Statistics & Data Science Community

Hi Everyone,

The DIA Statistics and Data Science Community is pleased to announce a new webinar which will be held on Thursday 9th May, 2024. The "Open Source Software for Clinical Trial Reporting and Regulatory Submissions" webinar will feature presentations from industry and regulatory experts. Further details are given below. Registration for this free webinar is now open and is accessible via this web address: https://diaglobal.zoom.us/meeting/register/tJcqd-GurjkrGtwVlzPSc67AfVe58a9domMW

Webinar Abstract: Validated proprietary software systems and packages have traditionally been the norm for statistical analyses underlying regulatory submissions for approval of new therapeutic products. While academic institutions and other industries have embraced open-source software, the pharmaceutical industry has been slower to adopt the open-source counterpart. This webinar brings in several industry and regulatory experts to share their experiences and perspectives on using open source software for clinical trial reporting and regulatory submissions.

Webinar presentations and abstracts:

1. Eric Nantz (Director, Eli Lilly and Company): Highlights of the Successful R-Consortium Pilot Submissions

Abstract: Within the life sciences industry, the usage of open-source statistical software has made tremendous gains across the lifecycle of clinical studies in many organizations. One particular area that open source has encountered challenges historically is the clinical submission process. The R Consortium R Submissions working group, with representatives from industry sponsors and regulatory agencies, was created to assess the feasibility of using the R statistical programming language to create clinical submission deliverables while adhering to current guidelines used in submissions. This presentation will highlight the successful pilot submissions that cover a wide spectrum of using R to produce traditional clinical outputs, sophisticated Shiny applications, and analytical data sets. Additionally, we will highlight the ongoing efforts that aim to push the envelope even further with the use of web-assembly and container technology to distribute a Shiny application in a future pilot.

2. Ning Leng (People and Product Leader (Director), Genentech): Embracing open source language and modernized technologies - Roche's journey in clinical trial reporting

Abstract: In 2024, Roche embarks on a transformative journey aimed at modernizing our clinical studies by embracing cloud-based system, container and modernized version control solutions. This transition also empowers individuals to utilize the R language for generating SDTM, ADaM, and TLG outputs. This presentation will delve into Roche's transformational path, highlighting our inaugural milestone of leveraging end-to-end R solutions for pivotal readouts and filings. Additionally, we will discuss our dedication to the open-source community and our endeavors to enhance data science efficiency through the adoption of LLM.

3. Regulatory Expert: Open-Source Software for Regulatory Submissions and Regulatory Environments

Abstract: Regulatory submissions and regulatory computing environments have traditionally been associated with the use of proprietary software packages. While academic institutions have embraced open-source software, both industry and government have been slower to adopt open-source alternatives. I will discuss some of the challenges and issues with using open-source software in a regulatory environment, followed by some of the lessons learned in the ongoing R Consortium R Submission Pilot, as well as emerging issues

Hi Everyone,

The final webinar of the Interdisciplinary Safety Evaluation for Learning and Decision-Making series will be taking place on 16 November at 10:00 (ET), titled ‘Interdisciplinary Safety Evaluation for Learning and Decision-Making: Education for Executives’.

This webinar will highlight how the IND Safety Reporting Final Rule and new FDA guidelines can drive profitability, PR risk management, and culture change in clinical safety evaluations.

It will also address the shift to innovative, interdisciplinary approaches, covering aggregate safety assessment planning, scientific techniques, FDA guideline implementation, and better collaboration with the FDA for more effective safety assessments.

Registration and further information: https://advance.phuse.global/display/WEL/Interdisciplinary+Safety+Evaluation+for+Learning+and+Decision-Making:+Education+for+Executives?utm_source=newsletter&utm_medium=email&utm_campaign=november_news_updates&utm_term=2023-11-13

The DIA Statistics and Data Science Community are pleased to announce that registrations are now being accepted for our next webinar. The Utilization of Historical Trial/Registry Data in Drug Development will be held on17 Nov 2023, 11am - 12:30pm EST and will feature presentations from Dr Melanie Quintana, Direction and Senior Statistical Scientist at Berry Consultants and Dr Tao Lui, Associate Professor at Brown University.

The webinar is free to attend and registration can be completed using this web address:

https://diaglobal.zoom.us/meeting/register/tJUkf--prjkoGNWkAFnDeCODPdctL_5Bg7Vs

We hope to see you there!

Further details on the abstracts can be found below:

Title: Use of PRO-ACT Database in designing and analyzing clinical trials for amyotrophic lateral sclerosis (ALS)

Speaker: Melanie Quintana, PhD; Director and Senior Statistical Scientist at Berry Consultants

There is a growing need to learn from our past in clinical trial design and analysis.  In light of this, numerous efforts are being made to promote the creation of shared disease-specific databases with patient-level historical control and observational data.  With these efforts in mind, we discuss how we can synthesize and make better use of this historical information to design more informed and powerful clinical trials.  Throughout this presentation, we highlight the use of the shared Pooled Resource Open-Access ALS Clinical Trials Database (PRO-ACT) in designing and analyzing clinical trials for amyotrophic lateral sclerosis (ALS).  The PRO-ACT database provides patient-level longitudinal data from placebo and treatment arms from over 29 Phase II/III clinical trials and is an exemplary effort to share data and learn from past studies.  Access to rich clinical trial patient-level data within the PRO-ACT database provides many advantages in designing and analyzing trials in ALS, including informing the creation of realistic clinical trial simulations to optimize key design elements and supplementing data from randomized trials with external information.  

Title: Emulating target clinical trials using real-world databases for treating renal cell carcinoma

Speaker: Tao Liu, PhD; Associate Professor, Brown University 
 
Abstract: 
Emulating clinical trials provides an alternative approach to evaluating therapeutic values of a clinical treatment when it is practically difficult or costly to evaluate the treatment effectiveness using standard RCT.  Using the National Cancer Database, we emulated separately an index trial of patients with cT1-3cN0cM0 renal cell carcinoma (RCC), designed to resemble EORTC 30881 (“index trial emulation”), and a hypothetical trial of patients at increased risk for lymph node metastases with cT1-4cN0-1cM0 RCC (“high-risk trial emulation”). A propensity score for lymph node dissection (LND) was estimated using preoperative features (Model 1) or preoperative and pathologic features (Model 2). The impacts of LND on overall survival (OS) were estimated using Cox regression on the two emulated trials. In this presentation, I will present an overview of the study design and analyses.  The benefits and risks of emulating trials also will be discussed.