Newsletter for Statistical Programmers and Biostatisticians #40

SAS

Automating Defensive Programming in Macros from Craig Parry. To any SAS Programmer, I had an idea on how defensive macro programming could somewhat be semi-automated, so I wrote article about automating some of the checks. Note, the article excludes the obvious testing phase, which all macros will go through eventually. Link

Finding observations that are not common to both datasets using Proc SQL. From Kiran Venna Link

SAS Macro Series Part 7a (Macro functions): Macro Quoting functions. From Kiran Venna Link

Linux commands and scripts that are useful for SAS programmers working in the Linux platform. From Hengwei Liu

Biostatistics (thanks to Stefano Vezzoli)

Combining individual patient data from randomized and non-randomized studies to predict real-world effectiveness of interventions. From Thomas Debray. Latest publication on prediction of personalized treatment effects using data from randomized and non-randomized studies. Link

Substantial delays in clinical data published by the European Medicines Agency – a cross sectional study. Reporting bias poses a fundamental threat to the transparency and validity of interpretations of clinical trials, which may, in part, be mitigated through access Clinical Study Reports (CSRs). The European Medicines Agency (EMA), under their Policy 0070, prospectively publishes clinical data, including CSRs, submitted as part of marketing authorization applications or post-authorization procedures Link

Biopharmaceutical Report - Spring 2022, by ASA Biopharmaceutical Section. Link

• Deployment and application of multi-modal sensors in clinical trials
• Statistical challenges of modeling of mobile digital health data
• Accelerating MRNA process development with digital twins
• Digital biomarkers of glucose control – reproducibility challenges and opportunities

Slides by Lucy D'Agostino McGowan (Wake Forest University): "p-values: The ASA Statement and Beyond". From the seminar "What is the value of the p-value? A panel discussion on the use and misuse of the p-value in health research" (26 April 2022). Link

Inference in Experiments Conditional on Observed Imbalances in Covariates. This article studies the theoretical properties of both the difference-in-means and OLS estimators conditional on observed differences in covariates. By deriving the statistical properties of the conditional estimators, we can establish guidance for how to deal with covariate imbalances. Link

Machine Learning Prediction of Clinical Trial Operational Efficiency. We develop a machine learning model to predict clinical trial operational efficiency using a novel dataset from Roche containing over 2,000 clinical trials across 20 years and multiple disease areas. Our results demonstrate that operational efficiency can be predicted robustly using trial features, which can provide useful insights to trial designers on the potential impact of their decisions on patient recruitment success and trial duration. Link

Webinars

PSI Webinar: Novel composite estimands and their analysis. When an intercurrent event in itself is considered to be informative about the treatments' effect on patients' outcomes, the intercurrent event is often incorporated into the definition of the variable. The ICH E9 (R1) addendum refers to this as the composite strategy. In this event, speakers will present different composite estimand strategies for clinical trials, the analyses that target these estimands (e.g., trimmed means, rank-based approaches), and regulatory considerations for clinical trials with composite estimands and endpoints. A discussant will reflect on the presentations. Link

How do I debug SAS DATA Step? Q&A, Slides, and On-Demand Recording. You will learn: hat the SAS DATA Step Debugger is and where to find it. How to use the debugger to set breakpoints, watch values and solve logic problems. The limitations of the debugger. Link

Free online training course on Adaptive Designs and Clinical Trial simulation from Alex Dmitrienko. It's a 10-part training program which includes, Adaptive designs with sample size re-estimation, Adaptive designs with treatment selection, Adaptive designs with population selection and more! Link

Advanced Sample Size Determination for Counts and Rates. Count and incidence rate data is a common outcome in areas such as chronic respiratory diseases and imaging studies. Many methods exist for the analysis count and incidence rate data such as Poisson or Negative Binomial regression but sample size methods have been relatively basic up until recently. Significant progress has been made in some areas including overdispersion, unequal follow-up, and group sequential design. Free webinar Link

Events

PharmaSUG 2022: May 22-25 in Austin, TX A special list for PharmaSUG 2022 Paper Presentations from my network:

• AP-038 Bartosz Szymecki Fast hashes for complex joins
• AP-053 Murali Neela Data quality awareness while working on Clinical programming
• AP-108 Nancy Brucken From Codelists to Format Library

The Turing-Roche knowledge share series: Predictive modelling in healthcare. This event will be exploring the topic of predictive modelling in healthcare- how this branch of advanced analytics can potentially predict and help improve patient outcomes and beyond. Monday 25 Apr 2022 Time: 14:00 - 15:00 Link

European Federation of Statisticians in the Pharmaceutical Industry is pleased to announce the 7th regulatory statistics workshop that will take place on We are planning the event in Basel with a focus on in-person attendance. However, sessions will also be broadcasted and recorded (all pending speaker approval). The workshop will discuss opportunities and challenges of statistical topics in drug development between regulators, academics, and industry. The two days will be filled with various formats such as presentations, roundtable discussions, the well-established short topic session, lots of coffee breaks, and the legendary wine tasting. 14th-15th September 2022. Link

PSI Training Course: Hybrid Frequentist / Bayesian Power and Bayesian Power in Planning Clinical Trials! Learn how to use Expected Power, Average Power, Predicted Power, Probability of Success and Assurance, and Bayesian Power when planning clinical trials. Monday 4th, Wednesday 6th & Friday 8th July 2022 Link