A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim

A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim: Second Edition

Volumn , Issue , 2010, Pages

  Liu, Margaret B ^a,b   Davis, Kate ^b  

^a Clinical Trials Consulting   (Singapore)

^b DUKE CLINICAL RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84455177519     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781444315219     Document Type: Book

References (188)

1. http://www.fda.gov/opacom/backgrounders/miles.html
2. http://www.pbs.org/newshour/extra/features/jan-june06/jungle_5-10.html
3. http://www.cdc.gov/nchstp/od/tuskegee/time.htm
4. http://www.fda.gov/oc/history/elixir.html
5. http://www.ushmm.org/wlc/article.php?lang=en&ModuleId=10007035
6. http://www.law.umkc.edu/faculty/projects/ftrials/nuremberg/nurembergACCO UNT.html
7. Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History by Linda Bren. U.S. Food and Drug Administration FDA Consumer Magazine. March-April 2001
8. http://www.wma.net/e/
9. Beecher, HK, Ethics and Clinical Research. NEJM 1966; 274:1354-60
10. http://www.cdc.gov/nchstp/od/tuskegee/time.htm
11. http://www.hhs.gov/ohrp/belmontArchive.html
12. FDA in a Quandary Over Pediatric Rule. Nature Medicine 2002; 8:541-542.
13. The Pediatric Studies Incentive: Equal Medicines For All. White Paper by Christopher-Paul Milne, Assistant Directory, Tufts Center for the Study of Drug Development
14. http://www.fda.gov/fdac/features/2000/500_gene.html
15. http://www.hhs.gov/ocr/privacysummary.pdf
16. http://www.hhs.gov/hipaafaq/about/187.html
17. http://www.grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html
18. http://publicaccess.nih.gov/
19. Merrill, Richard A, Regulation of Drugs and Devices: An Evolution. Health Affairs, Summer 1994: 47-69
20. Plotkin, SL, Plotkin, SA, A Short History of Vaccines. In: Plotkin, SA, Orenstein, PA, Offit, PA, Vaccines. 5th ed. Elsevier Health Sciences: 20083 21 CFR 312.42 Clinical holds
21. 21 CFR 312.21 Phases of an investigation
22. http://www.cancer.gov/newscenter/pressreleases/PhaseZeroNExTQandA
23. http://www.fda.gov/cder/guidance/6384dft.htm
24. http://www.cancer.gov/newscenter/pressreleases/PhaseZeroNExTQandA
25. http://www.emea.europa.eu/pdfs/human/swp/2836707en.pdf
26. Spilker, Bert, Guide to Clinical Trials, 1991, p. 604
27. http://www.fda.gov/cder/reports/rtn/2005/rtn2005.htm: Report to the Nation 2005
28. http://www.fda.gov/CBER/faq.htm#1
29. http://www.fda.gov/CBER
30. http://stemcells.nih.gov/info/basics/basics1.asp
31. http://www.fda.gov/CbER/gdlns/fsttrk.pdf: Guidance for Industry: Fast Track for Drug Development Programs; January 2006
32. http://www.fda.gov/cder/rdmt/NDAapps93-06.htm
33. http://www.fda.gov/Cder/rdmt/default.htm
34. 21 CFR 312.34(a) Treatment use of an investigational new drug
35. FDA Information Sheet: Treatment Use of Investigational Drugs, October 1, 1995
36. http://irb.mc.duke.edu/InvestigationalProducts.htm
37. FDA Information Sheet: Treatment Use of Investigational Drugs, October 1, 1995
38. 21 CFR 312.36 Emergency use of an investigational new drug
39. http://www.fda.gov/consumer/updates/oda020808.html
40. http://www.fda.gov/fdac/special/newdrug/orphan.html: Orphan Products: New Hope for People with Rare Disorders
41. http://www.fda.gov/consumer/updates/oda020808.html
42. FDA Press Release: New Medical Products March 2008. www.fda.gov/bbs/topics/NEWS/2007/NEW01761.html
43. Merrill, Richard A, Regulation of Drugs and Devices: An Evolution. Health Affairs, Summer 1994: 47-69
44. http://www.fda.gov/cdrh/devadvice/312.html: Is the Product a Medical Device?
45. http://www.fda.gov/cdrh/devadvice/312.html#link_2
46. http://www.fda.gov/cdrh/devadvice/ide/approval.shtml
47. http://www.fda.gov/cdrh/devadvice/3132.html: Device Classes
48. 21 CFR 807.81
49. www.fda.gov/cdrh/newdevice.html
50. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInformation.c fm
51. http://www.fda.gov/cdrh/devadvice/ide/early.shtml#continuedaccess
52. http://www.fda.gov/cdrh/devadvice/overview.html
53. 21 CFR 3.2
54. Zuckerman BD. Device Trials Regulation. Lecture presented at: Annual Clinical Trials Network Best Practices Study Coordinator Symposium, American College of Cardiology Annual Meeting; March 2007; New Orleans, LA
55. http://www.fda.gov/CDER/DRUG/infopage/vioxx/vioxxQA.htm.
56. U.S. Congress, Safe Medical Device Amendments to the Food, Drug & Cosmetic Act, Section 522(a)(1)(1990)
57. http://www.fda.gov/medwatch/what.htm
58. MedWatch: Reporting Adverse Events: March 2008. www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm
59. http://www.fda.gov/medwatch/hipaa.htm
60. From OCR Guidance Explaining Significant Aspects of the Privacy Rule - Disclosures for Public Health Activities, p. 28.
61. See also 45 CFR 164.512 (b)(1)(i) and (iii)
62. www.fda.gov/oc/gcp/comparison.html
63. http://grants.nih.gov/grants/policy/hs_educ_faq.htm
64. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html
65. http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_200 1.htm
66. http://www.hhs.gov/ohrp/assurances/assurances_index.html
67. http://www.hhs.gov/hipaafaq/about/192.html
68. http://www.hhs.gov/hipaafaq/about/188.html
69. 45 CFR 160.102, 160.103
70. http://www.fda.gov/cdrh/devadvice/ide/financial.shtml
71. 21 CFR 54.2
72. 21 CFR 54.2(d)
73. http://www.grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html
74. http://www.ag.ca.gov/research/pdfs/bill_of_rights.pdf
75. 21 CFR 812.100
76. 21 CFR 56.102(g)
77. 21 CFR 56.102(j)
78. 21 CFR 312.52
79. 21 CFR 312.56
80. Vaughn, V and Osler, W, Discussion of G.M. Sternberg, The Bacillus icteroides (Sanarelli) and Bacillus X (Sternberg). Trans. Assoc. Am. Phys. 1898; 13:70-71
81. A Brief History of Military Contributions to Ethical Standards for Research Involving Human Subjects by Arthur O. Anderson. Scribd (Internet publisher): 8 September 2008
82. http://www.hsl.virginia.edu/historical/medical_history/yellow_fever/mosq uitoes.cfm
83. ICH E6: Guideline for Good Clinical Practice: Glossary 1.28
84. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research: 1979
85. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office: 1949
86. http://www.hhs.gov/ohrp/informconsfaq.html#q6
87. 21 CFR 50.27(b)(2)
88. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research: 1979
89. http://www.plainlanguage.gov/index.cfm
90. 45 CFR 164.508 Privacy of Individually Identifiable Health Information: Uses and disclosures for which an authorization is required
91. 21 CFR 50.20 General Requirements for Informed Consent
92. http://www.harrymclaughlin.com/SMOG.htm
93. 21 CFR 56.107(b)(c)
94. 21 CFR 56.107(a)
95. http://www.noblood.org/press-releases/2547-polyheme-trial-begin-mondaydu ke-university-hospital.html
96. 21 CFR 56.107(e)
97. 21 CFR 56.107(a)
98. ICH E6: Guideline for Good Clinical Practice, Glossary 1.61 Vulnerable Subjects
99. 21 CFR 56.107(f)
100. ICH E6 Good Clinical Practice, Consolidated Guideline. Institutional Review Board Responsibilities 3.1.2
101. http://www.hhs.gov/ohrp/sachrp/sachrpltrtohhssec.html SACHRP Chair Letter to HHS Secretary Regarding Recommendations
102. 21 CFR 56.108 and 46 CFR 46.110
103. 21 CFR 56.110
104. http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm
105. http://www.dhhs.gov/ohrp/irb/irb_chapter3.htm#e7. Institutional Review Boards Guidebook. Chapter 3, Basic IRB Review
106. Policy on Research Databases and Specimen Repositories (Version 06/01/04) Duke University Health System (DUHS) Institutional Review Board (IRB)
107. www.fda.gov/oc/ohrt/irbs/review.html. U.S. Food and Drug Administration Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators 1998 Update; Continuing Review After Study Approval
108. http://www.research.ucsf.edu/chr/Guide/Adverse_Events_Guidelines.pdf
109. 21 CFR 312.66 and 45 CFR 46.103(b)(4)(iii)
110. 21 CFR 56.108(a)(3) and 45 CFR 46.103(b)(5)(i)
111. Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators 1998 Update. Frequently Asked Questions. http://www.fda.gov/oc/ohrt/IRBS/faqs.html
112. 21 CFR 56.115(b)
113. http://www.aahrpp.org Association for the Accreditation of Human Research Protection Programs
114. http://www.aahrpp.org Association for the Accreditation of Human Research Protection Programs
115. http://www.aahrpp.org Association for the Accreditation of Human Research Protection Programs
116. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM171256.p df. Guidance for Institutional Review Boards (IRBs). Frequently Asked Questions - IRB Registration. July 2009, pg 2
117. Department of Health and Human Services. Food and Drug Administration 21 CFR part 56: Docket No. FDA-2004-N-0117. Institutional Review Boards; Registration Requirements. Final Rule
118. s21 CFR 312.84(a)
119. sModified from the definition of serious adverse drug experience in FDA regulations 21 CFR 312.32(a)
120. shttp://www.fda.gov/cder/guidance/OC2008150fnl.htm
121. shttp://www.research.ucsf.edu/chr/Guide/Adverse_Events_Guidelines.asp#6
122. s21 CFR 56.108(b)(1) and 45 CFR 46.103(b)(5)
123. shttp://www.fda.gov/cder/guidance/OC2008150fnl.htm
124. sGuidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs. January 2009
125. s21 CFR 812.3(s)
126. s21 CFR 812.150(a)(1)
127. http://www.fda.gov/cder/guidance/OC2008150fnl.htm
128. http://www.fda.gov/cder/guidance/OC2008150fnl.htm
129. 21 CFR 812.46(b), §812.150(b)(1)
130. 21 CFR 312.50, 21 CFR 812.40
131. "Improve Quality With a Trial Monitoring Program" Clinical Trials Administrator November 2005; 127-130
132. ICH E6. Glossary 1.51 and 1.52
133. http://www.fda.gov/ora/compliance-ref/bimo/background.html
134. http://www.fda.gov/OC/OHRT/IRBS/investigator.pdf
135. http://ori.dhhs.gov/policies/documents/ViewPublication-VAMisconduct.pdf
136. 21 CFR 54.2(d)
137. http://www.hhs.gov/ohrp/humansubjects/finreltn/fguid.pdf
138. 21CFR56.107(e)
139. Vogeli, C, Koski, G, Campbell, EG, Policies and Management of Conflicts of Interest Within Medical Research Institutional Review Boards: Results of a National Study. Acad Med. 2009 Apr; 84(4):488-494
140. http://www.ncicirb.org/
141. 21 CFR 312.2(b)(1) Exemptions from the requirements for an IND application
142. http://www3.niaid.nih.gov/research/resources/toolkit/protocol/
143. Ware JE Jr, Snow KK, Kosinski M, Gandek B. SF-36 Health Survey: Manual & Interpretation Guide. Boston: Nimrod Press, 1993s
144. Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol 1989;64:651-4
145. Fleming TR, et al. Ann Intern Med 1996;125:605-613s
146. Preliminary Report: Effect of Encainide and Flecainide on Mortality in a Randomized Trial of Arrhythmia Suppression after Myocardial Infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators. N Engl J Med. 1989; 321:406-412
147. Echt, DS, Liebson, PR, Mitchell, LB, Peters, RW, Obias-Manno, D, Barker, AH, et al. Mortality and Morbidity in Patients Receiving Encainide, Flecainide, or Placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991; 324:781-788
148. Effect of the Antiarrhythmic Agent Moricizine on Survival After Myocardial Infarction. The Cardiac Arrhythmia Suppression Trial II Investigators. N Engl J Med. 1992; 327:227-233
149. Moseley, JB, O'Malley, K, Petersen, NJ, et al. A Controlled Trial of Arthroscopic Surgery for Osteoarthritis of the Knee. N Engl J Med 2002; 347:81-88
150. Streitberger, K, Kleinhenz, J. Introducing a Placebo into Acupuncture Research. Lancet 1998; 352:364-365
151. University of Adelaide Web site. RA Fisher digital archive. Available at: http://digital.library.adelaide.edu.au/coll/special//fisher/index.html (accessed April 2, 2009)
152. History of Medicine by J.V. Hirschmann. Benjamin Franklin and Medicine 6 December 2005 Annals of Internal Medicine - Number 11 Volume 143:832
153. Section 4: Measurement and Quantitation. Chapter 17: "Statistics." In: Iverson, C, Flanagin, A, Fontanarosa, P, et al., eds. American Medical Association Manual of Style. 9th ed. New York, NY: Lippincott Williams and Wilkins: 1998
154. http://www.nhlbi.nih.gov/about/framingham/design.htm
155. http://www.framinghamheartstudy.org/about/milestones.html
156. Section 4: Measurement and Quantitation. Chapter 17: "Statistics." In: Iverson, C, Flanagin, A, Fontanarosa, P, et al., eds. American Medical Association Manual of Style. 9th ed. New York, NY: Lippincott Williams and Wilkins: 1998
157. BMJ 2005; 331(7511):295 (30 July), doi:10.1136/bmj.331.7511.295
158. Ogden, C.L. Prevalence of Overweight and Obesity in the United States, 1999-2004. JAMA, April 5, 2006; 295(13)
159. https://www.murdock-study.com/
160. Guide to Clinical Trials by Bert Spilker, p. 148. Raven Press: 1991
161. 21 CFR 312.30
162. 21 CFR 56.110
163. http://www.hhs.gov/hipaafaq/about/188.html U.S. Department of Health and Human Services: Why Is the HIPAA Privacy Rule needed?
164. Part 164.501 Security and Privacy; Subpart E - Privacy of Individually Identifiable Health Information
165. OCR HIPAA Privacy. http://www.hhs.gov/ocr/hipaa/guidelines/research.pdf
166. 45 CFR 164.512(ii)(f)(g)(h)
167. OCR HIPAA Privacy. http://www.hhs.gov/ocr/hipaa/guidelines/research.pdf
168. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ ctcaev3.pdf
169. 21 CFR 11.10(a)
170. 21 CFR 11.10(c)(d)
171. 21 CFR 11.100(a)(c)(1)(2)
172. PURSUIT (Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin (Eptifibatide) Therapy), GUSTO-IIb (Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes), and IMPACT-II (Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis)
173. Mahaffey, KW, Disagreements Between Central Clinical Events Committee and Site Investigator Assessments of Myocardial Infarction Endpoints in an International Clinical Trial: Review of the PURSUIT Study. Curr Control Trials Cardiovasc Med 2001; 2:187-194
174. http://www.fda.gov/cder/drug/InfoSheets/HCP/carbamazepineHCP.htm
175. Lifeline. National University Hospital, Singapore. October-December 2008, p. 9
176. http://www.blogs.wsj.com/health/2009/07/30/for-up-to-75-millionpfizer-pu ts-nigeria-lawsuit-behind-it/JacobGoldstein
177. Joe Stephens, "Pfizer Faces Criminal Charges in Nigeria." Washington Post, May 30, 2007 http://www.washingtonpost.com/wp-dyn/content/article/2007/05/29/AR200705 2902107.html
178. http://www.gatesfoundation.org/topics/Pages/hiv-aids.aspx accessed 10 April 2009
179. http://www.gatesfoundation.org/topics/Pages/malaria.aspx# accessed 10 April 2009
180. http://www.theglobalfund.org/en/tuberculosis/background/?lang=en accessed 10 April 2009
181. http://www.polioeradication.org/content/general/LatestNews200903.asp accessed 10 April 2009
182. http://www.accessexcellence.org/AE/AEC/CC/polio.php
183. http://www.ich.org/cache/compo/276-254-1.html
184. ICH Global Cooperation Group. http://www.ich.org/cache/html/5017-272-1.html accessed 15 April, 2009.
185. Ethical and Scientific Implications of the Globalization of Clinical Research. Schulman, K. et al. NEJM February 19, 2009
186. See Note 12 above.
187. Roses, Allen D., Pharmacogenetics in Drug Discovery and Development: A Translational Perspective. Nature Reviews: Drug Discovery 2008 (October)