Newsletter for Statistical Programmers and Biostatisticians #59

Programming

Jagadish K. writes about SDTM IM guide - How many times I've gone through the SDTM IM guide, I've come across some new concepts. One particular point I'd like to discuss is whether we truly adhere to the guidelines when working with SUPP-- domains. Although many of you are experts and may already be familiar with this, it's crucial to consider our practices in real-time scenarios. Join the conversation here - Link

Robert Rachford - Being recognized at work is important not only for your career growth but also for building trust with your colleagues, managers and other stakeholders. Check this interesting post about work recognition and why it is important for programmers Link

Mazi ?? Ntintelo - A table reporting descriptive statistics for AVAL and CHG variables. Look at the final post from Mazi on table programming and his typical aproach to them. Link

David Bosak - Search for files for R programmers. Sometimes you need a file and don't know the exact location. Here are some functions to help you find files programmatically. Link

Joachim Schork - How to create your own package in the R programming language. The tutorial was created in collaboration with Wolf Riepl. Link

Ross Farrugia has announced two Pharmaverse blogs:

- Tips for First Time Contributors (Link): I get asked a lot how best to get started in contributing to open source so thought I'd share some thoughts with all via a blog, and thanks to Céline Piraux for providing her personal story which we included.

- Rhino: A Step Forward in Validating Shiny Apps (Link): Kamil ?y?a & Ege Can Ta?l??ukur from Appsilon share how the Rhino framework aids in ensuring reliability and accuracy of Shiny applications.

Trinath Panda - Explains Date and Time imputation variable, a crucial process in data analysis. Date imputation converts partial dates in datasets like ADCM, ADAE, and ADMH to complete dates, addressing data collection issues. Link

Biostatistics

Imanol Zubizarreta - Introducing multiple imputation and the associated between-sample variance. New post where I will be emphasizing the benefits multiple imputation brings over single imputation methods (pretty obvious for many, not for all!) and will try demystifying the “between-sample variance” and its importance when it comes to accounting for the uncertainty due to missing data with some visualizations. Link

Justin Bélair has recommended two interesting books about statistics:

Computer Age Statistical Inference Algorithms, Evidence, and Data Science Bradley Efron Trevor Hastie - Link

ANOVA and ANCOVA: A GLM Approach - Link

Andrea Vele shared a paper by Shuai Wang, Robert Frederich and James P. Mancuso.?Imputation of Missing Data for Time-to-Event Endpoints Using Retrieved Dropouts. We have explored several statistical approaches to impute missing time-to-event data that arise from outcome trials with relatively long follow-up periods. Aligning with the primary estimand, such analyses evaluate the robustness of results by imposing an assumption different from censoring at random (CAR). Although there have been debates over which assumption and which method is more appropriate to be applied to the imputation, we propose to use the collection of retrieved dropouts as the basis of missing data imputation. Link

Tim Morris - Categorisation of continuous covariates for stratified randomisation: How should we adjust? Led by Tom Sullivan, ft. Brennan Kahan, Alana Cuthbert and Lisa Yelland. To obtain valid inference following stratified randomisation, treatment effects should be estimated with adjustment for stratification variables. Stratification sometimes requires categorisation of a continuous prognostic variable (eg, age), which raises the question: should adjustment be based on randomisation categories or underlying continuous values? Check this post by Tim - Link

A paper from Brad Carlin and Fabrice Nollevaux Bayesian Complex Innovative Trial Designs (CIDs) and Their Use in Drug Development for Rare Diseas has been awarded a prize as one of the top downloaded paper in Journal of Clinical Pharmacology. In this article, authors review a broad collection of Bayesian techniques useful in rare disease research, indicating the benefits and risks associated with each. Link

Darko Medin - Network Meta-analysis. Orientation. I strongly recommend this article for all those interested in my upcoming series on Network Meta-analysis using R programming language and RStudio (Posit). This is the orientation and some foundational perspectives on Network-meta analysis and its differences relevant to pairwise Meta-analysis. Link

Real World Evidence

Paul Arora - writes about a BMJ study written by Haiqiang Yao et al,"Comparative effectiveness of GLP-1 receptor agonists on glycaemic control, body weight, and lipid profile for type 2 diabetes: systematic review and network meta-analysis". Read more how authors leverage #RWE to understand efficacy and safety, guiding more informed clinical decisions and potentially revealing nuances in treatment response across diverse patient populations. Link

Paul Arora - comments on article Harnessing the Potential of Real-World Evidence Master Protocols from Adam Aten, Matthew D'Ambrosio and Dr. Rachele Hendricks-Sturrup. This paper provides insightful recommendations on the use of master protocols for real-world evidence (RWE) and non-randomized studies, addressing these critical questions. Link

Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products. FDA is issuing this draft guidance as part of a series of guidance documents under its Real-World Evidence (RWE) Program and to satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision-making.? The draft guidance provides recommendations to sponsors who are considering submitting a non-interventional study, also referred to as an observational study, to FDA to contribute to a demonstration of substantial evidence of effectiveness and/or evidence of safety of a drug.?Link

Webinars, Events and Courses

Sunil Gupta - Open enrollment for my next Practical R for the Pharmaceutical Industry UCSD on-line class! The R class is from 3/26/24 to 5/4/24. Learn to Create Regulatory Compliance Deliverables for Pharmaceutical Industry: SDTMs, ADaMs, Tables, Lists and Graphs. Link

Transformation in Trials - How can you ?? radically shorten drug development timelines? By running trial simulations with existing trial data. This week Ivanna Rosendal speaks to Pierre COLIN of Bristol Myers Squibb and Boaz Adler of Cytel about ?? innovative trial design - and how trial simulations can help us select the right path. Not only can trial simulations help us shave ?? months off the drug development timelines - they can also reduce the need for giving the standard of care to patients in your trial. Link

Joachim Schork has announced that registration for the Statistics Globe online course on Principal Component Analysis (PCA): From Theory to Application in R has just opened! Click here for more info: Link

Participants get access to:

- 16 video lectures.

- A group chat for questions and exchange.

- Exercises and example projects.

- R scripts and a large collection of resources.

IBIG - Italian Biostatistics Group organize webinar series for 2024 within the initiative "Biostatistics Journal Club 2024".

First webinar starts March 22! Modern approaches for evaluating treatment effect heterogeneity from clinical trials and observational data. Ilya Lipkovich, Link

The ASA SSGG Member Engagement Committee presents a webinar on The importance of genetic evidence to improve productivity in drug discovery and development. Distinguished speaker for this event is Dr. Matthew Nelson. Kui Shen will co-host this event with Dr. Judong Shen from Merck. 3/25/2024 | 1:00 - 2:00 PM (Eastern) / 10:00 - 11:00 AM (Pacific)Registration (free but required): Link

In one week, Boston Area SAS Users Group (BASUG) is hosting a free live webinar with Jane Eslinger. If you can, pop in early for casual 'pre-game' chat with Jane starting around 11:45am ET and/or stay late to participate in the 'hallway chat' session. See you next week!??? Mar 27th ??12 PM ET ??www.basug.org/events

Join the PSI: Statisticians in the Pharmaceutical Industry Webinar: Open Source Software - is it really a free-for-all? ?? on April 17th and explore the dynamic world of open-source solutions in the pharmaceutical industry!Dive deep into the power of R in the programming community, and learn from the experiences of teams working with R and software beyond SAS in the pharma industry. Link

Free Webinar April 25th 2024! Joint PSI: Statisticians in the Pharmaceutical Industry / EFSPI (European Federation of Statisticians in the Pharmaceutical Industry) SIG Webinar: "Statistical and Mechanistic Models for Correlates of Protection"

In this webinar, we will hear about two complementary approaches:

- Statistical Models: Providing a quantitative framework for identifying and validating potential CoPs.

- Mechanistic Models: Aiming to understand the biological mechanisms driving immune responses and protection. Link

Call for Papers for the EU Connect 2024 is now open! Explore the diverse selection of Streams for you to base your abstract around here: Link. We have even introduced the Open Source Technologies Stream for the first time at an EU Connect! Submit your 150-word abstract by 26 April. Link

Essentials of Clinical Trials (London) This course gives attendees a clear understanding of the fundamental principles of Randomised Clinical Trials (RCTs). Live lectures and practical sessions will cover the key issues in design, conduct, analysis and reporting, with a focus on major clinical trials that directly influence clinical practice. Topics are addressed with perspectives from both public sector research and the pharmaceutical industry. Link

Take advantage of the #PharmaSUG2024 early registration rates before they end on March 31st. Link