Publication Information

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2082, 2094, 2107, 2133, 2139, 2163, 2166, 2227, 2242, 2253, 2264, 2271, 2286, 2296, 2336, 2340, 2392, 2397, 2410, 2447, 2472, 2476, 2492, 2500, 2521, 2608, 2634, 2650, 2681, 2728, 2733, 2753, 2770, 2793, 2823, 2841, 2884, 2895, 2902, 2909, 2931, 2985, 3108, 3513, 3583, 3680, 3790, 3825], 'favoritesDownload': [529], 'CitationsTrack': [530], 'CitationsPermissions': [531], 'ShareFacebookTwitterLinkedInRedditEmail': [532], 'Join': [533], 'the': [534, 542, 576, 695, 729, 734, 770, 781, 784, 867, 916, 936, 976, 1024, 1032, 1046, 1160, 1170, 1180, 1187, 1206, 1228, 1244, 1253, 1257, 1266, 1293, 1316, 1397, 1430, 1457, 1464, 1491, 1516, 1522, 1536, 1601, 1608, 1612, 1627, 1641, 1672, 1684, 1687, 1691, 1696, 1699, 1703, 1706, 1712, 1715, 1733, 1760, 1767, 1801, 1863, 1880, 1936, 1944, 1954, 2062, 2078, 2099, 2127, 2142, 2221, 2224, 2248, 2298, 2357, 2478, 2523, 2549, 2554, 2563, 2585, 2615, 2635, 2673, 2705, 2738, 2741, 2757, 2812, 2815, 2844, 2853, 2862, 2874, 2880, 2890, 2903, 2925, 2966, 2973, 2986, 2996, 3047, 3068, 3119, 3142, 3167, 3269, 3331, 3440, 3487, 3624, 3660, 3668, 3856, 3867, 4017], 'dialogue': [535], 'on': [536, 541, 1088, 1490, 1573, 1766, 1897, 2077, 2811, 2995, 3013, 3031, 3074, 3154, 3172, 3184, 3196, 3208, 3219, 3250, 3313, 3353, 3377, 3460, 3839], 'health': [537, 572, 590, 617, 1635, 2178, 2320, 2417, 2835, 2988, 3635], 'care': [538, 570, 588, 601, 615, 748, 1333, 1636, 1837, 2321, 2418, 2989], 'reform.': [539], 'Comment': [540, 3683], 'perspectives': [543], 'published': [544], 'in': [545, 560, 568, 711, 733, 745, 761, 894, 1193, 1247, 1329, 1393, 1402, 1424, 1445, 1473, 1478, 1921, 1949, 2006, 2028, 2070, 2086, 2305, 2457, 2534, 2543, 2568, 2663, 2745, 2873, 2924, 3114, 3166, 3412, 3445, 3486, 3551, 3603, 3632], 'Annals': [546], 'offer': [548, 2915], 'ideas': [549], 'your': [551], 'own.': [552], 'All': [553], 'thoughtful': [554], 'voices': [555], 'should': [556, 1805, 2439, 2764], 'be': [557, 658, 1099, 1380, 1433, 1512, 1592, 1723, 1850, 1866, 2134, 2337, 2440, 2473, 2509, 2702, 2754, 2765, 2779, 2900], 'heard.While': [558], 'advances': [559], 'medical': [561, 569, 587, 680, 1270, 1290, 1332, 2711, 2855], 'science': [562], 'have': [563, 828, 883, 1969, 2023, 2471, 2723, 2920, 2935], 'led': [564], 'continued': [566], 'improvements': [567, 970], 'outcomes,': [573, 1471], 'evidence': [574, 624, 703, 1225, 1323, 1353, 1552, 1830, 1885, 2057, 2624, 3370], 'comparative': [577, 626, 649, 655, 701, 1267, 1658, 2661], 'effectiveness': [578, 650, 656, 702, 1268, 1411, 1659, 1676, 2539, 2668, 2698, 3042], 'alternative': [580, 1664, 2794], 'management': [581, 2795], 'options': [582], 'remains': [583], 'inadequate': [584], 'informed': [586, 659, 2175], 'policy': [591, 1373, 1824, 2179, 2232, 2774, 2818], 'decision': [592, 670, 1374, 2322, 2341, 2493, 3630], 'making.': [593, 1375], 'result': [595, 2550, 2763], 'is': [596, 630, 1043, 1056, 1123, 1148, 1154, 1158, 1302, 1314, 1341, 1610, 1695, 1702, 1711, 1730, 1742, 1979, 2119, 2124, 2132, 2162, 2325, 2335, 2540, 2547, 2631, 2735, 2802, 2821], 'frequently': [597, 2312], 'suboptimal': [598], 'inefficient': [600, 826], 'as': [602, 604, 616, 717, 964, 991, 1310, 1322, 1327, 1354, 1554, 1683, 1784, 1818, 1884, 2102, 2104, 2122, 2207, 2430], 'well': [603, 1367, 2354, 2463], 'unsustainable': [605], 'costs.': [606], 'To': [607], 'enhance': [608, 808], 'or': [609, 1351, 1422, 1855, 2270, 2346, 2465, 2517, 2559, 2562, 2787, 3417], 'at': [610, 932, 1604, 3011, 3029, 3152, 3170, 3194, 3217, 3234, 3248, 3351, 3375, 3458], 'least': [611, 933], 'maintain': [612], 'quality': [613, 1047, 1109, 1181, 1195, 1216, 2208, 2687], 'reform': [618], 'cost': [620, 1541], 'containment': [621], 'occurs,': [622], 'better': [623, 1303], 'clinical': [627, 664, 685, 691, 841, 988, 1001, 1016, 1051, 1075, 1090, 1232, 1248, 1371, 1618, 1644, 1810, 2176, 2230, 2307, 2348, 2458, 2525, 2772, 2816, 2913, 2967, 3075, 3112, 3143, 3190, 3210, 3275, 3288, 3621, 3627, 3633], 'cost-effectiveness': [629], 'required': [631, 1263, 1542], '(1).': [632], 'American': [634, 3020, 3335], 'Recovery': [635, 3021], 'Reinvestment': [637, 3023], 'Act': [638, 3024], '2009': [640], 'allocated': [641, 1878], 'a': [642, 708, 848, 877, 902, 965, 992, 1014, 1038, 1212, 1286, 1330, 1358, 1383, 1503, 1909, 1939, 1980, 1990, 1994, 2117, 2326, 2407, 2512, 2535, 2544, 2569, 2921, 2939, 3044, 3115, 3508, 3581, 3862], '$1.1': [643], 'billion': [644], '"down': [645], 'payment"': [646], 'support': [648], 'research': [651, 1017, 2669, 2699, 2845, 2969, 3628], '(CER)': [652], '(2).': [653], 'Although': [654, 1439], 'can': [657, 1379, 1432, 1534, 1587, 1735, 1758, 1865, 1889], 'by': [660, 876, 931, 1058, 1084, 1169, 1413, 1547, 1744, 1813, 1825, 2191, 2618, 2888, 2937, 2954, 3540], 'synthesis': [661], 'existing': [663, 1549, 1829, 2113, 2871], 'information': [665, 1427, 1497, 1507, 1546, 1555, 2115, 2165, 2662, 2769, 2917], '(systematic': [666], 'reviews,': [667, 1560], 'meta-analysis,': [668], 'modeling)': [671], 'analysis': [673, 893, 2042, 3329], 'observational': [675, 1565, 2588, 2906], 'data': [676, 1087, 1108, 2907], '(administrative': [677], 'claims,': [678], 'electronic': [679], 'records,': [681], 'registries': [682], 'other': [684, 1238, 1750, 2838], 'cohorts,': [686], 'case–control': [688], 'studies),': [689], 'randomized': [690, 2626, 3398, 3509], 'trials': [692, 842, 853, 861, 1052, 1091, 1336, 1405, 1893, 1926, 1951, 2311, 2349, 2365, 2414, 2630, 2700, 2914, 3113], '(RCTs)': [693], 'are': [694, 724, 825, 959, 1092, 1222, 1365, 1443, 1776, 1877, 1927, 2043, 2089, 2239, 2292, 2303, 2343, 2353, 2389, 2461, 2595, 2718], 'most': [696, 1207, 1614, 1768, 1881, 2079, 2251, 2338, 2396, 2490], 'rigorous': [697], 'method': [698], 'generating': [700, 1085, 1223, 2621], 'will': [705, 1199, 1251, 1511, 1518, 1719, 2137, 2470, 2613, 2645, 2659, 2670, 2846, 2899, 2971], 'necessarily': [706], 'occupy': [707], 'central': [709], 'role': [710], 'an': [712, 892, 921, 1127, 1828, 2255, 2503, 2566, 3006, 3480, 3545, 3665], 'expanded': [713], 'national': [714], 'CER': [715, 799, 1378, 1568, 2056, 2131, 2161, 2481, 2616, 2638, 2734, 2881, 2926, 3801], 'agenda.However,': [716], 'currently': [718, 822, 1093, 1716], 'designed': [719, 2120, 2703, 2822, 2826], 'conducted,': [721, 823], 'many': [722, 1440, 2018, 2182], 'RCTs': [723, 796, 824, 1167, 1262, 1442, 2153, 2183, 2331, 2932], 'ill': [725], 'suited': [726, 1304, 1368], 'meet': [728, 2055, 2847], 'evidentiary': [730], 'needs': [731, 756, 2636, 2708], 'implicit': [732], 'IOM': [735], 'definition': [736], 'CER:': [738], 'comparison': [739], 'effective': [741, 1596, 2368, 2643], 'interventions': [742, 1321, 1581, 1590, 1782, 2302, 2872], 'among': [743, 2044], 'patients': [744, 1844, 1876, 2371, 2398, 2454, 3414], 'typical': [746], 'patient': [747, 755, 1078, 1764, 1856, 2084, 2187, 2204, 2433, 2557, 2571, 2786], 'settings,': [749, 2072], 'with': [750, 859, 1237, 1451, 1671, 1821, 1914, 2008, 2356, 2372, 2737, 2979, 3347, 3419], 'decisions': [751, 2419], 'tailored': [752], 'individual': [754], '(3).': [757], 'Without': [758], 'major': [759], 'changes': [760, 1246, 3073], 'how': [762, 1089, 1096, 1506, 1515, 1652, 2514], 'we': [763, 2136, 2857, 2934], 'conceive,': [764], 'design,': [765], 'conduct,': [766], 'analyze': [768], 'RCTs,': [769], 'nation': [771], 'risks': [772, 2866], 'spending': [773], 'large': [774, 2014], 'sums': [775], 'money': [777], 'inefficiently': [778], 'answer': [780], 'wrong': [782], 'questions—or': [783], 'right': [785], 'questions': [786, 2819, 2860, 2891], 'too': [787], 'late.This': [788], 'article': [789], 'addresses': [790], 'several': [791, 1407, 2045, 2676], 'fundamental': [792], 'limitations': [793], 'traditional': [795, 1281, 1335], 'meeting': [798, 1194], 'objectives': [800, 1182, 2849], 'offers': [802], '3': [803, 912, 1140, 2599], 'potentially': [804], 'transformational': [805], 'approaches': [806, 1533, 1917, 2037, 2051, 2581, 2607, 2930], 'their': [809, 2029, 2316, 2848], 'operational': [810, 922, 2948], 'efficiency,': [811, 813, 2602, 2604, 2981], 'analytical': [812, 1338, 1532, 2603], 'generalizability': [815], 'CER.Enhancing': [817], 'Structural': [818], 'Operational': [820], 'EfficiencyAs': [821], 'become': [829, 1582], 'more': [830, 1066, 1434, 1875, 2090, 2174, 2498, 2619, 2691, 2803], 'complex,': [831], 'time': [832, 868, 930, 2665], 'consuming,': [833], 'expensive.': [835], 'More': [836], 'than': [837, 1067, 1382, 1436, 1749, 1993, 2805], '90%': [838], 'industry-sponsored': [840, 852], 'experience': [843], 'delayed': [844], 'enrollment': [845], '(4).': [846], 'In': [847, 889, 1235, 1681, 1934, 3679], 'study': [849, 887, 913, 928, 946, 961, 998, 1104, 1114, 1470, 2118, 2289, 2370, 2945, 3399, 3548], 'comparing': [850, 1320, 1611], '28': [851], 'started': [854, 862], 'between': [855, 863, 997, 1852], '1999': [856], '2002': [858], '29': [860], '2003': [864], '2006,': [866], 'from': [869, 907, 1065, 1499, 1508, 1556, 2382, 2502, 2511, 2584, 2625, 2672, 3046, 3812], 'protocol': [870, 2444, 3071], 'approval': [871, 909, 2268], 'database': [873], 'lock': [874], 'increased': [875, 1390], 'median': [878, 903], '70%': [880], '(4).Several': [881], 'organizations': [882], 'sought': [884], 'streamline': [886], 'start-up.': [888], 'response': [890, 1425, 2792], 'Cancer': [895, 918, 974, 979, 3102, 3122, 3148, 3179], 'Leukemia': [897, 3104, 3124], 'Group': [898, 3105, 3125], 'B': [899], 'that': [900, 1129, 1151, 1417, 1420, 1698, 1714, 1737, 1874, 2000, 2052, 2291, 2415, 2438, 2487, 2582, 2746, 2790, 2843, 2933, 2964, 3865], 'found': [901], '580': [905], 'days': [906], 'concept': [908, 2739, 2804], 'phase': [911, 1139, 3110, 3272, 3510, 3514], 'activation': [914, 929], '(5),': [915], 'National': [917, 949, 973, 1171, 3178, 3318], 'established': [920, 1031, 2533], 'efficiency': [923, 1049, 1153, 2628, 2684], 'working': [924], 'group': [925], 'reduce': [927, 1535], '50%,': [934], 'increase': [935, 1252], 'proportion': [937], 'studies': [939, 1811, 1834], 'reaching': [940], 'accrual': [941], 'targets,': [942], 'improve': [944, 1045, 1231, 2682], 'timely': [945, 2768], 'completion': [947], '(6).The': [948], 'Institutes': [950, 1172], "Health's": [952], 'Science': [956, 3163], 'Award': [957], 'recipients': [958], 'documenting': [960], 'start-up': [962], 'metrics': [963], 'first': [966], 'step': [967], 'fostering': [969, 3799], '(7).': [971], 'CEO': [977, 3182], 'Roundtable,': [978], 'Centers,': [980], 'Cooperative': [982, 3116], 'Groups': [983], 'developed': [984, 1753, 2464, 2475], 'standard': [985, 1384, 1437, 1441, 1657], 'terms': [986], 'trial': [989, 1141, 1233, 1249, 1431, 1569, 1609, 1647, 1660, 1685, 1802, 1853, 1972, 1977, 1992, 2149, 2225, 2427, 2459, 2609, 2716, 2968, 3076, 3144, 3191, 3211, 3484, 3512, 3585, 3802], 'agreements': [990], 'starting': [993], 'point': [994, 1577], 'negotiations': [996], 'sponsors': [999, 1204], 'sites': [1002], '(8).': [1003], "Medicine's": [1007], 'Drug': [1008, 1028, 1958, 3228, 3292, 3436], 'Forum': [1009], 'also': [1010, 1757, 1806, 1890, 2246], 'commissioned': [1011], 'development': [1012, 2031, 3145, 3868], 'template': [1015], 'agreement': [1018, 1150], '(9).Through': [1019], 'its': [1020, 2807], 'Critical': [1021], 'Path': [1022], 'Program,': [1023], 'U.S.': [1025, 2854, 3225, 3433], 'Food': [1026, 3226, 3434], 'Administration': [1029], '(FDA)': [1030], 'Transformation': [1035, 3243], 'Initiative': [1036], '(CTTI),': [1037], 'public–private': [1039, 2678], 'partnership': [1040], 'whose': [1041, 1410, 2332], 'goal': [1042], '(10).': [1053], 'CTTI': [1055, 1082, 1157], 'hosted': [1057], 'has': [1062, 1130, 1284, 1918, 2531], 'broad': [1063], 'representation': [1064], '50': [1068, 3415], 'member': [1069], 'organizations,': [1070, 3814], 'including': [1071, 1240, 3804, 3815, 3873], 'academia,': [1072], 'government,': [1073], 'industry,': [1074], 'investigators,': [1076], 'advocates': [1079], '(11).': [1080], 'works': [1083], 'empirical': [1086, 1224], 'conducted': [1094, 1564], 'they': [1097, 2245, 2722, 2747], 'may': [1098, 2507, 2577, 2778], 'improved.': [1100], 'Initial': [1101, 3840], 'priorities': [1102], 'include': [1105, 2061, 2366, 3796], 'design': [1106, 1517, 1570, 1661, 2040, 2048, 2413, 2428, 2460, 2946, 3072, 3485], 'principles,': [1107, 2947], 'quantity': [1111], '(including': [1112], 'monitoring),': [1113], 'start-up,': [1115], 'adverse': [1117, 3420], 'event': [1118], 'reporting.One': [1119], "CTTI's": [1121], 'projects': [1122], 'addressing': [1124], 'site': [1125], 'monitoring,': [1126], 'area': [1128], 'been': [1131, 1919, 2532, 2726], 'estimated': [1132], 'absorb': [1134], '25%': [1135], '30%': [1137], 'costs': [1142, 3270], '(12)': [1143], 'which': [1146, 1472, 1901, 2087, 2301, 2324, 2591], 'there': [1147, 2898], 'widespread': [1149], 'improved': [1152, 2929], 'needed.': [1155], 'determining': [1159, 1186], 'current': [1161, 1617], 'range': [1162], 'monitoring': [1164, 1191, 1209, 1453], 'practices': [1165, 1192, 1250], 'used': [1168, 2200, 2304], 'Health,': [1174], 'academic': [1175, 2955], 'institutions,': [1176], 'industry;': [1178], 'assessing': [1179], 'monitoring;': [1184], 'performance': [1188], 'various': [1190, 1509], 'objectives.': [1196], 'This': [1197, 1620, 1887, 2421], 'project': [1198], 'provide': [1200, 2164, 2272], 'criteria': [1201], 'help': [1203, 2054, 2167, 2411, 3584], 'select': [1205], 'appropriate': [1208], 'methods': [1210, 1363, 1948, 2146, 2586, 2717, 2732, 2777, 2894, 2951, 3367, 3870], 'trial,': [1213, 1359, 1761], 'thereby': [1214], 'improving': [1215], 'while': [1217, 1520, 2685], 'optimizing': [1218], 'resources.Collectively,': [1219], 'these': [1220, 1589, 2469, 2731, 2911], 'efforts': [1221], 'developing': [1227], 'mechanisms': [1229, 2279, 2519], 'efficiency.': [1234], 'conjunction': [1236], 'improvements,': [1239], 'those': [1241, 1450], 'described': [1242], 'below,': [1243], 'resulting': [1245, 1398, 2310], 'feasibility': [1254, 2974], 'mounting': [1256], 'scale': [1258], 'scope': [1260], 'evaluate': [1265, 2002], 'care.Analytical': [1271], 'Efficiency:': [1272], 'Potential': [1274], 'Role': [1275], 'Bayesian': [1277, 1481, 1688, 1772, 1892, 1915, 1931, 1947, 1971, 2025, 2713, 3287, 3365, 3443, 3805], 'Adaptive': [1279, 3397], 'ApproachesThe': [1280], 'frequentist': [1282, 1458], 'school': [1283], 'provided': [1285], 'solid': [1287], 'foundation': [1288], 'statistics.': [1291], 'But': [1292], 'artificial': [1294], 'division': [1295], 'results': [1297, 2226], 'into': [1298, 1567, 1835, 2098, 2274], '"significant"': [1299], '"nonsignificant"': [1301], 'one-time': [1306], 'dichotomous': [1307], 'decisions,': [1308], 'such': [1309, 1362, 1814, 2364], 'regulatory': [1311, 2959], 'approval,': [1312], 'not': [1315, 1366, 1849, 2314, 2462, 2508, 2541, 2719, 2724], 'best': [1317, 1704, 1864], 'model': [1318, 1654], 'accumulates': [1324], 'over': [1325], 'time,': [1326, 1539, 1607], 'occurs': [1328], 'dynamic': [1331, 1621], 'system.With': [1334], 'methods,': [1339], 'it': [1340, 1355, 1741, 2123, 2820], 'difficult': [1342, 2499], 'make': [1344, 2108, 2173, 2488, 2496], 'optimal': [1345, 2109], 'use': [1346, 1418, 1945, 2110], 'relevant': [1348, 1615, 1769, 1899, 2186, 2839], 'existing,': [1349], 'ancillary,': [1350], 'new': [1352, 1580, 1986, 2096, 2145, 2869], 'arises': [1356], 'during': [1357, 1429, 2442, 2756], 'thus': [1361, 1762], 'often': [1364], 'facilitate': [1370, 1903], 'Furthermore,': [1376], 'real-world': [1377, 2071], '"noisier"': [1381], 'RCT.': [1385], 'Standard': [1386], 'statistical': [1387, 1746, 2148, 2950, 3366], 'techniques': [1388], 'require': [1389, 2578, 2646, 2828], 'sample': [1391, 1537, 2648], 'sizes,': [1392], 'part': [1394, 1403], 'because': [1395, 1462, 2639], 'additional': [1399], 'variability': [1400], 'when': [1404, 1792, 2116], 'compare': [1406, 2065], 'active': [1408, 2067], 'treatments': [1409, 2003, 2088, 2097, 2644], 'differs': [1412], 'relatively': [1414], 'small': [1415], 'amounts.Designs': [1416], 'features': [1419], 'change': [1421, 1519], '"adapt"': [1423], 'generated': [1428, 1812], 'efficient': [1435], 'approaches.': [1438], 'adaptive': [1444, 1531, 1584, 1774, 1916, 2026, 2036, 2715, 3481, 3546, 3806], 'limited': [1446], 'ways': [1447], '(for': [1448], 'example,': [1449, 2528], 'interim': [1452], 'stopping': [1455], 'rules),': [1456], 'paradigm': [1459], 'inhibits': [1460], 'adaptation': [1461, 1799], 'requirement': [1465], 'prespecify': [1467], 'all': [1468, 1494, 1678, 2013, 2112], 'possible': [1469], 'turn': [1474, 1720], 'requires': [1475], 'some': [1476, 2228], 'rigidity': [1477], 'design.': [1479, 1803], 'approach,': [1482], 'using': [1483, 1930, 2976], 'formal,': [1484], 'probabilistic': [1485], 'statements': [1486], 'uncertainty': [1488], 'based': [1489, 2810], 'combination': [1492], 'sources': [1495, 1510], 'both': [1498, 1640, 2868], 'within': [1500], 'outside': [1502], 'study,': [1504], 'prespecifies': [1505], 'combined': [1513], 'controlling': [1521], 'probability': [1523, 1697, 1713, 1729], 'false-positive': [1525], 'false-negative': [1527], 'conclusions': [1528], '(13).Bayesian': [1529], 'size,': [1538], 'obtain': [1544], 'decision-relevant': [1545], 'incorporating': [1548], 'high-quality': [1550], 'external': [1551], '(such': [1553, 1783, 2206, 2429], 'pivotal': [1557], 'trials,': [1558], 'systematic': [1559], 'models,': [1561], 'rigorously': [1563], 'studies)': [1566], 'drawing': [1572], 'observed': [1574, 2524], 'within-trial': [1575], 'end': [1576], 'relationships.': [1578], 'If': [1579, 1726, 2126], 'available,': [1583], 'RCT': [1585, 2039, 2579, 2683, 2944], 'designs': [1586, 1775, 1932, 2027, 2290], 'allow': [1588, 2748], 'added': [1593], 'less': [1595, 1989, 2294], 'ones': [1597], 'dropped': [1598], 'without': [1599], 'restarting': [1600], 'trial;': [1602], 'therefore,': [1603], 'any': [1605], 'given': [1606], 'alternatives': [1613], 'practice.': [1619, 2308, 2712], '"learning': [1622, 1634, 2742], 'adaptive"': [1623], 'feature': [1624], '(analogous': [1625], 'Evidence-Based': [1631, 3314], "Roundtable's": [1633], 'system"': [1637, 2744], '[14])': [1638], 'improves': [1639], 'timeliness': [1642], 'relevance': [1645, 2222], 'results.The': [1648], 'following': [1649], 'example': [1650], 'shows': [1651], 'this': [1653, 1727, 1985, 2548, 2574, 2886, 2977, 3881], 'operates.': [1655], 'A': [1656, 3137, 3575, 3682, 4014], '4': [1663, 1679, 1707], 'strategies': [1665, 1756, 1883, 1905, 2069], 'HIV': [1667, 1754], 'infection': [1668], 'treatment': [1669, 1738, 1755, 1770, 2068], 'starts': [1670], 'hypothesis': [1673], 'equal': [1675, 1851], 'treatments.': [1680, 1751], 'contrast,': [1682], 'progresses,': [1686], 'approach': [1689], 'answers': [1690], 'pragmatic': [1692, 2345, 2606, 3601, 3663], 'questions:': [1693], '"What': [1694, 1710], 'favored': [1700], 'therapy': [1701, 1718], 'therapies?"': [1708], 'worst': [1717], 'out': [1721], 'best?"': [1724], '(15).': [1725], 'latter': [1728], 'low': [1731], 'enough,': [1732], 'trialists': [1734], 'drop': [1736], 'even': [1739], 'if': [1740, 2529, 2611], 'not,': [1743], 'conventional': [1745], 'testing,': [1747], 'worse': [1748], 'Newly': [1752], 'enter': [1759], 'focusing': [1763], 'resources': [1765, 2076], 'comparison.': [1771], 'particularly': [1777, 1981, 2453, 2632], 'useful': [1778, 1808, 2408, 2491, 2781], 'rapidly': [1780, 2783], 'evolving': [1781, 2784], 'devices,': [1785], 'procedures,': [1786, 2949], 'practices,': [1787], 'systems': [1789], 'interventions),': [1790], 'especially': [1791, 2780], 'outcomes': [1793, 2205, 2388], 'occur': [1794], 'soon': [1795], 'enough': [1796], 'permit': [1798, 1891], 'They': [1804], 'prove': [1807], 'conditional': [1815, 2798], 'coverage': [1816, 2799], 'schemes': [1817], "Medicare's": [1819], 'Coverage': [1820, 3346], 'Evidence': [1822, 3348], 'Development': [1823], 'adding': [1826], 'onto': [1827], 'base': [1831], '"adapting"': [1833], 'community': [1836, 2383, 2710], 'settings': [1838], 'interest': [1840], 'payers': [1842, 2172, 2658], '(16,': [1845], '17).Random': [1846], 'allocation': [1847, 1870], 'need': [1848, 2063, 2138], 'arms': [1854], 'subgroups.': [1857], 'Probabilities': [1858], 'each': [1860], 'intervention': [1861, 2555], 'being': [1862, 1988, 2809], 'updated': [1867], 'random': [1869], 'probabilities': [1871], 'revised,': [1872], 'so': [1873], 'promising': [1882, 2046, 2080], 'accumulates.': [1886], 'flexibility': [1888], 'focus': [1895, 2074], 'experimentation': [1896], 'clinically': [1898, 2185, 2236, 2367, 2766], 'subgroups,': [1900], 'could': [1902, 2053], 'tailoring': [1904], 'particular': [1907], 'patients,': [1908, 2168, 2655, 2694, 2832], 'key': [1910, 2600], 'element': [1911], 'CER.Experience': [1913], 'growing': [1920], 'recent': [1922], 'years.': [1923], 'Early-phase': [1924], 'cancer': [1925, 3483], 'commonly': [1928, 2199], 'performed': [1929], '(18).': [1933], '2005,': [1935], 'FDA': [1937, 1955, 2266, 3454], 'released': [1938], 'draft': [1940], 'guidance': [1941], 'document': [1942], 'device': [1950, 2021], '(19),': [1952], 'Evaluation': [1959, 1966], 'Research': [1961, 1968, 2994, 3852], 'Biologics': [1965], 'accepted': [1970], 'designs.': [1973], 'I-Spy': [1975], '2-design': [1976], '(20)': [1978], 'interesting': [1982], 'implementation': [1983], 'paradigm,': [1987], 'single': [1991], 'set': [1995], 'ongoing': [1997, 2677], 'evaluation': [1998, 2100], 'processes': [1999], 'simultaneously': [2001], 'biomarkers': [2005], 'women': [2007], 'advanced-stage': [2009], 'breast': [2010, 3482], 'cancer.': [2011], 'Nearly': [2012], 'pharmaceutical': [2015], 'companies': [2016, 2022], 'biotechnology': [2019], 'implemented': [2024], 'product': [2030], 'process': [2032, 2101], '(21,': [2033], '22).Bayesian': [2034], 'novel': [2047, 3800], 'analytic': [2050, 2580], 'challenges.': [2058], 'These': [2059, 2218, 2283, 2776], 'challenges': [2060], 'multiple': [2066, 2642], 'experimental': [2075, 2114], 'approaches,': [2081], 'identify': [2083, 2598], 'subgroups': [2085, 2188, 2238], '(or': [2091], 'less)': [2092], 'effective,': [2093], 'introduce': [2095], 'quickly': [2103], 'possible,': [2105], 'conducted.': [2125], 'promised': [2128], 'potential': [2129, 2317], 'realized,': [2135], 'keep': [2140], 'exploring': [2141], 'possibilities': [2143], 'design.Pragmatic': [2150], 'Trials:': [2152], 'Designed': [2154], 'Decision': [2156], 'MakersA': [2157], 'defining': [2158], 'objective': [2159], 'consumers,': [2169], 'clinicians,': [2170, 2450, 2656, 2695], 'decisions.': [2180, 2775], 'However,': [2181], 'exclude': [2184], '(as': [2189], 'defined': [2190], 'age,': [2192], 'sex,': [2193], 'race,': [2194], 'ethnicity,': [2195], 'comorbid': [2197, 2374], 'conditions),': [2198], 'comparator': [2201], 'interventions,': [2202, 2785], 'important': [2203, 2229, 2237, 2424, 2575], 'life': [2210, 3816], 'longer-term': [2212], 'effect),': [2213], 'nonexpert': [2215], 'providers': [2216, 2381], '(23).': [2217, 2420], 'exclusions': [2219, 2234], 'diminish': [2220], 'decisions.Although': [2233], 'sometimes': [2240, 2495], 'due': [2241], 'risk–benefit': [2243], 'concerns,': [2244], 'reflect': [2247, 2297, 2393], 'purpose': [2249, 2334, 2358], 'RCTs:': [2252], 'determine': [2254], "intervention's": [2256], 'net': [2257], 'benefit': [2258, 2671], 'under': [2259, 2300], 'ideal': [2260], 'circumstances': [2261], '(efficacy),': [2262], 'either': [2263], 'satisfy': [2265], 'marketing': [2267], 'requirements': [2269, 2813], 'insights': [2273], 'disease': [2275, 2281], 'etiology': [2276], 'underlying': [2278], '(24).': [2282], 'goals': [2284], 'lead': [2285], 'tightly': [2287], 'controlled': [2288], 'consequently': [2293], 'likely': [2295], 'conditions': [2299, 2375], 'common': [2306, 2373], 'do': [2313], 'reach': [2315], 'value': [2318, 2479, 2904, 3625], 'making,': [2323], 'serious': [2327], 'waste': [2328], 'resources.The': [2330], 'explicit': [2333], 'informative': [2339, 2692], 'makers': [2342, 2494], 'called': [2344], 'practical': [2347], '(PCTs)': [2350], '(23–26)': [2351], 'aligned': [2355], 'CER.': [2360, 2729], 'Common': [2361], 'elements': [2362], 'comparators,': [2369], 'diverse': [2377], 'demographic': [2378], 'characteristics,': [2379], 'settings.': [2384], 'Primary': [2385], 'secondary': [2387], 'patient-centered,': [2390], 'chosen': [2391], 'what': [2394], 'matters': [2395], 'clinicians.The': [2400], 'Pragmatic-Explanatory': [2401], 'Continuum': [2402], 'Indicator': [2403], 'Summary': [2404, 3310], '(PRECIS)': [2405], 'provides': [2406], 'framework': [2409], 'researchers': [2412], 'inform': [2416, 2771, 2910], 'tool': [2422, 3582], 'identifies': [2423], 'domains': [2425], 'eligibility': [2431], 'criteria,': [2432], 'adherence,': [2434], 'practitioner': [2436], 'expertise)': [2437], 'considered': [2441], 'PCT': [2443, 2513, 2801], 'development.': [2445], 'Strategies': [2446], 'involve': [2448], 'practicing': [2449], 'payers,': [2451, 2834], 'consumers': [2456], 'widely': [2466], 'practiced,': [2467], 'further': [2474], 'maximize': [2477], '(3).The': [2482], 'very': [2483], 'aspects': [2484], 'PCTs': [2486, 2827], 'them': [2489, 2497, 2690], 'interpret': [2501], 'explanatory': [2504], 'perspective.': [2505], 'It': [2506], 'clear': [2510], 'biological,': [2515], 'etiologic,': [2516], 'behavioral': [2518], 'interact': [2520], 'produce': [2522], 'outcomes.': [2526], 'For': [2527], 'efficacy': [2530, 2567], 'narrow': [2536], 'population': [2537], 'but': [2538, 2721], 'seen': [2542], 'broader': [2545, 2570], 'population,': [2546], 'misapplication': [2552], '(poor': [2556], 'adherence': [2558], 'provider': [2560], 'performance)': [2561], 'absence': [2564], 'group?': [2572], 'Addressing': [2573], 'question': [2576], 'borrow': [2583], 'studies,': [2589], 'bias': [2592], 'confounding': [2594], 'endemic': [2596], 'problems.DiscussionWe': [2597], 'issues—operational': [2601], 'design—that,': [2610], 'embraced,': [2612], 'advance': [2614], 'initiative': [2617, 2882], 'efficiently': [2620], 'valid,': [2622], 'generalizable': [2623], 'trials.Operational': [2627], 'germane': [2633], 'comparisons': [2640], 'larger': [2647], 'sizes': [2649], 'reliably': [2651], 'detect': [2652], 'differences': [2653], 'demand': [2660], 'shorter': [2664], 'frames.': [2666], 'activities': [2674, 3795], 'initiatives': [2679], 'seeking': [2680], 'maintaining': [2686], 'making': [2689, 3631], 'payers.Comparative': [2697], 'must': [2701, 2919], 'dynamic,': [2706], 'unique': [2707], 'new,': [2720], 'yet': [2725], 'applied': [2727], 'Applying': [2730], 'consistent': [2736], 'healthcare': [2743], 'flexible,': [2749], 'adaptive,': [2750], 'cumulative': [2751], 'learning': [2752], 'incorporated': [2755], 'conduct': [2758], 'trials.': [2760, 3276, 3289, 3605], 'ultimate': [2762], 'relevant,': [2767], 'subgroup': [2788], 'characteristics': [2789], 'predict': [2791], 'strategies,': [2796], 'schemes.The': [2800], 'method,': [2806], 'form': [2808], 'address.': [2824], 'Properly': [2825], 'meaningful': [2829], 'involvement': [2830], 'physicians,': [2833], 'policymakers,': [2836], 'stakeholders': [2840], 'ensure': [2842, 2972], 'decision-making': [2851], 'needs.In': [2852], 'system,': [2856], 'face': [2858], 'countless': [2859], 'about': [2861], 'relative': [2863], 'benefits': [2864], 'setting': [2875, 3488], 'usual': [2877], 'care.': [2878], 'As': [2879], 'begins': [2883], 'tackle': [2885], 'challenge': [2887], 'prioritizing': [2889], 'recommending': [2893], 'address': [2896], 'them,': [2897], 'limits': [2901], 'alone': [2908], 'decisions.Randomized': [2912], 'reliable': [2916], 'prominent': [2922], 'place': [2923], 'agenda.': [2927], 'discussed,': [2936], 'requiring': [2938], 'thorough': [2940], 'CER-focused': [2941], 'rethinking': [2942, 3141], 'rules': [2953], 'disciplines,': [2956], 'funding': [2957, 3811], 'agencies,': [2958], 'authorities,': [2960], 'business': [2962], 'interests': [2963], 'comprise': [2965], 'enterprise,': [2970], 'methodology': [2978], 'greater': [2980], 'generalizability,': [2982], 'responsiveness': [2984], 'changing': [2987], 'system.References1.': [2990], 'Congressional': [2991], 'Budget': [2992], 'Office.': [2993], 'Treatments:': [3001], 'Issues': [3002], 'Options': [3004], 'Expanded': [3007], 'Federal': [3008], 'Role.': [3009], 'Accessed': [3010, 3028, 3151, 3169, 3193, 3216, 3233, 3247, 3350, 3374, 3457], 'www.cbo.gov/ftpdocs/88xx/doc8891/12-18-ComparativeEffectiveness.pdf': [3012], '19': [3014, 3032, 3354], 'June': [3015, 3033, 3156, 3355, 3379, 3462], '2009.': [3016, 3026, 3034, 3157, 3175, 3200, 3222, 3238, 3253, 3356, 3373, 3380, 3463], 'Google': [3017, 3035, 3158, 3176, 3201, 3223, 3239, 3254, 3322, 3338, 3357, 3381, 3464], 'Scholar2.': [3018], 'H.R.1.': [3027], 'thomas.loc.gov/': [3030], 'Scholar3.': [3036], 'Sox': [3037, 4023], 'HC,': [3038], 'Greenfield': [3039], 'S.': [3040], 'research:': [3043], 'report': [3045], 'Medicine.': [3050, 3205], 'Ann': [3051], 'Intern': [3052], 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'System:': [3308], 'Workshop': [3309], '(IOM': [3311], 'Medicine).': [3315], 'Washington,': [3316], 'DC:': [3317], 'Academies': [3319], 'Pr;': [3320], '2007.': [3321], 'Scholar15.': [3323], 'Berger': [3324], 'JO,': [3325], 'Statistical': [3328], 'illusion': [3332], 'objectivity.': [3334], 'Scientist.': [3336], '1988;76:159-165.': [3337], 'Scholar16.': [3339], 'Centers': [3340, 3359], 'Medicare': [3342, 3361, 3369], 'Medicaid': [3344, 3363], 'Services.': [3345, 3364], 'Development.': [3349], 'www.cms.hhs.gov/CoverageGenInfo/03_CED.asp': [3352], 'Scholar17.': [3358], 'MEDCAC': [3371], 'meeting.': [3372], 'www.cms.hhs.gov/mcd/viewmcac.asp?from2=viewmcac.asp&where=index&mid=49&#roster': [3376], 'Scholar18.': [3382], 'Giles': [3383], 'FJ,': [3384], 'Kantarjian': [3385], 'HM,': [3386], 'Cortes': [3387], 'JE,': [3388], 'Garcia-Manero': [3389], 'G,': [3390], 'Verstovsek': [3391], 'S,': [3392, 3394, 3568, 3646, 3652], 'Faderl': [3393], 'al.': [3396, 3574], 'idarubicin': [3401, 3411], 'cytarabine': [3403, 3407], 'versus': [3404, 3408], 'troxacitabine': [3405, 3409], 'untreated': [3413], 'years': [3416], 'older': [3418], 'karyotype': [3421], 'acute': [3422, 3552], 'myeloid': [3423], 'leukemia.': [3424], '2003;21:1722-7.': [3428], '12721247]': [3430], 'Scholar19.': [3432], 'Guidance': [3438, 3450], 'Use': [3441], 'Statistics': [3444], 'Device': [3447], 'Trials—Draft': [3449], 'Industry': [3452], 'Staff.': [3455], '2006.': [3456], 'www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071072.htm': [3459], '22': [3461], 'Scholar20.': [3465], 'Barker': [3466], 'AD,': [3467, 3566], 'Sigman': [3468], 'CC,': [3469], 'Kelloff': [3470], 'GJ,': [3471], 'Hylton': [3472], 'NM,': [3473], 'DA,': [3475], 'Esserman': [3476], 'LJ.': [3477], 'I-SPY': [3478], '2:': [3479], 'neoadjuvant': [3490], 'chemotherapy.': [3491], 'Pharmacol': [3493], '2009;86:97-100.': [3495], '19440188]': [3497], 'Scholar21.': [3499], 'Inoue': [3500], 'LY,': [3501], 'Thall': [3502], 'PF,': 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