Streamlining clinical reporting in pharma: highlights from the CDISC COSA hackathon

How can we make clinical reporting more efficient and transparent? 

A group of software developers gathered virtually to tackle this long-standing issue in the pharmaceutical industry. In February, participants of the CDISC Open-Source Alliance (COSA) Hackathon were introduced to the first generation of open-source tools for clinical reporting, including {admiral} which is an R package for the Analysis Data Model (ADaM) dataset creation. Among these passionate innovators were Avenga’s employees, who were eager to gain expertise and skills in this critical area.

The hackathon was designed to provide the pharmaceutical programming community with a set of open-source modularized toolboxes that allow the development of ADaM datasets in R. This approach invests in and validates specialists in order to help them revamp the accuracy of clinical reporting. Here are several other challenges that were in the spotlight during the event:

• How can we provide every company or organization with free software to alleviate the process of clinical submission?
• What are the opportunities to build consistent packages with reliable and trustworthy code across the industry?
• How can we empower individual researchers in their quest for simplified clinical reporting procedures?
• How do we craft and support interactive tools that reflect the need for paperless submissions?

These are fundamental questions that must be addressed if we want to improve the efficiency of clinical reporting. Open-source standardized methods lend a helping hand in this case. With them, the data can be easily analyzed and compared across trials. They lead to a better understanding of treatment efficacy and potential side effects in patients, and help save time and resources, which is critical given the ever-increasing data generated by clinical trials.

The CDISC COSA Hackathon created space for non-competitive collaboration that focused on better patient outcomes and greater open source opportunities. Reaching beyond the usual stiff competition that characterizes the industry, the participants engaged in dynamic discussions and synergetic problem-solving. They brought together shared values and diverse perspectives on the challenges and opportunities facing the field.

As a result, not only was this hackathon an excellent opportunity for tech professionals to upskill in R, but it also united mutual efforts to drive further progress in clinical reporting for organizations of any scale or individual researchers. It also proved to be a great source of knowledge regarding any questions about R or {admiral} in particular.

The hackathon relies strongly upon the contributions of the pharmaverse. This project brings together organizations and specialists that cooperate in the development of open-source R packages. It is spearheaded by a large variety of specialists from leading companies, including GSK, Roche, Johnson & Johnson, and Atorus. Their extensive resources and expertise have played a pivotal role in establishing and growing this platform. The initiative’s collaborative nature ensures that the industry’s best minds work together toward the common goal of advancing clinical research.

The initiative’s joint structure also makes sure that the brightest minds brainstorm together toward the prevailing  objective of advancing clinical research at various stages, from the Case Report Form (CRF) to the clinical trial analysis reporting. In addition, pharmaverse supports an inclusive think-tank model that allows organizations from the clinical trial analysis pipeline to test and contribute their vision of current projects within the pharmaverse.

Our company’s participation in this event was instrumental in keeping us ahead of the curve in clinical reporting technology. Our employees gained hands-on experience in working with SDTM datasets and transforming them into analysis datasets using {admiral} and other R packages. This experience has strengthened us as we  continue to deliver cutting-edge solutions to our clients, ensuring that we remain in touch with the latest industry developments.