Publications - Forum for Collaborative Research

2026

Advancing the inclusion of pregnant and lactating populations in HIV PrEP research: ethical, regulatory, and surveillance recommendations from a multisectoral working group
Osakwe C E, Schaefer R, Donaldson L, Abiodun A S, Chatani-Gada M, Chigome A K, Day S, Deaton C, Elemuwa U G, Ingold H, Joseph Davey D, Kersey K, Lamprianou S, Lyerly A D, Noguchi L M, Nyambayo P P M, Mpaso C, Robertson M N, Renaud F, Sehloho T, van Wyk J, Vannappagari V, Warren M, Miller V, Long-Acting PrEP during Pregnancy and Lactation Working Group. Frontiers in Public Health. 2026; 10.3389/fpubh.2026.1811039

Refractory mucocutaneous infections by herpes simplex virus (HSV) in hematopoietic cell transplant recipients: A real-world, multicenter study
Papanicolaou G A, Lee Y J, Shafat T, Li Y, Young J H, Spallone A, Obeid K M, Shah G L, Flaherty P W, Sekhon M K, Chiu K, Dioverti V, Hammond S P, Dadwal S, Hill J A, Kotton C N, Miller V, Ljungman P, Chemaly R F, HSV Resistance Working Group of the Transplant Associated Viral Infections Forum. Open Forum Infectious Diseases. 2026; 10.1093/ofid/ofag377

Global position statement supporting a World Health Assembly resolution on steatotic liver disease
Lazarus J, Halpern B, Schwarz P E H, Boudou D, Van Spall H G C, Miller V, Duseja A. Nat Rev Gastroenterol Hepatol. 2026; 10.1038/s41575-026-01201-z

2025

Strengthening hepatitis B virus clinical research in Africa: the need for multistakeholder collaboration, funding, and political will
Leus M, Osakwe C E, Adda D, El-Sayed M, Hicks J, Ibrahim Y, Matthews P C, Ndembi N, Owusu-Ansah T, Spearman C W, Sonderup M W, Ward J, Schaefer R, Miller V. The Lancet Microbe. 2025; 10.1016/j.lanmic.2025.101266

SMART Steps to HBV Cure
Miller V, Terrault N. Hepatology, 82(6). 2025; 10.1097/HEP.0000000000001499

Challenges and opportunities in developing integrated sexual and reproductive health programmes
Mayer K H, Beyrer C, Cohen M S, El-Sadr W M, Grinsztejn B, Head J M, Keuroghlian A S, Miller V, Phanuphak N, Rees H, Reid M, Starrs A, Warren M, Bekker L. The Lancet, Volume 406, Issue 10515. 2025; 10.1016/S0140-6736(25)01246-2

Multisector global collaboration to advance the inclusion of pregnant and lactating people in HIV prevention research
Schaefer R, Lievense B, Day S, Donaldson L, Bekker L, Chigome A, Kumwenda G, Noguchi L, Osakwe C, Miller V, Lyerly A, Chatani-Gada M. AIDS. 2025; 10.1097/QAD.0000000000004257

Do we need a regulatory path for HIV post-exposure prophylaxis?
Miller V, Schaefer R. J Int AIDS. 2025; 10.1002/jia2.26449

Standardising HBV nomenclature: a call to action from the HBV Forum
Wang S, Leus M, Cornberg M, Ghany M, Hwang C, Lim S G, McMahon B, Spearman C W, Miller V. The Lancet Gastroenterology & Hepatology. 2025; 10.1016/S2468-1253(25)00158-X

Multipurpose prevention technologies for the prevention of unintended pregnancy, HIV, and other sexually transmitted infections: regulatory pathways and challenges
Donaldson L, Schaefer R, Alhakimi S, Akulu R, Palanee-Phillips T, Young Holt B, Miller V. Front. Reprod. Health. 2025; 10.3389/frph.2025.1591232

Antiretroviral use for HIV prevention during pregnancy: the need to strengthen regulatory and surveillance systems in Africa
Schaefer R, Donaldson L, Chigome A, Escudeiro dos Santos M, Lamprianou S, Ndembi N, Nwokike JI, Nyambayo P, Palmi V, Renaud F, Gonzalez Tome M, Miller V. Drug Safety. 2025; 10.1007/s40264-024-01494-6

Refractory and Resistant Herpes Simplex Virus Mucocutaneous Infections in Immunocompromised Patients: Literature Review and Proposed Definitions for Use in Clinical Trials
Chemaly R F, Shafat T, Wald A, Kotton C N, Papanicolaou G, Yong M K, Miller V, Komatsu T E, Mullick C, Hodowanec A C, Westman G, Khawaja F, Birkmann A, Ljungman P, HSV Resistance Working Group of the Transplant Associated Viral Infections Forum. Clinical Infectious Diseases. 2025; 10.1093/cid/ciae638

2024

Promising results of HIV prevention trials highlight the benefits of collaboration in global health: The perspective of the Forum HIV Recency Assay Working Group
Schaefer R, Donaldson L, Leus M, Osakwe CE, Chimukangara B, Dalal S, et al. PLOS Glob Public Health. 2024; 10.1371/journal.pgph.0003878

Twenty-five years of addressing cutting-edge scientific, policy, and regulatory issues through collaboration: The Forum for Collaborative Research
Schaefer R, Ayvaz A, Hoffman C, Yann M, Rooney Z, Leus M, Mitra S, Miller V, for the Forum for Collaborative Research. Clinical and Translational Science 2024; 10.1111/cts.70051.

Integrating liver endpoints in clinical trials of cardiovascular and kidney disease
Zannad F, Sanyal AJ, Butler J, Miller V, Harrison SA. Nature Medicine 2024; 10.1038/s41591-024-03223-z.

Chronic Hepatitis B Finite Treatment: similar and different concerns with new drug classes
Peters MG, Yuen MF, Terrault N, Fry J, Lampertico P, Gane E, Hwang C, Stamm LM, Leus M, Maini MK, Mendez P, Lonjon-Domanec I, Berg T, Wang S, Mishra P, Donaldson E, Buchholz S, Miller V, Lenz O. Clin Inf Dis. 2023; 10.1093/cid/ciad506.

Consensus Definitions of Cytomegalovirus (CMV) Infection and Disease in Transplant Patients Including Resistant and Refractory CMV for Use in Clinical Trials: 2024 Update From the Transplant Associated Virus Infections Forum
Ljungman P, Chemaly RF, Khawaya F, Alain S, Avery R, Badshah C, Boeckh M, Fournier M, Hodowanec A, Komatsu T, Limaye AP, Manuel O, Natori Y, Navarro D, Pikis A, Razonable RR, Westman G, Miller V, Griffiths PD, Kotton CN for the CMV Definitions Working Group. Clin Inf Dis. 2024; 10.1093/cid/ciae321.

Recommendations from the Forum for Collaborative Research’s symposium on hepatitis B elimination and universal hepatitis B adult vaccination in the United States.
Leus M, Treat M, Miller V, Reingold A. J Virus Erad. 2024; 10.1016/j.jve.2024.100376.

A Surrogate Endpoint Based Provisional Approval Causal Roadmap
Gilbert PB, Peng J, Han L, Lange T, Lu Y, Nie L, Shih M, Waddy SP, Wiley K, Yann M, Zafari Z, Ghosh D, Follmann D, Juraska M, Díaz I. arXiv 2024; 10.48550/arXiv.2407.06350.

Long-acting HIV Treatments: Study Design, Logistics, and Access
Murdock NA, Alajaji NE, Schaefer R, Boone CA, Campo RE, Dore GJ, Gandhi M, Gorospe JR, Gulick RM, Hodder SL, Liu J, Rhee MS, Rooney JF, Vannappagari V, Wilkin T, Miller V. Open Forum Infectious Diseases. 2024; 10.1093/ofid/ofae337.

2023

Liver biopsy for assessment of suspected drug-induced liver injury in metabolic dysfunction-associated steatohepatitis clinical trials: Expert consensus from the Liver Forum
Palmer M, Kleiner DE, Goodman Z, Brunt E, Avigan M, Regev A, Hayashi P, Lewis J, Mehta R, Harrison S, Siciliano M, McWherter CA, Vuppalanchi R, Behling C, Miller V, Chalasani N, Sanyal A. Aliment Pharmacol Ther. 2024; 10.1111/apt.17762.

Facilitating Next-Generation Pre-Exposure Prophylaxis Clinical Trials Using HIV Recent Infection Assays: A Consensus Statement from the Forum HIV Prevention Trial Design Project
Parkin N, Gao F, Grebe E, Cutrell A, Das M, Donnell D, Duerr A, Glidden DV, Hughes JP, Murray J, Robertson MN, Zinserling J, Lau J, Miller V. Clin Pharmacol Ther. 2022; 10.1002/cpt.2830.

A proposal from the Liver Forum for the management of comorbidities in nonalcoholic steatohepatitis therapeutic trials
Pais R, Cariou B, Noureddin M, Francque S, Schattenberg JM, Abdelmalek MF, Lalazar G, Varma S, Dietrich J, Miller V, Sanyal A, Ratziu V. J Hepatol 2023; 10.1016/j.jhep.2023.03.014.

HDV RNA Assays: Performance characteristics, clinical utility and challenges
Wedermeyer H, Leus M, Battersby TR, Glenn J, Gordien E, Kamili S, Kapoor J, Kessler HH, Lenz O, Luetgehetmann M, Mixson-Hayden T, Simon CO, Thomson M, Westman G, Miller V, Terrault N, Lampertico P. Hepatology 2023; 10.1097/HEP.0000000000000584.

2022

Consensus Definitions of BK Polyomavirus Nephropathy in Renal Transplant Recipients for Clinical Trials
Imlay H, Baum P, Brennan DC, Hanson KE, Hodges MR, Hodowanec AC, Komatsu TE, Ljungman P, Miller V, Natori Y, Nickeleit V, O'Rear J, Pikis A, Randhawa PS, Sawinski D, Singh H K, Westman G, Limaye AP. Clin Inf Dis. 2022; 75(7): 1210-1216.10.1093/cid/ciac071.

Application of Bayesian methods to accelerate rare disease drug development: scopes and hurdles
Kidwell KM, Roychoudhury S, Wendelberger B, Scott J, Moroz T, Yin S, Majumder M, Zhong J, Huml RA, Miller V. Orphanet J Rare Dis. 2022; 17(1): 186.10.1186/s13023-022-02342-5.

Immunological biomarker discovery in cure regimens for chronic hepatitis B virus infection
Gehring AJ, Mendez P, Richter K, Ertl H, Donaldson EF, Mishra P, Maini M, Boonstra A, Lauer G, de Creus A, Whitaker K, Martinez SF, Weber J, Gainor E, Miller V. J Hepatol 2022; 10.1016/j.jhep.2022.02.020.

A systematic review of limiting antigen avidity enzyme immunoassay for detection of recent HIV-1 infection to expand supported applications
Lau J, Murdock N, Murray J, Justman J, Parkin N, Miller V. J Virus Erad. 2022; 8(3): 100085.10.1016/j.jve.2022.100085.

Nomenclature of HBV core protein-targeting antivirals
Zoulim F, Zlotnick A, Buchholz S, Donaldson E, Fry J, Gaggar A, Hu J, Kann M, Lenz O, Lin K, Mani N, Nassal M, Delaney W, Wang S, Westman G, Miller V, Janssen HLA. Nat Rev Gastroenterol Hepatol 2022; 19(12): 748-750.10.1038/s41575-022-00700-z.

2021

Association between rectal gonorrhoea and HIV incidence in men who have sex with men: a meta-analysis
Donnell D, Zewdie K, Ratna N, Miller V, Saunders J, Gill O, Delpech V, Mohammed H. Sexually Transmitted Infections 2022; 10.1136/sextrans-2021-055254.

Association Between Seroclearance of Hepatitis B Surface Antigen and Long-term Clinical Outcomes of Patients With Chronic Hepatitis B Virus Infection: Systematic Review and Meta-analysis
Anderson RT, Choi HSJ, Lenz O, Peters MG, Janssen HLA, Mishra P, Donaldson E, Westman G, Buchholz S, Miller V, Hansen BE. Clin Gastroenterol Hepatol 2021; 19(3): 463-472.10.1016/j.cgh.2020.05.041.

The Use of External Controls in FDA Regulatory Decision Making
Jahanshahi M, Gregg K, Davis G, Ndu A, Miller V, Vockley J, Ollivier C, Franolic T, Sakai S. Ther Innov Regul Sci. 2021; 55(5): 1019-1035.10.1007/s43441-021-00302-y.

Commentary title: COVID-19 research, Africa, and global health
Mbichila T, Kumwenda G, Yola N, Karim QA, Tchelidze T, Lau J, Buchholz S, Lehnert R, Molina JM, Mayer K, Miller V. Virus Erad. 2021; 7(1): 100030.10.1016/j.jve.2021.100030.

2020

Standardization of diet and exercise in clinical trials of NAFLD-NASH: Recommendations from the Liver Forum
Glass O, Filozof C, Noureddin M, Berner-Hansen M, Schabel E, Omokaro SO, Schattenberg JM, Barradas K, Miller Standardization of Diet, Francque S, Abdelmalek MF. J Hepatol 2020; 73(3): 680-693.10.1016/j.jhep.2020.04.030.

Attribution of Nonalcoholic Steatohepatitis as an Etiology of Cirrhosis for Clinical Trials Eligibility: Recommendations from the Multi-stakeholder Liver Forum
Noureddin M, Chan JL, Barradas K, Dimick-Santos L, Schabel E, Omokaro SO, Anania FA, Myers RP, Miller V, Sanyal AJ, Chalasani N. Gastroenterology 2020; 159(2): 422-427 e421.10.1053/j.gastro.2020.04.039.

2019

Liver safety assessment in clinical trials of new agents for chronic hepatitis B
Fontana RJ, Avigan MI, Janssen HLA, Regev A, Mishra P, Gaggar A, Brown N, Wat C, Mendez P, Anderson RT, Given B, Miller V, Beumont M. J Viral Hepat. 2020; 27(2): 96-109.10.1111/jvh.13223.

Factors to Consider in Development of Drugs for Pediatric Nonalcoholic Fatty Liver Disease
Vos MB, Dimick-Santos L, Mehta R, Omokaro SO, Taminiau J, Schabel E, Kleiner DE, Szitanyi P, Socha P, Schwimmer JB, Noviello S, Silberg DG, Torstenson R, Miller V, Lavine JE, Liver Forum Pediatric Working Group. Gastroenterology 2019; 157(6): 1448-1456 e1441.10.1053/j.gastro.2019.08.048.

Defining Improvement in Nonalcoholic Steatohepatitis for Treatment Trial Endpoints: Recommendations From the Liver Forum
Cheung A, Neuschwander-Tetri BA, Kleiner DE, Schabel E, Rinella M, Harrison S, Ratziu V, Sanyal AJ, Loomba R, Jeannin Megnien S, Torstenson R, Miller V, Liver Forum Case Definitions Working Group. Hepatology 2019; 70(5): 1841-1855.10.1002/hep.30672.

Challenges, Considerations, and Principles to Guide Trials of Combination Therapies for Chronic Hepatitis B Virus
Anderson RT, Lim SG, Mishra P, Josephson F, Donaldson E, Given B, Miller V. Gastroenterology 2019; 156(3): 529-533 e524.10.1053/j.gastro.2018.11.062.

2018

Use of Viral Load as a Surrogate Marker in Clinical Studies of Cytomegalovirus in Solid Organ Transplantation: A Systematic Review and Meta-analysis
Natori Y, Alghamdi A, Tazari M, Miller V, Husain S, Komatsu T, Griffiths P, Ljungman P, Orchanian-Cheff A, Kumar D, Humar A. Clin Infect Dis. 2018; 66(4): 617-631.10.1093/cid/cix793.

Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science
Siddiqui MS, Harrison SA, Abdelmalek MF, Anstee QM, Bedossa P, Castera L, Dimick-Santos L, Friedman SL, Greene K, Kleiner DE, Megnien S, Neuschwander-Tetri BA, Ratziu V, Schabel E, Miller V, Sanyal AJ, Liver Forum Case Definitions Working Group. Hepatology 2018; 67(5): 2001-2012.10.1002/hep.29607.

Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials
Chemaly RF, Chou S, Einsele H, Griffiths P, Avery R, Razonable RR, Mullane KM, Kotton C, Lundgren J, Komatsu TE, Lischka P, Josephson F, Douglas CM, Umeh O, Miller V, Ljungman P, Resistant Definitions Working Group of the CMV Forum. Clin Infect Dis. 2019; 68(8): 1420-1426.10.1093/cid/ciy696

2017

Optimizing diagnosis of viraemic hepatitis C infection: the development of a target product profile
Ivanova Reipold E, Easterbrook P, Trianni A, Panneer N, Krakower D, Ongarello S, Roberts T, Miller V, Denkinger C. BMC Infect Dis. 2017; 17(Suppl 1): 707.10.1186/s12879-017-2770-5.

The HepTestContest: a global innovation contest to identify approaches to hepatitis B and C testing
Tucke JD, Meyers K, Best J, Kaplan K, Pendse R, Fenton KA, Andrieux-Meyer I, Figueroa C, Goicochea P, Gore C, Ishizaki A, Khwairakpam G, Miller V, Mozalevskis A, Ninburg M, Ocama P, Peeling R, Walsh N, Colombo MG, Easterbrook P. BMC Infect Dis. 2017; 17(Suppl 1): 701.10.1186/s12879-017-2771-4.

Baseline Parameters in Clinical Trials for Nonalcoholic Steatohepatitis: Recommendations From the Liver Forum
Patel YA, Imperial JC, Muir AJ, Anstee QM, DeBrota D, Dimick-Santos L, Filozof C, Mehta R, Sanyal AJ, Schabel E, Neuschwander-Tetri BA, Miller V, Liver Forum's Data Standardization Working Group. Gastroenterology 2017; 153(3): 621-625 e627.10.1053/j.gastro.2017.07.024.

Advancing the regulatory path on hepatitis B virus treatment and curative research: a stakeholders' consultation
Liu J, Goicochea P, Block T, Brosgart CL, Donaldson EF, Lenz E, Lim SG, Marins EG, Mishra P, Peters MG, Miller V. Journal of Virus Eradication 2017; 3:1-6.

Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials
Ljungman P, Boeckh M, Hirsch HH, Josephson F, Lundgren J, Nichols G, Pikis A, Razonable RR, Miller V, Griffiths PD. Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum. Clin Infect Dis. 2017; 64(1): 87-91.10.1093/cid/ciw668

Publications/Reports