User menu

Society for immunotherapy of cancer (SITC) statement on the proposed changes to the common rule.

Bibliographic reference Kaufman, Howard L ; Butterfield, Lisa H ; Coulie, Pierre ; Demaria, Sandra ; Ferris, Robert L ; et. al. Society for immunotherapy of cancer (SITC) statement on the proposed changes to the common rule.. In: Journal for ImmunoTherapy of Cancer, Vol. 4, no.1, p. 37 (2016)
Permanent URL http://hdl.handle.net/2078.1/175484
  1. Rosenberg Steven A., Decade in review—cancer immunotherapy: Entering the mainstream of cancer treatment, 10.1038/nrclinonc.2014.174
  2. Pardoll D., Immunotherapy: It Takes a Village, 10.1126/science.344.6180.149-a
  3. Larkin James, Chiarion-Sileni Vanna, Gonzalez Rene, Grob Jean Jacques, Cowey C. Lance, Lao Christopher D., Schadendorf Dirk, Dummer Reinhard, Smylie Michael, Rutkowski Piotr, Ferrucci Pier F., Hill Andrew, Wagstaff John, Carlino Matteo S., Haanen John B., Maio Michele, Marquez-Rodas Ivan, McArthur Grant A., Ascierto Paolo A., Long Georgina V., Callahan Margaret K., Postow Michael A., Grossmann Kenneth, Sznol Mario, Dreno Brigitte, Bastholt Lars, Yang Arvin, Rollin Linda M., Horak Christine, Hodi F. Stephen, Wolchok Jedd D., Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma, 10.1056/nejmoa1504030
  4. Protection of human subjects; informed consent; standards for institutional review boards for clinical investigations – FDA. Final rule. Fed Reg Title 21. 1991; 56(117):28025–9
  5. American Society of Clinical Oncology Policy Statement: Oversight of Clinical Research, 10.1200/jco.2003.04.026
  6. Mondragon-Barrios L. Informed consent: a dialogic praxis for the research. Rev Invest Clin. 2009;61(1):73–82.
  7. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Department of Health, Education and Welfare (DHEW). The Belmont report. Washington, DC: United States Government Printing Office; 1978.
  8. Hudson Kathy L., Collins Francis S., Bringing the Common Rule into the 21st Century, 10.1056/nejmp1512205
  9. Topalian Suzanne L., Hodi F. Stephen, Brahmer Julie R., Gettinger Scott N., Smith David C., McDermott David F., Powderly John D., Carvajal Richard D., Sosman Jeffrey A., Atkins Michael B., Leming Philip D., Spigel David R., Antonia Scott J., Horn Leora, Drake Charles G., Pardoll Drew M., Chen Lieping, Sharfman William H., Anders Robert A., Taube Janis M., McMiller Tracee L., Xu Haiying, Korman Alan J., Jure-Kunkel Maria, Agrawal Shruti, McDonald Daniel, Kollia Georgia D., Gupta Ashok, Wigginton Jon M., Sznol Mario, Safety, Activity, and Immune Correlates of Anti–PD-1 Antibody in Cancer, 10.1056/nejmoa1200690
  10. Robert Caroline, Ribas Antoni, Wolchok Jedd D, Hodi F Stephen, Hamid Omid, Kefford Richard, Weber Jeffrey S, Joshua Anthony M, Hwu Wen-Jen, Gangadhar Tara C, Patnaik Amita, Dronca Roxana, Zarour Hassane, Joseph Richard W, Boasberg Peter, Chmielowski Bartosz, Mateus Christine, Postow Michael A, Gergich Kevin, Elassaiss-Schaap Jeroen, Li Xiaoyun Nicole, Iannone Robert, Ebbinghaus Scot W, Kang S Peter, Daud Adil, Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial, 10.1016/s0140-6736(14)60958-2
  11. Gettinger Scott N., Horn Leora, Gandhi Leena, Spigel David R., Antonia Scott J., Rizvi Naiyer A., Powderly John D., Heist Rebecca S., Carvajal Richard D., Jackman David M., Sequist Lecia V., Smith David C., Leming Philip, Carbone David P., Pinder-Schenck Mary C., Topalian Suzanne L., Hodi F. Stephen, Sosman Jeffrey A., Sznol Mario, McDermott David F., Pardoll Drew M., Sankar Vindira, Ahlers Christoph M., Salvati Mark, Wigginton Jon M., Hellmann Matthew D., Kollia Georgia D., Gupta Ashok K., Brahmer Julie R., Overall Survival and Long-Term Safety of Nivolumab (Anti–Programmed Death 1 Antibody, BMS-936558, ONO-4538) in Patients With Previously Treated Advanced Non–Small-Cell Lung Cancer, 10.1200/jco.2014.58.3708
  12. Yuan Jianda, Hegde Priti S., Clynes Raphael, Foukas Periklis G., Harari Alexandre, Kleen Thomas O., Kvistborg Pia, Maccalli Cristina, Maecker Holden T., Page David B., Robins Harlan, Song Wenru, Stack Edward C., Wang Ena, Whiteside Theresa L., Zhao Yingdong, Zwierzina Heinz, Butterfield Lisa H., Fox Bernard A., Novel technologies and emerging biomarkers for personalized cancer immunotherapy, 10.1186/s40425-016-0107-3
  13. Garon Edward B., Rizvi Naiyer A., Hui Rina, Leighl Natasha, Balmanoukian Ani S., Eder Joseph Paul, Patnaik Amita, Aggarwal Charu, Gubens Matthew, Horn Leora, Carcereny Enric, Ahn Myung-Ju, Felip Enriqueta, Lee Jong-Seok, Hellmann Matthew D., Hamid Omid, Goldman Jonathan W., Soria Jean-Charles, Dolled-Filhart Marisa, Rutledge Ruth Z., Zhang Jin, Lunceford Jared K., Rangwala Reshma, Lubiniecki Gregory M., Roach Charlotte, Emancipator Kenneth, Gandhi Leena, Pembrolizumab for the Treatment of Non–Small-Cell Lung Cancer, 10.1056/nejmoa1501824