Pragmatic Clinical Trial Resources-Streamlining and incorporating pragmatic elements into oncology trials

Streamlining and incorporating pragmatic elements into oncology trials

Video Transcription

Video Summary

Grace Mishkin from NCI described efforts to make cancer clinical trials more pragmatic by streamlining data collection and related trial processes. She explained that not all trials should be fully pragmatic, but most can adopt elements that improve feasibility, lower burden, and broaden participation. NCI initiatives include broadening eligibility, allowing qualified advanced practice providers to write study orders, supporting shipment of oral investigational drugs, expanding community site participation, and using decentralized trial tools.  <br /><br />Her main focus was NCTN Streamlined Data Standard Practices for certain phase II/III trials, which limit submitted data to what is needed for prespecified analyses, eligibility, treatment assignment, and reporting. For adverse events, only grade 3 or higher are generally reported unless lower grades are essential. Similar limits apply to medical history, labs, and patient-reported outcomes. She emphasized that strong central review and the willingness to reject unnecessary exceptions are essential for success.

Asset Subtitle

Streamlining and incorporating pragmatic elements into oncology trials by Grace Mishkin

Keywords

cancer clinical trials

pragmatic trials

streamlined data collection

NCTN data standards

decentralized trial tools