COVID-19 clinical trial participation and awareness in Texas

References

• Warren RC, Forrow L, Hodge DA, Truog RD. Trustworthiness before trust - COVID-19 vaccine trials and the black community. N Engl J Med. 2020;383(22). doi:10.1056/NEJMp2030033.
   Web of Science ®Google Scholar
• Kuter BJ, Offit PA, Poland GA. The development of COVID-19 vaccines in the United States: why and how so fast? Vaccine. 2021;39(18):2491–10. doi:10.1016/j.vaccine.2021.03.077.
   PubMed Web of Science ®Google Scholar
• Seguin-Fowler RA, Amos C, Beech BM, Ferrer RL, McNeill L, Opusunju JJ, Spence E, Thompson EL, Torres-Hostos LR, Vishwanatha JK, et al. The Texas community-engagement research alliance against COVID-19 in disproportionately affected communities (TX CEAL) consortium. J Clin Transl Sci. 2022;6(1):e64. doi:10.1017/cts.2022.395.
   PubMedGoogle Scholar
• Abu-Farha RK, Alzoubi KH, Khabour OF. Public willingness to participate in COVID-19 vaccine clinical trials: a study from Jordan. Patient Prefer Adherence. 2020;14:2451–2458. doi:10.2147/PPA.S284385.
   PubMed Web of Science ®Google Scholar
• Detoc M, Bruel S, Frappe P, Tardy B, Botelho-Nevers E, Gagneux-Brunon A. Intention to participate in a COVID-19 vaccine clinical trial and to get vaccinated against COVID-19 in France during the pandemic. Vaccine. 2020;38(45):7002–7006. doi:10.1016/j.vaccine.2020.09.041.
   PubMed Web of Science ®Google Scholar
• Echoru I, Ajambo PD, Keirania E, Bukenya EEM. Sociodemographic factors associated with acceptance of COVID-19 vaccine and clinical trials in Uganda: a cross-sectional study in western Uganda. BMC Public Health. 2021;21(1). doi:10.1186/s12889-021-11197-7.
   PubMed Web of Science ®Google Scholar
• Enitan SS, Oyekale A, Akele R, Olawuyi K, Olabisi E, Nwankiti A, Enitan C. Assessment of knowledge, perception and readiness of Nigerians to participate in the COVID-19 vaccine trial. Int J Vaccine Immun. 2020;4(1):1–13. doi:10.16966/2470-9948.123.
   Google Scholar
• Sun SF, Lin DH, Operario D. Interest in COVID-19 vaccine trials participation among young adults in China: willingness, reasons for hesitancy, and demographic and psychosocial determinants. Prev Med Reports. 2021;22:22. doi:10.1016/j.pmedr.2021.101350.
   Google Scholar
• Thompson HS, Manning M, Mitchell J, Kim S, Harper FW, Cresswell S, Johns K, Pal S, Dowe B, Tariq M, et al. Factors associated with racial/ethnic group–based medical mistrust and perspectives on COVID-19 vaccine trial participation and vaccine uptake in the US. JAMA Netw Open. 2021;4(5):e2111629–e. doi:10.1001/jamanetworkopen.2021.11629.
   PubMed Web of Science ®Google Scholar
• Emanuel EJ, Boyle CW. Assessment of length and readability of informed consent documents for COVID-19 Vaccine trials. JAMA Netw Open. 2021;4(4):e2110843. doi:10.1001/jamanetworkopen.2021.10843.
   PubMed Web of Science ®Google Scholar
• Wentzell E, Racila AM. The social experience of participation in a COVID-19 vaccine trial: subjects’ motivations, others’ concerns, and insights for vaccine promotion. Vaccine. 2021;39(17):2445–2451. doi:10.1016/j.vaccine.2021.03.036.
   PubMed Web of Science ®Google Scholar
• Gottlieb S. The need for a US national clinical trial infrastructure in a public health crisis. JAMA Health Forum. 2021;2(8):e213223. doi:10.1001/jamahealthforum.2021.3223.
   PubMedGoogle Scholar
• Tikkinen KAO, Malekzadeh R, Schlegel M, Rutanen J, Glasziou P. COVID-19 clinical trials: learning from exceptions in the research chaos. Nat Med. 2020;26(11):1671–1672. doi:10.1038/s41591-020-1077-z.
   PubMed Web of Science ®Google Scholar
• R Core Team. R: a language and environment for statistical computing. Vuebbam Austria: R Foundation for Statistical Computing; 2023.
   Google Scholar
• Wickham H, Averick M, Bryan J, Chang W, McGowan LD, François R, Grolemund G, Hayes A, Henry L, Hester J, Kuhn M. Welcome to the tidyverse. J Open Source Softw. 2019;4(43):1686. doi:10.21105/joss.01686.
   Google Scholar
• Brown M, Moyer A. Predictors of awareness of clinical trials and feelings about the use of medical information for research in a nationally representative US sample. Ethn Health. 2010;15(3):223–236. doi:10.1080/13557851003624281.
   PubMed Web of Science ®Google Scholar
• Jiang SH, Hong YA. Clinical trial participation in America: the roles of eHealth engagement and patient–provider communication. Digital Health. 2021;7:205520762110676. doi:10.1177/20552076211067658.
   Web of Science ®Google Scholar
• Yadav S, Todd A, Patel K, Tabriz AA, Nguyen O, Turner K, Hong YR. Public knowledge and information sources for clinical trials among adults in the USA: evidence from a health information national trends survey in 2020. Clin Med (Northfield Il). 2022;22(5):416–422. doi:10.7861/clinmed.2022-0107.
   PubMed Web of Science ®Google Scholar
• Sedrak MS, Freedman RA, Cohen HJ, Muss HB, Jatoi A, Klepin HD, Wildes TM, Le‐Rademacher JG, Kimmick GG, Tew WP, et al. Older adult participation in cancer clinical trials: a systematic review of barriers and interventions. CA Cancer J Clin. 2021;71(1):78–92. doi:10.3322/caac.21638.
   PubMed Web of Science ®Google Scholar
• Sedrak MS, Mohile SG, Sun V, Sun CL, Chen BT, Li D, Wong AR, George K, Padam S, Liu J, et al. Barriers to clinical trial enrollment of older adults with cancer: a qualitative study of the perceptions of community and academic oncologists. J Geriatr Oncol. 2020;11(2):327–334. doi:10.1016/j.jgo.2019.07.017.
   PubMed Web of Science ®Google Scholar
• Basche M, Baron AE, Eckhardt SG, Balducci L, Persky M, Levin A, Jackson N, Zeng C, Vranas P, Steiner JF, et al. Barriers to enrollment of elderly adults in early-phase cancer clinical trials. J Oncol Pract. 2008;4(4):162–168. doi:10.1200/JOP.0842001.
   PubMedGoogle Scholar
• Skinner JS, Fair AM, Holman AS, Boyer AP, Wilkins CH. The impact of an educational video on clinical trial enrollment and knowledge in ethnic minorities: a randomized control trial. Front Public Health. 2019;7. doi:10.3389/fpubh.2019.00104.
   PubMed Web of Science ®Google Scholar
• Castellon-Lopez Y, Landovitz R, Ntekume E, Porter C, Bross R, Hilder R, Lucas-Wright A, Daar ES, Chavez P, Blades C, et al. A community-partnered approach for diversity in COVID-19 vaccine clinical trials. J Clin Transl Sci. 2022;7(1). doi:10.1017/cts.2022.471.
   PubMedGoogle Scholar
• Cottingham MD, Fisher JA. Gendered logics of biomedical research: women in US phase I clinical trials. Soc Probl. 2022;69(2):492–509. doi:10.1093/socpro/spaa035.
   PubMed Web of Science ®Google Scholar
• Merkatz RB. Inclusion of women in clinical trials: a historical overview of scientific ethical and legal issues. J Obstet Gynecol Neonatal Nurs. 1998;27(1):78–84. doi:10.1111/j.1552-6909.1998.tb02594.x.
   PubMedGoogle Scholar
• US Food & Drug Administration. Regulations, guidance, and reports related to women’s health. 2019.
   Google Scholar
• Kons KM, Wood ML, Peck LC, Hershberger SM, Kunselman AR,Stetter C, Legro RS, Deimling TA. Exclusion of reproductive-aged women in COVID-19 vaccination and clinical trials. Womens Health Issues. 2022;32(6):557–563. doi:10.1016/j.whi.2022.06.004.
   PubMed Web of Science ®Google Scholar
• Barre I, Cunningham-Erves J, Moss J, Parham I, Alexander LR, Davis J. Motivators and Barriers to COVID-19 research participation at the onset of the COVID-19 pandemic in Black communities in the USA: an exploratory study. J Racial Ethn Health Disparities. 2022;10(6):2890–2899. doi:10.1007/s40615-022-01466-5.
   PubMed Web of Science ®Google Scholar
• Lawrence EM. Why do college graduates behave more healthfully than those who are less educated? J Health Soc Behav. 2017;58(3):291–306. doi:10.1177/0022146517715671.
   PubMed Web of Science ®Google Scholar
• Harrington N, Chen YK, AM O, Fang CY. The role of trust in HPV vaccine uptake among racial and ethnic minorities in the United States: a narrative review. AIMS Public Health. 2021;8(2):352–68. doi:10.3934/publichealth.2021027.
   PubMed Web of Science ®Google Scholar
• Pariera KL, Murphy ST, Meng JB, McLaughlin ML. Exploring willingness to participate in clinical trials by ethnicity. J Racial Ethn Health Disparities. 2017;4(4):763–769. doi:10.1007/s40615-016-0280-6.
   PubMed Web of Science ®Google Scholar
• Hughes-Morley A, Young B, Waheed W, Small N, Bower P. Factors affecting recruitment into depression trials: systematic review, meta-synthesis and conceptual framework. J Affect Disord. 2015;172:274–290. doi:10.1016/j.jad.2014.10.005.
   PubMed Web of Science ®Google Scholar
• Rivers D, August EM, Sehovic I, Green BL, Quinn GP. A systematic review of the factors influencing African Americans’ participation in cancer clinical trials. Contemp Clin Trials. 2013;35(2):13–32. doi:10.1016/j.cct.2013.03.007.
   PubMed Web of Science ®Google Scholar
• Ellis PM, Butow PN, Tattersall MHN, Dunn SM, Houssami N. Randomized clinical trials in oncology: understanding and attitudes predict willingness to participate. J Clin Oncol. 2001;19(15):3554–3561. doi:10.1200/JCO.2001.19.15.3554.
   PubMed Web of Science ®Google Scholar
• Gotay CC. Accrual to cancer clinical trials: directions from the research literature. Soc Sci Med. 1991;33(5):569–577. doi:10.1016/0277-9536(91)90214-W.
   PubMed Web of Science ®Google Scholar
• McNeil C. Why patients enroll in clinical trials: physicians play a key role. J Natl Cancer Inst. 1996;88(11):709–711. doi:10.1093/jnci/88.11.709.
   PubMedGoogle Scholar
• Prescott R, Counsell C, Gillespie WJ, Grant AM, Russell IT, Kiauka S, Colthart IR, Ross S, Shepherd SM. Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess Rep (Winchester, England). 1999;3(20):1–143. doi:10.3310/hta3200.
   PubMedGoogle Scholar
• Quinn GP, Bell BA, Bell MY, Caraway VD, Conforte D, Graci LB, Powell-Stafford VL, Sapp AL, Shimizu CO, Vaughn EJ. et al. The guinea pig syndrome: improving clinical trial participation among thoracic patients. J Thorac Oncol. 2007;2(3):191–196. doi:10.1097/JTO.0b013e318031cdb6.
   PubMed Web of Science ®Google Scholar
• Sood A, Prasad K, Chhatwani L, Shinozaki E, Cha SS, Loehrer LL, Wahner-Roedler DL. Patients’ attitudes and preferences about participation and recruitment strategies in clinical trials. Mayo Clin Proc. 2009;84(3):243–247. doi:10.4065/84.3.243.
   PubMed Web of Science ®Google Scholar
• Unger JM, Vaidya R, Hershman DL, Minasian LM, Fleury ME. Systematic review and meta-analysis of the magnitude of structural, clinical, and physician and patient barriers to cancer clinical trial participation. J Natl Cancer Inst. 2019;111(3):245–255. doi:10.1093/jnci/djy221.
   PubMedGoogle Scholar
• Catania C, De Pas T, Goldhirsch A, Radice D, Adamoli L, Medici M, Verri E, Marenghi C, de Braud F, Nolè F, et al. Participation in clinical trials as viewed by the patient: understanding cultural and emotional aspects which influence choice. Oncology. 2008;74(3–4):177–187. doi:10.1159/000151365.
   PubMed Web of Science ®Google Scholar
• Mills E, Cooper C, Guyatt G, Gilchrist A, Rachlis B, Sulway C, Wilson K. Barriers to participating in an HIV vaccine trial: a systematic review. AIDS. 2004;18(17):2235–2242. doi:10.1097/00002030-200411190-00003.
   PubMed Web of Science ®Google Scholar
• Kazdin AE. Evidence-based treatment and practice - new opportunities to bridge clinical research and practice, enhance the knowledge base, and improve patient care. Am Psychol. 2008;63(3):146–159. doi:10.1037/0003-066X.63.3.146.
   PubMed Web of Science ®Google Scholar
• Corbie-Smith G, Thomas SB, Williams MV, Moody-Ayers S. Attitudes and beliefs of African Americans toward participation in medical research. J Gen Int Med. 1999;14(9):537–546. doi:10.1046/j.1525-1497.1999.07048.x.
   PubMed Web of Science ®Google Scholar
• Unger JM, Cook E, Tai E, Bleyer A. The role of clinical trial participation in cancer research: barriers, evidence, and strategies. Am Soc Clin Oncol Educ Book. 2016;36(36):185–198. doi:10.1200/EDBK_156686.
   Google Scholar
• Weckstein DJ, Thomas CA, Emery IF, Shea BF, Fleury A, White ME, Chase E, Robinson C, Frazier S, Pilar C. et al. Assessment of perceived cost to the patient and other barriers to clinical trial participation. J Oncol Pract. 2011;7(5):330–333. doi:10.1200/JOP.2011.000236.
   PubMedGoogle Scholar
• Winkfield KM, Phillips JK, Joffe S, Halpern MT, Wollins DS, Moy B. Addressing financial barriers to patient participation in clinical trials: ASCO policy statement. J Clin Oncol. 2018;36(33):3331–3339. doi:10.1200/JCO.18.01132.
   Web of Science ®Google Scholar