Head of Therapeutic Area Strategy, Head of Specialized Support Services, PSI
Sasha Moskalenko
Senior Director Project Management, PSI
Yuri Titov
Senior Director Clinical Operations, PSI
The US FDA’s Real-Time Oncology Review (RTOR) program is changing the pace of oncology regulatory review, with approximately one in five oncology approvals now coming through this pathway. By giving the FDA access to key clinical data before the complete application is submitted, RTOR can shorten the time between pivotal trial results and regulatory review, but it also places greater demands on how quickly sponsors and CROs can prepare data and documentation for review.
From an operational perspective, RTOR does not fundamentally change how a clinical trial is run. Rather, it changes the pace at which it needs to be run.
Read our commentary on what RTOR means in practice, and how sponsors and CROs can prepare for the faster pace of execution it demands.
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RTOR in practice: Same trial, faster pace
Rhonda Critchlow
Head of Therapeutic Area Strategy, Head of Specialized Support Services, PSI
Sasha Moskalenko
Senior Director Project Management, PSI
Yuri Titov
Senior Director Clinical Operations, PSI
The US FDA’s Real-Time Oncology Review (RTOR) program is changing the pace of oncology regulatory review, with approximately one in five oncology approvals now coming through this pathway. By giving the FDA access to key clinical data before the complete application is submitted, RTOR can shorten the time between pivotal trial results and regulatory review, but it also places greater demands on how quickly sponsors and CROs can prepare data and documentation for review.
From an operational perspective, RTOR does not fundamentally change how a clinical trial is run. Rather, it changes the pace at which it needs to be run.
Read our commentary on what RTOR means in practice, and how sponsors and CROs can prepare for the faster pace of execution it demands.
Unlock the PDF
Enter your details below to read the full article or download a PDF version.
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