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Items: 1 to 50 of 109

1.

The bench is closer to the bedside than we think: Uncovering the ethical ties between preclinical researchers in translational neuroscience and patients in clinical trials.

Yarborough M, Bredenoord A, D'Abramo F, Joyce NC, Kimmelman J, Ogbogu U, Sena E, Strech D, Dirnagl U.

PLoS Biol. 2018 Jun 6;16(6):e2006343. doi: 10.1371/journal.pbio.2006343. [Epub ahead of print]

2.

Better to be in The Placebo Arm for Trials of Neurological Therapies?

Kimmelman J.

Cell Transplant. 2018 Jan 1:963689718755708. doi: 10.1177/0963689718755708. [Epub ahead of print]

PMID:
29855198
3.

The paradox of precision medicine.

Kimmelman J, Tannock I.

Nat Rev Clin Oncol. 2018 Jun;15(6):341-342. doi: 10.1038/s41571-018-0016-0. No abstract available.

PMID:
29674669
4.

Bystander risk, social value, and ethics of human research.

Shah SK, Kimmelman J, Lyerly AD, Lynch HF, Miller FG, Palacios R, Pardo CA, Zorrilla C.

Science. 2018 Apr 13;360(6385):158-159. doi: 10.1126/science.aaq0917. Epub 2018 Apr 12. No abstract available.

PMID:
29650663
5.

Clinical Trials in Medical Center Advertising.

London AJ, Kimmelman J.

JAMA Oncol. 2018 Jun 1;4(6):769-770. doi: 10.1001/jamaoncol.2018.0181. No abstract available.

PMID:
29621381
6.

Preclinical efficacy studies in investigator brochures: Do they enable risk-benefit assessment?

Wieschowski S, Chin WWL, Federico C, Sievers S, Kimmelman J, Strech D.

PLoS Biol. 2018 Apr 5;16(4):e2004879. doi: 10.1371/journal.pbio.2004879. eCollection 2018 Apr.

7.

Trials that say "maybe": the disconnect between exploratory and confirmatory testing after drug approval.

Carlisle B, Federico CA, Kimmelman J.

BMJ. 2018 Mar 20;360:k959. doi: 10.1136/bmj.k959. No abstract available.

PMID:
29559429
8.

Risk and surrogate benefit for pediatric Phase I trials in oncology: A systematic review with meta-analysis.

Waligora M, Bala MM, Koperny M, Wasylewski MT, Strzebonska K, Jaeschke RR, Wozniak A, Piasecki J, Sliwka A, Mitus JW, Polak M, Nowis D, Fergusson D, Kimmelman J.

PLoS Med. 2018 Feb 20;15(2):e1002505. doi: 10.1371/journal.pmed.1002505. eCollection 2018 Feb.

9.

Drug Development at the Portfolio Level Is Important for Policy, Care Decisions and Human Protections.

Kimmelman J, Carlisle B, Gönen M.

JAMA. 2017 Sep 19;318(11):1003-1004. doi: 10.1001/jama.2017.11502. No abstract available.

PMID:
28837722
10.

Can cancer researchers accurately judge whether preclinical reports will reproduce?

Benjamin D, Mandel DR, Kimmelman J.

PLoS Biol. 2017 Jun 29;15(6):e2002212. doi: 10.1371/journal.pbio.2002212. eCollection 2017 Jun.

11.

Nonpublication of trial results for new neurological drugs: A systematic review.

Hakala AK, Fergusson D, Kimmelman J.

Ann Neurol. 2017 Jun;81(6):782-789. doi: 10.1002/ana.24952. Epub 2017 Jun 5. Review.

PMID:
28486773
12.

Burdensome Research Procedures in Trials: Why Less Is More.

Kimmelman J, Resnik DB, Peppercorn J, Ratain MJ.

J Natl Cancer Inst. 2017 Apr 1;109(4). doi: 10.1093/jnci/djw315.

13.

Increasing efficiency of preclinical research by group sequential designs.

Neumann K, Grittner U, Piper SK, Rex A, Florez-Vargas O, Karystianis G, Schneider A, Wellwood I, Siegerink B, Ioannidis JP, Kimmelman J, Dirnagl U.

PLoS Biol. 2017 Mar 10;15(3):e2001307. doi: 10.1371/journal.pbio.2001307. eCollection 2017 Mar.

14.

Inefficiencies and Patient Burdens in the Development of the Targeted Cancer Drug Sorafenib: A Systematic Review.

Mattina J, Carlisle B, Hachem Y, Fergusson D, Kimmelman J.

PLoS Biol. 2017 Feb 3;15(2):e2000487. doi: 10.1371/journal.pbio.2000487. eCollection 2017 Feb. Review.

15.

Consider drug efficacy before first-in-human trials.

Kimmelman J, Federico C.

Nature. 2017 Jan 30;542(7639):25-27. doi: 10.1038/542025a. No abstract available.

PMID:
28150789
16.

The Challenges of Validating in Precision Medicine: The Case of Excision Repair Cross-Complement Group 1 Diagnostic Testing.

Barsanti-Innes B, Hey SP, Kimmelman J.

Oncologist. 2017 Jan;22(1):89-96. doi: 10.1634/theoncologist.2016-0188. Epub 2016 Oct 24.

17.

Translational research and the U.S. federal elections.

Kimmelman J, Kesselheim AS.

Sci Transl Med. 2016 Oct 19;8(361):361ed13. No abstract available.

PMID:
27798261
18.

Is Participation in Cancer Phase I Trials Really Therapeutic?

Kimmelman J.

J Clin Oncol. 2017 Jan 10;35(2):135-138. doi: 10.1200/JCO.2016.67.9902. Epub 2016 Sep 30. No abstract available.

19.

Accelerated Drug Approval and Health Inequality.

London AJ, Kimmelman J.

JAMA Intern Med. 2016 Jul 1;176(7):883-4. doi: 10.1001/jamainternmed.2016.2534. No abstract available.

PMID:
27295005
20.

Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy.

Mattina J, MacKinnon N, Henderson VC, Fergusson D, Kimmelman J.

Cancer Res. 2016 Aug 15;76(16):4627-36. doi: 10.1158/0008-5472.CAN-15-3455. Epub 2016 Jun 3.

21.

Do We Know Whether Researchers and Reviewers are Estimating Risk and Benefit Accurately?

Hey SP, Kimmelman J.

Bioethics. 2016 Oct;30(8):609-17. doi: 10.1111/bioe.12260. Epub 2016 May 16.

PMID:
27197044
22.

Policy: Global standards for stem-cell research.

Kimmelman J, Hyun I, Benvenisty N, Caulfield T, Heslop HE, Murry CE, Sipp D, Studer L, Sugarman J, Daley GQ.

Nature. 2016 May 19;533(7603):311-3. doi: 10.1038/533311a. No abstract available.

PMID:
27193661
23.

Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines.

Daley GQ, Hyun I, Apperley JF, Barker RA, Benvenisty N, Bredenoord AL, Breuer CK, Caulfield T, Cedars MI, Frey-Vasconcells J, Heslop HE, Jin Y, Lee RT, McCabe C, Munsie M, Murry CE, Piantadosi S, Rao M, Rooke HM, Sipp D, Studer L, Sugarman J, Takahashi M, Zimmerman M, Kimmelman J.

Stem Cell Reports. 2016 Jun 14;6(6):787-97. doi: 10.1016/j.stemcr.2016.05.001. Epub 2016 May 12.

24.

Ethical considerations of e-cigarette use for tobacco harm reduction.

Franck C, Filion KB, Kimmelman J, Grad R, Eisenberg MJ.

Respir Res. 2016 May 17;17(1):53. doi: 10.1186/s12931-016-0370-3. Review.

25.

New ISSCR guidelines: clinical translation of stem cell research.

Kimmelman J, Heslop HE, Sugarman J, Studer L, Benvenisty N, Caulfield T, Hyun I, Murry CE, Sipp D, Daley GQ.

Lancet. 2016 May 14;387(10032):1979-81. No abstract available.

PMID:
27179752
26.

SCIENTIFIC COMMUNITY. Confronting stem cell hype.

Caulfield T, Sipp D, Murry CE, Daley GQ, Kimmelman J.

Science. 2016 May 13;352(6287):776-7. doi: 10.1126/science.aaf4620. Epub 2016 May 12. No abstract available.

PMID:
27174977
27.

How do researchers decide early clinical trials?

Grankvist H, Kimmelman J.

Med Health Care Philos. 2016 Jun;19(2):191-8. doi: 10.1007/s11019-016-9685-6.

PMID:
26833467
28.

Where Have All the Rodents Gone? The Effects of Attrition in Experimental Research on Cancer and Stroke.

Holman C, Piper SK, Grittner U, Diamantaras AA, Kimmelman J, Siegerink B, Dirnagl U.

PLoS Biol. 2016 Jan 4;14(1):e1002331. doi: 10.1371/journal.pbio.1002331. eCollection 2016 Jan.

29.

The Research Optimist's Defense.

Benjamin D, Kimmelman J.

Perspect Biol Med. 2016;59(4):491-506. doi: 10.1353/pbm.2016.0043.

PMID:
28690240
30.

Why clinical translation cannot succeed without failure.

London AJ, Kimmelman J.

Elife. 2015 Nov 24;4:e12844. doi: 10.7554/eLife.12844.

31.

Benefit, Risk, and Outcomes in Drug Development: A Systematic Review of Sunitinib.

Carlisle B, Demko N, Freeman G, Hakala A, MacKinnon N, Ramsay T, Hey S, London AJ, Kimmelman J.

J Natl Cancer Inst. 2015 Nov 7;108(1). pii: djv292. doi: 10.1093/jnci/djv292. Print 2016 Jan. Review.

32.

Assessing risk/benefit for trials using preclinical evidence: a proposal.

Kimmelman J, Henderson V.

J Med Ethics. 2016 Jan;42(1):50-3. doi: 10.1136/medethics-2015-102882. Epub 2015 Oct 13.

33.

A meta-analysis of threats to valid clinical inference in preclinical research of sunitinib.

Henderson VC, Demko N, Hakala A, MacKinnon N, Federico CA, Fergusson D, Kimmelman J.

Elife. 2015 Oct 13;4:e08351. doi: 10.7554/eLife.08351.

34.

Increasing placebo responses over time in U.S. clinical trials of neuropathic pain.

Tuttle AH, Tohyama S, Ramsay T, Kimmelman J, Schweinhardt P, Bennett GJ, Mogil JS.

Pain. 2015 Dec;156(12):2616-26. doi: 10.1097/j.pain.0000000000000333. Review.

PMID:
26307858
35.

Patient-Funded Trials: Opportunity or Liability?

Wenner DM, Kimmelman J, London AJ.

Cell Stem Cell. 2015 Aug 6;17(2):135-7. doi: 10.1016/j.stem.2015.07.016.

36.

The secret realm of phase I trials in healthy volunteers.

Kimmelman J.

BMJ. 2015 Jun 26;350:h3444. doi: 10.1136/bmj.h3444. No abstract available.

PMID:
26116281
37.

Ethics of Cancer Gene Transfer Clinical Research.

Kimmelman J.

Methods Mol Biol. 2015;1317:263-85. doi: 10.1007/978-1-4939-2727-2_15.

PMID:
26072412
38.

Elements of informed consent and decision quality were poorly correlated in informed consent documents.

Brehaut JC, Carroll K, Elwyn G, Saginur R, Kimmelman J, Shojania K, Syrowatka A, Nguyen T, Fergusson D.

J Clin Epidemiol. 2015 Dec;68(12):1472-80. doi: 10.1016/j.jclinepi.2015.03.002. Epub 2015 Mar 7. Review.

PMID:
25857675
39.

Accessibility of trial reports for drugs stalling in development: a systematic assessment of registered trials.

Hakala A, Kimmelman J, Carlisle B, Freeman G, Fergusson D.

BMJ. 2015 Mar 9;350:h1116. doi: 10.1136/bmj.h1116.

40.

Rejoinder.

Hey SP, Kimmelman J.

Clin Trials. 2015 Apr;12(2):125-7. doi: 10.1177/1740774515569014. Epub 2015 Feb 3. No abstract available.

PMID:
25649107
41.

Are outcome-adaptive allocation trials ethical?

Hey SP, Kimmelman J.

Clin Trials. 2015 Apr;12(2):102-6. doi: 10.1177/1740774514563583. Epub 2015 Feb 3.

42.

The structure of clinical translation: efficiency, information, and ethics.

Kimmelman J, London AJ.

Hastings Cent Rep. 2015 Mar-Apr;45(2):27-39. doi: 10.1002/hast.433. Epub 2015 Jan 27.

PMID:
25628068
43.

Unsuccessful trial accrual and human subjects protections: an empirical analysis of recently closed trials.

Carlisle B, Kimmelman J, Ramsay T, MacKinnon N.

Clin Trials. 2015 Feb;12(1):77-83. doi: 10.1177/1740774514558307. Epub 2014 Dec 4.

44.

The risk-escalation model: a principled design strategy for early-phase trials.

Hey SP, Kimmelman J.

Kennedy Inst Ethics J. 2014 Jun;24(2):121-39.

45.

Consent for nondiagnostic research biopsies: a pilot study of participant recall and therapeutic orientation.

Abadie R, Kimmelman J, Lafleur J, Lemmens T.

IRB. 2014 May-Jun;36(3):9-15. No abstract available.

PMID:
24946507
46.

Distinguishing between exploratory and confirmatory preclinical research will improve translation.

Kimmelman J, Mogil JS, Dirnagl U.

PLoS Biol. 2014 May 20;12(5):e1001863. doi: 10.1371/journal.pbio.1001863. eCollection 2014 May.

47.

Late, never or non-existent: the inaccessibility of preclinical evidence for new drugs.

Federico CA, Carlisle B, Kimmelman J, Fergusson DA.

Br J Pharmacol. 2014 Sep;171(18):4247-54. doi: 10.1111/bph.12771. Epub 2014 Jul 2.

48.

The questionable use of unequal allocation in confirmatory trials.

Hey SP, Kimmelman J.

Neurology. 2014 Jan 7;82(1):77-9. doi: 10.1212/01.wnl.0000438226.10353.1c. Epub 2013 Dec 4. Review.

49.

Threats to validity in the design and conduct of preclinical efficacy studies: a systematic review of guidelines for in vivo animal experiments.

Henderson VC, Kimmelman J, Fergusson D, Grimshaw JM, Hackam DG.

PLoS Med. 2013;10(7):e1001489. doi: 10.1371/journal.pmed.1001489. Epub 2013 Jul 23. Review.

50.

Reporting practices of pharmacodynamic studies involving invasive research procedures in cancer trials.

Freeman GA, Kimmelman J, Dancey J, Monzon JG.

Br J Cancer. 2013 Aug 20;109(4):897-908. doi: 10.1038/bjc.2013.417. Epub 2013 Jul 25.

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