Steven Joffe, MD, MPH

Papers

2015

Weiss EM, Joffe S. Promoting informed decision making for comparative effectiveness randomized trials. JAMA 2015 Sep;169(9):803-4.

Cho MK, Magnus D, Constantine M, Lee SS, Kelley M, Alessi S, Korngiebel D, James C, Kuwana E, Gallagher TH, Diekema D, Capron AM, Joffe S, Wilfond BS. Attitudes toward risk and informed consent for research on medical practices: A cross-sectional survey. Ann Intern Med. 2015 May 19;162(10):690-6.

Goldberg AJ, Maschke KJ, Joffe S, Botkin JR, Rothwell E, Murray TH, Anderson R, Deming N, Rosenthal BF, Rivera SM. IRB practices and policies regarding the secondary research use of biospecimens. BMC Med Ethics. 2015 May 8;16:32.

Guilcher GM, Fernandez CV, Joffe S. Are hybrid umbilical cord blood banks really the best of both worlds? J Med Ethics. 2015 Mar;41(3):272-5

Majhail NS, Mau LW, Chitphakdithai P, Payton T, Eckrich M, Joffe S, Lee SJ, LeMaistre CF, LeRademacher J, Loberiza F, Logan B, Parsons SK, Repaczki-Jones R, Robinett P, Rizzo JD, Murphy E, Denzen EM. National Survey of Hematopoietic Cell Transplant Center Personnel, Infrastructure and Models of Care Delivery. Biol Blood Marrow Transplant. 2015 Mar 31. [Epub ahead of print]

Amendola LM, Dorschner MO, Robertson PD, Salama JS, Hart R, Shirts BH, Murray ML, Tokita MJ, Gallego CJ, Kim DS, Bennett JT, Crosslin DR, Ranchalis J, Jones KL, Rosenthal EA, Jarvik ER, Itsara A, Turner EH, Herman DS, Schleit J, Burt A, Jamal SM, Abrudan JL, Johnson AD, Conlin LK, Dulik MC, Santani A, Metterville DR, Kelly M, Foreman AK, Lee K, Taylor KD, Guo X, Crooks K, Kiedrowski LA, Raffel LJ, Gordon O, Machini K, Desnick RJ, Biesecker LG, Lubitz SA, Mulchandani S, Cooper GM, Joffe S, Richards CS, Yang Y, Rotter JI, Rich SS, O'Donnell CJ, Berg JS, Spinner NB, Evans JP, Fullerton SM, Leppig KA, Bennett RL, Bird T, Sybert VP, Grady WM, Tabor HK, Kim JH, Bamshad MJ, Wilfond B, Motulsky AG, Scott CR, Pritchard CC, Walsh TD, Burke W, Raskind WH, Byers P, Hisama FM, Rehm H, Nickerson DA, Jarvik GP. Actionable exomic incidental findings in 6503 participants: challenges of variant classification. Genome Res. 2015 Mar;25(3):305-15.

2014

Wang B, Joffe S, Kesselheim AS. Chemotherapy parity laws: a remedy for high drug costs? JAMA Intern Med. 2014 Nov;174(11):1721-2.

Ballen KK, Joffe S, Brazauskas R, Wang Z, Aljurf MD, Akpek G, Dandoy C, Frangoul HA, Freytes CO, Khera N, Lazarus HM, LeMaistre CF, Mehta P, Parsons SK, Szwajcer D, Ustun C, Wood WA, Majhail NS: Hospital Length of Stay in the First 100 Days after Allogeneic Hematopoietic Cell Transplantation for Acute Leukemia in Remission: Comparison among Alternative Graft Sources. Biol Blood Marrow Transplant. 2014 Nov;20(11):1819-27.

Lamont EB, Schilsky RL, He Y, Muss H, Cohen HJ, Hurria A, Meilleur A, Kindler HL, Venook A, Lilenbaum R, Niell H, Goldberg RM, Joffe S, Alliance for Clinical Trials in Oncology. Generalizability of trial results to elderly medicare patients with advanced solid tumors (alliance 70802). J Natl Cancer Inst. 2014 Nov 27;107(1):336.

Henderson GE, Wolf SM, Kuczynski KJ, Joffe S, Sharp RR, Parsons DW, Knoppers BM, Yu JH, Appelbaum PS. The challenge of informed consent and return of results in translational genomics: empirical analysis and recommendations. J Law Med Ethics. 2014 Fall;42(3):344-55.

Gray SW, Martins Y, Feuerman L, Bernhardt BA, Biesecker BB, Christensen KD, Joffe S, Rini C, Veenstra D, McGuire AL. Social and behavioral research in genomic sequencing: Approaches from the Clinical Sequencing Exploratory Research Consortium Outcomes and Measures Working Group. Genet Med. 2014 Oct;16(10):727-35.

Rathi VK, Strait KM, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM,Dzara K, Ross JS. Predictors of Clinical Trial Data Sharing: An Exploratory Analysis of a Cross-Sectional Survey. Trials. 2014 Oct 2;15:384

Joffe S, Miller FG. The ethics of cancer clinical trials in low-resource settings. J Clin Oncol. 2014 Oct 1;32(28):3192-6.

Miller FG, Joffe S, Kesselheim AS. Evidence, errors, and ethics. Perspect Biol Med. 2014;57(3):299-307.

Paquette ET, Najita J, Morley DS, Joffe S. Child and parent understanding of clinical trials: The Semi-Structured Comprehension Interview. Am J Bioeth. 2014;6(2):23-32.

Holm IA, Savage SK, Green RC, Juengst E, McGuire A, Kornetsky S, Brewster SJ, Joffe S, Taylor P. Guidelines for Return of Research Results from Pediatric Genomic Studies: Deliberations of the Boston Children's Hospital Gene Partnership Informed Cohort Oversight Board. Genet Med. 2014 Jul;16(7):547-52.

Hwong AR, Qaragholi N, Carpenter D, Joffe S, Campbell EG, Lehmann LS. A systematic review of state and manufacturer physician payment disclosure websites: Implications for implementation of the Sunshine Act. J Law Med Ethics. 2014 Summer;42(2):208-19

Van Allen EM, Wagle N, Stojanov P, Perrin DL, Cibulskis K, Marlow S, Jane-Valbuena J, Friedrich DC, Kryukov G, Carter SL, McKenna A, Sivachenko A, Rosenberg M, Kiezun A, Voet D, Lawrence M, Lichtenstein LT, Gentry JG, Huang FW, Fostel J, Farlow D, Barbie D, Gandhi L, Lander ES, Gray SW, Joffe S, Janne P, Garber J, MacConaill L, Lindeman N, Rollins B, Kantoff P, Fisher SA, Gabriel S, Getz G, Garraway LA. Whole-exome sequencing and clinical interpretation of formalin-fixed, paraffin-embedded tumor samples to guide precision cancer medicine. Nat Med. 2014 Jun;20(6):682-8.

Wood WA, Lee SJ, Brazauskas R, Wang Z, Aljurf MD, Ballen KK, Buchbinder DK, Dehn J, Freytes CO, Lazarus HM, Lemaistre CF, Mehta P, Szwajcer D, Joffe S, Majhail NS. Survival improvements in adolescents and young adults after myeloablative allogeneic transplantation for acute lymphoblastic leukemia. Biol Blood Marrow Transplant. 2014 Jun;20(6):829-36.

Joffe S, Wertheimer A. Determining minimal risk for comparative effectiveness research. IRB. 2014 May-Jun;36(3):16-8.

Amendola LM, Dorschner MO, Robertson PD, Salama JS, Hart R, Shirts BH, Murray ML, Tokita MJ, Gallego CJ, Kim DS, Bennett JT, Crosslin DR, Ranchalis J, Jones KL, Rosenthal EA, Jarvik ER, Itsara A, Turner EH, Herman DS, Schleit J, Burt A, Jamal SM, Abrudan JL, Johnson AD, Conlin LK, Dulik MC, Santani A, Metterville DR, Kelly M, Foreman AK, Lee K, Taylor KD, Guo X, Crooks K, Kiedrowski LA, Raffel LJ, Gordon O, Machini K, Desnick RJ, Biesecker LG, Lubitz SA, Mulchandani S, Cooper GM, Joffe S, Richards CS, Yang Y, Rotter JI, Rich SS, O'Donnell CJ, Berg JS, Spinner NB, Evans JP, Fullerton SM, Leppig KA, Bennett RL, Bird T, Sybert VP, Grady WM, Tabor HK, Kim JH, Bamshad MJ, Wilfond B, Motulsky AG, Scott CR, Pritchard CC, Walsh TD, Burke W, Raskind WH, Byers P, Hisama FM, Rehm H, Nickerson DA, Jarvik GP. Actionable exomic incidental findings in 6503 participants: challenges of variant classification. Genome Res. 2015 Mar;25(3):305-15.

DeCamp M, Joffe S, Fernandez CV, Faden RR, Unguru Y; Working Group on Chemotherapy Drug Shortages in Pediatric Oncology. Chemotherapy Drug Shortages in Pediatric Oncology: A Consensus Statement. Pediatrics. 2014 Mar;133(3):e716-24.

Clayton EW, McCullough LB, Biesecker LG, Joffe S, Ross LF, Wolf SM. Addressing the Ethical Challenges in Genetic Testing and Sequencing of Children. Am J Bioeth. 2014 Mar;14(3):3-9.

Doody RS, Thomas RG, Farlow M, Iwatsubo T, Vellas B, Joffe S, Kieburtz K, Raman R, Sun X, Aisen PS, Siemers E, Liu-Seifert H, Mohs R. Alzheimer's Disease Cooperative Study Steering Committee; Solanezumab Study Group: Phase 3 trials of solanezumab for mild-to-moderate Alzheimer's disease. N Engl J Med. 2014 Jan 23;370(4):311-21.

2013

Miller FG, Joffe S. Phase 1 Oncology Trials and Informed Consent. J Med Ethics. 2013 Dec;39(12):761-4.

Ramoni RB, McGuire AL, Robinson JO, Morley DS, Plon SE, Joffe S. Experiences and attitudes of genome investigators regarding return of individual genetic test results. Genet Med. 2013 Nov;15(11):882-7.

Denicoff AM, McCaskill-Stevens W, Grubbs SS, Bruinooge SS, Comis RL, Devine P, Dilts DM, Duff ME, Ford JG, Joffe S, Schapira L, Weinfurt KP, Michaels M, Raghavan D, Richmond ES, Zon R, Albrecht TL, Bookman MA, Dowlati A, Enos RA, Fouad MN, Good M, Hicks WJ, Loehrer PJ Sr, Lyss AP, Wolff SN, Wujcik DM, Meropol NJ. The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: Summary and Recommendations. J Oncol Pract. 2013 Nov;9(6):267-76.

Majhail NS, Tao L, Bredeson C, Davies S, Dehn J, Gajewski JL, Hahn T, Jakubowski A, Joffe S,  Lazarus HM, Parsons SK, Robien K, Lee SJ, Kuntz KM. Prevalence of hematopoietic cell transplant survivors in the United States. Biol Blood Marrow Transplant. 2013 Oct;19(10):1498-501.

Doody R, Raman R, Siemers E, Sethuraman G, Mohs R, Farlow M, Iwatsubo T, Vellas B, Joffe S, Kieburtz K, He F, Sun X, Thomas R, Aisen P. A Phase 3 Trial of Semagacestat for Treatment of Alzheimer's Disease. N Engl J Med. 2013 Jul 25;369(4):341-50.

McCarthy PL Jr, Hahn T, Hassebroek A, Bredeson C, Gajewski J, Hale G, Isola L, Lazarus HM, Lee SJ, Lemaistre CF, Loberiza F, Maziarz RT, Rizzo JD, Joffe S, Parsons S, Majhail NS. Trends in Use of and Survival After Autologous Hematopoietic Cell Transplantation in North America, 1995-2005: Significant Improvement in Survival for Lymphoma and Myeloma During a Period of Increasing Recipient Age. Biol Blood Marrow Transplant. 2013 Jul;19(7):1116-23.

Hahn T, McCarthy PL Jr, Hassebroek A, Bredeson C, Gajewski JL, Hale GA, Isola LM, Lazarus HM, Lee SJ, Lemaistre CF, Loberiza F, Maziarz RT, Rizzo JD, Joffe S, Parsons S, Majhail NS. Significant Improvement in Survival After Allogeneic Hematopoietic Cell Transplantation During a Period of Significantly Increased Use, Older Recipient Age, and Use of Unrelated Donors. J Clin Oncol. 2013 Jul 1;31(19):2437-49.

Reeve BB, Withycombe JS, Baker JN, Hooke MC, Lyons JC, Mowbray C, Wang J, Freyer DR, Joffe S, Sung L, Tomlinson D, Gold SH, Hinds PS. The First Step to Integrating the Child's Voice in Adverse Event Reporting in Oncology Trials: A Content Validation Study Among Pediatric Oncology Clinicians. Pediatr Blood Cancer. 2013 Jul;60(7):1231-6.

McGuire AL, Joffe S, Koenig BA, Biesecker BB, McCullough LB, Blumenthal-Barby JS, Caulfield T, Terry SF, Green RC. Point-counterpoint. Ethics and genomic incidental findings. Science. 2013 May 31;340(6136):1047-8.

Jimenez R, Zhang B, Joffe S, Nilsson M, Rivera L, Mutchler J, Lathan C, Paulk ME, Prigerson HG. Clinical Trial Participation Among Ethnic/Racial Minority and Majority Patients with Advanced Cancer: What Factors Most Influence Enrollment? J Palliat Med. 2013 Mar;16(3):256-62.

Unguru Y, Joffe S, Fernandez CV, Yu AL. Ethical Issues for Control-Arm Patients After Revelation of Benefits of Experimental Therapy: A Framework Modeled in Neuroblastoma. J Clin Oncol. 2013 Feb 10;31(5):641-6.

McGuire AL, Robinson JO, Ramoni RB, Morley DS, Joffe S, Plon SE. Returning Genetic Research Results: Study Type Matters. Per Med. 2013 Jan;10(1):27-34.

Abstracts

2015

Jarvik GP, Salama JS, Amendola LM, Appelbaum PS, Berg JS, Biesecker LG, Chinnaiyan AM, Chung WK, Clayton EE, Cooper G, Evans JP, Garraway LA, Garrett JR, Henderson GE, Holm IA, Joffe S, Koenig BA, Knoppers BM, Krantz ID, Janne PA, Huckaby-Lewis MH, Myers RM, Parsons DW, Petersen GM, Plon SE, Sharp RR, Spinner NB, Tabor HK, Wilfond B, Wolf SR, Caga-Anan CF, Hutter CM, McEwen JE, Hindorff LA, Goddard KAB, Green RC, The CSER Consortium. Clinical Sequencing Exploratory Research: Integrating Genomic Sequencing into the Clinic. CSER Consortium, American College of Medical Genetics (ACMG) March 2015.

Books

Chapters

Joffe S, Truog RD. Consent to Medical Care: The Importance of Fiduciary Context. Miller FG, Wertheimer A, editors. The Ethics of Consent: Theory and Practice. Oxford: Oxford University Press; page: 347-73, 2010.

Joffe S, Kesselheim JC, and Shurin SB. Ethical considerations in pediatric oncology. In: Pizzo, PA and Poplack, DG, editors. Principles and Practice of Pediatric Oncology. Philadelphia: Lippincott Williams & Wilkins; page: 1347-66, October 2010.

Joffe S, Truog RD. Equipoise and Randomization. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. Oxford Textbook of Research Ethics. Oxford, UK: Oxford University Press; p. 245-60, 2008.

Posters and Presentations

2015

"Children as Stem Cell Donors in Research," Workshop Leader, National Institutes of Health. Mar, 2015

"The Patient-Doctor Relationship," Department of Bioethics, National Institutes of Health Clinical Center. Mar, 2015

"Involving Children in Important Medical Decisions" - Pediatric Ethics Grand Rounds, Visiting Scholar, Department of Pediatrics and Center for Bioethics, UNC Chapel Hill School of Medicine. Feb, 2015

"Nonfinancial Incentives to Research Participants" - Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, Harvard Law School, presented at Brocher Institute, Hermance, Switzerland. Jan, 2015

2014

"Views of Patients and Physicians about Protocolized Dialysis Treatment in RCTs and Clinical Care" - PRIM&R Annual Meeting, Baltimore MD. Dec, 2014

"Returning Hemoglobinopathy Results to Blood Donors: Ethical Considerations" - Testimony given to Advisory Committee on Blood & Tissue Safety & Availability, Department of Health and Human Services, Arlington VA. Nov, 2014



"Informed Consent for Cluster Trials: Necessary or Not?" - American Society of Nephrology Annual Meeting, Philadelphia PA. Nov, 2014

"Ethics of children as stem cell donors" - American Association of Blood Banks Annual Meeting, Philadelphia PA. Oct, 2014



"Conflicts of Interest" - Ethical and Regulatory Aspects of Clinical Research, National Institutes of Health Clinical Center, Bethesda MD. Oct, 2014

"The ethics of early-phase trials in children with cancer" - Treuman Katz Lectureship, Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital, Seattle WA. Oct, 2014

"Informed Consent to Treatment and Research" - Ethics Fellowship, Harvard Medical School, Cambridge MA. Oct, 2014

"Learning Healthcare Systems: Ethically Integrating Research into Pediatric Care" - Tenth Annual Pediatric Bioethics Conference, Seattle Children's Hospital, Seattle WA. Jul, 2014

"Ethics of Early-Phase Trials in Children with Cancer" - Australian and New Zealand Children's Haematology/Oncology Group Annual Scientific Meeting, Sydney, Australia. Jun, 2014



"Ethical Challenges in Genomic Medicine" - Australian and New Zealand Children's Haematology/Oncology Group Annual Scientific Meeting, Sydney, Australia. Jun, 2014 

"Informed Consent and Privacy in Genomic Research" - Allen Institute, Seattle WA. May, 2014

"The Clinical Use of Genetics in Pediatrics" - Pediatrics Pharmacogenomics & Personalized Medicine, Children's Mercy Hospital, Kansas City MO. Apr, 2014

"Attitudes Towards Return of Incidental Genetic Findings Among Participants in the Jackson and Framingham Heart Studies" - Genetics Research Seminar, Dana-Farber Cancer Institute, Boston MA. Apr, 2014

"The Patient-Doctor Relationship" - Department of Bioethics, National Institutes of Health, Washington DC. Feb, 2014

"The Case for a Stringent Approach to Returning Results" - Committee on National Statistics, National Academies of Sciences, Washington, DC. Feb, 2014 

2013

"Returning Genetic Results from Biobank Research: A Reality-Based Perspective" - Returning Genetic Results in Biobanks: Opening an International Dialogue, Brocher Institute, Hermance, Switzerland. Nov, 2013

"Framing the protections for children in research" - Public Responsibility in Medicine & Research (PRIM&R) Annual Meeting, Boston, MA. Nov, 2013

"Children's capacity to make research decisions" - Public Responsibility in Medicine & Research (PRIM&R), Boston, MA. Nov, 2013

"A pediatric perspective on biobank research" - Public Responsibility in Medicine & Research (PRIM&R), Boston, MA. Nov, 2013

"Who Decides? Parent and Child Perspectives about Children Participating in Research" - American Society for Bioethics & Humanities (ASBH) 2013 Annual Meeting, Atlanta, GA. Oct, 2013

"Clarifying risks and benefits in_transplant clinical trials" - National Marrow Donor Program Council Meeting Plenary, Minneapolis, MN. Oct, 2013

"Conflicts of Interest" - Ethical and Regulatory Aspects of Clinical Research, National Institutes of Health Clinical Center, Bethesda, MD. Oct, 2013

"Involving Children in Decisions about Research" - Achieving Excellence in Clinical Research, Advocate Health Care, Oak Brook, IL. Sep, 2013

"Is Equipoise Necessary for Ethical Clinical Trials?" - Achieving Excellence in Clinical Research, Advocate Health Care, Oak Brook, IL. Sep, 2013

"Children's capacity to participate in research decisions" - Department of Pediatrics Grand Rounds, Connecticut Children's Medical Center, Hartford, CT. Apr, 2013

"An integrated germline analysis platform for comprehensive clinical cancer genomics" - American Association for Cancer Research 2013 Annual Meeting, Washington, DC. Apr, 2013

"The Patient-Doctor Relationship" - Department of Bioethics Fellows Seminar, National Institutes of Health. Feb, 2013