Newsletter for Statistical Programmers and Biostatisticians #43

Statistical Programming

A collaborative approach to software development: The crmPack experience. From Burak Kürsad Günhan. Burak and Oliver Boix (Bayer AG) will be co-presenting the experience regarding the collaborative effort of further developing the crmPack R package in ISCB conference International Society for Clinical Biostatistics:?face-to-face! It is a flexible tool for dose-escalation trials.?Link

If you are looking for an R equivalent of PROC REPORT and ODS, it is the reporter package. This package can output reports in TXT, PDF, RTF, HTML, and DOCX. Supports spanning headers, automatic page breaks, graphics, and lots more! Check it out! From David Bosak Link

State Space Modeling of Time Series and Longitudinal Data by PROC SSM and PROC UCM by Rajesh Selukar. ?This presentation provides an overview of the modeling capabilities of different procedures.?Without assuming familiarity with the SSMs, the modeling techniques are introduced using easy-to-follow, real-life examples and useful references are provided for additional information. Link

A Beginner’s Babblefish: Basic Skills for Translation Between R and SAS? by Sarah Woodruf This paper serves as a basic tutorial on some of the most critical functions in R and shows their parallel in SAS to aid in the translation process between the two software packages. Sarah is a senior systems analyst at Westat and has been programming in SAS professionally for fifteen years.

Biostatistics

From Cytel - Sufficient Information Threshold for Effective Bayesian Applications. Read the paper to learn. How the concept of the Sufficient Information Threshold can aid teams in determining whether their trial has accumulated sufficient data for their goals. How clinical development teams can utilize a simple format to frame complex questions that can arise during the development cycle to ensure trials are efficient, effective, and ethical. How decision-makers can work with statisticians to utilize Bayesian predictive power and also conditional power, to see if clinical trials have achieved the Sufficient Information Threshold. Link

Using Quantitative Bias Analysis in Real World Data Strategy - an article from Cytel's Paul Arora. He writes about role of quantitative bias analysis for decision-makers, how to use QBA to address missing data, how to use QBA to address unmeasured confounding. Link

'Hypothetical estimands in clinical trials: a unification of causal inference and missing data methods' - now open access in Statistics in Biopharmaceutical Research. From Jonathan Bartlett - Link

Master Thesis: "Increasing the power in randomised clinical trials using digital twins" From Emilie H?jbjerre-Frandsen ,? Mathias Lerbech Jeppesen ,? Rasmus Kuhr Jensen - Link

Special theme issue of Contemporary Clinical Trials on Pragmatic and Virtual Trials. Topics include "Digital technologies and the democratization of clinical research: Social media, wearables, and artificial intelligence." "The challenges of data safety monitoring for a pragmatic study: Lessons from the ADAPTABLE study." And many others! Link

A unified framework for weighted parametric group sequential design. Group sequential design (GSD) is widely used in clinical trials in which correlated tests of multiple hypotheses are used. Multiple primary objectives resulting in tests with known correlations include evaluating (1) multiple experimental treatment arms, (2) multiple populations, (3) the combination of multiple arms and multiple populations, or (4) any asymptotically multivariate normal tests. In this paper, we focus on the first three of these. From Keaven Anderson,?Zifang Guo,?Jing Zhao,?Linda Sun - Link

Again, from Cytel - Adaptive Designs Are?(Once Again) Re-Defining Drug Development. Adaptive designs are studies that “include a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study,”1?with the aim to provide opportunity to gather more complete information about the therapeutic intervention from interim analyses. This lessens the unpredictability and reduces the risk of failure of Phase III confirmatory trials due to safety and efficacy concerns. Check more - Link

Events & conferences

Bayes - Bayesian Biostatistics. Short Course on Bayesian CID and Invited Speakers confirmed. Call for abstracts is still open and registrations are open.12-14 October 2022 Bethesda, Maryland - USA - Link

PHUSE?US Connect - Orlando - 2023. Call for Papers opens July 11 The US Connect 2023, 5–8 March, will ensure attendees can stay ahead of the newest trends, whilst picking up valuable tools and tips on how to implement them. Link

European Statistical Forum Statistical Reasoning in Drug Development. 25 October 2022 Barcelona, Spain. The European Statistical Forum (ESForum) shall include presentations focusing on various aspects of statistical reasoning: Reproducibility, Hidden bias, Multiplicity (endpoint selection, subgroups, etc.), Choice of scales and effect measures, Prediction, attribution, estimation, Association vs. causation, Statistical significance vs. clinical relevance, Pattern detection, The interpretation of inferential statistics both in the frequentist as well as in the Bayesian framework. Link

Statistical Meetings (JSM) is knocking on the door! Washington, DC between August 6-11, 2022. The details of these events are in the following link. JSM 2022 Conference Program Link

NON-CLINICAL STATISTICS CONFERENCE NCS 2022. The conference is aimed at statisticians with an interest in the application of statistics to non-clinical areas of the drug development and production process. 19th–21st October 2022 Louvain-la-Neuve, Belgium. Link

EFSPI Regulatory Statistics Workshop 2022 14th-15th September 2022, Basel, Switzerland. Program: 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. Link

On 03-Aug, the Western Users of SAS Software is offering a free webinar on Professional Growth for programmers. In this webinar, we ask four industry leaders to share their thoughts on their own professional growth journey. We will be honored to hear from?Richann Watson,?Joshua Horstman,?Janette Garner, and?Carey Smoak?as they share their experiences with leadership, collaboration, and volunteering in the professional community. We will have a Q&A as well. The event is free, but registration is required. (https://lnkd.in/g67uFsNa)