Rejoinder to the discussion on "LEAP: the latent exchangeability prior for borrowing information from historical data".

The discussions of our paper provide insights into the practical considerations of the latent exchangeability prior while also highlighting further extensions. In this rejoinder, we briefly summarize the discussions and provide comments.

Catalytic hairpin self-assembly amplification fluorescence detection of chloramphenicol based on cross-shaped DNA and UiO-66.

A catalytic hairpin self-assembly (CHA) amplification method was developed for CAP detection based on cross-shaped DNA and UiO-66. MOF was used to quench the fluorescent signal of FAM labeled DNA. Cross-shaped DNA with four fluorophore group (FAM) was utilized to enhance the fluorescent intensity.

Noninvasive external therapy of traditional Chinese medicine for preventing postpartum urinary retention in women with vaginal delivery: A network meta-analysis.

Background: To compare the effect of different noninvasive external therapies of traditional Chinese medicine (TCM) on the prevention of postpartum urinary retention (PUR) using a network meta-analysis (NMA).

Methods: A search of the China National Knowledge Infrastructure, WanFangDate, VIP, China Biomedical Literature Database, PubMed, The Cochrane Library, Embase, and Web of Science databases were reviewed for related randomized controlled trials dated between database inception and December 31, 2022, on the prevention of PUR by noninvasive TCM. Two researchers independently screened the literature, extracted the data, and assessed the risk of bias in the included studies; then, a NMA was performed using Revman5.

Landmark mediation survival analysis using longitudinal surrogate.

Clinical cancer trials are designed to collect radiographic measurements of each patient's baseline and residual tumor burden at regular intervals over the course of study. For solid tumors, the extent of reduction in tumor size following treatment is used as a measure of a drug's antitumor activity. Statistical estimation of treatment efficacy routinely reduce the longitudinal assessment of tumor burden to a binary outcome describing the presence versus absence of an objective tumor response as defined by RECIST criteria.

Predicting outcomes of phase III oncology trials with Bayesian mediation modeling of tumor response.

Pivotal cancer trials often fail to yield evidence in support of new therapies thought to offer promising alternatives to standards-of-care. Conducting randomized controlled trials in oncology tends to be considerably more expensive than studies of other diseases with comparable sample size. Moreover, phase III trial design often takes place with a paucity of survival data for experimental therapies.

Bayesian adaptive design for concurrent trials involving biologically related diseases.

We develop a Bayesian design method for a clinical program where an investigational product is to be studied concurrently in a set of clinical trials involving related diseases with the goal of demonstrating superiority to a control in each. The approach borrows information on treatment effectiveness using correlated mixture priors using an analysis procedure that is closely related Bayesian model averaging. Mixture priors are constructed by eliciting conjugate priors based on pessimistic and enthusiastic predictions for the data to be observed for each disease and then by eliciting mixture weights for all possible configurations of the pessimistic and enthusiastic priors across the diseases to be studied.

A "turn-on" and proximity ligation assay dependent DNA tweezer for one-step amplified fluorescent detection of DNA.

A "turn-on" and proximity ligation assay dependent DNA tweezer was proposed for one-step amplified fluorescent detection of DNA. Target DNA can anneal with capture probe to form an entire long sequence. The formed long sequence can circularly open the hairpin, resulting the "turn-on" of DNA tweezers.

Pharmacokinetic/pharmacodynamic data extrapolation models for improved pediatric efficacy and toxicity estimation, with application to secondary hyperparathyroidism.

In most drug development settings, the regulatory approval process is accompanied by extensive studies performed to understand the drug's pharmacokinetic (PK) and pharmacodynamic (PD) properties. In this article, we attempt to utilize the rich PK/PD data to inform the borrowing of information from adults during pediatric drug development. In pediatric settings, it is especially crucial that we are parsimonious with the patients recruited for experimentation.

A simple and programmed DNA tweezer probes for one-step and amplified detection of UO.

A simple DNA tweezer was proposed for one-step and amplified detection of UO based on DNAzyme catalytic cleavage. The two arms of DNA tweezers are close in the original form. Thus, the fluorescent signal of fluorophore at the end of arm is dramatically quenched.

Comparative preservation effect of water-soluble and insoluble chitosan from Tenebrio molitor waste.

Edible films and coatings have been developed based on numerous natural biopolymers, which have been used to increase fresh-cut fruit shelf life. Here, we present the preparation, characteristics and preservation effect of water-soluble chitosan (WSC) and water-insoluble chitosan (WIC) from Tenebrio molitor waste (TMW) on fresh-cut apple slices. WIC was isolated from TMW in four steps and WSC was obtained from the WIC solution by 8% HO treatment at 40 °C for 3 h.

Statistical modeling for Bayesian extrapolation of adult clinical trial information in pediatric drug evaluation.

Children represent a large underserved population of "therapeutic orphans," as an estimated 80% of children are treated off-label. However, pediatric drug development often faces substantial challenges, including economic, logistical, technical, and ethical barriers, among others. Among many efforts trying to remove these barriers, increased recent attention has been paid to extrapolation; that is, the leveraging of available data from adults or older age groups to draw conclusions for the pediatric population.

Wheat Blast and Fusarium Head Blight Display Contrasting Interaction Patterns on Ears of Wheat Genotypes Differing in Resistance.

The interaction of wheat with two ear pathogens, Magnaporthe wheat blast (MWB) and Fusarium graminearum (Fusarium head blight, FHB), was studied on the phenotypic, histological, and gene expression level. Most of the 27 wheat cultivars inoculated with MWB and F. graminearum displayed inverse disease responses to blast and FHB infection.

The FDA's Final Rule on Expedited Safety Reporting: Statistical Considerations.

In March 2011, a Final Rule for expedited reporting of serious adverse events took effect in the United States for studies conducted under an Investigational New Drug (IND) application. In December 2012, the U.S.

Intensified specimen collection to improve tuberculosis diagnosis in children from Rural South Africa, an observational study.

Background: In drug-resistant TB settings, specimen collection is critical for drug-susceptibility testing (DST). This observational study included multiple specimen types collected from pediatric TB suspects with the aim to determine diagnostic yield and inform clinical practice in children with drug-resistant and drug-susceptible TB.

Methods: From 03/2009-07/2010, TB suspects aged ≥6 months and ≤12 years were recruited among outpatient and inpatient settings.

Statistical Evaluation of Drug Safety Data.

There has been growing awareness of the importance of the statistical evaluation of drug safety data both in the premarketing and postmarketing settings. Careful and comprehensive approaches are warranted in safety evaluation. This paper offers a high-level review of some key issues and emerging statistical methodological developments.

Safety monitoring in clinical trials.

Monitoring patient safety during clinical trials is a critical component throughout the drug development life-cycle. Pharmaceutical sponsors must work proactively and collaboratively with all stakeholders to ensure a systematic approach to safety monitoring. The regulatory landscape has evolved with increased requirements for risk management plans, risk evaluation and minimization strategies.

Guidance on the implementation and reporting of a drug safety Bayesian network meta-analysis.

The Drug Information Association Bayesian Scientific Working Group (BSWG) was formed in 2011 with a vision to ensure that Bayesian methods are well understood and broadly utilized for design and analysis and throughout the medical product development process, and to improve industrial, regulatory, and economic decision making. The group, composed of individuals from academia, industry, and regulatory, has as its mission to facilitate the appropriate use and contribute to the progress of Bayesian methodology. In this paper, the safety sub-team of the BSWG explores the use of Bayesian methods when applied to drug safety meta-analysis and network meta-analysis.

Bayesian methods for design and analysis of safety trials.

Safety assessment is essential throughout medical product development. There has been increased awareness of the importance of safety trials recently, in part due to recent US Food and Drug Administration guidance related to thorough assessment of cardiovascular risk in the treatment of type 2 diabetes. Bayesian methods provide great promise for improving the conduct of safety trials.

The practice of pre-marketing safety assessment in drug development.

The last 15 years have seen a substantial increase in efforts devoted to safety assessment by statisticians in the pharmaceutical industry. While some of these efforts were driven by regulations and public demand for safer products, much of the motivation came from the realization that there is a strong need for a systematic approach to safety planning, evaluation, and reporting at the program level throughout the drug development life cycle. An efficient process can help us identify safety signals early and afford us the opportunity to develop effective risk minimization plan early in the development cycle.

Meta-analysis of clinical trial safety data in a drug development program: answers to frequently asked questions.

Background: Meta-analyses of clinical trial safety data have risen in importance beyond regulatory submissions. During drug development, sponsors need to recognize safety signals early and adjust the development program accordingly, so as to facilitate the assessment of causality. Once a product is marketed, sponsors add postapproval clinical trial data to the body of information to help understand existing safety concerns or those that arise from other postapproval data sources, such as spontaneous reports.

Bayesian meta-experimental design: evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes.

Recent guidance from the Food and Drug Administration for the evaluation of new therapies in the treatment of type 2 diabetes (T2DM) calls for a program-wide meta-analysis of cardiovascular (CV) outcomes. In this context, we develop a new Bayesian meta-analysis approach using survival regression models to assess whether the size of a clinical development program is adequate to evaluate a particular safety endpoint. We propose a Bayesian sample size determination methodology for meta-analysis clinical trial design with a focus on controlling the type I error and power.

Bayesian hierarchical modeling for detecting safety signals in clinical trials.

Detection of safety signals from clinical trial adverse event data is critical in drug development, but carries a challenging statistical multiplicity problem. Bayesian hierarchical mixture modeling is appealing for its ability to borrow strength across subgroups in the data, as well as moderate extreme findings most likely due merely to chance. We implement such a model for subject incidence (Berry and Berry, 2004 ) using a binomial likelihood, and extend it to subject-year adjusted incidence rate estimation under a Poisson likelihood.

[Effect of fertilization on the absorption, partition and accumulation of carbon and nitrogen of rice under the equal N conditions].

In this study, the assimilation, partition and accumulation of carbon (C) and nitrogen (N), as well as the relationship between C and N accumulation of rice, were studied from typical paddy ecosystems under long-term fertilizer applications with equal N inputs in subtropical China. The results showed that chemical fertilizer plus low organic manure (LOM) could promote effectively the distribution of C in the rice plant. The N content in the stem-leaf and grain of rice under organic-inorganic fertilization was 8.