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Impact of an Oncology Clinical Pharmacist Intervention on Clinical Trial Enrollment in The US Oncology Network's
Elizabeth Koselke1, Lisa C Kaspin-Powell2, Shannon Hough1
1From US Oncology Network, McKesson Specialty Health, The Woodlands, Texas.
Introduction:
The Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium™ (MYLUNG) clinical trial platform aims to advance the use of precision medicine in patients with non-small cell lung cancer through a series of prospective and iterative clinical trials. Timely patient accrual onto oncology clinical trials is a known practice challenge and impaired accrual rates can lead to premature trial closure or properly powered trial outcomes. The US Oncology Network recently implemented a clinical pharmacist (ClinReview) initiative to provide remote clinical services to screen patients for enrollment onto MYLUNG Protocol 2. This study aims to evaluate the effect of the remote clinical pharmacist intervention on study enrollment rates.
Methods:
An oncology-trained clinical pharmacist remotely reviewed systemic chemotherapy treatment orders during normal workflow and, in addition, a weekly custom recruitment report within six community Network practices (149 physicians). The pharmacist identified, screened, and assisted with the communication regarding eligible patients for enrollment. The onsite research team received timely and relevant patient data to facilitate expedited enrollment. Enrollment and intervention data were tracked to monitor the impact of the pharmacist intervention. Monthly enrollment was evaluated using a paired t-test.
Results:
Over 8 months, the pharmacist screened 506 potentially eligible patients; 34% were enrolled. Average monthly enrollment was significantly greater following the ClinReview intervention (3.4 vs. 6.6 patients/month; p = .02). Among the 289 patients not enrolled, 73% exceeded their eligibility window, 9% died or enrolled into hospice, 4% declined participation, and 13% transferred care or were treated at outside facilities.
Conclusions:
Incorporating an oncology clinical pharmacist into the clinical research team was associated with improved clinical trial enrollment. Validation of the effect of multidisciplinary interventions across a broader spectrum of differentially resourced oncology practices will be conducted within future MYLUNG iterations.
Insights
A clinical pharmacist intervention significantly increased patient enrollment in lung cancer clinical trials. This initiative improved monthly enrollment rates, aiding precision medicine advancements in non-small cell lung cancer research.
Area of Science:
- Oncology
- Clinical Trials
- Precision Medicine
Background:
- Advancing precision medicine in non-small cell lung cancer (NSCLC) requires effective patient accrual to clinical trials.
- Challenges in timely patient enrollment can jeopardize trial outcomes and lead to premature closure.
- The MYLUNG clinical trial platform aims to enhance NSCLC treatment through iterative studies.
Purpose of the Study:
- To evaluate the impact of a remote clinical pharmacist intervention on patient enrollment rates in the MYLUNG clinical trial platform.
- To assess the effectiveness of a novel remote clinical service in overcoming patient accrual barriers.
Main Methods:
- An oncology-trained clinical pharmacist remotely screened patients for MYLUNG Protocol 2 across six community practices.
- The pharmacist reviewed chemotherapy orders and recruitment reports, identifying and facilitating communication for eligible patients.
- Monthly enrollment data were collected and analyzed using a paired t-test to compare pre- and post-intervention rates.
Main Results:
- The intervention screened 506 potentially eligible patients over 8 months, with a 34% enrollment rate.
- Average monthly enrollment significantly increased from 3.4 to 6.6 patients post-intervention (p = .02).
- Key reasons for non-enrollment included exceeding eligibility windows (73%) and patient decline (4%).
Conclusions:
- Integrating an oncology clinical pharmacist into research teams improves clinical trial enrollment rates.
- This multidisciplinary approach supports the advancement of precision medicine in community cancer networks.
- Future MYLUNG iterations will validate these findings across diverse oncology practices.
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