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Clinical Research in Hepatology in the COVID- 19 Pandemic and Post- Pandemic Era: Challenges and the Need for Innovation

dc.contributor.authorVerna, Elizabeth C.
dc.contributor.authorSerper, Marina
dc.contributor.authorChu, Jaime
dc.contributor.authorCorey, Kathleen
dc.contributor.authorFix, Oren K.
dc.contributor.authorHoyt, Karen
dc.contributor.authorPage, Kimberly A.
dc.contributor.authorLoomba, Rohit
dc.contributor.authorLi, Ming
dc.contributor.authorEverson, Gregory T.
dc.contributor.authorFried, Michael W.
dc.contributor.authorGarcia‐tsao, Guadalupe
dc.contributor.authorTerrault, Norah
dc.contributor.authorLok, Anna S.
dc.contributor.authorChung, Raymond T.
dc.contributor.authorReddy, K. Rajender
dc.date.accessioned2020-12-02T14:39:01Z
dc.date.availableWITHHELD_12_MONTHS
dc.date.available2020-12-02T14:39:01Z
dc.date.issued2020-11
dc.identifier.citationVerna, Elizabeth C.; Serper, Marina; Chu, Jaime; Corey, Kathleen; Fix, Oren K.; Hoyt, Karen; Page, Kimberly A.; Loomba, Rohit; Li, Ming; Everson, Gregory T.; Fried, Michael W.; Garcia‐tsao, Guadalupe ; Terrault, Norah; Lok, Anna S.; Chung, Raymond T.; Reddy, K. Rajender (2020). "Clinical Research in Hepatology in the COVID- 19 Pandemic and Post- Pandemic Era: Challenges and the Need for Innovation." Hepatology (5): 1819-1837.
dc.identifier.issn0270-9139
dc.identifier.issn1527-3350
dc.identifier.urihttps://hdl.handle.net/2027.42/163610
dc.publisherJohn Wiley & Sons
dc.titleClinical Research in Hepatology in the COVID- 19 Pandemic and Post- Pandemic Era: Challenges and the Need for Innovation
dc.typeArticle
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelInternal Medicine and Specialties
dc.subject.hlbtoplevelHealth Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/163610/2/hep31491.pdfen_US
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/163610/1/hep31491_am.pdfen_US
dc.identifier.doi10.1002/hep.31491
dc.identifier.sourceHepatology
dc.identifier.citedreferenceAlessandra M. The pandemic and the female academic. April 17, 2020. https://www.nature.com/articles/d41586- 020- 01135- 9AMn. Accessed September 2, 2020.
dc.identifier.citedreferenceAbrahamson M, Hooker E, Ajami NJ, Petrosino JF, Orwoll ES. Successful collection of stool samples for microbiome analyses from a large community- based population of elderly men. Contemp Clin Trials Commun 2017; 7: 158 - 162.
dc.identifier.citedreferenceHughes SR, Chapleau RR. Comparing DNA quantity and quality using saliva collection following food and beverage consumption. BMC Res Notes 2019; 12: 165.
dc.identifier.citedreferenceBarrett JR. Do- it- yourself biospecimens: the benefits of home collection. Environ Health Perspect 2004; 112: A51.
dc.identifier.citedreferenceNational Institutes of Health. NIH begins study to quantify undetected cases of coronavirus infection. April 10, 2020. https://www.nih.gov/news- events/news- releases/nih- begins- study- quantify- undetected- cases- coronavirus- infection. Accessed September 2, 2020.
dc.identifier.citedreferenceBezerra JA, Wells RG, Mack CL, Karpen SJ, Hoofnagle JH, Doo E, et al. Biliary atresia: clinical and research challenges for the twenty- first century. Hepatology 2018; 68: 1163 - 1173.
dc.identifier.citedreferenceThe Childhood Liver Disease Research Network (ChiLDReN). https://childrennetwork.org. Accessed September 2, 2020.
dc.identifier.citedreferenceMehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration UK. COVID- 19: consider cytokine storm syndromes and immunosuppression. Lancet 2020; 395: 1033 - 1034.
dc.identifier.citedreferenceAlonso EM, Horslen SP, Behrens EM, Doo E. Pediatric acute liver failure of undetermined cause: a research workshop. Hepatology 2017; 65: 1026 - 1037.
dc.identifier.citedreferenceSquires JE, Ng VL, Hawthorne K, Henn LL, Sorensen LG, Fredericks EM, et al. Neurodevelopmental outcomes in preschool and school aged children with biliary atresia and their native liver. J Pediatr Gastroenterol Nutr 2020; 70: 79 - 86.
dc.identifier.citedreferenceSociety of Pediatric Liver Transplantation. COVID- 19 Post Liver Transplantation Data Collection Registry for Pediatric Patients (0- 21 years). https://tts.org/initiatives/split- covid- 19- post- liver- transplantation- data- collection- registry. Accessed September 2, 2020.
dc.identifier.citedreferenceChowkwanyun M, Reed AL, Jr. Racial health disparities and Covid- 19- caution and context. N Engl J Med 2020; 383: 201 - 203.
dc.identifier.citedreferenceLucy F. Moving remote: the post- pandemic clinical trial. April 3, 2020. https://social.eyeforpharma.com/clinical/moving- remote- post- pandemic- clinical- trial. Accessed September 2, 2020.
dc.identifier.citedreferenceNicola D. Telemedicine: The future of clinical trials? December 13, 2019. https://social.eyeforpharma.com/clinical/telemedicine- future- clinical- trials. Accessed September 2, 2020.
dc.identifier.citedreferenceMarrero JA, Kulik LM, Sirlin CB, Zhu AX, Finn RS, Abecassis MM, et al. Diagnosis, staging, and management of hepatocellular carcinoma: 2018 practice guidance by the American Association for the Study of Liver Diseases. Hepatology 2018; 68: 723 - 750.
dc.identifier.citedreferenceU.S. Department of Health and Human Services Office for Human Research Protections, Food and Drug Administration Center for Drug Evaluation and Research. Use of electronic informed consent: questions and answers. Published December 2016. https://www.fda.gov/media/116850/download. Accessed June 2020.
dc.identifier.citedreferenceWorld Health Organization. mHealth: new horizons for health through mobile technologies. 2011. http://www.who.int/goe/publications/goe_mhealth_web.pdf. Accessed June 2020.
dc.identifier.citedreferenceKakkar AK, Sarma P, Medhi B. mHealth technologies in clinical trials: opportunities and challenges. Indian J Pharmacol 2018; 50: 105 - 107.
dc.identifier.citedreferenceOrri M, Lipset CH, Jacobs BP, Costello AJ, Cummings SR. Web- based trial to evaluate the efficacy and safety of tolterodine ER 4 mg in participants with overactive bladder: REMOTE trial. Contemp Clin Trials 2014; 38: 190 - 197.
dc.identifier.citedreferenceBorno HT, Zhang L, Siegel A, Chang E, Ryan CJ. At what cost to clinical trial enrollment? A retrospective study of patient travel burden in cancer clinical trials. Oncologist 2018; 23: 1242 - 1249.
dc.identifier.citedreferenceHealthMeasures. www.healthmeasures.net. Accessed June, 2020.
dc.identifier.citedreferenceLei BUW, Prow TW. A review of microsampling techniques and their social impact. Biomed Microdevices 2019; 21: 81.
dc.identifier.citedreferenceGould B. Lyft and Uber address transportation challenges for clinical trial patients. https://www.mdconnectinc.com/medical- marketing- insights/lyft- and- uber- address- transportation- challenges. Accessed June, 2020.
dc.identifier.citedreferenceSeidler EM, Keshaviah A, Brown C, Wood E, Granick L, Kimball AB. Geographic distribution of clinical trials may lead to inequities in access. Clin Investig 2014; 4: 373 - 380.
dc.identifier.citedreferenceUren SC, Kirkman MB, Dalton BS, Zalcberg JR. Reducing clinical trial monitoring resource allocation and costs through remote access to electronic medical records. J Oncol Pract 2013; 9: e13 - e16.
dc.identifier.citedreferenceNouri S, Khoong EC, Lyles CR, Karliner L. Addressing equity in telemedicine for chronic disease management during the Covid- 19 pandemic. NEJM Catalyst Innovations in Care Delivery 2020; 1.
dc.identifier.citedreferenceDuley L, Antman K, Arena J, Avezum A, Blumenthal M, Bosch J, et al. Specific barriers to the conduct of randomized trials. Clin Trials 2008; 5: 40 - 48.
dc.identifier.citedreferenceBorno HT, Small EJ. Does the COVID- 19 outbreak identify a broader need for an urgent transformation of cancer clinical trials research? Contemp Clin Trials 2020; 92: 105997.
dc.identifier.citedreferenceKing TE, Jr. Racial disparities in clinical trials. Mass Medical Soc 2002; 346: 1400 - 1402.
dc.identifier.citedreferenceFalade- Nwulia O, Suarez- Cuervo C, Nelson DR, Fried MW, Segal JB, Sulkowski MS. Oral direct- acting agent therapy for hepatitis C virus infection: a systematic review. Ann Intern Med 2017; 166: 637 - 648.
dc.identifier.citedreferenceZoulim F, Lebossé F, Levrero M. Current treatments for chronic hepatitis B virus infections. Curr Opin Virol 2016; 18: 109 - 116.
dc.identifier.citedreferenceYounossi ZM, Ratziu V, Loomba R, Rinella M, Anstee QM, Goodman Z, et al. Obeticholic acid for the treatment of non- alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo- controlled phase 3 trial. Lancet 2019; 394: 2184 - 2196.
dc.identifier.citedreferenceSeeff LB, Beebe GW, Hoofnagle JH, Norman JE, Buskell- Bales Z, Waggoner JG, et al. A serologic follow- up of the 1942 epidemic of post- vaccination hepatitis in the United States Army. N Engl J Med 1987; 316: 965 - 970.
dc.identifier.citedreferenceDi Bisceglie AM, Shiffman ML, Everson GT, Lindsay KL, Everhart JE, Wright EC, et al. Prolonged therapy of advanced chronic hepatitis C with low- dose peginterferon. N Engl J Med 2008; 359: 2429 - 2441.
dc.identifier.citedreferenceEvon DM, Sarkar S, Amador J, Lok AS, Sterling RK, Stewart PW, et al. Patient- reported symptoms during and after direct- acting antiviral therapies for chronic hepatitis C: the PROP UP study. J Hepatol 2019; 71: 486 - 497.
dc.identifier.citedreferenceMishra P, Florian J, Peter J, Vainorius M, Fried MW, Nelson DR, et al. Public- private partnership: targeting real- world data for hepatitis C direct- acting antivirals. Gastroenterology 2017; 153: 626 - 631.
dc.identifier.citedreferenceMendenhall CL, Moritz TE, Roselle GA, Morgan TR, Nemchausky BA, Tamburro CH, et al. A study of oral nutritional support with oxandrolone in malnourished patients with alcoholic hepatitis: results of a Department of Veterans Affairs cooperative study. Hepatology 1993; 17: 564 - 576.
dc.identifier.citedreferenceMorgan TR, Weiss DG, Nemchausky B, Schiff ER, Anand B, Simon F, et al. Colchicine treatment of alcoholic cirrhosis: a randomized, placebo- controlled clinical trial of patient survival. Gastroenterology 2005; 128: 882 - 890.
dc.identifier.citedreferenceGaziano JM, Concato J, Brophy M, Fiore L, Pyarajan S, Breeling J, et al. Million veteran program: a mega- biobank to study genetic influences on health and disease. J Clin Epidemiol 2016; 70: 214 - 223.
dc.identifier.citedreferencePadala PR, Jendro AM, Gauss CH, Orr LC, Dean KT, Wilson KB, et al. Participant and caregiver perspectives on clinical research during Covid- 19 pandemic. J Am Geriatr Soc 2020; 68: E14 - E18.
dc.identifier.citedreferenceThabane L, Mbuagbaw L, Zhang S, Samaan Z, Marcucci M, Ye C, et al. A tutorial on sensitivity analyses in clinical trials: the what, why, when and how. BMC Med Res Methodol 2013; 13: 92.
dc.identifier.citedreferenceJanssen KJ, Donders ART, Harrell FE, Jr., Vergouwe Y, Chen Q, Grobbee DE, et al. Missing covariate data in medical research: to impute is better than to ignore. J Clin Epidemiol 2010; 63: 721 - 727.
dc.identifier.citedreferenceYin G. Clinical trial design: Bayesian and frequentist adaptive methods. Hoboken, NJ: John Wiley & Sons; 2012.
dc.identifier.citedreferenceAtkins D, Kilbourne AM, Shulkin D. Moving from discovery to system- wide change: the role of research in a learning health care system: experience from three decades of health systems research in the Veterans Health Administration. Annu Rev Public Health 2017; 38: 467 - 487.
dc.identifier.citedreferenceU.S. National Library of Medicine. Trend, Charts, and Maps. September 2, 2020. https://clinicaltrials.gov/ct2/resources/trends#RegisteredStudiesOverTime. Accessed September 2, 2020.
dc.identifier.citedreferenceFood and Drug Administration. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID- 19 Public Health Emergency. July 2, 2020. https://www.fda.gov/media/136238/download. Accessed September 2, 2020.
dc.identifier.citedreferenceNational Institutes of Health. Guidance for NIH- funded Clinical Trials and Human Subjects Studies Affected by COVID- 19. March 16, 2020. https://grants.nih.gov/grants/guide/notice- files/NOT- OD- 20- 087.html. Accessed September 2, 2020.
dc.identifier.citedreferenceMehta HB, Ehrhardt S, Moore TJ, Segal JB, Alexander GC. Characteristics of registered clinical trials assessing treatments for COVID- 19: a cross- sectional analysis. BMJ Open 2020; 10: e039978.
dc.identifier.citedreferenceAmero S. Temporary, emergency situations due to COVID- 19 and application scores received during peer review. Extramural Nexus. 2020. https://nexus.od.nih.gov/all/2020/04/21sz/temporary- emergency- situations- due- to- covid- 19- and- application- scores- received- during- peer- review/. Accessed August 19, 2020.
dc.identifier.citedreferenceSherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, et al. Real- world evidence- what is it and what can it tell us? N Engl J Med 2016; 375: 2293 - 2297.
dc.identifier.citedreferenceRichardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW, et al. Presenting characteristics, comorbidities, and outcomes among 5700 patients hospitalized with COVID- 19 in the New York City area. JAMA 2020; 323: 2052 - 2059.
dc.identifier.citedreferenceGarg S, Kim L, Whitaker M, O- Halloran A, Cummings C, Holstein R, et al. Hospitalization rates and characteristics of patients hospitalized with laboratory- confirmed coronavirus disease 2019- COVID- NET, 14 states, March 1- 30, 2020. MMWR Morb Mortal Wkly Rep 2020; 69: 458 - 464.
dc.identifier.citedreferenceFabio C, Antonella C, Patrizia RQ, Francesco C, Annalisa R, Laura G, et al. Early predictors of clinical outcomes of COVID- 19 outbreak in Milan, Italy. Clin Immunol 2020; 217: 108509.
dc.identifier.citedreferenceGrein J, Ohmagari N, Shin D, Diaz G, Asperges E, Castagna A, et al. Compassionate use of remdesivir for patients with severe Covid- 19. N Engl J Med 2020; 382: 2327 - 2336.
dc.identifier.citedreferenceAntinori S, Cossu MV, Ridolfo AL, Rech R, Bonazzetti C, Pagani G, et al. Compassionate remdesivir treatment of severe Covid- 19 pneumonia in intensive care unit (ICU) and non- ICU patients: clinical outcome and differences in post- treatment hospitalisation status. Pharmacol Res 2020; 158: 104899.
dc.identifier.citedreferenceGautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, et al. Hydroxychloroquine and azithromycin as a treatment of COVID- 19: results of an open- label non- randomized clinical trial. Int J Antimicrob Agents 2020; 56: 105949.
dc.identifier.citedreferenceAnguera JA, Jordan JT, Castaneda D, Gazzaley A, Arean PA. Conducting a fully mobile and randomised clinical trial for depression: access, engagement and expense. BMJ Innov 2016; 2: 14 - 21.
dc.identifier.citedreferenceKim AHJ, Sparks JA, Liew JW, Putman MS, Berenbaum F, Duarte- Garcia A, et al. A rush to judgment? Rapid reporting and dissemination of results and its consequences regarding the use of hydroxychloroquine for COVID- 19. Ann Intern Med 2020; 172: 819 - 821.
dc.identifier.citedreferenceMehra MR, Desai SS, Ruschitzka F, Patel AN. Retraction- hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID- 19: a multinational registry analysis. Lancet 2020; 395: 1820.
dc.identifier.citedreferenceMehra MR, Desai SS, Kuy S, Henry TD, Patel AN. Retraction: cardiovascular disease, drug therapy, and mortality in Covid- 19. N Engl J Med 2020; 382: 2582.
dc.identifier.citedreferenceWang W, Xu Y, Gao R, Lu R, Han K, Wu G, et al. Detection of SARS- CoV- 2 in different types of clinical specimens. JAMA 2020; 323: 1843 - 1844.
dc.identifier.citedreferenceAzzi L, Carcano G, Gianfagna F, Grossi P, Gasperina DD, Genoni A, et al. Saliva is a reliable tool to detect SARS- CoV- 2. J Infect 2020; 81: e45 - e50.
dc.identifier.citedreferenceNational Center for Immunization and Respiratory Diseases (NCIRD), Division of Viral Diseases. Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID- 19). August 11, 2020. https://www.cdc.gov/coronavirus/2019- ncov/lab/lab- biosafety- guidelines.html. Accessed September 2, 2020.
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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