New Policy Will More Fully Incorporate APPs in Cancer Clinical Trials

By Leah Lawrence - Last Updated: September 6, 2022

In recent years, there has been increasing integration of advanced practice providers (APPs) into the oncology workforce; however, there is a missed opportunity to incorporate these practitioners more fully into the clinical research arena, according to an editorial published in JCO Oncology Practice.

Christa Braun-Inglis, MS, APRN, FNP-BC, AOCN, and colleagues discussed the underuse of APPs, which include nurse practitioners, physician assistants, advanced-degree nurses and others. A research survey found that although more than 70% of APPs reported their practice participating in National Cancer Institute (NCI) clinical trials, only 35% were registered with the NCI as investigators.

Better integrating these professionals could benefit cancer care on multiple levels, they wrote.

“Their involvement in trials could span the four major steps in trial accrual: (1) promote awareness of available trials; (2) identify eligible patients; (3) explain standard treatment and trial options to patients; and (4) complete enrollment,” Braun-Inglis and colleagues wrote. “Indeed, we believe that—acknowledging heterogeneity in communication and relationship skills among individual practitioners—APPs may tend to have interests and qualities highly relevant to clinical trial access, participation, conduct, and monitoring.”

Once patients are enrolled, APPs may be able to provide more informative and complete medical records as compared with physicians. They may also enhance team communication with clinical research coordinators and personnel.

Many patients who enroll in clinical trials have multiple comorbidities and require management of multiple side effects. Oncology APPs are a key player in symptom management and coordination of care.

Unfortunately, among the factors limiting APP involvement in research is the NCI Cancer Therapy Evaluation Program (CTEP) policy that requires qualified physician investigators to co-sign APP orders for study agents on NCI-sponsored trials.

“In response to concerns that not permitting APPs to sign treatment orders independently (1) presented a barrier to trial conduct, (2) differed from approaches of other study sponsors, and (3) restricted APP practice beyond state regulations and some institutional policies, CTEP revised its policy,” Braun-Inglis and colleagues wrote. “Effective September 7, 2021, CTEP released new guidance allowing qualified (ie, appropriately privileged and credentialed) APPs to sign treatment orders, including investigational new drug agents and standard-of-care agents, without physician cosignature.”

Important next steps will include figuring out how to optimize APP inclusion in clinical trial operations.

“Adding APPs to the clinical research team is a welcome, logical, and overdue step to enhance the reach, diversity, equity, and quality of care in cancer clinical trials,” they concluded.



Better late than never: fully incorporating oncology advanced practice providers into cancer clinical trials.