrhythmic effects. The first was spermine concentration, which varies with metabolic status; the second was L-type calcium permeability that could occur due to mutations. Twenty-eight drugs were examined throughout this study, and qNet was analyzed as an essential feature. Even though there were some discrepancies of TdP risk predictions from the baseline model, we found that considering the inter-individual variability might change the TdP risk of drugs. Several drugs in the high-risk drugs group were predicted to affect as intermediate and low-risk drugs in some individuals and vice versa. Also, most intermediate-risk drugs were expected to act as low-risk drugs. When compared, the effects of inter-individual variability of L-type calcium were more significant than spermine in altering the TdP risk of compounds. These results emphasize the importance of considering inter-individual variability to assess drugs.","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11224897/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141555568","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Pharmacokinetics and bioequivalence study of candesartan cilexetil tablet in Chinese volunteers under fasting condition: an open-label, randomized-sequence, 2-period crossover study. 空腹状态下中国志愿者服用坎地沙坦西来替酯片剂的药代动力学和生物等效性研究：一项开放标签、随机序列、2 期交叉研究。

IF 1.1

Translational and Clinical Pharmacology Pub Date : 2024-06-01 Epub Date: 2024-06-26 DOI: 10.12793/tcp.2024.32.e10

Meiling Han, Yingxia He, Jun Liang, Fang Yao, Pan Lu, Hegui Yan, Jie Wang, Yafang Xie, Xiuwen Li, Qiangwei Liu, Yang Liu, Baodong Yuan, Ming Zhou

{"title":"Pharmacokinetics and bioequivalence study of candesartan cilexetil tablet in Chinese volunteers under fasting condition: an open-label, randomized-sequence, 2-period crossover study.","authors":"Meiling Han, Yingxia He, Jun Liang, Fang Yao, Pan Lu, Hegui Yan, Jie Wang, Yafang Xie, Xiuwen Li, Qiangwei Liu, Yang Liu, Baodong Yuan, Ming Zhou","doi":"10.12793/tcp.2024.32.e10","DOIUrl":"10.12793/tcp.2024.32.e10","url":null,"abstract":"Candesartan is an antihypertensive agent that acts on an angiotensin II receptor. Candesartan cilexetil is a prodrug that is converted into the active form of candesartan during intestinal absorption. This study aimed to assess the pharmacokinetics and bioequivalence of a reference and a test formulation of candesartan cilexetil tablets in healthy Chinese volunteers. A randomized, open-label, single-dose, crossover study was conducted with two treatment periods. Forty-eight healthy Chinese volunteers participated under fasted conditions. Qualified subjects were randomly divided into two groups (1:1 ratio) to receive either the test or reference formulation first. A washout period of 14 days separated the administration of the two formulations. Blood samples were collected at specific time points and analyzed for candesartan concentration using Ultra High-Performance Liquid Chromatography Tandem Mass Spectrometry (UPLC-MS/MS). The maximum concentration (Cmax), the AUC from time zero to the last measured time point (AUC0-t) and the AUC from time zero to infinity (AUC0-∞) fell within the bioequivalence range of 80% to 125%. These results suggest that the test and reference formulations of candesartan cilexetil tablets are bioequivalent, meaning they have similar rates and extents of absorption in healthy Chinese volunteers. No serious adverse events or side effects were reported throughout the study.","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11224900/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141555570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Enhancing drug administration flexibility: evaluation of pharmacokinetic properties of tegoprazan orally disintegrating tablet (ODT) administered via nasogastric tube or oral dosing. 提高给药灵活性：评估经鼻胃管或口服给药的替戈拉赞口腔崩解片（ODT）的药代动力学特性。

IF 1.1

Translational and Clinical Pharmacology Pub Date : 2024-06-01 Epub Date: 2024-06-26 DOI: 10.12793/tcp.2024.32.e9

Ho-Sook Kim, Young-Kyung Choi, Minkyung Oh, Yong-Soon Cho, Jong-Lyul Ghim

{"title":"Enhancing drug administration flexibility: evaluation of pharmacokinetic properties of tegoprazan orally disintegrating tablet (ODT) administered via nasogastric tube or oral dosing.","authors":"Ho-Sook Kim, Young-Kyung Choi, Minkyung Oh, Yong-Soon Cho, Jong-Lyul Ghim","doi":"10.12793/tcp.2024.32.e9","DOIUrl":"10.12793/tcp.2024.32.e9","url":null,"abstract":"Tegoprazan orally disintegrating tablet (ODT) formulation is a novel formulation to improve a convenience in comparison to taking the conventional tablet of tegoprazan, a potassium-competitive acid blocker. The purpose of this study was to evaluate the pharmacokinetic and safety profiles of tegoprazan ODT when administered via two routes: nasogastric tube or oral dosing. This study is expected to expand the administration route of tegoprazan ODT. The study was conducted in an open-label, randomized, single-dose, two-way crossover design with a 1-week washout period. Healthy subjects aged 19 to 45 years were administered 50 mg of tegoprazan ODT orally or dissolved in water via nasogastric tube. Tegoprazan, the active ingredient, was quantified using a ultra-high performance liquid chromatography tandem mass spectroscopy (UPLC-MS/MS), and pharmacokinetic parameters were determined through non-compartmental analysis. Safety was monitored throughout the study. A total of 48 subjects, successfully completed the trial. The geometric mean ratios for log-transformed Cmax and AUCt, representing the ratio of nasogastric tube group to oral dosing group, along with 90% confidence intervals, were 1.1087 (1.0243-1.2000) and 1.0023 (0.9620-1.0442), respectively. All adverse events were unrelated to tegoprazan and mild in intensity. The pharmacokinetic profiles of tegoprazan ODT were equivalent between the nasogastric tube and oral administration. Considering the demonstrated linear pharmacokinetics and concentration-dependent pharmacodynamics of tegoprazan, the administration via nasogastric tube is expected to yield effects equivalent to those of oral administration. This approach offers a viable alternative, especially beneficial for patients with oral intake difficulties.","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11224899/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141555569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The landscape of decentralized clinical trials (DCTs): focusing on the FDA and EMA guidance. 分散临床试验 (DCT) 的现状：重点关注美国食品药物管理局 (FDA) 和欧洲医学管理局 (EMA) 的指导意见。

IF 0.9

Translational and Clinical Pharmacology Pub Date : 2024-03-01 Epub Date: 2024-02-20 DOI: 10.12793/tcp.2024.32.e2

Jiyeon Park, Ki Young Huh, Woo Kyung Chung, Kyung-Sang Yu

{"title":"The landscape of decentralized clinical trials (DCTs): focusing on the FDA and EMA guidance.","authors":"Jiyeon Park, Ki Young Huh, Woo Kyung Chung, Kyung-Sang Yu","doi":"10.12793/tcp.2024.32.e2","DOIUrl":"https://doi.org/10.12793/tcp.2024.32.e2","url":null,"abstract":"Decentralized clinical trials (DCTs) consist of off-site trial-related procedures referred to as decentralized elements. We aimed to provide an overview of the landscape of DCTs by comparing regulatory guidance reports and analyzing decentralized elements from clinical trial registries. Two guidance reports on DCTs published by the U.S. Food and Drug Administration and the European Medicines Agencies were summarized and analyzed. Both guidance publications commonly emphasized an assessment of the appropriateness of decentralized elements along 2 axes: patient safety and data integrity. DCT cases were identified from ClinicalTrials.gov by searching with 6 keywords: decentralized, remote, mobile, digital, virtual, and hybrid. Cases where the keyword was used in a non-DCT context, such as digital flexor tendon, were excluded by means of natural language processing. A total of 4,874 trials were identified as DCT cases, with annual increases, especially after 2020. The most common keywords were 'mobile' and 'digital' (36.2% and 24.8%, respectively). Interventions in the DCT cases were analyzed by means of a network analysis. Behavioral and technological tokens were frequently combined, such as 'rehabilitation' and 'app.' Drugs were used in only 1.8% of the DCT cases. Of these, most drugs had been approved previously (96.8%) and were in oral formulation (67.2%). Most of the DCT cases identified in this study involved simple interventions and low-risk drugs. These characteristics were in accordance with the common recommendations in the DCT guidance publications.","PeriodicalId":23288,"journal":{"name":"Translational and Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10990725/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140870025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0