Abstract
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.
References
Abdel Shaheed, C., Maher, C. G., Williams, K. A., & McLachlan, A. J. (2014). Participation of pharmacists in clinical trial recruitment for low back pain. International Journal of Clinical Pharmacy, 36(5), 986–994. https://doi.org/10.1007/s11096-014-9985-y
American Cancer Society Cancer Action Network. (2019). Barriers to patient enrollment in therapeutic clinical trials for cancer. https://www.fightcancer.org/policy-resources/barriers-patient-enrollment-therapeutic-clinical-trials-cancer#collapse1
Bakouny, Z., Labaki, C., Bhalla, S., Schmidt, A. L., Steinharter, J. A., Cocco, J.,...Doroshow, D. B. (2022). Oncology clinical trial disruption during the COVID-19 pandemic: A COVID-19 and cancer outcomes study. Annals of Oncology, 33(8), 836–844. https://doi.org/10.1016/j.annonc.2022.04.071
Baquet, C. R., Henderson, K., Commiskey, P., & Morrow, J. N. (2008). Clinical trials: The art of enrollment. Seminars in Oncology Nursing, 24(4), 262–269. https://doi.org/10.1016/j.soncn.2008.08.006
Bennette, C. S., Ramsey, S. D., McDermott, C. L., Carlson, J. J., Basu, A., & Veenstra, D. L. (2016). Predicting low accrual in the National Cancer Institute’s cooperative group clinical trials. Journal of the National Cancer Institute, 108(2), djv324. https://doi.org/10.1093/jnci/djv324
Borno, H. T., Lin, T. K., Zhang, S., Skafel, A., Lalanne, A., Dornsife, D.,...Rhoads, K. F. (2021). Accelerating cancer clinical trial recruitment through a financial reimbursement program integrated with patient navigation: an interrupted time series analysis. Journal of Cancer Policy, 30, 100305. https://doi.org/10.1016/j.jcpo.2021.100305
Braun-Inglis, C., Boehmer, L. M., Zitella, L. J., Hoffner, B., Shvetsov, Y. B., Berenberg, J. L.,...Benson, A. B., 3rd. (2022). Role of oncology advanced practitioners to enhance clinical research. Journal of the Advanced Practitioner in Oncology, 13(2), 107–119. https://doi.org/10.6004/jadpro.2022.13.2.2
Brooks, S. E., Muller, C. Y., Robinson, W., Walker, E. M., Yeager, K., Cook, E. D.,...McCaskill-Stevens, W. (2015). Increasing minority enrollment onto clinical trials: practical strategies and challenges emerge from the NRG Oncology Accrual Workshop. Journal of Oncology Practice, 11(6), 486–490. https://doi.org/10.1200/jop.2015.005934
Chen, L., Grant, J., Cheung, W. Y., & Kennecke, H. F. (2013). Screening intervention to identify eligible patients and improve accrual to phase II-IV oncology clinical trials. Journal of Oncology Practice, 9(4), e174–e181. https://doi.org/10.1200/JOP.2012.000763
Cunanan, K. M., Gonen, M., Shen, R., Hyman, D. M., Riely, G. J., Begg, C. B., & Iasonos, A. (2017). Basket trials in oncology: A trade-off between complexity and efficiency. Journal of Clinical Oncology, 35(3), 271–273. https://doi.org/10.1200/jco.2016.69.9751
Denicoff, A. M., McCaskill-Stevens, W., Grubbs, S. S., Bruinooge, S. S., Comis, R. L., Devine, P.,...Meropol, N. J. (2013). The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: Summary and recommendations. Journal of Oncology Practice, 9(6), 267–276. https://doi.org/10.1200/jop.2013.001119
Embi, P. J., Jain, A., Clark, J., Bizjack, S., Hornung, R., & Harris, C. M. (2005). Effect of a clinical trial alert system on physician participation in trial recruitment. Archives of Internal Medicine, 165(19), 2272–2277. https://doi.org/10.1001/archinte.165.19.2272
Embi, P. J., & Leonard, A. C. (2012). Evaluating alert fatigue over time to EHR-based clinical trial alerts: Findings from a randomized controlled study. Journal of the American Medical Informatics Association, 19(e1), e145–148. https://doi.org/10.1136/amiajnl-2011-000743
Evangelist, M. C., Jotte, R. M., Spira, A. I., Waterhouse, D. M., Ali, K., Alwardt, S.,...Coleman, R. L. (2021). Clinical trials in progress: MYLUNG: Molecularly informed lung cancer treatment in a community cancer network: A pragmatic prospective real world evidence (RWE) program. World Conference on Lung Cancer, September 8–14, Virtual.
Fletcher, J. M., Saunders-Smith, T., Manns, B. J., Tsuyuki, R., Hemmelgarn, B. R., Tonelli, M., & Campbell, D. J. T. (2020). Pharmacist and patient perspectives on recruitment strategies for randomized controlled trials: a qualitative analysis. BMC Medical Research Methodology, 20(1), 270. https://doi.org/10.1186/s12874-020-01140-6
Getz, K. A. (2013). Impact of in-pharmacy education on patients’ knowledge and attitudes about clinical trials. Therapeutic Innovation & Regulatory Science, 47(3), 336–340. https://doi.org/10.1177/2168479013478953
Haddad, T. C., Helgeson, J., Pomerleau, K., Makey, M., Lombardo, P., Coverdill, S.,...LaRusso, N. (2018). Impact of a cognitive computing clinical trial matching system in an ambulatory oncology practice. Journal of Clinical Oncology, 36(15_suppl), 6550. https://doi.org/10.1200/JCO.2018.36.15_suppl.6550
Hallquist Viale, P. (2016). Participation in cancer clinical trials: Researching the causes of low accrual. Journal of the Advanced Practitioner in Oncology, 7, 143–144. https://doi.org/10.6004/jadpro.2016.7.2.1
Hauck, C. L., Kelechi, T. J., Cartmell, K. B., & Mueller, M. (2021). Trial-level factors affecting accrual and completion of oncology clinical trials: a systematic review. Contemporary Clinical Trials Communications, 24, 100843. https://doi.org/10.1016/j.conctc.2021.100843
Hematology/Oncology Pharmacy Association. (2019). Further defining the scope of hematology/oncology pharmacy practice. https://www.hoparx.org/documents/94/HOPA18_Scope-2_Web2.pdf
Hillyer, G. C., Beauchemin, M., Hershman, D. L., Kelsen, M., Brogan, F. L., Sandoval, R.,...Schwartz, G. K. (2020). Discordant attitudes and beliefs about cancer clinical trial participation between physicians, research staff, and cancer patients. Clinical Trials, 17(2), 184–194. https://doi.org/10.1177/1740774520901514
Jacobs, S. R., Weiner, B. J., Reeve, B. B., Weinberger, M., Minasian, L. M., & Good, M. J. (2014). Organizational and physician factors associated with patient enrollment in cancer clinical trials. Clinical Trials, 11(5), 565–575. https://doi.org/10.1177/1740774514536000
Robert, N. J., Espirito, J. L., Chen, L., Nwokeji, E., Karhade, M., Evangelist, M.,...Coleman, R. L. (2022). Biomarker testing and tissue journey among patients with metastatic non-small cell lung cancer receiving first-line therapy in The US Oncology Network. Lung Cancer, 166, 197–204. https://doi.org/10.1016/j.lungcan.2022.03.004
Robert, N. J., Nwokeji, E. D., Espirito, J. L., Chen, L., Karhade, M., Evangelist, M. C.,...Coleman, R. L. (2021). Biomarker tissue journey among patients (pts) with untreated metastatic non-small cell lung cancer (mNSCLC) in The US Oncology Network community practices. Journal of Clinical Oncology, 39(15_suppl). https://doi.org/10.1200/JCO.2021.39.15_suppl.9004
The US Oncology Network. (2022). Empowering local cancer care. https://www.usoncology.com/our-company