{"product_id":"clinical-trials-handbook-design-and-conduct-1st-edition","title":"Clinical Trials Handbook: Design and Conduct 1st Edition,","description":"\u003cdiv data-cel-widget=\"bookDescription_feature_div\" data-csa-c-id=\"7y9w7h-rgk3d4-2xixgp-6jetc1\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"0993745598\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-content-id=\"bookDescription\" data-csa-c-type=\"widget\" data-feature-name=\"bookDescription\" class=\"celwidget\" id=\"bookDescription_feature_div\"\u003e\n\u003cdiv class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\" data-a-expander-collapsed-height=\"280\" data-a-expander-name=\"book_description_expander\"\u003e\n\u003cdiv class=\"a-expander-content a-expander-partial-collapse-content\" aria-expanded=\"false\"\u003e\n\u003cdiv id=\"bookDescription_feature_div\" class=\"celwidget\" data-feature-name=\"bookDescription\" data-csa-c-type=\"widget\" data-csa-c-content-id=\"bookDescription\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-asin=\"1975136373\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-id=\"3xu427-hdulpm-xey1d9-kajk0v\" data-cel-widget=\"bookDescription_feature_div\"\u003e\n\u003cdiv data-a-expander-name=\"book_description_expander\" data-a-expander-collapsed-height=\"280\" class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\"\u003e\n\u003cdiv aria-expanded=\"false\" class=\"a-expander-content a-expander-partial-collapse-content\"\u003e\n\u003cdiv id=\"bookDescription_feature_div\" class=\"celwidget\" data-feature-name=\"bookDescription\" data-csa-c-type=\"widget\" data-csa-c-content-id=\"bookDescription\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-asin=\"3031783212\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-id=\"fcrmv0-5d2i6h-7rlxmn-tieqc\" data-cel-widget=\"bookDescription_feature_div\"\u003e\n\u003cdiv data-a-expander-name=\"book_description_expander\" data-a-expander-collapsed-height=\"280\" class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\"\u003e\n\u003cdiv data-expanded=\"false\" class=\"a-expander-content a-expander-partial-collapse-content\"\u003e\n\u003cdiv data-cel-widget=\"bookDescription_feature_div\" data-csa-c-id=\"fp884q-ajyjgl-oloyur-e2b1bd\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"B0DLLHMC3L\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-content-id=\"bookDescription\" data-csa-c-type=\"widget\" data-feature-name=\"bookDescription\" class=\"celwidget\" id=\"bookDescription_feature_div\"\u003e\n\u003cdiv class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\" data-a-expander-collapsed-height=\"280\" data-a-expander-name=\"book_description_expander\"\u003e\n\u003cdiv class=\"a-expander-content a-expander-partial-collapse-content\" data-expanded=\"false\"\u003e\n\u003cdiv data-cel-widget=\"bookDescription_feature_div\" data-csa-c-id=\"xuilf-kf8jxd-gl0izj-j8ubn3\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-content-id=\"bookDescription\" data-csa-c-type=\"widget\" data-feature-name=\"bookDescription\" class=\"celwidget\" id=\"bookDescription_feature_div\"\u003e\n\u003cdiv class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\" data-a-expander-collapsed-height=\"280\" data-a-expander-name=\"book_description_expander\"\u003e\n\u003cdiv class=\"a-expander-content a-expander-partial-collapse-content\" data-expanded=\"false\"\u003e\n\u003cp\u003e\u003c!--StartFragment --\u003e\u003c\/p\u003e\n\u003cdiv id=\"bookDescription_feature_div\" class=\"celwidget\" data-feature-name=\"bookDescription\" data-csa-c-type=\"widget\" data-csa-c-content-id=\"bookDescription\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-asin=\"\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-id=\"jcyb4c-xh16e5-g3rxm8-7b27gv\" data-cel-widget=\"bookDescription_feature_div\"\u003e\n\u003cdiv data-a-expander-name=\"book_description_expander\" data-a-expander-collapsed-height=\"280\" class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\"\u003e\n\u003cdiv data-expanded=\"false\" class=\"a-expander-content a-expander-partial-collapse-content\"\u003e\n\u003cdiv data-cel-widget=\"bookDescription_feature_div\" data-csa-c-id=\"29gs8q-nkwmn0-jkthhp-dkje0\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"1032421282\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-content-id=\"bookDescription\" data-csa-c-type=\"widget\" data-feature-name=\"bookDescription\" class=\"celwidget\" id=\"bookDescription_feature_div\"\u003e\n\u003cdiv class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\" data-a-expander-collapsed-height=\"280\" data-a-expander-name=\"book_description_expander\"\u003e\n\u003cdiv class=\"a-expander-content a-expander-partial-collapse-content\" data-expanded=\"false\"\u003e\n\u003cp\u003e\u003c!--StartFragment --\u003e\u003c\/p\u003e\n\u003cdiv id=\"bookDescription_feature_div\" class=\"celwidget\" data-feature-name=\"bookDescription\" data-csa-c-type=\"widget\" data-csa-c-content-id=\"bookDescription\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-asin=\"1032008431\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-id=\"b6wwvw-bz3rmm-3urw9p-3pgp5l\" data-cel-widget=\"bookDescription_feature_div\"\u003e\n\u003cdiv data-a-expander-name=\"book_description_expander\" data-a-expander-collapsed-height=\"280\" class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\"\u003e\n\u003cdiv data-expanded=\"false\" class=\"a-expander-content a-expander-partial-collapse-content\"\u003e\n\u003cdiv data-cel-widget=\"bookDescription_feature_div\" data-csa-c-id=\"vveok4-6789v-a28uab-7odkn\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"1032260157\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-content-id=\"bookDescription\" data-csa-c-type=\"widget\" data-feature-name=\"bookDescription\" class=\"celwidget\" id=\"bookDescription_feature_div\"\u003e\n\u003cdiv class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\" data-a-expander-collapsed-height=\"280\" data-a-expander-name=\"book_description_expander\"\u003e\n\u003cdiv class=\"a-expander-content a-expander-partial-collapse-content\" data-expanded=\"false\"\u003e\n\u003cp\u003e\u003cspan class=\"a-text-italic\"\u003e\u003c!--StartFragment --\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cdiv data-cel-widget=\"bookDescription_feature_div\" data-csa-c-id=\"4n3dc7-pgrjua-owk3bw-n89vol\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"0190908327\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-content-id=\"bookDescription\" data-csa-c-type=\"widget\" data-feature-name=\"bookDescription\" class=\"celwidget\" id=\"bookDescription_feature_div\"\u003e\n\u003cdiv class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\" data-a-expander-collapsed-height=\"280\" data-a-expander-name=\"book_description_expander\"\u003e\n\u003cdiv class=\"a-expander-content a-expander-partial-collapse-content\" data-expanded=\"false\"\u003e\n\u003cdiv id=\"bookDescription_feature_div\" class=\"celwidget\" data-feature-name=\"bookDescription\" data-csa-c-type=\"widget\" data-csa-c-content-id=\"bookDescription\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-asin=\"\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-id=\"uxpum0-xj1s1w-iclems-at1f49\" data-cel-widget=\"bookDescription_feature_div\"\u003e\n\u003cdiv data-a-expander-name=\"book_description_expander\" data-a-expander-collapsed-height=\"280\" class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\"\u003e\n\u003cdiv data-expanded=\"false\" class=\"a-expander-content a-expander-partial-collapse-content\"\u003e\n\u003c!--StartFragment --\u003e\n\u003cdiv id=\"bookDescription_feature_div\" class=\"celwidget\" data-feature-name=\"bookDescription\" data-csa-c-type=\"widget\" data-csa-c-content-id=\"bookDescription\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-asin=\"\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-id=\"6gahqp-flj7xl-gugx7r-lnvbfa\" data-cel-widget=\"bookDescription_feature_div\"\u003e\n\u003cdiv data-a-expander-name=\"book_description_expander\" data-a-expander-collapsed-height=\"280\" class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\"\u003e\n\u003cdiv data-expanded=\"false\" class=\"a-expander-content a-expander-partial-collapse-content\"\u003e\n\u003cp\u003e\u003c!--StartFragment --\u003e\u003c\/p\u003e\n\u003cdiv data-expanded=\"true\" class=\"a-expander-content a-expander-partial-collapse-content a-expander-content-expanded\"\u003e\n\u003cdiv id=\"bookDescription_feature_div\" class=\"celwidget\" data-feature-name=\"bookDescription\" data-csa-c-type=\"widget\" data-csa-c-content-id=\"bookDescription\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-asin=\"9819984408\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-id=\"3id2jy-cym4a2-bxve36-6avmxn\" data-cel-widget=\"bookDescription_feature_div\"\u003e\n\u003cdiv data-a-expander-name=\"book_description_expander\" data-a-expander-collapsed-height=\"280\" class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\"\u003e\n\u003cdiv data-expanded=\"false\" class=\"a-expander-content a-expander-partial-collapse-content\"\u003e\n\u003cdiv data-cel-widget=\"bookDescription_feature_div\" data-csa-c-id=\"txcuh-puuq32-c3xxig-qfp1sj\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"9811284563\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-content-id=\"bookDescription\" data-csa-c-type=\"widget\" data-feature-name=\"bookDescription\" class=\"celwidget\" id=\"bookDescription_feature_div\"\u003e\n\u003cdiv class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\" data-a-expander-collapsed-height=\"280\" data-a-expander-name=\"book_description_expander\"\u003e\n\u003cdiv class=\"a-expander-content a-expander-partial-collapse-content\" data-expanded=\"false\"\u003e\n\u003cdiv data-cel-widget=\"bookDescription_feature_div\" data-csa-c-id=\"e5lepz-l35fpq-6r3ivs-dxm2tq\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"9819959241\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-content-id=\"bookDescription\" data-csa-c-type=\"widget\" data-feature-name=\"bookDescription\" class=\"celwidget\" id=\"bookDescription_feature_div\"\u003e\n\u003cdiv class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\" data-a-expander-collapsed-height=\"280\" data-a-expander-name=\"book_description_expander\"\u003e\n\u003cdiv class=\"a-expander-content a-expander-partial-collapse-content\" data-expanded=\"false\"\u003e\n\u003cdiv data-cel-widget=\"bookDescription_feature_div\" data-csa-c-id=\"k8ycuv-p75ti2-vlqtvt-53m6j3\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"9814968781\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-content-id=\"bookDescription\" data-csa-c-type=\"widget\" data-feature-name=\"bookDescription\" class=\"celwidget\" id=\"bookDescription_feature_div\"\u003e\n\u003cdiv class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\" data-a-expander-collapsed-height=\"280\" data-a-expander-name=\"book_description_expander\"\u003e\n\u003cdiv class=\"a-expander-content a-expander-partial-collapse-content\" data-expanded=\"false\"\u003e\n\u003cp\u003e\u003c!--StartFragment --\u003e\u003c\/p\u003e\n\u003cp\u003e\u003c!--StartFragment --\u003e\u003c\/p\u003e\n\u003cdiv data-cel-widget=\"bookDescription_feature_div\" data-csa-c-id=\"llby3t-ifhn3l-7pwpg9-89ehkm\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"3031093410\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-content-id=\"bookDescription\" data-csa-c-type=\"widget\" data-feature-name=\"bookDescription\" class=\"celwidget\" id=\"bookDescription_feature_div\"\u003e\n\u003cdiv class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\" data-a-expander-collapsed-height=\"280\" data-a-expander-name=\"book_description_expander\"\u003e\n\u003cdiv class=\"a-expander-content a-expander-partial-collapse-content\" data-expanded=\"false\"\u003e\n\u003cdiv data-expanded=\"true\" class=\"a-expander-content a-expander-partial-collapse-content a-expander-content-expanded\"\u003e\n\u003cdiv data-cel-widget=\"bookDescription_feature_div\" data-csa-c-id=\"7f9unj-xdyryf-y6f0su-1hut58\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"9811662673\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-content-id=\"bookDescription\" data-csa-c-type=\"widget\" data-feature-name=\"bookDescription\" class=\"celwidget\" id=\"bookDescription_feature_div\"\u003e\n\u003cdiv class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\" data-a-expander-collapsed-height=\"280\" data-a-expander-name=\"book_description_expander\"\u003e\n\u003cdiv class=\"a-expander-content a-expander-partial-collapse-content\" data-expanded=\"false\"\u003e\n\u003cdiv data-cel-widget=\"bookDescription_feature_div\" data-csa-c-id=\"z8dzbo-84ywks-lqyeuc-qt8v3a\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"1799874605\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-content-id=\"bookDescription\" data-csa-c-type=\"widget\" data-feature-name=\"bookDescription\" class=\"celwidget\" id=\"bookDescription_feature_div\"\u003e\n\u003cdiv class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\" data-a-expander-collapsed-height=\"280\" data-a-expander-name=\"book_description_expander\"\u003e\n\u003cdiv class=\"a-expander-content a-expander-partial-collapse-content\" data-expanded=\"false\"\u003e\n\u003cdiv id=\"bookDescription_feature_div\" class=\"celwidget\" data-feature-name=\"bookDescription\" data-csa-c-type=\"widget\" data-csa-c-content-id=\"bookDescription\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-asin=\"\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-id=\"iy9e36-wdxedj-izxmvq-4ohupr\" data-cel-widget=\"bookDescription_feature_div\"\u003e\n\u003cdiv data-a-expander-name=\"book_description_expander\" data-a-expander-collapsed-height=\"280\" class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\"\u003e\n\u003cdiv data-expanded=\"false\" class=\"a-expander-content a-expander-partial-collapse-content\"\u003e\n\u003cdiv id=\"bookDescription_feature_div\" class=\"celwidget\" data-feature-name=\"bookDescription\" data-csa-c-type=\"widget\" data-csa-c-content-id=\"bookDescription\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-asin=\"1599049961\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-id=\"7xfutl-b1yucx-as0myj-fbzez9\" data-cel-widget=\"bookDescription_feature_div\"\u003e\n\u003cdiv data-a-expander-name=\"book_description_expander\" data-a-expander-collapsed-height=\"280\" class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\"\u003e\n\u003cdiv data-expanded=\"false\" class=\"a-expander-content a-expander-partial-collapse-content\"\u003e\n\u003cdiv data-cel-widget=\"bookDescription_feature_div\" data-csa-c-id=\"6ogylt-iupx1h-mngvsd-3l9j2a\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-content-id=\"bookDescription\" data-csa-c-type=\"widget\" data-feature-name=\"bookDescription\" class=\"celwidget\" id=\"bookDescription_feature_div\"\u003e\n\u003cdiv class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\" data-a-expander-collapsed-height=\"280\" data-a-expander-name=\"book_description_expander\"\u003e\n\u003cdiv class=\"a-expander-content a-expander-partial-collapse-content\" data-expanded=\"false\"\u003e\n\u003cp class=\"a-text-italic\"\u003e\u003c!--StartFragment --\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003c!--StartFragment --\u003e\u003c\/p\u003e\n\u003cdiv id=\"bookDescription_feature_div\" class=\"celwidget flavor-872\" data-feature-name=\"bookDescription\" data-csa-c-type=\"widget\" data-csa-c-content-id=\"bookDescription\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-asin=\"1264131275\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-id=\"9mb8m1-3p87wr-1ek9qt-u7ndiw\" data-cel-widget=\"bookDescription_feature_div\"\u003e\n\u003cdiv data-a-expander-name=\"book_description_expander\" data-a-expander-collapsed-height=\"280\" class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv id=\"tellAmazon_feature_div\" class=\"celwidget\" data-feature-name=\"tellAmazon\" data-csa-c-type=\"widget\" data-csa-c-content-id=\"tellAmazon\" data-csa-c-slot-id=\"tellAmazon_feature_div\" data-csa-c-asin=\"1264131275\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-id=\"7po1c5-j25ush-pnsdtx-ia9uic\" data-cel-widget=\"tellAmazon_feature_div\"\u003e\n\u003cdiv class=\"celwidget c-f\" data-csa-op-log-render=\"\" data-csa-c-content-id=\"DsUnknown\" data-csa-c-slot-id=\"DsUnknown-10\" data-csa-c-type=\"widget\" data-csa-c-painter=\"tell-amazon-desktop-cards\" data-csa-c-id=\"yyd4qm-1vntsa-rrify7-9i4juo\" data-cel-widget=\"tell-amazon-desktop_DetailPage_9\"\u003e\n\u003cdiv id=\"CardInstanceb5mobGxiUMyNxNv4TBhY7A\" data-card-metrics-id=\"tell-amazon-desktop_DetailPage_9\" data-acp-tracking=\"{}\" data-mix-claimed=\"true\"\u003e\n\u003cdiv data-asin=\"1264131275\" data-marketplace=\"ATVPDKIKX0DER\" data-logged-in=\"false\" class=\"_tell-amazon-desktop_style_tell_amazon_div__1YDZk\"\u003e\n\u003cp\u003e\u003cspan class=\"a-text-bold\"\u003eA systematic approach to all aspects of designing and conducting clinical trials\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe success or failure of clinical trials hinges on hundreds of details that need to be developed, often under less than ideal conditions. Written by one of the world's leading trialists, \u003c\/span\u003e\u003cspan class=\"a-text-italic\"\u003eClinical Trials Handbook: Design and Conduct\u003c\/span\u003e\u003cspan\u003e provides clinicians with a complete guide to designing, conducting, and evaluating clinical trials—teaching them how to simplify the process and avoid costly mistakes.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe author draws on his extensive clinical trials experience to outline all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. Along the way, practical advice is offered while also addressing a mix of logistical, ethical, psychological, behavioral, and administrative issues inherent to clinical trials. Topics of coverage include:\u003c\/span\u003e\u003c\/p\u003e\n\u003cul class=\"a-unordered-list a-vertical\"\u003e\n\u003cli\u003e\u003cspan class=\"a-list-item\"\u003e\u003cspan\u003eProtocols for drug masking, controls, and treatment randomization\u003c\/span\u003e\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan class=\"a-list-item\"\u003e\u003cspan\u003eConsent, enrollment, eligibility, and follow-up procedures\u003c\/span\u003e\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan class=\"a-list-item\"\u003e\u003cspan\u003eDifferent types of sample size design and data collection and processing\u003c\/span\u003e\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan class=\"a-list-item\"\u003e\u003cspan\u003eWorking with study centers, research staff, and various committees\u003c\/span\u003e\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan class=\"a-list-item\"\u003e\u003cspan\u003eMonitoring treatment effects and performance, and ensuring quality control\u003c\/span\u003e\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan class=\"a-list-item\"\u003e\u003cspan\u003eData analysis and access policies for study data and documents\u003c\/span\u003e\u003c\/span\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cspan class=\"a-text-italic\"\u003eClinical Trials Handbook\u003c\/span\u003e\u003cspan\u003e is invaluable for practicing clinicians and trialists who would like to learn more about or improve their understanding of the design and execution of clinical trials. The book is also an excellent supplement for courses on clinical trials at the graduate level.\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv data-asin=\"1264131275\" data-marketplace=\"ATVPDKIKX0DER\" data-logged-in=\"false\" class=\"_tell-amazon-desktop_style_tell_amazon_div__1YDZk\"\u003e\n\u003cspan\u003e\u003c\/span\u003e\u003cbr\u003e\n\u003c\/div\u003e\n\u003cdiv data-asin=\"1264131275\" data-marketplace=\"ATVPDKIKX0DER\" data-logged-in=\"false\" class=\"_tell-amazon-desktop_style_tell_amazon_div__1YDZk\"\u003e\n\u003cspan\u003e\u003c!--StartFragment --\u003e\u003c\/span\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eAbout the Author\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eCURTIS L. MEINERT, PhD, \u003c\/span\u003e\u003cspan class=\"cf1\"\u003eis Professor in the Departments of Epidemiology and Biostatistics at the Johns Hopkins Bloomberg School of Public Health, where he served as founder of the Johns Hopkins Center for Clinical Trials. He is a Fellow of the American College of Epidemiology, the American Association for the Advancement of Science, the American Heart Association, and the Society for Clinical Trials. Dr. Meinert has focused his research on the methodological issues in clinical trials, including their design, conduct, policy, and practice. He is the author of \u003c\/span\u003e\u003cspan class=\"cf2\"\u003eClinical Trials Dictionary: Terminology and Usage Recommendations, Second Edition \u003c\/span\u003e\u003cspan class=\"cf1\"\u003e(Wiley).\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e \u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003eTable of Contents\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003eAcknowledgments xi\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003ePreface xiii\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003eOn planning xv\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003eExplanatory notes, focus, and conventions xvii\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003eAbbreviations and designations xxi\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eI. General1\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e1. Terminology 3\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e2. Definitions 5\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e3. Measurement units 7\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e4. Trial type 9\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e5. Design and flow schematics 13\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e6. Design and operating principles 15\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e7. Counting and analysis rules 17\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e8. Multi-study umbrella name 19\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e9. Study name 21\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eII. Design Specifications25\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e10. Objective 27\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e11. Specific aims 29\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e12. Experimental variable 31\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e13. Treatment unit 33\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e14. Primary outcome 35\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e15. Outcome measures 39\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e16. Design synopsis 41\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eIII. Funding45\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e17. Type of funding initiative 47\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e18. Funding: Specifications 49\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e19. Funding: Terminology 51\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e20. Funding: Type 59\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e21. Funding: Initiative 61\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e22. Funding: Period 63\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e23. Funding: Budget 65\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e24. Funding: Mode 67\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eIV. Treatment Groups\/Treatment Administration69\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e25. Study groups 71\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e26. Comparison group 73\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e27. Study treatments 75\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e28. Test treatments 77\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e29. Control\/comparison treatment 79\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e30. Placebo treatment 87\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e31. Sham treatment 91\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e32. Treatment modality 93\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e33. Treatment schedule 95\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e34. Treatment compliance measures 97\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e35. Protocol overrides 101\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e36. Protocol bailouts 103\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eV. Masking 105\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e37. Mask\/masking: Definitions 107\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e38. Masking principles 111\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e39. Masking, censoring, and shielding specifications 113\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e40. Drug masking procedure 115\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e41. Drug packaging and labeling 117\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e42. Drug supply 121\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e43. Masking safeguards 123\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e44. Unmasking treatment assignment 125\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e45. Results blackouts 127\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eVI. Bias and Variance Control129\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e46. Bias control procedures 131\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e47. Stratification 135\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e48. Variance control procedures 139\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e49. Separations 141\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eVII. Treatment Assignment\/Randomization 143\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e50. Assignment methods: Fixed vs. adaptive 145\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e51. Treatment assignment: Random vs. nonrandom 147\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e52. Randomization: Complete vs. restricted 151\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e53. Randomization unit 155\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e54. Randomization: Procedures 157\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eVIII. IRBs and Consents159\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e55. IRBs 161\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e56. IRBs: Models and procedures 163\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e57. Consent 169\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e58. Consent: Checklist 177\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e59. Consent: Disclaimers and notifications 181\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e60. Consent: Principles and purpose 183\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e61. Consent: Process 185\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e62. Consent: Types 189\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e63. Consent: Questions and answers 191\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eIX. Enrollment and Followup195\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e64. Notation 197\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e65. Timing conventions 199\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e66. Required approvals, permissions, accesses, and supplies 201\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e67. Start-up design 203\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e68. Start-up checklist 207\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e69. Recruitment design 209\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e70. Enrollment goals 211\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e71. Enrollment quotas 213\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e72. Followup: Terminology 217\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e73. Followup: Method 221\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e74. Followup: Length 223\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e75. Closeout design 225\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e76. Missed visit 229\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e77. Dropout 231\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e78. Loss to followup 235\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e79. Study timetable 239\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e80. Critical event path analysis 241\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e81. Eligibility criteria 243\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e82. Exclusions from enrollment 245\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e83. Eligibility and exclusions by reason 249\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eX. Sample Size251\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e84. Sample size: Design 253\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e85. Sample size: Specifications 257\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e86. Sample size: Calculation 259\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e87. Fixed vs. sequential sample size designs 261\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e88. Fixed vs. adaptive designs 263\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e89. Designed subgroup comparisons 265\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eXI. Data Collection and Processing267\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e90. Contact schedule 269\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e91. Examinations\/visits 271\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e92. Examination\/clinic visit schedule 275\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e93. Data collection 279\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e94. Data collection: Schedules and procedures 281\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e95. Data flow 283\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e96. Data processing procedures 285\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e97. Laboratory tests 287\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e98. Readings 289\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e99. Tissue repositories 293\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e100. Form design: Principles and procedures 295\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e101. Time window specifications 299\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e102. Data entry design 301\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e103. Data sharing: Internal 307\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e104. Data sharing: External 311\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eXII. Study Centers315\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e105. Center types 317\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e106. Centers 323\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e107. Center requirements 325\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eXIII. Investigators\/Study Staff329\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e108. Investigator requirements 331\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e109. Clinic staffing requirements 333\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e110. Research group\/Investigators 335\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eXIV. Committees337\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e111. Key Committees 339\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e112. Standing and working committees 341\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e113. Committee rules and procedures 343\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e114. Study officers 347\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e115. Study chair\/vice-chair 349\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e116. Executive committee 353\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e117. Executive committee members 357\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e118. Steering committee 359\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e119. Steering committee members 361\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e120. Steering committee: Questions, answers, and observations 363\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e121. Steering committee representation models 367\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eXV. Treatment Effects Monitoring371\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e122. Treatment effects monitoring 373\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e123. Treatment effects monitoring: Purpose 375\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e124. Treatment effects monitoring: Approach 377\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e125. Treatment effects monitoring: Masking 379\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e126. Stopping rules and guidelines 381\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e127. Treatment effects monitoring: Questions and answers 383\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e128. Treatment effects monitoring committee 387\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e129. Treatment effects monitoring committee: Questions and answers 391\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eXVI. Quality Control and Assurance393\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e130. Quality control and assurance procedures 395\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e131. Performance monitoring 399\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e132. Training procedures 401\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e133. Assurances and certifications 403\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e134. Site visiting procedures 405\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e135. Audit procedures 409\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eXVII. Data Analysis413\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e136. Analysis datasets 415\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e137. Analysis questions regarding study results publications 417\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e138. Frequentist vs. Bayesian analysis 419\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e139. Final analysis 421\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e140. Subgroup analysis 423\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eXVIII. Publication\/Presentation425\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e141. Publication 427\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e142. Publication policy 429\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e143. Authorship 431\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e144. Credits 435\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e145. Presentation policy 439\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eXIX. Policies441\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e146. Policies 443\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e147. Publicity policy 445\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e148. Policy on access to study documents 447\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e149. Policy on access to study data and results 449\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e150. Policy on advertising for patients 453\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e151. Policy on incentive payments 455\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e152. Policy on payment of patient-related travel expenses 457\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e153. Ancillary study policy 459\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e154. Policy on patient-care-related payments 461\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e155. Policy on conflicts of interest 463\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e156. Substudy policy 467\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eXX. Adverse Events469\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e157. Adverse events 471\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e158. Adverse event reporting procedures 475\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eXXI. Miscellaneous479\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e159. Key study documents 481\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e160. Design synopsis 483\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e161. Slide sets 485\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e162. Study CV 487\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e163. Study website 489\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e164. Study history log 491\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e165. Landmark events and dates 493\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003e166. Registration 495\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf0\"\u003eAppendices497\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003eAppendix 1. Design summaries for selected finished trials 499\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003eAppendix 2. Sample design slide sets 517\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003eAppendix 3. Template summary worksheet 537\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003eReferences 551\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003eIndex 557\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf1\"\u003eReviews\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"pf0\"\u003e\u003cspan class=\"cf3\"\u003e“In summary, Clinical Trials Handbook is a user friendly book with numerous examples from the real clinical trials. It outlines all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. It is an asset to practicing clinicians and trialists who would like to learn more about or improve their understanding of the design and execution of clinical trials. The book is also an excellent supplement for courses on clinical trials at the graduate level.”  (\u003c\/span\u003e\u003cspan class=\"cf2\"\u003eJournal of Biopharmaceutical Statistics\u003c\/span\u003e\u003cspan class=\"cf1\"\u003e, 1 April 2013)\u003c\/span\u003e\u003c\/p\u003e\n\u003cspan\u003e\u003c!--EndFragment --\u003e\u003c\/span\u003e\u003cbr\u003e\n\u003c\/div\u003e\n\u003cdiv data-asin=\"1264131275\" data-marketplace=\"ATVPDKIKX0DER\" data-logged-in=\"false\" class=\"_tell-amazon-desktop_style_tell_amazon_div__1YDZk\"\u003e\n\u003cspan\u003e\u003c\/span\u003e\u003cbr\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cp\u003e\u003c!--EndFragment --\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv data-cel-widget=\"hushpuppyUpsell_feature_div\" data-csa-c-id=\"kdwktr-arvsmh-r61jq6-yq8e4r\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"\" data-csa-c-slot-id=\"hushpuppyUpsell_feature_div\" data-csa-c-content-id=\"hushpuppyUpsell\" data-csa-c-type=\"widget\" data-feature-name=\"hushpuppyUpsell\" class=\"celwidget\" id=\"hushpuppyUpsell_feature_div\"\u003e\u003c\/div\u003e\n\u003cdiv data-cel-widget=\"richProductInformation_feature_div\" data-csa-c-id=\"sxqlnc-nj35vg-vu8nz8-idjk1j\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"\" data-csa-c-slot-id=\"richProductInformation_feature_div\" data-csa-c-content-id=\"richProductInformation\" data-csa-c-type=\"widget\" data-feature-name=\"richProductInformation\" class=\"celwidget\" id=\"richProductInformation_feature_div\"\u003e\n\u003cdiv data-cel-widget=\"rich_product_information\" data-csa-c-id=\"jhenf8-xmwmbr-b57t4g-7hw7fa\" class=\"a-section a-spacing-none celwidget\" id=\"rich_product_information\"\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cb\u003eBOOKREAD™ 5-STEP SATISFACTION GUARANTEE\u003c\/b\u003e\u003c\/strong\u003e\u003cbr\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e\u003cstrong\u003e1. No Risk, 30-Day Money-Back Guarantee. \u003cbr\u003e2. instant download. No surprises or hidden fees.\u003cbr\u003e3. Safe Payments via Credit\/Debit Card or PayPal® \u003cbr\u003e4. McAfee™ and SSL secured shopping cart.\u003cbr\u003e5. lifetime customer support.\u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"My Store","offers":[{"title":"PDF","offer_id":56778159456587,"sku":null,"price":29.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1031\/1204\/8971\/files\/41XPYxHdCrL.jpg?v=1773317022","url":"https:\/\/bookread.io\/products\/clinical-trials-handbook-design-and-conduct-1st-edition","provider":"bookread","version":"1.0","type":"link"}