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  1. 1.   Virologic effects of broadly neutralizing antibodies VRC01LS and VRC07-523LS on chronic HIV-1 infection
  2. Happe, Myra; Lynch, Rebecca M; Fichtenbaum, Carl J; Heath, Sonya L; Koletar, Susan L; Landovitz, Raphael J; Presti, Rachel M; Santana-Bagur, Jorge L; Tressler, Randall L; Holman, LaSonji A; Novik, Laura; Roa, Jhoanna C; Rothwell, Ro Shauna; Strom, Larisa; Wang,Jing; Hu, Zonghui; Conan-Cibotti, Michelle; Bhatnagar, Anjali M; Dwyer, Bridget; Ko, Sung Hee; Belinky, Frida; Namboodiri, Aryan M; Pandey, Janardan P; Carroll, Robin; Basappa, Manjula; Serebryannyy, Leonid; Narpala, Sandeep R; Lin, Bob C; McDermott, Adrian B; Boritz, Eli A; Capparelli, Edmund V; Coates, Emily E; Koup, Richard A; Ledgerwood, Julie E; Mascola, John R; Chen, Grace L; Tebas, Pablo
  3. JCI Insight. 2025, Feb 24; 10(4):
  1. 2.   Examining the bias-efficiency tradeoff from incorporation of nonconcurrent controls in platform trials: A simulation study example from the adaptive COVID-19 treatment trial
  2. Bonnett,Tyler; Potter, Gail E; Dodd, Lori E
  3. Clinical Trials (London, England). 2025, Feb 08; 17407745251313928.
  1. 3.   Practical application of good participatory practices for trials of emerging pathogens: Developing materials for use in ACTIV-3, -3b, and ACTIV-associated COVID-19 trials
  2. Guerra-de-Blas, Paola Del Carmen; Marines-Price, Rubria; Milman, Olga; Deal,Danae; Marchand,Jon; Linton,Jessica; Meger, Sue; Rule, John; Holland, Thomas L; Kitonsa, Jonathan; Delph, Yvette
  3. Journal of Clinical and Translational Science. 2024, Oct 15; 8(1): e157.
  1. 4.   Focusing HIV-1 Gag T-cell Responses to Highly Conserved Regions by DNA Vaccination in HVTN 119
  2. Kalams, Spyros A; Felber,Barbara; Mullins, James I; Scott, Hyman M; Allen, Mary A; De Rosa, Stephen C; Heptinstall, Jack; Tomaras, Georgia D; Hu, Jiani; deCamp, Allan C; Rosati,Margherita; Bear,Jenifer; Pensiero, Michael N; Eldridge, John; Egan, Michael A; Hannaman, Drew; McElrath, M Juliana; Pavlakis,George
  3. JCI Insight. 2024, Aug 01;
  1. 5.   Recommendations for assessing appearance concerns related to plexiform and cutaneous neurofibromas in neurofibromatosis 1 clinical trials
  2. Merker, Vanessa L; Thompson, Heather L; Wolters, Pamela L; Buono, Frank D; Hingtgen, Cynthia M; Rosser, Tena; Barton, Belinda; Barnett, Carolina; Smith, Taylor; Haberkamp, Diana; McManus, Miranda L; Baldwin,Andrea; Moss, Irene P; Röhl, Claas; Martin, Staci
  3. Clinical Trials (London, England). 2023, Dec 23; 17407745231205577.
  1. 6.   Perspectives of adults with neurofibromatosis regarding the design of psychosocial trials: Results from an anonymous online survey
  2. Wolters, Pamela L; Al Ghriwati,Nour; Baker, Melissa; Martin, Staci; Berg, Dale; Erickson, Gregg; Franklin, Barbara; Merker, Vanessa L; Oberlander, Beverly; Reeve, Stephanie; Rohl, Claas; Rosser, Tena; Vranceanu, Ana-Maria
  3. Clinical Trials (London, England). 2023, Nov 14;
  1. 7.   A phase III randomized crossover trial of plerixafor versus G-CSF for treatment of WHIM syndrome
  2. McDermott, David H; Velez, Daniel; Cho, Elena; Cowen, Edward W; DiGiovanna, John J; Pastrana, Diana V; Buck, Christopher B; Calvo, Katherine R; Gardner, Pamela J; Rosenzweig, Sergio D; Stratton, Pamela; Merideth, Melissa A; Kim, H Jeffrey; Brewer, Carmen; Katz, James D; Kuhns,Doug; Malech, Harry L; Follmann, Dean; Fay, Michael P; Murphy, Philip M
  3. The Journal of Clinical Investigation. 2023, Oct 2; 133(19): e164918.
  1. 8.   Evaluating Demographic Representation in Clinical Trials: Use of the Adaptive Coronavirus Disease 2019 Treatment Trial (ACTT) as a Test Case
  2. Ortega-Villa, Ana M; Hynes, Noreen A; Levine, Corri B; Yang, Katherine; Wiley, Zanthia; Jilg, Nikolaus; Wang,Jing; Whitaker, Jennifer A; Colombo, Christopher J; Nayak, Seema U; Kim, Hannah Jang; Iovine, Nicole M; Ince, Dilek; Cohen, Stuart H; Langer, Adam J; Wortham, Jonathan M; Atmar, Robert L; El Sahly, Hana M; Jain, Mamta K; Mehta, Aneesh K; Wolfe, Cameron R; Gomez, Carlos A; Beresnev, Tatiana; Mularski, Richard A; Paules, Catharine I; Kalil, Andre C; Branche, Angela R; Luetkemeyer, Annie; Zingman, Barry S; Voell, Jocelyn; Whitaker, Michael; Harkins, Michelle S; Davey, Richard T; Grossberg, Robert; George, Sarah L; Tapson, Victor; Short, William R; Ghazaryan, Varduhi; Benson, Constance A; Dodd, Lori E; Sweeney, Daniel A; Tomashek, Kay M
  3. Open Forum Infectious Diseases. 2023, Jun; 10(6): ofad290.
  1. 9.   Phase I/II study of PexaVec in combination with immune checkpoint inhibition in refractory metastatic colorectal cancer
  2. Monge, Cecilia; Xie, Changqing; Myojin, Yuta; Coffman, Kelley; Hrones, Donna Mabry; Wang, Sophie; Hernandez, Jonathan M; Wood, Bradford J; Levy, Elliot B; Juburi, Israa; Hewitt, Stephen M; Kleiner, David E; Steinberg, Seth M; Figg, William D; Redd, Bernadette; Homan,Philip; Cam, Maggie; Ruf, Benjamin; Duffy, Austin G; Greten, Tim F
  3. Journal for Immunotherapy of Cancer. 2023, Feb; 11(2):
  1. 10.   Improving Patient Advocacy in NCI Scientific Steering Committees and Task Forces
  2. Bangs, Rick; Lynn, Jean M; Obot,Evelyn; Osborne, Sherill; Norris, Kim
  3. Journal of the National Cancer Institute. 2022, May 12;
  1. 11.   Phase I study of single agent NIZ985, a recombinant heterodimeric IL-15 agonist, in adult patients with metastatic or unresectable solid tumors
  2. Conlon, Kevin; Watson, Dionysios C; Waldmann, Thomas A; Valentin,Antonio; Bergamaschi,Cristina; Felber,Barbara; Peer, Cody J; Figg, William D; Potter, E Lake; Roederer, Mario; McNeel, Douglas G; Thompson, John A; Gupta, Sumati; Leidner, Rom; Wang-Gillam, Andrea; Parikh, Nehal S; Long, Debby; Kurtulus, Sema; Ho Lee, Lang; Chowdhury, Niladri Roy; Bender, Florent; Pavlakis,George
  3. Journal for immunotherapy of cancer. 2021, Nov; 9(11):
  1. 12.   Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3)
  2. Murray, Daniel D.; Babiker, Abdel G.; Baker, Jason; Barkauskas, Christina E.; Brown, Samuel M.; Chang, Christina C.; Davey, Victoria J.; Gelijns, Annetine C.; Ginde, Adit A.; Grund, Birgit; Higgs, Elizabeth; Hudson, Fleur; Kan, Virginia L.; Lane, H. Clifford; Murray, Thomas A.; Paredes, Roger; Parmar, Mahesh K. B.; Pett, Sarah; Phillips, Andrew N.; Polizzotto, Mark N.; Reilly, Cavan; Sandkovsky, Uriel; Sharma, Shweta; Teitelbaum,Marc; Thompson, B. Taylor; Young, Barnaby E.; Neaton, James D.; Lundgren, Jens D.
  3. Clinical Trials. 2021, Oct 10;
  1. 13.   Performance of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus) Instrument in Patients With Coronavirus Disease 2019
  2. Richard, Stephanie A; Epsi, Nusrat J; Pollett, Simon; Lindholm, David A; Malloy, Allison M W; Maves, Ryan; Utz, Gregory C; Lalani, Tahaniyat; Smith, Alfred G; Mody, Rupal M; Ganesan, Anuradha; Colombo, Rhonda E; Colombo, Christopher J; Chi, Sharon W; Huprikar, Nikhil; Larson, Derek T; Bazan, Samantha; Madar, Cristian; Lanteri, Charlotte; Rozman, Julia S; English, Caroline; Mende, Katrin; Tribble, David R; Agan, Brian K; Burgess, Timothy H; Powers,John
  3. Open Forum Infectious Diseases. 2021, Oct 8; 8(12): ofab517.
  1. 14.   Consequences of hemophagocytic lymphohistiocytosis-like cytokine release syndrome toxicities and concurrent bacteremia
  2. Masih, Katherine E.; Ligon, John A.; Yates, Bonnie; Shalabi, Haneen; Little, Lauren; Islam, Zahin; Ombrello, Amanda K.; Inglefield,Jon; Nussenblatt, Veronique; Manion, Maura; Khan, Javed; Shah, Nirali N.
  3. Pediatric blood & cancer. 2021, Jul 26;
  1. 15.   Veterinary Cooperative Oncology Group-Common Terminology Criteria for Adverse Events (VCOG-CTCAE v2) following investigational therapy in dogs and cats
  2. LeBlanc, Amy K.; Atherton, Matthew; Bentley, R. Timothy; Boudreau, C. Elizabeth; Burton, Jenna H.; Curran, Kaitlin M.; Dow, Steven; Giuffrida, Michelle A.; Kellihan, Heidi B.; Mason, Nicola J.; Oblak, Michelle; Selmic, Laura E.; Selting, Kimberly A.; Singh, Ameet; Tjostheim, Sonja; Vail, David M.; Weishaar, Kristen M.; Berger,Erika; Rossmeisl, John H.; Mazcko, Christina
  3. VETERINARY AND COMPARATIVE ONCOLOGY. 2021, Jun; 19(2): 311-352.
  1. 16.   Heterodimeric IL-15 in Cancer Immunotherapy
  2. Bergamaschi,Cristina; Stravokefalou,Vasiliki; Stellas,Dimitris; Karaliota,Sevasti; Felber,Barbara; Pavlakis,George
  3. Cancers. 2021, Feb 17; 13(4):
  1. 17.   Endpoints for randomized controlled clinical trials for COVID-19 treatments
  2. Dodd, Lori E; Follmann, Dean; Wang,Jing; Koenig, Franz; Korn, Lisa L; Schoergenhofer, Christian; Proschan, Michael; Hunsberger, Sally; Bonnett,Tyler; Makowski, Mat; Belhadi, Drifa; Wang, Yeming; Cao, Bin; Mentre, France; Jaki, Thomas
  3. Clinical trials (London, England). 2020, Jul 16; pii: 1740774520939938.
  1. 18.   Neoadjuvant PROSTVAC prior to radical prostatectomy enhances T-cell infiltration into the tumor immune microenvironment in men with prostate cancer
  2. Abdul Sater, Houssein; Marté, Jennifer L; Donahue, Renee N; Walter-Rodriguez, Beatriz; Heery, Christopher R; Steinberg, Seth M; Cordes, Lisa M; Chun, Guinevere; Karzai, Fatima; Bilusic, Marijo; Harmon,Stephanie; Turkbey, Ismail Baris; Choyke, Peter L; Schlom, Jeffrey; Dahut, William L; Madan, Ravi A; Pinto, Peter A; Gulley, James L
  3. Journal for immunotherapy of cancer. 2020, Mar; 8(1): pii : jitc-2020-000655.
  1. 19.   A Rare Opportunity: Examining the Experience of a New Institutional Review Board
  2. Parreco, Linda; Rooney, Lisa; Hampp, Sharon; Brown, Amanda; Minasian, Lori
  3. Journal of empirical research on human research ethics : JERHRE. 2019, Jul; 14(3): 274-285.
  1. 20.   Measuring IRB Regulatory Compliance: Development, Testing, and Use of the National Cancer Institute StART Tool
  2. Rooney, Lisa; Covington, Laura; Dedier, Andrea; Samuel, Birdena
  3. JOURNAL OF EMPIRICAL RESEARCH ON HUMAN RESEARCH ETHICS. 2019, Apr; 14(2): 95-106.
  1. 21.   Population Pharmacokinetics and Pharmacodynamics of Disulfiram on Inducing Latent HIV-1 Transcription in a Phase 2b Trial
  2. Lee, Sulggi A; Elliott, Julian H; McMahon, James; Hartogenesis, Wendy; Bumpus, Namandje N; Lifson, Jeffrey; Gorelick, Robert; Bacchetti, Peter; Deeks, Steven G; Lewin, Sharon R; Savic, Radojka M
  3. Clinical pharmacology and therapeutics. 2019, Mar; 105(3): 692-702.
  1. 22.   Half blind superiority tests for clinical trials of anti-infective drugs
  2. Follmann, Dean; Brittain, Erica; Lumbard, Keith
  3. Statistics in Medicine. 2019, Jan 15; 38(1): 31-43.
  1. 23.   Analysis Populations in Anti-Infective Clinical Trials: Whom to Analyze?
  2. Evans, Scott; Rubin, Daniel B; Powers,John; Follmann, Dean
  3. Statistical communications in infectious diseases. 2018, Dec; 10(1): pii: 20170002..
  1. 24.   Outcomes of Children and Adolescents with Advanced Hereditary Medullary Thyroid Carcinoma Treated with Vandetanib
  2. Kraft, Ira L.; Akshintala, Srivandana; Zhu, Yuelin; Lei, Haiyan; Derse-Anthony, Claudia; Dombi, Eva; Steinberg, Seth M.; Lodish, Maya; Waguespack, Steven G.; Kapustina, Oxana; Fox, Elizabeth; Balis, Frank M.; Merino, Maria J.; Meltzer, Paul S.; Glod, John W.; Shern, Jack F.; Widemann, Brigitte C.
  3. CLINICAL CANCER RESEARCH. 2018, Feb 15; 24(4): 753-765.
  1. 25.   Performance Observations of Scanner Qualification of NCI-Designated Cancer Centers: Results From the Centers of Quantitative Imaging Excellence (CQIE) Program
  2. Rosen, Mark; Kinahan, Paul E; Gimpel, James F; Opanowski, Adam; Siegel, Barry A; Hill, Gordon; Weiss, Linda; Shankar, Lalitha
  3. Academic Radiology. 2017, Feb; 24(2): 232-245.
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