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Background: To demonstrate bioequivalence between two drug formulations, a pilot trial is often conducted prior to a pivotal trial to assess feasibility and gain preliminary information about the treatment effect. Due to the limited sample size, it is not recommended to perform significance tests at the conventional 5% level using pilot data to determine if a pivotal trial should take place. Whilst some authors suggest to relax the significance level, a Bayesian framework provides an alternative for informing the decision-making. Moreover, a Bayesian approach also readily permits possible incorporation of pilot data in priors for the parameters that underpin the pivotal trial. Methods: We consider two-sequence, two-period crossover designs that compare test (T) and reference (R) treatments. We propose a robust Bayesian hierarchical model, embedded with a scaling factor, to elicit a Go/No-Go decision using predictive probabilities. Following a Go decision, the final analysis to formally establish bioequivalence can leverage both the pilot and pivotal trial data jointly. A simulation study is performed to evaluate trial operating characteristics. Results: Compared with conventional procedures, our proposed method improves the decision-making to correctly allocate a Go decision in scenarios of bioequivalence. By choosing an appropriate threshold, the probability of correctly (incorrectly) making a No-Go (Go) decision can be ensured at a desired target level. Using both pilot and pivotal trial data in the final analysis can result in a higher chance of declaring bioequivalence. The false positive rate can be maintained in situations when T and R are not bioequivalent. Conclusions: The proposed methodology is novel and effective in different stages of bioequivalence assessment. It can greatly enhance the decision-making process in bioequivalence trials, particularly in situations with a small sample size. [ABSTRACT FROM AUTHOR]

A fuzzy set extension known as the hesitant fuzzy set (HFS) has increased in popularity for decision making in recent years, especially when experts have had trouble evaluating several alternatives by employing a single value for assessment when working in a fuzzy environment. However, it has a significant problem in its uses, i.e., considerable data loss. The probabilistic hesitant fuzzy set (PHFS) has been proposed to improve the HFS. It provides probability values to the HFS and has the ability to retain more information than the HFS. Previously, fuzzy regression models such as the fuzzy linear regression model (FLRM) and hesitant fuzzy linear regression model were used for decision making; however, these models do not provide information about the distribution. To address this issue, we proposed a probabilistic hesitant fuzzy linear regression model (PHFLRM) that incorporates distribution information to account for multi-criteria decision-making (MCDM) problems. The PHFLRM observes the input–output (IPOP) variables as probabilistic hesitant fuzzy elements (PHFEs) and uses a linear programming model (LPM) to estimate the parameters. A case study is used to illustrate the proposed methodology. Additionally, an MCDM technique called the technique for order preference by similarity to ideal solution (TOPSIS) is employed to compare the PHFLRM findings with those obtained using TOPSIS. Lastly, Spearman's rank correlation test assesses the statistical significance of two rankings sets. [ABSTRACT FROM AUTHOR]

Basket trials have emerged as a new class of efficient approaches in oncology to evaluate a new treatment in several patient subgroups simultaneously. In this article, we extend the key ideas to disease areas outside of oncology, developing a robust Bayesian methodology for randomized, placebo-controlled basket trials with a continuous endpoint to enable borrowing of information across subtrials with similar treatment effects. After adjusting for covariates, information from a complementary subtrial can be represented into a commensurate prior for the parameter that underpins the subtrial under consideration. We propose using distributional discrepancy to characterize the commensurability between subtrials for appropriate borrowing of information through a spike-and-slab prior, which is placed on the prior precision factor. When the basket trial has at least three subtrials, commensurate priors for point-to-point borrowing are combined into a marginal predictive prior, according to the weights transformed from the pairwise discrepancy measures. In this way, only information from subtrial(s) with the most commensurate treatment effect is leveraged. The marginal predictive prior is updated to a robust posterior by the contemporary subtrial data to inform decision making. Operating characteristics of the proposed methodology are evaluated through simulations motivated by a real basket trial in chronic diseases. The proposed methodology has advantages compared to other selected Bayesian analysis models, for (i) identifying the most commensurate source of information and (ii) gauging the degree of borrowing from specific subtrials. Numerical results also suggest that our methodology can improve the precision of estimates and, potentially, the statistical power for hypothesis testing. [ABSTRACT FROM AUTHOR]

Biomedical research has come to rely on p-values as a deterministic measure for data-driven decision-making. In the largely extended null hypothesis significance testing for identifying statistically significant differences among groups of observations, a single p-value is computed from sample data. Then, it is routinely compared with a threshold, commonly set to 0.05, to assess the evidence against the hypothesis of having non-significant differences among groups, or the null hypothesis. Because the estimated p-value tends to decrease when the sample size is increased, applying this methodology to datasets with large sample sizes results in the rejection of the null hypothesis, making it not meaningful in this specific situation. We propose a new approach to detect differences based on the dependence of the p-value on the sample size. We introduce new descriptive parameters that overcome the effect of the size in the p-value interpretation in the framework of datasets with large sample sizes, reducing the uncertainty in the decision about the existence of biological differences between the compared experiments. The methodology enables the graphical and quantitative characterization of the differences between the compared experiments guiding the researchers in the decision process. An in-depth study of the methodology is carried out on simulated and experimental data. Code availability at https://github.com/BIIG-UC3M/pMoSS. [ABSTRACT FROM AUTHOR]

If artificial intelligence (AI) is to help solve individual, societal and global problems, humans should neither underestimate nor overestimate its trustworthiness. Situated in-between these two extremes is an ideal 'Goldilocks' zone of credibility. But what will keep trust in this zone? We hypothesise that this role ultimately falls to the social cognition mechanisms which adaptively regulate conformity between humans. This novel hypothesis predicts that human-like functional biases in conformity should occur during interactions with AI. We examined multiple tests of this prediction using a collaborative remembering paradigm, where participants viewed household scenes for 30 s vs. 2 min, then saw 2-alternative forced-choice decisions about scene content originating either from AI- or human-sources. We manipulated the credibility of different sources (Experiment 1) and, from a single source, the estimated-likelihood (Experiment 2) and objective accuracy (Experiment 3) of specific decisions. As predicted, each manipulation produced functional biases for AI-sources mirroring those found for human-sources. Participants conformed more to higher credibility sources, and higher-likelihood or more objectively accurate decisions, becoming increasingly sensitive to source accuracy when their own capability was reduced. These findings support the hypothesised role of social cognition in regulating AI's influence, raising important implications and new directions for research on human–AI interaction. [ABSTRACT FROM AUTHOR]