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KMDATA: a curated database of reconstructed individual patient-level data from 153 oncology clinical trials.

ABSTRACT: We created a database of reconstructed patient-level data from published clinical trials that includes multiple time-to-event outcomes such as overall survival and progression-free survival. Outcomes were extracted from Kaplan-Meier (KM) curves reported in 153 oncology Phase III clinical trial publications identified through a PubMed search of clinical trials in breast, lung, prostate and colorectal cancer, published between 2014 and 2016. For each trial that met our search criteria, we curated study-level information and digitized all reported KM curves with the software Digitizelt. We then used the digitized KM survival curves to estimate (possibly censored) patient-level time-to-event outcomes. Collections of time-to-event datasets from completed trials can be used to support the choice of appropriate trial designs for future clinical studies. Patient-level data allow investigators to tailor clinical trial designs to diseases and classes of treatments. Patient-level data also allow investigators to estimate the operating characteristics (e.g. power and type I error rate) of candidate statistical designs and methods. Database URL: https://10.6084/m9.figshare.14642247.v1.

SUBMITTER: Fell G

PROVIDER: S-EPMC8234134 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:To compare the characteristics, quality and treatment effects of randomised clinical trials (RCTs) by individual patient data (IPD) availability, in trials eligible for 18 IPD meta-analyses (MA).Trial characteristics, risk of bias (RoB) and hazard ratio (HR) for overall survival were extracted from IPD-MA publications and/or RCTs publications. Data for the RoB assessment were extracted for a subset of 73 RCTs. Two investigators blinded to whether IPD was available or not evaluated the RoB for these trials. Treatment effects were compared using ratios of global HRs (RHRs) of IPD-unavailable trials and IPD-available trials. RHR were pooled using a fixed-effect model.We examined the IPD availability for each trial eligible for each IPD-MA; when the IPD was not available for a trial, we used information from published sources.We selected all published IPD-MAs conducted at Gustave Roussy and the RCTs eligible for each.349 RCTs (73?018 patients) from 18 MAs were eligible: 60 RCTs (5890 patients) had unavailable IPD and 289 RCTs (67?128 patients) had available IPD. The main reason for IPD unavailability was data loss by investigators. IPD-unavailable trials were smaller (p<0.001), more often monocentric (p<0.001) and non-international (p=0.0004) than IPD-available trials. Geographical areas differed (p=0.054) between IPD-unavailable IPD-available trials. RoB was higher in IPD-unavailable RCTs for random sequence generation (p=0.007) and allocation concealment (p=0.006). The HR and 95% confidence interval (CI) for overall survival were extractable from publications in 23/60 IPD-unavailable trials included in 10 different MAs. Treatment effects were significantly greater for IPD-unavailable trials compared with IPD-available trials (RHR=0.86 (95% CI 0.75 to 0.98)).IPD-unavailable RCTs were significantly different from IPD-available RCTs in terms of trial characteristics and were at greater RoB. IPD-unavailable RCTs had a significantly greater treatment effect.

Project description:IntroductionPsychotherapy may reduce suicidal thoughts and behaviour, but its effectiveness is not well examined. Furthermore, conventional meta-analyses are unable to test possible effects of moderators affecting this relationship. This protocol outlines the building of a comprehensive database of the literature in this research field. In addition, we will conduct an individual patient data meta-analysis (IPD-MA) to establish the effectiveness of psychotherapy in reducing suicidality, and to examine which factors moderate the efficacy of these interventions.Methods and analysisTo build a comprehensive database, randomised controlled trials examining the effect of any psychotherapy targeting any psychiatric disorder on suicidal thoughts or behaviour will be identified by running a systematic search in PubMed, Embase, PsycINFO, Web of Science, Scopus and The Cochrane Central Register of Controlled Trials from data inception to 12 August 2019. For the IPD-MA, we will focus on adult outpatients with suicidal ideation or behaviour. In addition, as a comparison group we will focus on a control group (waiting-list, care as usual or placebo). A 1-stage IPD-MA will be used to determine the effectiveness of psychotherapy on suicidal ideation, suicide attempts and/or suicide deaths, and to investigate potential patient-related and intervention-related moderators. Subgroup and sensitivity analyses will be conducted to test the robustness of the findings. Additionally, a conventional MA will be conducted to determine the differences between studies that provided IPD and those that did not. IPD-MA may determine the effectiveness of psychotherapy in reducing suicidality and provide insights into the moderating factors influencing the efficacy of psychotherapy. Answering these questions will inform mental healthcare practitioners about optimal treatments for different groups of individuals with suicidal ideation and/or behaviour and consequently help to reduce suicide risk.Ethics and disseminationAn ethical approval is not required for this study. The results will be published in a peer-review journal.Prospero registration numberCRD42020140573.

Project description:Recently, a sum of trials of programmed cell death-1 (PD-1) inhibitors combined with chemotherapy have shown excellent efficacy compared to chemotherapy alone in patients with previously untreated, advanced esophageal squamous cell carcinoma (ESCC). However, there is no head-to-head comparison and consensus on which immunotherapy regimen results in better survival outcomes. This study aimed to evaluate the survival efficacy of various PD-1 inhibitor-based therapies in the first-line treatments for patients with advanced ESCC. Data collected prior to 31 July 2023 were searched in the PubMed, Cochrane Library, Embase, Medline, and Web of Science databases. Overall survival (OS) and progression-free survival curves were pooled using the MetaSurv package. Survival data were compared by reconstructed individual patient data. A total of 4,162 patients and seven randomized controlled trials were included. After synthesizing, PD-1 inhibitors prolonged median OS from 11.3 months (95% CI (confidence interval) 10.7-11.7) to 15.6 months (95% CI 14.7-16.3). Based on reconstructed patient-level data, the toripalimab, tislelizumab, and sintilimab group achieved the longest OS, whereas the sintilimab and tislelizumab group had the lowest risk of recurrence than other treatments. In patients with a combined positive score of ≥10, sintilimab had better OS efficacy than pembrolizumab (HR: 0.71, 95% CI: 0.52-0.96). In terms of tumor proportion score of ≥1%, camrelizumab, nivolumab, and toripalimab showed proximate survival benefits in both OS and progression-free survival. PD-1 inhibitor combined with chemotherapy significantly improved the survival time of patients with advanced ESCC. Toripalimab, tislelizumab, and sintilimab plus chemotherapy showed the best OS benefit. Longer progression-free benefits might be generated from adding tislelizumab and sintilimab to chemotherapy. Sintilimab was strongly recommended for patients with high programmed cell death-ligand 1 abundance. [https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42024501086].

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KMDATA: a curated database of reconstructed individual patient-level data from 153 oncology clinical trials.

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