Table 2.
Pharmacy Services Conducted ≥50% of the Time
Pharmacy service | Phase 1 cancer trial services performed by pharmacists | ≤40 Phase 1 cancer clinical trials, % (N = 16) | >40 Phase 1 cancer clinical trials, % (N = 17) |
---|---|---|---|
Pretrial implementation support | Serve as a principal investigator | 0 | 0 |
Serve as a coinvestigator | 6.2 | 5.9 | |
Participate in development of investigator-initiated trials | 12.5 | 17.6 | |
Serve as a member of Institutional Review Board | 87.5 | 82.4 | |
Phase 1 clinical trial implementation support | Dedicate a pharmacist to work with phase 1 cancer trials | 50 | 58.9 |
Educate research staff on investigational drugs | 62.5 | 70.6 | |
Prepare patient counseling material | 31.2 | 29.4 | |
Serve as key personnel in the consenting process | 6.2 | 5.9 | |
Individuals are an Investigational Drug Service pharmacist | 81.2 | 70.6 | |
Individuals are an oncology clinical specialist | 56.2 | 64.7 | |
Pharmacists are involved with direct subject care | 18.8 | 47 | |
Pharmacists have an academic role with a pharmacy/medicine school | 31.2 | 47 | |
Medication profile review | Document medication list for phase 1 trial subjects before trial initiation | 18.8 | 41.1 |
Perform medication reconciliation | 37.5 | 41.1 | |
Screen subject profile for potential drug–drug interactions | 62.5 | 76.4 | |
Clinically review prescribed investigational drug orders before dispensing | 87.5 | 82.4 | |
Medication therapy management | Counsel trial subjects | 50 | 47 |
Recommend dose adjustments per protocol | 62.5 | 64.7 | |
Perform therapeutic drug monitoring | 25 | 35.3 | |
Determine protocol compliance with prohibitive medications | 56.2 | 64.7 | |
Miscellaneous support | Serve on the data safety monitoring committee | 31.2 | 47 |
Complete safety adverse event reports | 6.2 | 5.9 | |
Contribute to presentation or publication of phase 1 trial findings | 0 | 11.8 |