Premature termination of clinical trials in Spain: reasons, characteristics, and opportunities to improve.
Purpose: The aim of this study is to determine the rate of prematurely terminated clinical trials (CTs) and describe primary reasons and characteristics, and suggest strategies to improve. Methods: We performed a retrospective, observational, cross-sectional study including all CTs registered in the...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 79; no. 2; pp. 249 - 257 |
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| Autores principales: | , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Springer Nature
Feb2023
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=161515049&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 161515049 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Feb2023 vid: 79 iid: 2 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 161515049 160811777 161515049 161515049 10.1007/s00228-022-03437-5 161515049 ppf: 249 ppct: 8 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Premature termination of clinical trials in Spain: reasons, characteristics, and opportunities to improve. aug: au: Filippi-Arriaga, Francesca Boy, Ricardo Javier Del Gobbo, Alejandro Díaz Gallego, Alexis Rodríguez affil: Clinical Pharmacology Service, Hospital Universitari Vall d'Hebron, Barcelona, Spain sug: subj: Clinical Trials Research Subject Recruitment Evaluation Risk Assessment Spain Human Retrospective Design Nonexperimental Studies Cross Sectional Studies Clinical Trial Registry Relative Risk Confidence Intervals Treatment Outcomes Business Decision Making Descriptive Statistics Placebos Therapeutic Use Aged Infant, Newborn Child, Preschool Child Neoplasms Digestive System Pathology Age Factors Multicenter Studies Aged: 65+ years Infant, Newborn: birth-1 month Child, Preschool: 2-5 years Child: 6-12 years ab: Purpose: The aim of this study is to determine the rate of prematurely terminated clinical trials (CTs) and describe primary reasons and characteristics, and suggest strategies to improve. Methods: We performed a retrospective, observational, cross-sectional study including all CTs registered in the Spanish Registry of Clinical Studies (REec) from January 1, 2013 to November 31, 2021. A descriptive analysis of reasons for premature termination was made. To assess characteristics associated with a premature termination, the relative risks (RR) with a 95% confidence interval were calculated. Results: In total, 21% (718) of CT were prematurely terminated. Reasons for premature termination included patient recruitment issues in 25% (179) of cases, efficacy or futility problems in 18% (132), and commercial or strategic decisions from the sponsor in 12% (87). Characteristics significantly associated with an increased risk of premature termination included the following: presence of placebo (RR 2.08); multiple study sites (RR 1.32); pediatric and geriatric populations (RR 1.29 children; RR 1.47 preschoolers; RR 1.92 newborns; RR 1.27 > 64 years of age). In addition, circumstances such as investigations in phase II (RR 1.21), of cancer (RR 1.37), and of digestive pathology (RR 1.65) were also associated with increased risk of premature termination. Conclusion: Recruitment of the study subjects in a CT must be meticulous and account for age of participants. In addition, CT study sites should be evaluated to ensure they have appropriate resources and the desired patient population. Based on intermediate analyses, CT protocols should describe the criteria to terminate a study due to futility. These approaches are essential to avoid harm to participants, ensure internal validity of studies, and improve the use of resources in CT development. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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