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The Open Source Technology in Clinical Data Analysis (OSTCDA) project was set up with the aim to create a manuscript on the integration of open-source software solutions for clinical data management, analysis and reporting.

A significant amount of time and energy has been invested in recent years exploring the desirability (do we want it?), feasibility (can we do it?), and viability (is it worth it?) of integrating open source solutions into our clinical data pipelines which transform source data into clinical study reports and submission data packages. In this October edition of the Open Source Open Forums, we will update on the status of this initiative and continue to hear from you on what we’ve missed so far.  

When this manuscript is complete, we hope to put to rest some of the burning questions that we believe we now know the answers to. This will allow industry, and all the passionate people in it, to look ahead and start tackling the next horizon of challenges related to using open source solutions for clinical data pipelines. We hope you will contribute your expertise to this effort.

Questions we will address during this Webinar:

• Which of the previous questions posed has industry answered – and how do we know?
  • What is the true cost of adopting open-source tooling for clinical trial data analysis?
  • Can the industry fund open-source?
  • Will the FDA accept data and analyses generated with solutions developed and available as open source?
  • Will other regulatory agencies accept data and analyses generated with solutions developed and available as open source?
  • How do you establish reproducibility and traceability with open-source solutions, e.g. R package management?
  • How do you document your trust in an open-source solution to satisfy a third-party inquiry?
  • How do we ensure the solutions being developed today, which we build dependencies on, will maintain long-term viability, sustainability and maintainability?
  • For example, what if people retire, move on to other companies, leave the industry – how do we manage the risk?
  • How do we transform the traditional Statistical Analyst in Pharma into the future Data Scientist?
  • How do we support users in managing an ever-evolving environment of open-source packages?
• Which of the remaining questions are of most importance to address next?

In addition to the GitHub Discussion, we are hosting a series of forums throughout the year. See the Working Group Events page for further details.

This Forum will be taking place over Zoom on 11 October at 15:00-16:00 (BST) / 10:00-11:00 (EDT).