Is the End of SDTM in Sight?

About This Episode: 

Dr Derk Arts, Founder and CEO of Castor, lays out what he views as the next phase of data presentation to regulatory agencies, moving away from the standard SDTM (study data tabulation model) into something that more accurately represents the diverse streams of data that are being generated. Potential impacts include: drug approvals based on quality of life, a step forward into precision medicine, and overall increase in patient centricity.

Key Takeaways:

• How companies can prepare for a more data-friendly future
• Working groups at the FDA and their involvement in data submission 
• What this direction means for precision medicine, remote monitoring and other innovations in clinical research 

About the Speaker: 

Derk Arts, MD, PhD, has over fifteen years of experience in medicine, research and technology. He founded Castor to solve the biggest issues in clinical research: a lack of inclusivity, patient focus and impact of data. Castor enables sponsors worldwide to run patient-centric trials on a unified platform that helps them maximize the impact of research data on patient lives.

Dr Derk Arts believes the key to achieving lasting change in the industry is through scalability and standardization. Technology to run better trials and maximize the impact of data should be available to all researchers. 

Over the past 12 months, Castor provided pro-bono support to over 300 COVID-19 trials, and provided the entire infrastructure for the World Health Organizations’ Solidarity Trials.

For more information about innovation in clinical research, click here.