Listed below are publications from The BASE Lab research and partnerships with internal and external partners since 2017. The BASE Lab member names are in bold.
The Clinical Trial Transformation Initiative
*Corneli A, Hanlen-Rosado E, McKenna K, Araojo R, Corbett D, Vasisht K, Siddiqi B, Johnson T, Clark LT, Calvert SB. Enhancing diversity and inclusion in clinical trials. Clin Pharmacol Ther. 2023 Mar;113(3):489–499. doi:10.1002/cpt.2819. PMID: 36628990. https://pubmed.ncbi.nlm.nih.gov/36628990
*Among the top five most downloaded articles published in CPT in 2023. The article has been downloaded more than 5,000 times.
Perry B, Kehoe L, Swezey T, Le Masne Q, Goldhahn J, Staley A, Corneli A. How much evidence is enough? Research sponsor experiences seeking regulatory acceptance of digital health technology-derived endpoints. Digit Biomark. 2023;7(1):45–53. doi:10.1159/000529878. PMID: 37404865. PMCID: PMC10315005. https://pubmed.ncbi.nlm.nih.gov/37404865
Dombeck C, Swezey T, Forrest A, Tenaerts P, Corneli A. Stakeholders' views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2). Contemp Clin Trials Commun. 2022 Oct;29:100983. doi:10.1016/j.conctc.2022.100983. PMID: 36111176. PMCID: PMC9468347. https://pubmed.ncbi.nlm.nih.gov/36111176
Corneli A, Forrest A, Swezey T, Lin L, Tenaerts P. Stakeholders' recommendations for revising Good Clinical Practice. Contemp Clin Trials Commun. 2021 Jun;22:100776. doi:10.1016/j.conctc.2021.100776. PMID: 33997463. PMCID: PMC8100063. https://pubmed.ncbi.nlm.nih.gov/33997463
Corneli A, Dombeck CB, McKenna K, Calvert SB. Stakeholder experiences with the single IRB review process and recommendations for Food and Drug Administration guidance. Ethics Hum Res. 2021 May;43(3):26–36. doi:10.1002/eahr.500092. PMID: 34019339. PMCID: PMC8251897. https://pubmed.ncbi.nlm.nih.gov/34019339
Perry B, Dombeck C, Smalley JB, Levitan B, Leventhal D, Patrick-Lake B, Brennan L, McKenna K, Hallinan Z, Corneli A. Development and application of a patient group engagement prioritization tool for use in medical product development. Ther Innov Regul Sci. 2021 Mar;55(2):324–335. doi:10.1007/s43441-020-00217-0. PMID: 32996107. PMCID: PMC7864807. https://pubmed.ncbi.nlm.nih.gov/32996107
McKenna KC, Geoghegan C, Swezey T, Perry B, Wood WA, Nido V, Morin SL, Grabert BK, Hallinan ZP, Corneli AL. Investigator experiences using mobile technologies in clinical research: Qualitative descriptive study. Jmir Mhealth Uhealth. 2021 Feb 12;9(2):e19242. doi:10.2196/19242. PMID: 33576742. PMCID: PMC7910119. https://pubmed.ncbi.nlm.nih.gov/33576742
Swezey T, McGuire FH, Hurley P, Panhuis J, Goldstein K, Chuck T, Dombeck C, Perry B, Brennan C, Phrsai N, Corneli A. More than a box to check: Research sponsor and clinical investigator perspectives on making GCP training relevant. Contemp Clin Trials Commun. 2020 Sep;19:100606. doi:10.1016/j.conctc.2020.100606. PMID: 32817904. PMCID: PMC7426536. https://pubmed.ncbi.nlm.nih.gov/32817904
Apostolaros M, Babaian D, Corneli A, Forrest A, Hamre G, Hewett J, Podolsky L, Popat V, Randall P. Legal, regulatory, and practical issues to consider when adopting decentralized clinical trials: Recommendations from the Clinical Trials Transformation Initiative. Ther Innov Regul Sci. 2020 Jul;54(4):779–787. doi:10.1007/s43441-019-00006-4. PMID: 32557302. PMCID: PMC7362888. https://pubmed.ncbi.nlm.nih.gov/32557302
Corneli A, Calvert SB, Powers JH, Swezey T, Collyar D, Perry B, Farley JJ, Santiago J, Donnelly HK, De Anda C, Blanchard K, Fowler VG, Holland TL. Consensus on language for advance informed consent in health care-associated pneumonia clinical trials using a Delphi process. JAMA Netw Open. 2020 May 1;3(5):e205435. doi:10.1001/jamanetworkopen.2020.5435. PMID: 32442291. PMCID: PMC7244987. https://pubmed.ncbi.nlm.nih.gov/32442291
Dombeck CB, Hinkley T, Fordyce CB, Blanchard K, Roe MT, Corneli A. Continued investigator engagement: Reasons principal investigators conduct multiple FDA-regulated drug trials. Contemp Clin Trials Commun. 2020 Mar;17:100502. doi:10.1016/j.conctc.2019.100502. PMID: 31890985. PMCID: PMC6926102. https://pubmed.ncbi.nlm.nih.gov/31890985
Fordyce CB, Malone K, Forrest A, Hinkley T, Corneli A, Topping J, Roe MT. Improving and sustaining the site investigator community: Recommendations from the Clinical Trials Transformation Initiative. Contemp Clin Trials Commun. 2019 Dec;16:100462. doi:10.1016/j.conctc.2019.100462. PMID: 31701037. PMCID: PMC6831713. https://pubmed.ncbi.nlm.nih.gov/31701037
Perry B, Geoghegan C, Lin L, McGuire FH, Nido V, Grabert B, Morin SL, Hallinan ZP, Corneli A. Patient preferences for using mobile technologies in clinical trials. Contemp Clin Trials Commun. 2019 Sep;15:100399. doi:10.1016/j.conctc.2019.100399. PMID: 31312746. PMCID: PMC6610628. https://pubmed.ncbi.nlm.nih.gov/31312746
Corneli A, Perry B, Collyar D, Powers JH, Farley JJ, Calvert SB, Santiago J, Donnelly HK, Swezey T, Dombeck CB, De Anda C, Fowler VG, Holland TL. Assessment of the perceived acceptability of an early enrollment strategy using advance consent in health care-associated pneumonia. JAMA Netw Open. 2018 Dec 7;1(8):e185816. doi:10.1001/jamanetworkopen.2018.5816. PMID: 30646295. PMCID: PMC6324354. https://pubmed.ncbi.nlm.nih.gov/30646295
Corneli A, Wheeler C, Bradley J, Gamel B, Nambiar S, Noel GJ, Lin L, Roberts JN, Benjamin DK. Facilitators and barriers to the successful implementation of pediatric antibacterial drug trials: Findings from CTTI's survey of investigators. Contemp Clin Trials Commun. 2018 Mar;9:115–120. doi:10.1016/j.conctc.2018.01.003. PMID: 29696233. PMCID: PMC5898492. https://pubmed.ncbi.nlm.nih.gov/29696233
Greenberg RG, Corneli A, Bradley J, Farley J, Jafri HS, Lin L, Nambiar S, Noel GJ, Wheeler C, Tiernan R, Smith PB, Roberts J, Benjamin DK. Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative. Contemp Clin Trials Commun. 2018 Mar;9:7–12. doi:10.1016/j.conctc.2017.11.006. PMID: 29696219. PMCID: PMC5898553. https://pubmed.ncbi.nlm.nih.gov/29696219
Corneli A, Hallinan Z, Hamre G, Perry B, Goldsack JC, Calvert SB, Forrest A. The Clinical Trials Transformation Initiative: Methodology supporting the mission. Clin Trials. 2018 Feb;15(1_suppl):13–18. doi:10.1177/1740774518755054. PMID: 29452520. https://pubmed.ncbi.nlm.nih.gov/29452520
Perry B, Herrington W, Goldsack JC, Grandinetti CA, Vasisht KP, Landray MJ, Bataille L, DiCicco RA, Bradley C, Narayan A, Papadopoulos EJ, Sheth N, Skodacek K, Stem K, Strong TV, Walton MK, Corneli A. Use of mobile devices to measure outcomes in clinical research, 2010-2016: A systematic literature review. Digit Biomark. 2018;2(1):11–30. doi:10.1159/000486347. PMID: 29938250. PMCID: PMC6008882. https://pubmed.ncbi.nlm.nih.gov/29938250
Corneli A, Pierre C, Hinkley T, Lin L, Fordyce CB, Hamre G, Roe MT. One and done: Reasons principal investigators conduct only one FDA-regulated drug trial. Contemp Clin Trials Commun. 2017 Jun;6:31–38. doi:10.1016/j.conctc.2017.02.009. PMID: 29740635. PMCID: PMC5936741. https://pubmed.ncbi.nlm.nih.gov/29740635
Ethics
Corneli A, Starling S, Choi Y, Vosylius J, Madre L, Mackinnon A, Tenaerts P. Participant comprehension and acceptability of enhanced versus text-only electronic informed consent: An innovative qualitative pilot study. Pilot Feasibility Stud. 2024 Jan 17;10(1):10. doi: 10.1186/s40814-023-01432-w. PMID: 38233932; PMCID: PMC10792918. https://pubmed.ncbi.nlm.nih.gov/38233932
Corneli A, McKenna K, Hanlen-Rosado E, Calvert SB, Mah E, Rosenfeld SJ. Stakeholder reflections on implementing the National Institutes of Health's policy on single institutional review boards. Ethics Hum Res. 2023 Sep-Oct;45(5):15-26. doi: 10.1002/eahr.500179. PMID: 37777977. https://pubmed.ncbi.nlm.nih.gov/37777977
HIV Prevention
Fatola O, Corneli A, Perry B, Hanlen-Rosado E, Nsonwu A, Constantine EP, Thompson AB. "An extra variable to consider"-vaccine-induced seropositivity and adolescent HIV vaccine clinical trials. J Pediatric Infect Dis Soc. 2022 May 30;11(5):221–224. doi:10.1093/jpids/piac001. PMID: 35139223. PMCID: PMC9155599. https://pubmed.ncbi.nlm.nih.gov/35139223
Return of Results
Zimmerman KO, Perry B, Hanlen-Rosado E, Nsonwu A, Lane MD, Benjamin DK, Becker M, Corneli A, Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Developing lay summaries and thank you notes in pediatric pragmatic clinical trials. Health Expect. 2022 Jun;25(3):1029–1037. doi:10.1111/hex.13448. PMID: 35246906. PMCID: PMC9122399. https://pubmed.ncbi.nlm.nih.gov/35246906
Corneli A, Perry B, Benjamin DK, Zimmerman KO, Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. Pediatric Trials Network: Stakeholder views on thanking families and providing study findings on pragmatic pediatric clinical research. Contemp Clin Trials Commun. 2021 Jun;22:100792. doi:10.1016/j.conctc.2021.100792. PMID: 34136719. PMCID: PMC8181207. https://pubmed.ncbi.nlm.nih.gov/34136719