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Items: 1 to 20 of 80

1.

Rescuing clinical trials in the United States and beyond: a call for action.

Eapen ZJ, Vavalle JP, Granger CB, Harrington RA, Peterson ED, Califf RM.

Am Heart J. 2013 Jun;165(6):837-47. doi: 10.1016/j.ahj.2013.02.003. Epub 2013 Mar 13. Review.

PMID:
23708153
2.

The impact of escalating regulatory requirements on the conduct of clinical research.

Gordon BG, Kessinger A, Mann SL, Prentice ED.

Cytotherapy. 2003;5(4):309-13. Review.

PMID:
12944237
3.

Issues in data monitoring and interim analysis of trials.

Grant AM, Altman DG, Babiker AB, Campbell MK, Clemens FJ, Darbyshire JH, Elbourne DR, McLeer SK, Parmar MK, Pocock SJ, Spiegelhalter DJ, Sydes MR, Walker AE, Wallace SA; DAMOCLES study group.

Health Technol Assess. 2005 Mar;9(7):1-238, iii-iv. Review.

4.

Ethical issues during the conduct of clinical trials.

Silverman H.

Proc Am Thorac Soc. 2007 May;4(2):180-4; discussion 184.

PMID:
17494728
5.

Cardiovascular drug development: is it dead or just hibernating?

Fordyce CB, Roe MT, Ahmad T, Libby P, Borer JS, Hiatt WR, Bristow MR, Packer M, Wasserman SM, Braunstein N, Pitt B, DeMets DL, Cooper-Arnold K, Armstrong PW, Berkowitz SD, Scott R, Prats J, Galis ZS, Stockbridge N, Peterson ED, Califf RM.

J Am Coll Cardiol. 2015 Apr 21;65(15):1567-82. doi: 10.1016/j.jacc.2015.03.016. Review.

6.

A domain model of a clinical reading center - Design and implementation.

Lotz G, Peters T, Zrenner E, Wilke R.

Conf Proc IEEE Eng Med Biol Soc. 2010;2010:4530-3. doi: 10.1109/IEMBS.2010.5626032.

PMID:
21095788
7.

Issues in regulatory guidelines for data monitoring committees.

DeMets D, Califf R, Dixon D, Ellenberg S, Fleming T, Held P, Julian D, Kaplan R, Levine R, Neaton J, Packer M, Pocock S, Rockhold F, Seto B, Siegel J, Snapinn S, Stump D, Temple R, Whitley R.

Clin Trials. 2004;1(2):162-9. Review.

PMID:
16281888
9.

Executive Summary of the National Cancer Institute Workshop: Highlights and recommendations.

Lieberman R, Nelson WG, Sakr WA, Meyskens FL Jr, Klein EA, Wilding G, Partin AW, Lee JJ, Lippman SM.

Urology. 2001 Apr;57(4 Suppl 1):4-27.

PMID:
11295590
10.
11.
12.

Independent data monitoring committees: preparing a path for the future.

Hess CN, Roe MT, Gibson CM, Temple RJ, Pencina MJ, Zarin DA, Anstrom KJ, Alexander JH, Sherman RE, Fiedorek FT, Mahaffey KW, Lee KL, Chow SC, Armstrong PW, Califf RM.

Am Heart J. 2014 Aug;168(2):135-41.e1. doi: 10.1016/j.ahj.2014.05.003. Epub 2014 May 15.

13.

An opinion and practice survey on the structure and management of data and safety monitoring boards.

Tereskerz PM, Guterbock TM, Kermer DA, Moreno JD.

Account Res. 2011 Jan;18(1):1-30. doi: 10.1080/08989621.2011.542680.

PMID:
21287412
14.

Guidelines, editors, pharma and the biological paradigm shift.

Singh AR, Singh SA.

Mens Sana Monogr. 2007 Jan;5(1):27-30. doi: 10.4103/0973-1229.32176.

15.

The NCI All Ireland Cancer Conference.

Johnston PG, Daly PA, Liu E.

Oncologist. 1999;4(4):275-277.

16.

Pharmacoepidemiology 101: data monitoring committees in the post-marketing approval setting.

Lilienfeld DE.

Pharmacoepidemiol Drug Saf. 2004 Jun;13(6):381-5.

PMID:
15170767
17.

Cell-based interventions for neurologic conditions: ethical challenges for early human trials.

Mathews DJ, Sugarman J, Bok H, Blass DM, Coyle JT, Duggan P, Finkel J, Greely HT, Hillis A, Hoke A, Johnson R, Johnston M, Kahn J, Kerr D, Kurtzberg J, Liao SM, McDonald JW, McKhann G, Nelson KB, Rao M, Regenberg A, Siegel AW, Smith K, Solter D, Song H, Vescovi A, Young W, Gearhart JD, Faden R.

Neurology. 2008 Jul 22;71(4):288-93. doi: 10.1212/01.wnl.0000316436.13659.80. Epub 2008 May 7. Review.

PMID:
18463365
18.

Current controversies in data monitoring for clinical trials.

Pocock SJ.

Clin Trials. 2006;3(6):513-21.

PMID:
17170035
19.

The Clinical Trials Transformation Initiative (CTTI).

Grignolo A.

Ann Ist Super Sanita. 2011;47(1):14-8. doi: 10.4415/ANN_11_01_04. Review.

20.

Data safety monitoring boards: a word from a sponsor (NHLBI).

Mondoro TH.

Transfusion. 2009 Aug;49(8):1537-9. doi: 10.1111/j.1537-2995.2009.02184.x. No abstract available.

PMID:
19413736

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