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xiii | |
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xv | |
| Preface |
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xvii | |
| Epigraph |
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xix | |
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xxi | |
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Part I The background, the debate, and the ethics involved |
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1 Drug testing and pregnant women: background and significance |
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3 | (16) |
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3 | (1) |
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4 | (1) |
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5 | (4) |
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Significance of the issue |
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9 | (2) |
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11 | (1) |
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12 | (2) |
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14 | (5) |
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2 The rationales for and against inclusion |
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19 | (20) |
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Rationales against the inclusion of pregnant women in clinical research |
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21 | (1) |
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Rationale 1 The uncertain effect of new drugs on the mother and/or the fetus |
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21 | (1) |
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Rationale 2 Litigation risk---because birth defects are not uncommon, they may occur unrelated to experimental drug exposure and result in spurious litigation |
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22 | (1) |
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Rationale 3 The number of pregnant women needed to participate in the study in order to show efficacy may be unachievable |
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23 | (1) |
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Rationale 4 Safer study designs are available |
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24 | (1) |
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Rationale 5 Alternative treatments are often available |
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25 | (1) |
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Rationale 6 Little return on investment |
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25 | (1) |
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Rationale 7 Regulations do not require inclusion |
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26 | (1) |
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Rationales for the inclusion of pregnant women in clinical trials |
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26 | (1) |
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Rationale 1 To acquire knowledge that improves the medical treatment of pregnant women and their offspring |
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26 | (1) |
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Rationale 2 To improve birth outcomes |
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27 | (1) |
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Rationale 3 To improve pregnant women's access to the benefits of clinical research |
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28 | (1) |
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Rationale 4 To improve the ethical acquisition of information about exposed pregnancies |
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29 | (1) |
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Rationale 5 Regulations do not require the exclusion of pregnant women |
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30 | (1) |
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Rationale 6 Excluding pregnant women from participating in medical research is unethical and illegal---and may increase litigation risk |
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30 | (1) |
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Rationale 7 To follow the advice of experts in the field of women's health, law, and ethics |
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31 | (1) |
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32 | (7) |
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39 | (20) |
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39 | (1) |
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40 | (1) |
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The principle of respect for autonomy or respect for persons |
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40 | (1) |
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The principles of nonmaleficence, beneficence, and the double effect |
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41 | (1) |
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42 | (1) |
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43 | (1) |
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43 | (3) |
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46 | (2) |
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Special considerations for pregnancy/maternal-fetal ethics |
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48 | (2) |
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Application of an ethical framework for studies with pregnant women |
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50 | (2) |
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52 | (7) |
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Part II Quantitative and qualitative discoveries |
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59 | (12) |
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The US clinical trial system |
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59 | (2) |
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Are pregnant women excluded from US clinical trials? |
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61 | (2) |
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The measure of their exclusion |
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63 | (2) |
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65 | (3) |
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Application of the findings |
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68 | (1) |
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69 | (2) |
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5 Perspectives from the industry: on exclusion |
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71 | (18) |
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71 | (1) |
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Stakeholders on exclusion |
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72 | (1) |
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72 | (3) |
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Key findings for Question 1 |
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75 | (1) |
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Question 2 Policy and practice |
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75 | (2) |
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Key findings for Question 2 |
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77 | (1) |
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Question 3 Reasons for exclusion/barriers to inclusion |
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78 | (9) |
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Key findings for Question 3 |
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87 | (1) |
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88 | (1) |
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6 Perspectives from the industry: on inclusion |
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89 | (16) |
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89 | (1) |
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Question 4 Advocacy awareness |
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89 | (1) |
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Key findings for Question 4 |
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90 | (1) |
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Stakeholders on inclusion |
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91 | (1) |
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91 | (4) |
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Key findings to Question 5 |
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95 | (1) |
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Question 6 Safeguarding safety |
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96 | (1) |
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Key findings for Question 6 |
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97 | (1) |
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97 | (1) |
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Question 7 Other opportunities |
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97 | (5) |
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Key findings for Question 7 |
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102 | (1) |
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103 | (2) |
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7 Perspectives from the industry: on litigation, regulation, incentives, and indemnity |
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105 | (14) |
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105 | (1) |
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Question 8 Litigation risk |
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105 | (2) |
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Key findings for Question 8 |
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107 | (1) |
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Question 9 Litigation environment |
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107 | (4) |
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Key findings for Question 9 |
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111 | (1) |
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112 | (1) |
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Question 10 Regulatory agency support |
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112 | (2) |
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114 | (2) |
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Question 12 Indemnification |
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116 | (1) |
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Key findings for Questions 10, 11, and 12 |
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117 | (1) |
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118 | (1) |
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8 Perspectives from the industry: on ethics |
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119 | (10) |
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119 | (1) |
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Question 13 Ethical challenges |
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119 | (7) |
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Key findings for Question 13 |
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126 | (1) |
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126 | (3) |
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Part III Uniting the regulators, the industry, and the advocates |
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9 The FDA Guidance, public comment, and affinity with industry stakeholders |
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129 | (8) |
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Summary of US Food and Drug Administration guidance |
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129 | (2) |
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Kudos, comments, and criticisms to the draft guidance |
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131 | (4) |
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135 | (2) |
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10 Proposed actions for FDA and the pharmaceutical industry |
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137 | (20) |
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Reconciling FDA guidance and industry perspectives |
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137 | (1) |
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FDA and industry stakeholders agree |
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137 | (2) |
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Perceived barriers and potential solutions |
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139 | (1) |
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140 | (1) |
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Proposals for pharmaceutical industry: actions to support the enrollment of pregnant women in clinical research |
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140 | (4) |
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Proposals for FDA: actions to support industry's enrollment of pregnant women in clinical research |
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144 | (2) |
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Proposals for Pharmaceutical Research and Manufacturers' Association (PhRMA) and Biotechnology Innovation Organization (BIO): actions to support industry's enrollment of pregnant women in clinical research |
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146 | (1) |
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Proposals for pregnant women's advocacy groups: actions to support industry's enrollment of pregnant women in clinical research |
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147 | (1) |
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148 | (1) |
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Evaluation of the impact of the FDA guidance |
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148 | (2) |
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Benchmarking/best practices |
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150 | (1) |
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Additional recommendations in the stakeholders' words |
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150 | (1) |
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Question 14 Other solutions or incentives |
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150 | (4) |
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154 | (3) |
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157 | (16) |
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Kingdon's workstreams theory |
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157 | (1) |
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Advocates, policies, and politicians |
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158 | (1) |
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159 | (4) |
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Leadership in the problem stream |
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163 | (1) |
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164 | (1) |
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Leadership in the policy stream |
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165 | (1) |
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166 | (1) |
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Leadership in the political stream |
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167 | (2) |
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169 | (4) |
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173 | (10) |
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The pharmaceutical industry perspective |
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174 | (2) |
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The pregnant woman's perspective |
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176 | (1) |
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177 | (3) |
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180 | (1) |
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181 | (2) |
| Appendix I FDA draft guidance---Pregnant women: scientific and ethical considerations for inclusion in clinical trials |
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183 | (16) |
| Appendix II Executive summary: task force on research specific to pregnant women and lactating women |
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199 | (8) |
| Bibliography |
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207 | (12) |
| Index |
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219 | |
Lisainfo e-raamatute kohta