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Index Accidental deaths, 18 Acetazolamide, 188n.9 Activities of daily living, 61 Adoption of technology, vii-viii, 149, 151, 169, 171-173, see also Diffusion of technology, Translation of technology Agency for Health Care Policy and Research, 14, 47, 183-184 Agriculture, 147 AIDS, vii drugs, 1,2,21,30, 155 and intermediate endpoints, 177 Alanine aminotransferase testing, 83 Alcoholism, 5 Allopurinol, 188n.9 Alpha-blockage drugs, 38 Alpha receptors, 154 Amantadine, 188n.9 American Association of Neurological Surgeons, 192n.48 American Society of Anesthesiologists, 62 American Urological Association, 42 Analgesics, 193n.65 Anaphylactoid reactions, 20 Angina pectoris, 9, 183, 193n.63 beta-blockers treatment, =6, 154 coronary artery bypass grafting, 6-7 data base analysis, 63-64 213 PTCA catheter equipment, 7-8 Angioplasty, 56 coronary, 7-8, 9 laser, 165-166, 170 Animal testing, 4, 153-154, 158, 172, l91n.32 Antibiotics, 54, 140 Antidepressants, 3, 188n.9 Anti-infective drugs, 157, 186, 193n.65, 193-194n.66 Anti-inflammatory drugs, 70, 188n.9 Antineoplastic drugs, 186 Anxiety, 5 APACHE II system, 60 Apgar score, 93 Aplastic anemia, 158-159 Arrow, Kenneth, 43 Arterial grafts, l91n.36 Arteriography, 6 Artificial heart, 165 Artificial Heart Assessment Panel, 17 Aspirin, 140, 145, 188n.9 Association for the Advancement of Medical Instrumentation, 168 Asthma, 5 Astra, 188n.10 Atherosclerotic disease, 3 Auranofin, 29, 157 Australia, 47 AZT, 30

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214 Bacon, Francis, 1, 148 Bayesian statistical methods, 12, 101-116 hierarchical Bayes methods, 112 see also Meta-analysis Benign prostatic hyperplasia (BPH) 12, 33-38, 39-40, 41, 42, 81, 184 Benoxaprofen, 74 Bernard, Claude, 148 Beta-blockers, 9, 188nn.9, 10 angina pectoris treatment, 4-6, 193n.63 discovery of, 153, 154 practolol, 68 Beta receptors, 154 Biases, 129, 131, 133 case control studies and, 125, 126 coding, 56 Confidence Profile Method and, 102-103, 107-110, 113-114, 115 contact, 57 contamination, 102-103, 124, 130 cross-over, 102-103, 124, 125, 127, 129 databases and, 125, 126 dilution, 124, 130 intensity, 124 internal and external validity, 121, 124-126 meta-analysis and, 95 publication, 89 randomized controlled clinical trial and, 130, 157, 168, 189n.17 reporting and coding, 56-57 Bioengineering research, 162-163, l91n.31 Biological revolution, 1, 175 Biologicals, 149, 187-188n.4, 188n.5 Biomedical research, vii, 1, 9-10, 12, 149, 175, 178, 192n.46 Biomedical science, 43, 44, 45 Biotechnology industry, 151, 152 Black, James, 4 Blinding, 157, 189n.17 Blindness, 5 Blood cholesterol, 11, 18 Blood pressure, beta-blockers and, 154 Boehringer Ingelheim, 4n.3 Boston, 44 BPH, see Benign prostatic hyperplasia '`BPH Shared Medical Decision Making Procedure," 37-38, 40, 45-46 Breast cancer, 20 screening, 121-122, 127, 130-131 British Medical Journal, 18 Bronchodilators, 4 Bypass surgery, 54 CLOG, see Coronary artery bypass grafting Canada, 62 Cancer, 69 INDEX chemotherapy, 11, 17, 21 data bases, 62 drugs, 2, 21, 189n.19 mortality, 11, 18 surrogate endpoints and, 21 Captopril, 29, 157 Cardiac denervation, 6 Cardiac mortality, 11, 18 Cardiovascular disease data base, 7 Cardiovascular disease, surrogate endpoints end, 21 Cardiovascular drugs, 157, 186, 193n.65 Cardiovascular function, 24n.1 Cardiovascular implants, 165 Carotid endarterectomy, 54, 55 Case-control studies, 121, 122-123, 130, 161, 190n.28 bias in, 125, 126 Case Western Reserve University, 164 Central nervous system, 149 Cerebral ischemia, 3 Certificate of Need, 151, 169 Cesarean delivery, 92, 93 Charlson comorbidity index, 59 Chemical analysis, automated, 164 Chloramphenicol, 158-159 Cholecystectomy, 53-54, 175 Chymopapain, 20 Cimetidine, 177-178 Cleveland Clinic, 6 Clinical decision making, 10, 12-13, 43, 54 see also Decision making, shared Clinical endpoints, see Endpoints, Medical technologies Clinical evaluation, see Clinical procedures, Drugs, Medical devices, Observational studies, Surgical procedures Clinical procedures decision analysis and, 78-79, 85-86 development of, 149, 151, 170-173, 182-183, 192n.47 evaluation of, 3, 9, 13-14, 118, 128, 135-136, 173-174, 183-186, 187-188n.4 geographic variations, 3 post-marketing surveillance, 17-18, 144, 170175 research f~ndings and, 149, 175, 186 see also Medical technologies Clinical series, 121, 128 Clinical trials, 70, 83, 84, 184 data collection, 23-24 decision analysis and, 78-79, 82-83, 85-86 health status measures, 29, 32 Investigational New Drug, 155 medical devices, 166-168, l91n.38 new medical procedures, 173-174

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INDEX prazosin, 39-40 prostatectomy, 42 quality of life measures, 10, 23, 24-27, 29, 30 surgery, 192n.51 see also Post-marketing clinical trials, Pre-marketing evaluation, Randomized controlled clinical trials Coding, 55, 64 bias, 56 Cohort studies, 161, l90nn.28, 30 Colectomy, 173 Committee on the Safety of Medicines (CSM, United Kingdom), 5, 68, 70, 71, 73, 74, 76, 189-19On.23, l90n.27 Comorbidity index, 58-60 Confidence Profile Method, 101-105, 111-116 case study, 105-110 Congestive heart failure, 55 Conjunctivitis, 71 Constipation surgery, 172 Contact bias, 57 Contamination bias, 102-103, 124, 130 Cooper Committee, 165 Coronary angioplasty, 7-8 Coronary artery bypass grafting (CABG), ~7, 9, 89, 173, 193n.63 Coronary artery disease, 8, 63, 173 Coronary artery surgery, 89, 174 geographic variations, 182 Coronary Artery Surgery Study, 6-7, 174 Coronary death, 188n.9 Coronary thrombi, 16 Costs healthcare,41 45, 86, 127, 160, 169, 184, l90n.26 innovation, 118 new chemical enities, 176,192n.54, research, 161-162 Coumadin, 143 Courage to Fail (Fox and Swazey), 171 Crossover bias, see Biases Cyclosporine, 140 Data bases, 12, 47-50, 51-54, 121, 123 automated, 3-4, 161, 185 bias in, 125, 126 Manitoba, 55, 56, 57, 59 60, 62 Medicaid, 12, 52, 161 medical device evaluations, 170 Medicare, 47~8, 53, 55, 56, 57, 62, 64 meta-analysis, 92 outcome measures, 6~61 Oxford Perinatal Trials, 93 Prescription-Event Monitoring, 73 primary, 63-64 quality of, 89 215 record linkage, 61-63 risk adjustment, 58-60 strengths of, 49-54 weaknesses of, 55-58 see also Medical technologies Decision analysis, 12-13, 36, 45, 78-87, 185 Decision making, shared, 39, 40-41, 44, 45-46 Denmark, 42 Descartes, Rene, 148 Devices, see Medical devices Device Experience Network, 170 Diabetes insipidus, 188n.9 Diabetes mellitus, 55 Diagnosis-related groups (DRG), 169 Diagnostic data, 52, 55, 56-57 Diagnostic devices, evaluation of, 167, 181, 185 Diathermy, 38 Diazepam, 188n.9 Dichloroisoproterenol, 4, 154 Diethylstilbestrol (DES), 19, 20 Diffusion of technology, 128, 159, 16~162, 169-170, 185 see also Adoption of technology, Translation of technology Dilation catheter, 7-8 Dilution bias, 124, 130 Confidence Profile Method and, 102-103, 107-110, 113-114, 115 Diuretics, 76 DNA probes, 165 Dollery, Sir Colin, 76 Drug industry and post-marketing research, 13, 71, 76, 77, 140, 160 pre-marketing studies, 118, 138 and pricing, l90n.25 research investment, 14, 164, 175-176, 184 Drug Price Competition and Patent Term Restoration Act (1984), 178 Drugs adverse reactions, 68, 69-71, 72, 73, 141, 143-144, 160-161 AIDS, 1,2,21,30, 155 banning, 137, 143 categories, 193n.65 clinical evaluation of, 2-3, 5, 9, 23, 39, 45, 128, 135-136, 183-186, 189n.21 decision analysis and, 78 discovery and development of, 149, 151, 152-153, 154-159, 175-179, 186-187, 188n.5, 188-189n.13, 189-19On.23, 193n.56 discovery of, 152-154, 189n.20 FDA approval process, 13, 16, 17, 118, 137-138 observational evaluation, 11-12

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216 patent protection, 13, 178,188n.12,193nn.58,59 post-marketing surveillance, 75, 139-140, 141-142, 144, 16~162 pre-marketing studies, 138-139, 142, 143-144 pricing, 190n.25 prostate hyperplasia treatment, 38 regulation of, 192nn.54, 55 safety discontinuations, 2-3, 158, 187 side effects, 19-20, 30, 157, 159 anti-inflammatory drugs, 74-75 and human testing, 155 practolol, 5 pronethalol, 4, 154 tranylcypromine, 3 voluntary reporting systems, 7~71, 16~161 see also Medical technologies, New chemical entities, Phases I-IV studies Drug Safety Research Trust, 71 Drug Safety Research Unit (DSRU, United Kingdom), 68, 71, 72-73, 74, 75, 77, 161, 190n.29 Duke University cardiovascular disease data base, 7 Dyspepsia, 74 Effectiveness, 9, 10, 50, 51, 125, 129 breast cancer screening, 130-131 clinical procedures, 172, 174, 182, 183 drugs, 159, 177, 178 in Food, Drug, and Cosmetic Act, 2, 157, 189n.15 likelihood function and, 107 post-marketing studies, 11, 13, 161-162 p-value and, 126-127 randomized controlled clinical trials and, 41 Efficacy, 2n.2, 9, 10, 50-51, 83, 125, 189n.15 clinical procedures, 172, 174-175, 182, 183 coronary artery bypass grafting, 6-7 drugs, 11, 73, 138-140, 143-144, 155, 156, 158, 193-194n.66 FDAand,137, 142 medical devices, 164, 165, 167, 168, 170, 180, 191-192n.44 psychotherapy, 90, 91 randomized controlled clinical trials and, 157 surgical procedures, 62 Ehrlich, Paul, 152-153 Elderly, 62 Electronic fetal monitoring, 92-94 Emepronium bromide, 74 Enalapril, 75-76 Endarterectomy, carotid, 54, 55 Endocarditis, infective, 51-52, 54 Endpoints, 167 clinical, 11, 16, 18-20, 156 INDEX intermediate, 2, 1~11, 13, 16-17, 156, 177, 185 surrogate, 2~21, 139 England, 71-72 Enlightenment, 148 Enthusiasm variable, 69-70 Epidemiology, 140 Epilepsy, 173 Epinephrine, 154 Erythromycin estolate, 73-74 Erythropoietin (epo), 11, 156 Esophagitis, 74 Europe bioengineering research, 162 health insurance systems, 47 new drug development, 176, 187 European Cooperative Surgery Study, 6-7, 174 European Economic Community, 193n.60 Evaluation, see Clinical procedures, Drugs, Medical devices, Observational studies, Surgical procedures Event monitoring, 72 Experimental research designs, 13-14, 129 External validity, 121, 124-126 Extracranial-intracranial (EC/IC) bypass surgery, 3, 173, 192n.48 [amily Practitioner Committee (United Kingdom), 72 Favaloro, Rene, 6 Feinstein, Alvan, 139 Fenbufen, 74 Fetal monitoring, electronic, 92-94 Fetal scalp blood sampling, 94 Finney, David, 72 Food and Drug Administration (FDA), 70, 133-134 and beta-blockers, 5-6 Bureau of Biologics, l91n.36 Bureau of Drugs, l91n.36 Center for Devices and Radiological Health, 188n.5 Center for Drugs and Biologics, 188n.5 and chymopapain, 20 and data bases, 12, 161 and dilation catheters, 8 drug approval process, 17, 38, 118 and drug development, 154, 155, 158, 159, 160, 177, 189n.14 and intermediate endpoints, 11, 16, 21, 156 medical devices regulation, 164, 165, 166, 168-169, 170, l91n.42, 193n.62 and post-marketing surveillance, 136 and pre-marketing studies, 142, 143-144 regulatory role, 137-138, 139-140, 144, 151 and tissue plasminogen activator, 16-17

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INDEX see also Drugs, Investigational Device Exemption, Investigational New Drug, Medical devices, New Drug Application, Regulation Food, Drug, and Cosmetic Act (1938), 138, 144, 188n.5 Kefauver-Harns amendments (1962), 154, 176-177, 186, 188n.5, 189n.15 Medical Device Amendments (1976), 8, 164, 165, 168-169, 180, 188n.5 and post-marketing reporting, 160 and safety and effectiveness, 2, 13, 136-137, 142, 157 Fox, Renee, 150 France, 192n.46 Functional status, 30, 185 Funding bioengineering research, 162 clinical procedures development, 182 clinical procedures evaluation, 14, 184 Gallbladder disease, 57 Gallstones, 78, 183 Gastric bypass surgery, 19 Gastritis, 74 Gastrointestinal drugs, 186 Gastrointestinal hemorrhage, 70, 75 General Accounting Office (GAO), 166 Generic drugs, 13, 178, 193nn.58, 59 Geographic variation clinical procedures use, 182 medical care use, 33 prostatectomy rates, 35 see also Clinical procedures, Coronary artery surgury, Health care, Hip replacement, Lower back surgery, Surgical procedures Good Laboratory Practices (GMP) regulations, 188n.11 Good Manufacturing Practices regulations, 165, 168, 170, 190n.24, l91n.41 Green, Harold, 17 Gruentzig, Andreas, 7-8 Guillain-Barre syndrome, 19 Halothane, 18 Hanley, Dan, 33 Headache, 69, 70 Health care costs, 44 45, 86, 127, 160, 169, 184, 190n.26 data bases, 47-50 geographic variations in use, 33 meta-analysis of, 92 quality of, 53-54 Health Care Financing Administration (HCFA), 61, 63, 151, 169, 191-192n.44 217 Health insurance coverage, 57 data base research, 12, 47, 51, 52, 55, 57, 58-59, 60-62, 63-64, 175 Health maintenance organizations (HMOs), 161 Health outcomes, 117 Health status measurement, 10, 23-32 Heart attack, 119 beta-blockers and, 154 Heart disease, practolol treatment, 68 Heart surgery, 73 Heart transplants, 192n.50 Heparin, 140 Hepatitis, non-A non-B, 83, 84 Hepatitis B vaccination, 84-85, 86 Heuristics, 12, 126-128, 133 Hierarchical Bayes method, 112 see also Bayesian statistical methods Hip fractures, 63 Hip replacement, 55 geographic variations, 182 Hospitals data bases, 48, 55, 56-57, 58, 62 and medical devices, 169 mortality, 60, 63 readmission, 57, 61 Human testing, 154-155, 176, 186, 187-188n.4, 189n.14, 192n.53 Hyper-cholesterolemia, 156 Hyperkalemia, 76 Hypertension, 3, 5 Hysterectomy, 19, 52, 57, 175 Imaging techniques, 149 Immunoassays, 78 Immunosuppression, 143 Imperial Chemical Industries (ICI), 4, 5, 154, 188n.10 IMS America, 137 Inderal, 154 Index Medicus, 91, 93 Indomethacin, 74, 188n.9 Industrial revolution, 148, 175 Influenza vaccine, 52, 53 Infusion pumps, 166-167 Innovation, vii-ix, 1-2, 4-6, 7, 10, 11 13, 14, 149, 152, 178, 186 anesthetic, 92 clinical procedure, 171-173, 177 costs of, 118 empirical, 177 incremental, 20, 171, 172, 18~182 iterative model of, 149 linear model of, 9, 148-149 medical device, 163-164, 171, 177, 180-181 pharmaceutical, 177, 18~181

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218 radical, 171-173, 180, 182 role of market in, 149 surgical, 92 Institute of Medicine Committee on Technological Innovation in Medicine, vii-viii, 2, 4 Institutional Review Boards (IRB), 154, 165, 166, 172, 182, 183 Intelligence tests, 3~31 Intensity bias, 124 Intercontinental Medical Statistics Limited, 75 Intermediate endpoint, see Endpoints Internal validity, 121, 124-126 International Classification of Diseases (ICD-9), 55, 64 International Electrotechnical Commission, 168 International Pharmaceutical Abstracts, 91 Intrauterine device (IUD), 165, 191n.36 Investigational Device Exemption (IDE), 166, 168, 180, 191n.38, 193n.62 Investigational New Drug (~D) application, 154-155, 176, 186, 188-189n.13, 189-190n.23 treatment IND, 158 Japan biomedical research, 162, 192n.46 new drug development, 176 Jaundice, 74 Karnofsky Performance Status Index, 25 Kay, John, 148, 187n.2 Kidney dialysis, 171 Kidney stones, 78, 169 Kuhn, Thomas, 33, 43 Leukemia, 158 Levodopa, 161 Lidocaine, 188n.9 Life expectancy cancer chemotherapy, 21 coronary artery bypass grafting, 6 in data base analysis, 54 prostatectomy, 35, 43 see also Mortality Life-threatening diseases, 171 new drugs for, 2, 17, 158, 177 Likelihood function, 101-102, 103, 104 106, 107-111 Lilly, Eli, & Co., 4 Lipid drug trials, 18 Lithotriptor, 169 Litigation, 70 Little, Arthur D., Inc., 164 Liver failure, 18 Longitudinal studies, 49, 62 INDEX Lower back surgery, geographic variations, 182 Magnetic resonance imaging (MRI), 83~4, 180 Maine, prostatectomy survey, 33, 35, 41, 42 Mammary arteries, 7 Mammography, 130 Manitoba data system, 51-52, 55, 56, 57, 59-60, 62 prostatectomy survey, 42, 50, 53, 63 Massachusetts Institute of Technology, 164 Mastectomy, 20 Measuring Health (McDowell and Newell), 27 Medicaid, data base, 12, 52, 161 Medical audit, 2~21 Medical decision making, see Clinical decision making Medical Device Amendments, see Food, Drug, and Cosmetic Act Medical device industry, 29, 151, 178, 184 Medical devices, 191nn.36, 37 clinical evaluation of, 23, 135-136, 18~181, 183-186, 187-188n.4, 191n.32 decision analysis and, 78 development of, 9, 149, 151, 164-169, 18~182, 191n.35, 191-192n.44, 192n.45, 193n.61 invention of, 162-164 post-marketing surveillance, 144, 169-170 see also Medical technologies Medical profession and drug efficacy, 139 FDA and, 139 and post-marketing studies, 141-142, 144-145 and regulation, 135-138 see also Hospitals, Physicians Medical societies, 192n.47 Medical technologies biases and, 124-126, 127-128 clinical evaluation of, 1-4, 9-10, 13-14, 5~51, 117-120, 128-134, 135-136, 15~151, 183-186 data base research, 60 decision analysis and, 78 development of, 149-151, 187-188n.4 economic evaluation of, 2n.1 endpoints in, 16 post-marketing surveillance, 17-18 quality of information and, 121-124 technology families, 112, 113 see also Clinical procedures, Data bases, Drugs, Medical devices, Surgical proce- dures Medicare, 191-192n.44 Mortality Predictor System, 60

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INDEX prospective payment system, 160, 169 reimbursement, 193n.60 see also Data bases MedisGroups, 64 MEDLINE, 91, 93 Mental status, 24n.1 Merck Foundation, 73 Meta-analysis, 12, 88-89, 90-92, 95-97 Confidence Profile Method, 101-105, 110116 criticisms of, 94-95, 96 electronic fetal monitoring, 93-94 Miettinen, Ollie, 143 Mifespristone, 151 Mitral valve surgery, 172 Morbidity, 58, 6~61, 83-84 Mortality, 69, 72-73 as clinical endpoint, 16, 17, 18-19, 21, 156-157, 185 in data base analysis, 51, 58, 59-60 enalapril, 75-76 hospital, 60, 63 mitral valve operations, 172 occupational health risks, 63 offsetting, 11 prazosin, 39 surgery, 85-86 transurethral prostatectomy, 42, 43, 53, 81 see also Life expectancy Myocardial infarction, 7, 8, 57, 156 beta-blockers and, 5, 188n.9 as outcome measure, 61 Xomax and, 143 NationalCancerInstitute, 127, 189n.19 National Center for Health Services Research and Health Care Technology Assessment (NCHSR), 183-184 National Halothane Study, 18 National Health Service (United Kingdom), 71 National Heart, Lung, and Blood Institute, 8, - 161 National Institutes of Health, 8, 51, 162, 188n.8, 192n.47 National Research Council, l91n.31 National Science Foundation, 162 Neonatal seizures, 94 Neoplastic drugs, 155 Neurological disease, 171 Neurophysiology, 149, 154 New chemical entities (NCE), 187, 192n.54 cost of development, 176 human testing, 186, 189n.14, 192n.53 patent life, 178 see also Drugs 219 New Drug Application (NDA), 118, 178, 189-19On.23, 192n.53, 193n.64, 193-194n.66 electronic, 159 New England Journal of Medicine, 8, 17, 70, 192n.48 New Haven, 44 Newton, Isaac, 148 New York Heart Association Classification, 25 New Zealand, 17 health insurance systems, 47 Non-experimental study designs, 51, 181, 185, 186 Non-randomized trials, 3, 121 Non-steroidal anti-inflammatory drugs (NSAID), 70, 7~75, 143 Norepinephrine, 154 Northern Ireland, 71-72 Observational studies, 3, 11, 12, 13-14, 18, 20, 181, 185 Occupational health risks, 63 Office for Health Technology Assessment, 191-192n.44 Off~ce of Population Censuses and Surveys (United Kingdom), 72-73 Office of Technology Assessment (OTA), 162 Ophthalmologic disorders, 21 Oraflex, 74 Organization for Economic Cooperation and Development, 192nn.46, 52 Orphan drugs, 189-19On.23 Orthopedic surgery, 55 Osmosin, 74 Outcomes, 11, 13-14, 183, 185 all-cause, 11, 16, 18, 19, 21 conditionJdisease-specif~c, 11, 16, 18, 19, 20 data base analysis, 50, 51, 58, 60 61, 63, 175 errors in measurement of, 102, 124, 125, 127 research, 33, 38, 43, 45-46 surrogate endpoints and, 16, 20 Oxford Data Base of Perinatal Trials, 93 Oxicams, 155 Parkinson s disease, 171 Patent protection, 13, 163, 178, 186, 188n.12, 193nn.58, 59, 60 Patient events, 12 Patient Outcomes Research Team (PORT), 47 Patient-physician relationship, 43-45, 171, 172, 182 see also Rational agency theory Patient preferences, 10, 11, 12 in decision analysis, 87 and medical devices, 170

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220 in outcomes research, 3, 35, 36-38, 39, 45-46, 174, 185 Patient selection bias, 103, 124, 125, 127, 130 Peer Review Organizations, 64, 172 Pentostatin, 158 Peptic ulceration, 75 Percutaneous transluminal coronary angioplasty (PTCA), 7-8, 9 Pharmaceuticals, see Drugs Pharmacoepidemiology, 12, 52, 71, 140, 161 Phase I studies, 7, 39, 143, 155, 183, 187-188n.4 Phase II studies, 21, 23, 143, 156-158, 177, 187-188n.4 Phase III studies, 21, 23, 143, 144, 156, 157, 158, 159, 177, 184, 187-188n.4 Phase IV studies, 13, 144, 187-188n.4 Phenylbutazone, 188n.9 Phenytoin, 188n.9 Phocomelia, 19, 143 Photosensitivity, 74 Physicians, 192n.48 bias, 50 clinical procedures development of, 171, 182-183 evaluation of, 174 decision making clinical, 39, 43-44, 54, 135-136 shared, 37, 38, 39, 41 diagnoses, 52, 55 and medical devices, 169 and post-marketing surveillance, 75, 142, 145, 160-161, l90n.29 practice style, 33, 35, 36 "seven deadly sins," 70-71 see also Patient-physician relationship Piroxicam, 74, 155 Placebos, 168, 192n.51 Platelet modulators, 188n.9 Politicians, 137-138, 141-142 Population bias, 124, 125 Post-Graduate Medical School (London), 76 Post-marketing clinical trials, 75-76 Post-marketing surveillance (PMS), 13, 70, 75, 76, 144, 145, 187-188n.4 clinical procedures, 17-18, 174-175, 184 drugs, 3, 6, 17, 41, 71, 140-141, 142, 160-162, 177-178 FDA and, 11, 136 medical devices, 17, 170 Post-marketing Surveillance Unit (United Kingdom), 75 Practolol, 5, 68, 71, 76, 141 Prazosin, 38, 39-40, 41 Preference trial, 38, 40-41, 42~3 Prefrontal lobotomies, 173 INDEX Pregnancy cesarean delivery, 92, 93 diagnostic kits, 170 electronic fetal monitoring, 94 Pre-marketing approval (PMA), 168-169, l91n.42 Pre-marketing evaluation, 189n.15 dmgs, 2-3, 11, 138-139, 142, 143-144, 159, 177 medical devices, 8, 180 practolol, 5 Prescription-Event Monitoring (PEM, United Kingdom), 5, 11-12, 68, 71-74, 75, 76, 77 Prescription Pricing Authority (PPA, United Kingdom), 71, 72, 73 President's Commission on Post-Marketing Surveillance, 17 Preventive interventions, 84 Price and Profit Regulation Scheme (United Kingdom), l90n.25 Probenecid, 188n.9 Procedures, see Clinical procedures Product License Application, 159 Pronethalol, 4, 154 Propranolol, 4-5, 154 Prospect theory, 86-87 Prospective Payment System, 56, 160, 169 Prospective trials, 38, 105 Prostatectomy, 19, 50, 54, 62, 63, 175 effectiveness, 34-38, 41 mortality, 42-43, 53 Prostatic cancer, 143 Prostatic hyperplasia, benign (BPH), see Benign prostatic hyperplasia Prostatotomy, 38 Psychopharmacological drugs, 157, 186, 188n.9, 193n.65, 193-194n.66 Psychotherapy, 89-90, 91, 170 PTCA, see Percutaneous transluminal coronary angioplasty Public health, 92 Public Health Service Act (1944), 188n.5 Pulmonary embolism, 143 P-value, 126-127, 133 Quality of life in data analysis, 89 and endpoints, 19, 21, 6~61 measurement of, 10, 23, 24-27, 29, 30 and technology evaluation, 156-157, 170, 177, 185 Radiation therapy, 20 Random effects model, 112 Randomization, 189n.17

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INDEX Randomized controlled clinical trials, 51 bias in, 89, 125-126, 127, 129, 130 in clinical evaluation of technology, 3-4, 11, 117, 118, 121-123, 128, 133, 185 clinical procedures evaluations, 173-174, 183 Confidence Profile Method and, 105, 107, 108, 110, 115 coronary artery bypass grafting, 6, 9 cost of, 161-162 in drug development, 157, 159 mastectomy, 20 medical device evaluations, 165, 167-168, 170, 181 in meta-analysis, 93, 94 patient preference and, 38-43 PTCA catheters, 8 Rational agency theory, 43 14, 45, 79 see also Patient-physician relationship Receiver operating characteristic (ROC) analysis, 85, 167, 191n.40 Record linkage, 61-63, 161 Regret theory, 86-87 Regulation clinical procedures, 13, 172, 182 and drug development, 177, 186- 187, 188-189n.13, 192n.55, 193n.64, 193-194n.66 medical devices, 164, 165, 180 role of, 9, 135-138, 139-140, 141, 142, 114 145, 151, 183 see also Food and Drug Administration Renal failure, 75-76 Research, 50, 88, 149 costs, 161-162 drug development, 152-154, 164, 175-176, 186-187, 188n.11 integration of, 90, 9~95 meta-analysis, 90-92, 96-97 nerve, 154 planning, 113-114 see also Drug industry, Drugs, Medical device industry, Medical devices, National Institutes of Health Risk, 2, 64, 185 adjustment, 58-60 drugs, 178 medical devices, 165, 19 ln.37 treatment, 19, 54, 68-69 and vaccination, 84~5 Roussel Uclaf, 151 RU486, 151 Russell, Alice, 33 Sackett, David, 41 Safety, 9, 14 clinical procedures, 172, 174, 182, 183 221 coronary artery bypass grafting, 6-7 drug discontinuations, 2-3, 158, 187 drugs, 39, 76, 155, 177, 193-194n.66 in Food, Drug, and Cosmetic Act, 2, 13, 157, 189n.15 FDA and, 10, 137 medical devices, 164, 165, 167, 170, 180, 191-192n.44 Saphenous vein graft, 6, 7 Scandinavia, 139, 187 Schizophrenia, 173 Schneider-Medintag, 7-8 Science, 33, 43, 148 Science, 171 Scotland, 71-72 Sensitivity, 30, 64, 81, 83, 84, 93, 101, 102, 114, 167 Shared Medical Decision Making Procedure, 37-38, 40, 45-46 Sickness Impact Profile, 31 Small Business Innovation Research program, 162 Smoking, 64, 190n.30 Snow,C.P., 171 Social Science Citation Index, 91 Sones, Mason, 6 Soule, David, 33 Southampton, University of, 68, 71 Specific Activity Scale, 25 Specificity, 57, 83, 93, 167 Speirs, Christopher, 76 Spitzer, Walter, 143 Standard Industrial Classification codes, 162 Statistical methodology, 96-97 Statistical significance, 126 Statistics in Medicine, 21 Sterling-Winthrop, 140 Steroids, 188n.9 Streptokinase, 16-17 Stroke, 3, 61, 143, 173, 188n.9 "Structure of Scientific Revolutions" (Kuhn), 33 Sulfinpyrazone, 188n.9 Surgical procedures, 192n.51 angina pectoris, 6-7 data base analysis of, 55, 56, 61 development of, 3, 9, 170, 172-173 eff~cacy studies, 62 evaluation of, 41, 45, 54, 118, 174 geographic variations in rates, 35-38 mortality, 39, 60, 85-86 see also Clinical procedures, Medical technologies Surrogate endpoints, see Endpoints Sweden, 192n.46 Swine flu vaccine, 19 Switzerland, 192n.46

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222 Tariff codes, 55 Technicon, 164 Technology improvement, 147-152, 187nn.2, 3, 188n.6 see also Medical technologies Technology Transfer Act (1986), 188n.8 Temin, Peter, 186 Textile industry, 187n.2 Thalidomide, 19, 143, 186-187, 193-194n.66 Thiazide drugs, 188n.9 Third-party payers, 29, 150, 151, 160, l90n.26 Timothy, Robert P., 33-34 Tissue plasminogen activator (t-PA), 11, 16-17, 20, 21, 160 Toxicity testing, 137, 139-140, 153, 155, 157, 158-159, 188n.11 TOXL~E, 91 Tranquilizers, 186, 188n.9, 193-194n.66 Translation of technology, 1, 149, 175, 178 Transurethral resection of the prostate (TURP), 55,63 effectiveness, 38, 39, 51, 82, 84 mortality, 17-18, 42-43, 53, 81 Transverse myelitis, 20 Tranylcypromine, 3 Treatment IND, see Investigational New Drug Tubal ligation, 52 Ultrasound, 180 United Kingdom, 192n.50 biomedical research investment, 192n.46 Committee on the Safety of Medicines (CSM), 5, 68, 70, 71, 73, 74, 76, 189-19On.23, l90n.27 drug pricing regulation, l90n.25 Drug Safety Research Unit (DSRU), 68, 71, 72-73, 74, 75, 77, 161, l90n.29 medical device innovation, 164 new drug introductions, 4, 5, 187 post-marketing surveillance, 17, 75, 76, 139 Prescription-Event Monitoring (PEM), 5, 11-12,68,71-74,77 Yellow Card System, 70, 73-74, 16~161, l90n.27 INDEX United States biomedical research, 162, 192n.46 Congress, 14, 140, 176-177 drug pricing in, l90n.25 drug research investment, 175-177 health insurance systems, 47-48, 57, 62 medical device regulation, 164 new drug introductions, 187, 192n.54 patent law, 178 post-marketing surveillance in, 17, 139, 142, 160 see also Food and Drug Administration Urethra, 42 Urologists, 17-18, 33-34, 42 Utilities, see Patient preferences Vaccination hepatitis B. 84-85, 86 influenza, 52, 53 swine flu, 19 Vaginal cancer, 19 Validity, see External validity, Internal validity Variations, see Geographic vanations Vascular surgery, 55 Veterans Administration, 6-7, 8, 174 Videodisc technology, 37, 38 Vineberg procedure, 7n.4, 173 Viral diseases, 140 Wales, 71-72 WallStreet Journal, 16, 17 Watchful waiting, 35, 36-38, 39, 41, 54, 81, 82 Watt, James, 148 West Germany, biomedical research, 162, 192n.46 White, E. B., 43-44 Xomax, 143 Yellow Card System (United Kingdom), 70, 73-74, 16~161, l90n.27 Zomepirac, 74