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T h e e t h i c s o f r e s e a r c h i n v o l v i n g a n i m a l s common types <strong>of</strong> test required are single- and repeated-dose toxicity assessments and testing to determine any local irritation (see paragraphs 9–9-9.18). 33 Specific tests are also required to determine how effective the vaccine is in protecting <strong>animals</strong> against challenge with the pathogen. In order to assess efficacy, the test vaccine is administered to <strong>animals</strong> and the disease is subsequently induced. If the vaccine does not protect the <strong>animals</strong> they may experience pain or suffering related to the disease, although humane endpoints are usually chosen. Animals are euthanised when these are reached. 8.24 Veterinary medicines are generally evaluated for safety using the species in which they will eventually be used (see paragraph 8.19). Stages 6–8: clinical studies on humans 8.25 Potential new medicines are first tested on small groups <strong>of</strong> healthy human volunteers, and then on progressively larger groups <strong>of</strong> patients. 34 <strong>The</strong>se tests are organised into four consecutive trials, Phases I–IV (see Figure 8.3). Experimental medicine has enlarged the application <strong>of</strong> existing clinical tests that are used in these studies. <strong>The</strong>y include advanced blood and tissue diagnostics, and imaging techniques, such as MRI or PET scanning (see paragraph 5.12 and Box 11.1). Figure 8.3: <strong>The</strong> path to modern medicine – phases <strong>of</strong> pre-clinical and clinical development Source: GlaxoSmithKline 33 <strong>The</strong> European Agency for the Evaluation <strong>of</strong> Medicinal Products (1997) Note for Guidance on Preclinical Pharmacological and Toxicological Testing <strong>of</strong> Vaccines, available at: http://www.emea.eu.int/pdfs/human/swp/046595en.pdf. Accessed on: 26 Apr 2005. 34 See ABPI (2003) Clinical Trials - Developing New Medicines, available at: http://www.abpi.org.uk/publications/briefings/clinical_brief.pdf. Accessed on: 26 Apr 2005. 142
T h e e t h i c s o f r e s e a r c h i n v o l v i n g a n i m a l s Stage 6: concept testing 8.26 Typically, no more than a few candidate medicines for any given disease enter this stage. In Phase I <strong>of</strong> clinical trials, they are first tested in a limited number <strong>of</strong> healthy volunteers (see Figure 8.3). <strong>The</strong> purpose is to determine how well the active ingredient is actually tolerated in humans and whether it has the desired effect, to obtain information about suitable dosage and to determine whether it has characteristics that would allow it to be developed into a medicine. Use <strong>of</strong> <strong>animals</strong> 8.27 During the subsequent Phases II–IV, additional animal studies that aim to ensure the safety <strong>of</strong> the particular medicine and its application are undertaken. For example, if a medicine is intended to be given to women <strong>of</strong> childbearing age, reproductive toxicology would be assessed in <strong>animals</strong> prior to Phase II studies (see paragraphs 9.22–9.23 and Box 8.4). Stage 7: development for launch 8.28 If testing in healthy volunteers (Phase I) and a limited number <strong>of</strong> patients (Phase II) is successful then large-scale trials <strong>involving</strong> human volunteers are carried out (Phase III). Phase III trials involve between 1,000 and 5,000 patients, and provide the basis for the final decision as to whether to continue or abandon the project. <strong>The</strong> size and scale <strong>of</strong> Phase II and III studies make this stage the most expensive part <strong>of</strong> drug development (see Figure 8.3). 35 Use <strong>of</strong> <strong>animals</strong> 8.29 During clinical studies on humans, Phases I–III, a comprehensive set <strong>of</strong> safety tests in <strong>animals</strong> continues to be carried out. <strong>The</strong> project team that is developing the medicine liaises with the internal <strong>ethics</strong> committee and regulatory authorities, to define the tests that are required to ensure safety (see paragraphs 9.4–9.25). Vaccines and veterinary medicines 8.30 <strong>The</strong> clinical development <strong>of</strong> vaccines may require further safety tests in <strong>animals</strong>, which are broadly similar to those required for human medicines. 36 <strong>The</strong> exact nature <strong>of</strong> these tests depends on the results <strong>of</strong> clinical trials. 37 <strong>The</strong> data required for a marketing authorisation for a veterinary medicine concern pro<strong>of</strong> <strong>of</strong> efficacy and bioavailability <strong>of</strong> a product. 38 <strong>The</strong> scale and scope <strong>of</strong> the data provided are generally less comprehensive than for human medicines, although in some cases specific emphasis is given to certain areas. For example, in the case <strong>of</strong> food-producing <strong>animals</strong>, evidence is required on the potential for residues <strong>of</strong> new medicines to accumulate in food. 39 Bioavailability studies are similar to those undertaken for human medicines (see paragraph 9.24), although more-invasive muscle tissue samples may be taken in order to test for residues. 35 <strong>The</strong> average length <strong>of</strong> clinical phases (concept testing and development for launch) is eight to twelve years and the average cost <strong>of</strong> clinical phases is £350 million, see <strong>The</strong> Association <strong>of</strong> the British Pharmaceutical Industry <strong>The</strong> Development <strong>of</strong> Medicines, available at: http://www.abpi.org.uk//publications/briefings/Dev_Medicines.pdf. Accessed on: 26 Apr 2005. 36 <strong>The</strong> tests described in Chapter 9 may also apply to vaccines. CHAPTER 8 THE USE OF ANIMALS FOR RESEARCH IN THE PHARMACEUTICAL INDUSTRY 37 <strong>The</strong> European Agency for the Evaluation <strong>of</strong> Medicinal Products (1997) Note for Guidance on Preclinical Pharmacological and Toxicological Testing <strong>of</strong> Vaccines, available at: http://www.emea.eu.int/pdfs/human/swp/046595en.pdf. Accessed on: 26 Apr 2005. 38 Veterinary Medicines Directorate (2002) Application Form for a Marketing Authorisation, available at: http://www.vmd.gov.uk/lu/forms/appform1a.pdf. Accessed on: 2 May 2005. 39 See Veterinary Residues Committee Fact Sheet, available at: http://www.vet-residues-committee.gov.uk. Accessed on: 2 May 2005. 143
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The ethics
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The ethics
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Foreword The issue
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Table of contents
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Stages 1-2: discovery and selection
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Conclusions and recommendations ...
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Terms of reference
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T h e e t h i c s o f r e s e a r c
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Chapter 1 Introduction
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Chapter 2 The cont
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Chapter 3 Ethical issues raised by
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Chapter 4 The capa
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Section 2 Use of <
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Chapter 5 The use
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Section 4 Legal, ethical and policy
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Chapter 14 Discussion of</s
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Appendices
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Genetic screening: ethical issues P
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