Publications
2022
| Tafuto B, Vyas R, Pruis T. CTSA Search Solutions: A novel approach to searching CTSA hub website content. J Clin Transl Sci. 2022 Nov 10;6(1):e132. doi: 10.1017/cts.2022.485. PMID: 36756074; PMCID: PMC9879907. |
| Cooper L, Ajaj, M, Kopicko, K. US social media promotion violation trends in a postguidance era. Regulatory Focus. November 2022. |
| Chen J, Cooper L. 374 Therapeutic Class Labeling of EGFR Companion Diagnostics (CDxs). J Clin Transl Sci. 2022 Apr 19;6(s1):70. doi: 10.1017/cts.2022.213. PMCID: PMC9209237. |
| Cooper L, Chen J (2022). Changes in Companion Diagnostic Labelling: Implementation of FDA’s April 2020 Guidance for In Vitro CDx Labeling for Specific Oncology Therapeutic Groups. Ther Innov Regul Sci. 56(5):689-697. Doi:10.1007/s43441-022-00422-z. PMID: 35689144. PMCID: PMC9356945. |
2021
| Thaman P, Tafuto B, Gélinas C, Gaur S, Neubauer JA. Thaman P, Tafuto B, Gélinas C, Gaur S, Neubauer JA. The NJ Alliance for Clinical and Translational Science (NJ ACTS) experience: Responding at “Warp Speed” to COVID-19. J Clin Transl Sci. 2022 Apr 4;6(1):e62. doi: 10.1017/cts.2022.383. PMID: 35720969; PMCID: PMC9161045. |
| Cooper L, Lee I, Waldron Lechner D. COVID-19 Pandemic Response Varies by Clinical Trial Sponsor Type. J Clin Transl Sci. 2021 Mar 16;5(1):e111. doi: 10.1017/cts.2021.25. PMID: 34192064; PMCID: PMC8220021. |
| Cooper L, Wo E, Lee I (2021). A 15 Year Review (2006-2020) of Patient-Reported Outcomes (PRO) in United States Oncology Product Labeling and Trends in Sponsor Size and Oncology Experience, Arch Internal Med Res, 5(3): 412-419. |
| Aleksunes L, Ebanks Y, Chen S. 11554 Getting the Grant: Assessment of a Monthly Grant Writing Group for Junior Investigators. J Clin Transl Sci. 2021 Mar 30;5(Suppl 1):60. doi: 10.1017/cts.2021.557. PMCID: PMC8827727 |
2020
| Trinh P, Tafuto B, Ebanks Y, Zunaed Z, Lechner DW. Competency-Based Self-Assessment Tools: A Mixed-Methods Retrospective Analysis of Need. Princ Pract Clin Res. 2021 Oct-Dec;7(4):23-26. doi: 10.21801/ppcrj.2021.74.3. PMID: 35415235; PMCID: PMC9000906. |