Advances in the Use of Open-Source Tools in the Planning, Analysis, and Reporting of Clinical Trials

1607 

Topic-Contributed Paper Session 

Margaret Gamalo (1), Junjing Lin (3), Maria Matilde Kam (4), Maria Kudela (2), Melvin Munsaka (5), Chendi Liao (6), Neetu Sangari (1), Keaven Anderson (7)

(1) Pfizer, N/A, (2) N/A, N/A, (3) Takeda, N/A, (4) OB/OTS/CDER/FDA, N/A, (5) AbbVie, N/A, (6) Roche, N/A, (7) Merck & Co., Inc., N/A

Maria Kudela  
N/A

Junjing Lin  
Takeda

Maria Matilde Kam  
OB/OTS/CDER/FDA

Margaret Gamalo  
Pfizer

Melvin Munsaka  
AbbVie

Chendi Liao  
Roche

Neetu Sangari  
Pfizer

Keaven Anderson  
Merck & Co., Inc.

Open-source tools and platforms with various degrees of complexity and stakeholder base have gained traction in various industries, including the pharmaceutical industry, with some companies transitioning to full use of these tools. These tools offer cost-effective and collaborative solutions for data analysis, visualization, modelling, and other processes relevant to drug development. The elements in creating good open-source software business applications are like those for creating good software applications in general, e.g., well-documented codebase, sustainable/scalable development process, and security. This may involve things like setting up a continuous integration and deployment (CI/CD) pipeline and using issue tracking and project management tools. In addition, containerization platforms enable the creation of reproducible computing environments. These containers can encapsulate software dependencies and code, ensuring that analyses and processes can be replicated consistently, which is crucial for regulatory compliance.

The use of open-source software in submissions in support of NDAs is increasing concurrently, and it is likely to continue to grow in the future. This is because open-source software offers several advantages over proprietary software, such as increased transparency, reduced costs, improved collaboration, and accelerated innovation in addition to their powerful data visualization capabilities that support the presentation of data in regulatory submissions. Moreover, initiatives such as CDISC (Clinical Data Interchange Standards Consortium) provide open-source data standards that promote consistency in data collection, analysis, and submission. Using CDISC standards can facilitate the preparation of regulatory submissions. Open-source software can be used to format and convert data into required regulatory submission formats, such as the electronic Common Technical Document (eCTD) format.

In this session, we showcase examples and good practices of open-source applications development in pharma. It is recognized that while open-source software can offer many advantages, it is important to ensure that the tools and processes used adhere to regulatory requirements and validation standards. Open-source solutions should be validated and documented appropriately to meet regulatory expectations. It is also crucial to consider data privacy and security requirements to protect sensitive patient information and maintain compliance with regulations. When submitting a new drug application (NDA), it is important to ensure that the software and its associated technical specifications meet the regulatory requirements set forth by the relevant health authorities.

Speakers:
1. Melvin Munsaka (Abbvie): Considerations in Leveraging Open-Source Tools in the Analysis and Reporting of Clinical Trials Data – Meta-Analysis Tools
2. Chendi Liao (Roche): Unlocking the Power of Interactive Data Exploration of Clinical Trial Data - the Teal Tool
3. Neetu Sangari (Pfizer): Re-imagining Safety Review and Submissions Using Interactive Versus Static Outputs – the CVARS tool (Neetu to confirm title)
4. Keaven Anderson (Merck): Group Sequential Clinical Trial Designs Using the gsDesign Package
Discussant: FDA: Hye Soo Cho/Matilde Sanchez (FDA)

Biopharmaceutical Section ²

ENAR ³

Section for Statistical Programmers and Analysts ¹