Design, Execution, and Management of Medical Device Clinical Trials

Design, Execution, and Management of Medical Device Clinical Trials

Volumn , Issue , 2008, Pages 1-272

  Abdel Aleem, Salah ^a  

^a Fujitsu Research of America   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84889493375     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470475911     Document Type: Book

References (68)

1. Franciosi LG , Butterfi eld NN , MacLeod BA. Evaluating the process of generating a clinical trial protocol. Proc AMIA 2002: 1021.
2. Chiacchlerini RP. Medical device clinical trial design, conduct, and analysis. In: Health Care Technology Policy I: The Role of Technology in the Cost of Health Care 1994: 278-85.
3. Smith-Tyler J. Informed consent, confi dentiality, and subject rights in clinical trials. Proc Am Thorac Soc 2007 ; 4 ( 2 ): 189-93.
4. Schweickert W , Hall J. Informed consent in the intensive care unit: ensuring understanding in a complex environment. Curr Opin Crit Care 2005 ; 11 ( 6 ): 624-8.
5. Gammelgaard A. Informed consent in acute myocardial infarction research. J Med Philos 2004 ; 29 ( 4 ): 417-34.
6. Morin K , Rakatansky H , Riddick FA Jr , Morse LJ , O ' Bannon JM 3rd , Goldrich MS , Ray P , Weiss M , Sade RM , Spillman MA. Managing confl icts of interest in the conduct of clinical trials. JAMA 2002 ; 287 ( 1 ): 78-84.
7. Helft PR , Ratain MJ , Epstein RA , Siegler M. Inside information: fi nancial confl icts of interest for research subjects in early phase clinical trials. J Natl Cancer Inst 2004 ; 96 ( 9 ): 656-61.
8. Sandman L , Mosher A , Khan A , Tapy J , Condos R , Ferrell S , Vernon A , Tuberculosis Trials Consortium. Quality assurance in a large clinical trials consortium: the experience of the Tuberculosis Trials Consortium. Contemp Clin Trials 2006 ; 27 ( 6 ): 554-60.
9. Leap LL. Reporting of adverse events. NEJM 2002 ; 347: 1633-8.
10. Rogers AS , Israel E , Smith CR. Physician knowledge, attitudes, and behavior related to reporting adverse drug events. Arch Intern Med 1988 ; 148: 1589-92.
11. 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. Issues in regulatory guidelines for data monitoring committees. Clin Trials 2004 ; 1 ( 2 ):162-9.
12. Morse MA , Califf RM , Sugarman J. Monitoring and ensuring safety during clinical research. JAMA 2001 ; 285: 1201-5.
13. Lindquist M , Edwards IR. The WHO Programme for International Drug Monitoring, its database, and the technical support of the Uppsala Monitoring Center. J Rheumatol 2001 ; 28: 1180-7.
14. Kessler DA. Introducing MEDWatch. A new approach to reporting medication and device adverse effects and product problems. JAMA 1993 ; 269 ( 21 ): 2765-8.
15. Wittes J , Lakatos E , Probstfi eld J. Surrogate endpoints in clinical trials:cardiovascular diseases. Stat Med 1989 ; 8 ( 4 ): 415-25.
16. Prentice RL. Surrogate endpoints in clinical trials: Defi nition and operational criteria. Stat Med 1989 ; 8 ( 4 ): 431-40.
17. Gordon D.J. Cholesterol lowering and total mortality. In: Rifkind BM , ed. Contemporary Issues in Cholesterol Lowering: Clinical and Population Aspects. New York: Marcel Dekker ; 1994.
18. Collins R , Peto R , MacMahon S , Hebert P , Fiebach NH , Eberlein KA , et al. Blood pressure, stroke, and coronary heart disease. Part 2, Short-term reductions in blood pressure: overview of randomized drug trials in their epidemiological context. Lancet 1990 ; 335: 827-38.
19. Kleist P. Composite endpoints for clinical trials: current perspectives. Int J Pharmaceut Med 2007 ; 21 ( 3 ): 187-98.
20. The CAPRICORN Investigators. Effect of Carvedilol on outcome after myocardial Infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet 2001 ; 357: 1385-90.
21. Blackwelder W.C. " Proving the null hypothesis " in clinical trials. Control Clin Trials 1982 ; 3: 345-52.
22. Donner A. Approaches to sample size estimation in the design of clinical trials. Stat Med 1984 ; 3: 199-214.
23. Wittes J. Sample size calculations for randomized controlled trials. Epidemiol Rev 2002 ; 24: 39-53.
24. Altman D.G. Confi dence intervals for the number needed to treat. BMJ 1998 ; 317: 1309-12.
25. Briggs A. Economic evaluation and clinical trials: size matters: the need for greater power in cost analyses poses an ethical dilemma. BMJ 2000 ; 321 ( 7273 ): 1362-26.
26. Bernardo J.M., Smith A.F. Bayesian Statistical Theory. New York: Wiley , 2000.
27. French S., Smith JQ , eds. The Practice of Bayesian Analysis. New York :Wiley , 1997.
28. Geller J. FDA issues new guidance on device clinical trials and lessens the burden on IVD makers. J Clin Eng 2006 ; 31 ( 3 ): 119-20.
29. Fleiss JL. The statistical basis of meta-analysis. Stat Meth Med Res 1993 ; 2: 121-45.
30. Higgins P.T., Thompson S.G., Deeks J.J., Altman D.G. Measuring inconsistency in meta-analysis. BMJ 2003 ; 327: 557-60.
31. Normand S.L.T. Meta-analysis: formulating, evaluating, combining and reporting. Stat Med 1999 ; 18: 321-59.
32. Whitehead A. Meta-analysis of controlled clinical trials. New York: Wiley , 2002.
33. Pocock S.J., Clayton T.C., Altman D.G. Survival plots of time-to-event outcomes in clinical trials: good practice and pitfalls. Lancet 2002 ; 359: 1686-9.
34. Newell D.J. Intention-to-treat analysis: implications for quantitative and qualitative research. Int J Epidemiol 1992 ; 21: 837-41.
35. Bulpitt C. Randomised Controlled Clinical Trials , 2nd ed. Dordreicht :Kluwer Academic.
36. Auleley GR , Giraudeau B , Baron G , Maillefert JF , Dougados M , Ravaud P. The methods for handling missing data in clinical trials infl uence sample size requirements. J Clin Epidemiol 2004 ; 57 ( 5 ): 447-53.
37. Scott PE , Campbell G. Interpretation of subgroup analyses in medical device clinical trials. Drug Inf J 1997 ; 32: 213-20.
38. Warda HM , Warda H , Bax J , Bosch J , Atsma D , Jukemi J , Van der Wall E , Schalij M , Demrawsingh P. Effect of intracoronary aqueous oxygen on left ventricular remodeling after anterior wall ST-elevation acute myocardial infarction. A m J Cardiol 2005 ; 96 ( 1 ): 22-4.
39. Chatfi eld C , Collins AJ. Introduction to Multivariate Analysis. Oxford, UK :Chapman and Hall/CRC , 1981.
40. Emanuel E.J., Wendler D , Grady C. What makes clinical research ethical? JAMA 2000 ; 283 ( 20 ): 2701-11.
41. Ellenberg S , Fleming T. Data Monitoring Committees in Clinical Trials: A Practical Perspective. New York: Wiley , 2002.
42. Dickersin K , Rennie D. Registering clinical trials. JAMA 2003 ; 290 ( 4 ):516-23.
43. FDA guidance document for ClinTrials.gov ( http://www.fda.gov/cder/guidance/4856fnl.htm ).
44. Chow SC , Liu JP. Design and Analysis of Clinical Trials: Concept and Methodologies. New York: Wiley , 1998
45. Friedman LM , Furberg CD , Demets D. Fundamentals of Clinical Trials , 3rd ed. New York: Springer Verlag , 1998.
46. Fleiss JL. Design and Analysis of Clinical Experiments. New York: John Wiley , 1986.
47. Pocock SJ. Clinical Trials: A Practical Approach. New York: Wiley , 1983.
48. Cox DR. Regression models and life tables. J Roy Stat Soc 1972 ; B34: 187-220.
49. Cochran WG , Cox GM. Experimental Design , 2nd ed. New York :Wiley , 1957.
50. Mulrow CD , Cook DJ , Davidoff F. Systematic reviews: critical links in the great chain of evidence. Ann Intern Med 1997 ; 126 ( 5 ): 389-91.
51. Senn S. Cross-over Trials in Clinical Research , 2nd ed. New York: Wiley , 2002.
52. Lao CS. Application and analysis of repeated-measure design in medical device clinical trials: statistical considerations. J Biopharm Stat 2000 ; 10 ( 3 ):433-45.
53. Gayet JL. The OPTIMAAL trial: losartan or captopril after acute myocardial infarction. Lancet 2002 ; 360: 1884-5.
54. Hill RA , D ü ndar Y , Bakhai A , Dickson R , Walley T. Drug-eluting stents:an early systematic review to inform policy. Eur Heart J 2004 ; 25: 902-19.
55. Chen E , Sapirstein W , Ahn C , Swain J , Zuckerman B. FDA perspective on clinical trial design for cardiovascular devices. Ann Thorac Surg 2006 ; 82 ( 3 ): 773-5.
56. Parides MK , Moskowitz AJ , Ascheim DD , Rose EA , Gelijns AC. Progress versus precision: challenges in clinical trial design for left ventricular assist devices. Ann Thorac Surg 2006 ; 82 ( 3 ): 1140-6.
57. Grunkemeier GL , Jin R , Starr A. Prosthetic heart valves: objective performance criteria versus randomized clinical trial. Ann Thorac Surg 2006 ; 82 ( 3 ): 776-80.
58. Zuckerman BD , Muni NI. Cardiovascular device development: an FDA perspective. Am J Ther 2005 ; 12 ( 2 ): 176-8.
59. http://www.accessdata.fda.gov/scripts/cdrh/cfadvisory/details.cfm?mtg=266.
60. Transatlantic inter-society consensus (TASC) on management of peripheral arterial disease (PAD). J Vasc Surg 2000 ; 31: 1-296.
61. ICAI Study Group. Prostanoids for chronic critical leg ischemia: a randomized, controlled, open-label trial with Prostaglandin E1. Ann Intern Med 1999 ; 130: 412-21.
62. FDA Summary of Safety and Effectiveness (P040012). ACCULINK carotid stent system and RX ACCULINK carotid stent system, 2004.
63. North American Symptomatic Carotid Endarterectomy Trial. Methods, patient characteristics, and progress. Stroke 1991 ; 22 ( 6 ): 711-20.
64. Barnett HJ , Taylor DW , Eliasziw M , Fox AJ , Ferguson GG , Haynes RB , Rankin RN , Clagett GP , Hachinski VC , Sackett DL , Thorpe KE , Meldrum HE. Benefi t of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med 1998 ; 339 ( 20 ): 1415-25.
65. Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. JAMA 1995 ; 273 ( 18 ): 1421-8.
66. Department of Health and Human Services, Offi ce of Inspector General. The globalization of clinical trials: a growing challenge in protecting human subjects. September 2001 OEI-01-00-00190. http://oig.hhs.gov/oei.
67. Macrae DJ. The Council for International Organizations and Medical Sciences (CIOMS) guidelines on ethics of clinical trials. Proc Am Thorac Soc 2007 ; 4 ( 2 ): 176-8.
68. Dreyfuss D. Beyond randomized, controlled trials. Curr Opin Crit Care 2004 ; 10 ( 6 ): 574-8