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https://ctti-clinicaltrials.org/topics/novel/antibiotic-drug-development2/streamlining-habp-vabp/streamlining-safety-data-collection-in-hospital-acquired-bacterial-pneumonia-and-ventilator-associated-bacterial-pneumonia-trials-recommendations-of-the-clinical-trials-transformation-initiative-anti/ 2025-01-15T19:32:59+00:00 https://ctti-clinicaltrials.org/topics/novel/antibiotic-drug-development2/unmet-need/patient-and-physician-attitudes-regarding-risk-and-benefit-in-streamlined-development-programmes-for-antibacterial-drugs-a-qualitative-analysis/ 2025-01-29T19:28:19+00:00 https://ctti-clinicaltrials.org/topics/quality/reporting-challenges/improving-timely-accurate-and-complete-registration-and-reporting-of-summary-results-information-on-clinicaltrials-gov/ 2025-01-29T20:38:26+00:00 https://ctti-clinicaltrials.org/topics/quality/reporting-challenges/best-practices-for-complete-registration-and-reporting-of-summary-results-on-clinicaltrials-gov/ 2025-01-30T14:51:48+00:00 https://ctti-clinicaltrials.org/topics/novel/antibiotic-drug-development2/unmet-need/ctti-statistics-think-tank-for-anti-bacterial-drug-development-by-lisa-lavange/ 2025-01-30T15:22:27+00:00 https://ctti-clinicaltrials.org/topics/ethics/data-monitoring-committees/ctti-recommendations-data-monitoring-committees/ 2025-01-31T17:50:58+00:00 https://ctti-clinicaltrials.org/topics/ethics/data-monitoring-committees/recommendations-for-data-monitoring-committees-from-the-clinical-trials-transformation-initiative/ 2025-01-31T18:00:44+00:00 https://ctti-clinicaltrials.org/topics/ethics/data-monitoring-committees/enhancing-the-scientific-integrity-and-safety-of-clinical-trials-recommendations-for-data-monitoring-committees/ 2025-01-31T20:07:57+00:00 https://ctti-clinicaltrials.org/topics/ethics/data-monitoring-committees/understanding-the-functions-and-operations-of-data-monitoring-committees-survey-and-focus-group-findings/ 2025-01-31T20:46:59+00:00 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https://ctti-clinicaltrials.org/topics/engagement/patient-engagement-collaborative/pec-meeting-summary-july-2022/ 2025-02-07T01:58:43+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-engagement-collaborative/pec-meeting-summary-april-2022/ 2025-02-07T01:59:40+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-engagement-collaborative/pec-meeting-summary-january-2022/ 2025-02-07T02:00:48+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-engagement-collaborative/pec-meeting-summary-july-2021/ 2025-02-07T02:04:07+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-engagement-collaborative/pec-meeting-summary-october-2020-2/ 2025-02-07T02:05:02+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-engagement-collaborative/pec-meeting-summary-april-2020/ 2025-02-07T02:06:10+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-engagement-collaborative/pec-meeting-summary-september-2019/ 2025-02-07T02:07:12+00:00 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2025-02-07T15:19:10+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-groups-and-clinical-trials/expansion-of-expected-net-present-value-framework-for-evaluating-patient-engagement-methods/ 2025-02-07T15:20:06+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-groups-and-clinical-trials/tool-1-patient-group-organizational-expertise-and-assets-evaluation-tool/ 2025-02-07T15:22:44+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-groups-and-clinical-trials/tool-2-assessment-of-patient-group-internal-aspects-focus/ 2025-02-07T15:30:53+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-groups-and-clinical-trials/tool-3-assessment-of-patient-group-external-relationships-other-patient-groups/ 2025-02-07T16:58:06+00:00 https://ctti-clinicaltrials.org/type/media-coverage/patient-engagement-needs-more-benefit-analysis-less-theoretical-conversations/ 2025-02-07T17:31:36+00:00 https://ctti-clinicaltrials.org/type/publications/assessing-the-financial-value-of-patient-engagement/ 2025-02-07T17:32:56+00:00 https://ctti-clinicaltrials.org/type/publications/development-and-application-of-a-patient-group-engagement-prioritization-tool-for-use-in-medical-product-development-2/ 2025-02-07T17:34:16+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-groups-and-clinical-trials/value-of-patient-group-engagement-activities-summary-of-interview-findings/ 2025-02-07T17:38:45+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-groups-and-clinical-trials/the-rules-of-engagement-ctti-recommendations-for-successful-collaborations-between-sponsors-and-patient-groups-around-clinical-trials/ 2025-02-07T17:39:46+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-groups-and-clinical-trials/patient-engagement-practices-in-clinical-research-among-patient-groups-industry-and-academia-in-the-united-states-a-survey/ 2025-02-07T19:36:37+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-groups-and-clinical-trials/clinical-trials-do-participants-feel-safe-press-release/ 2025-02-07T19:40:47+00:00 https://ctti-clinicaltrials.org/type/case-study/can-patients-moderate-research-panels-as-effectively-as-clinicians-yes-and-they-might-be-better/ 2025-02-07T19:51:04+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-groups-and-clinical-trials/acta-uses-cttis-patient-group-engagement-recommendations-to-build-an-influential-toolkit-for-improving-research/ 2025-02-07T19:57:45+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-groups-and-clinical-trials/ppmd-delivers-patient-preference-studies-for-improved-engagement/ 2025-02-07T19:58:43+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-groups-and-clinical-trials/dcri-improves-recruitment-retention-and-grant-proposals-with-deep-patient-engagement-strategy/ 2025-02-07T19:59:40+00:00 https://ctti-clinicaltrials.org/topics/mobile/supporting-a-decentralized-trial/digital-health-trials-recommendations-to-sponsors-for-planning-decentralized-trials/ 2025-02-07T20:03:02+00:00 https://ctti-clinicaltrials.org/topics/mobile/supporting-a-decentralized-trial/clearing-a-path-for-broad-implementation-of-dcts/ 2025-02-07T20:05:44+00:00 https://ctti-clinicaltrials.org/topics/mobile/supporting-a-decentralized-trial/considerations-for-delivering-an-investigational-product/ 2025-02-07T20:07:53+00:00 https://ctti-clinicaltrials.org/topics/mobile/supporting-a-decentralized-trial/adoption-of-decentralization-are-our-perceptions-holding-us-back/ 2025-02-07T20:27:55+00:00 https://ctti-clinicaltrials.org/topics/mobile/supporting-a-decentralized-trial/legal-regulatory-and-practical-issues-to-consider-when-adopting-decentralized-clinical-trials-recommendations-from-the-clinical-trials-transformation-initiative/ 2025-02-07T20:29:04+00:00 https://ctti-clinicaltrials.org/type/case-study/long-shot-covid-19-treatment-yields-fast-promising-results-using-decentralized-trial-approach/ 2025-02-07T20:32:13+00:00 https://ctti-clinicaltrials.org/topics/mobile/supporting-a-decentralized-trial/curebase-pioneers-completely-virtual-site-to-meet-patients-where-they-are/ 2025-02-07T20:33:18+00:00 https://ctti-clinicaltrials.org/topics/quality/pregnancy-testing/recommendations-for-pregnancy-testing-in-clinical-trials/ 2025-02-07T20:37:16+00:00 https://ctti-clinicaltrials.org/topics/quality/pregnancy-testing/pregnancy-testing-outcomes-predictor-for-clinical-trials/ 2025-02-07T20:38:07+00:00 https://ctti-clinicaltrials.org/topics/quality/pregnancy-testing/evidence-based-pregnancy-testing-in-clinical-trials-recommendations-from-a-multi-stakeholder-development-process/ 2025-02-07T20:42:29+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/recommendations-for-quality-by-design/ 2025-02-10T15:44:32+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/recommendations-for-effective-and-efficient-monitoring-as-a-component-of-quality-assurance-in-the-conduct-of-clinical-trials/ 2025-02-10T15:45:39+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/critical-to-quality-ctq-factors-principles-document/ 2025-02-10T15:46:43+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/quality-by-design-maturity-model/ 2025-02-10T15:47:49+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/qbd-maturity-model-walkthrough-and-scoring-examples/ 2025-02-10T15:49:09+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/quality-by-design-metrics-framework/ 2025-02-10T15:50:31+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/quality-by-design-documentation-tool/ 2025-02-10T15:51:44+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/components-of-qbd-adoption/ 2025-02-10T15:53:13+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/case-study-university-of-oxford-ctsu/ 2025-02-10T15:54:25+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/case-study-dcri-streamlines-protocol-using-quality-by-design-thinking/ 2025-02-10T15:55:56+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/case-study-emphasis-on-protocol-design-helps-alexion-with-timeline-adherence/ 2025-02-10T15:57:08+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/case-study-the-medicines-company-developed-nimble-protocols-to-scale-for-global-trials/ 2025-02-10T15:58:16+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/measurement-for-individual-study-teams-leverage-plan-do-check-act-approach/ 2025-02-10T15:59:31+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/quality-by-design-implementation-guide-for-individual-clinical-trials/ 2025-02-10T16:01:07+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/team-recognition-and-ownership-of-the-process-helpful-hints/ 2025-02-10T16:02:19+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/setting-expectations/ 2025-02-10T16:13:42+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/case-study-a-study-to-evaluate-the-efficacy-and-safety-of-xxxx-compared-to-yyyy-in-the-treatment-of-patients-with-acute-episode-of-schizophrenia-hospitalized/ 2025-02-10T16:15:04+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/case-study-trial-of-nes-822-plus-amo-1002-vs-amo-1002-alone-as-first-line-therapy-in-patients-with-advanced-pancreatic-cancer/ 2025-02-10T16:16:18+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/case-study-a-prospective-multicenter-single-arm-clinical-cohort-study/ 2025-02-10T16:17:22+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/case-study-renin-angiotensin-system-combination-antagonists-for-life-rascal/ 2025-02-10T16:18:15+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/quality-by-design-workshop-facilitator-role/ 2025-02-10T16:19:20+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/perspectives-for-qbd-discussions-and-potential-champions/ 2025-02-10T16:20:18+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/enhancing-clinical-evidence-by-proactively-building-quality-into-clinical-trials/ 2025-02-10T16:53:39+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/monitoring-the-quality-of-conduct-of-clinical-trials-a-survey-of-current-practices/ 2025-02-10T16:59:42+00:00 https://ctti-clinicaltrials.org/topics/engagement/patient-groups-and-clinical-trials/fpwrs-questionnaire-measures-important-but-often-overlooked-concerns-for-prader-willi-patients-and-caregivers/ 2025-02-10T17:00:57+00:00 https://ctti-clinicaltrials.org/pillars/designed-with-quality-approach/bristol-myers-squibb-bms-co-hosts-quality-by-design-workshop-with-ctti-to-achieve-quality-culture-aligned-with-ich-e8r1/ 2025-02-10T17:02:11+00:00 https://ctti-clinicaltrials.org/topics/mobile/supporting-a-decentralized-trial/rho-combines-ctti-resources-to-operate-with-optimal-efficiency-and-data-quality/ 2025-02-10T17:03:15+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/university-of-california-irvines-multidisciplinary-trial-design-studios-yield-streamlined-considered-protocols/ 2025-02-10T17:05:09+00:00 https://ctti-clinicaltrials.org/topics/quality/quality-by-design/quality-by-design-helps-emd-serono-streamline-its-protocol-through-inclusion-of-new-perspectives/ 2025-02-10T17:07:03+00:00 https://ctti-clinicaltrials.org/topics/novel/real-world-data2/recommendations-for-using-real-world-data-to-plan-eligibility-criteria-and-enhance-recruitment/ 2025-02-10T17:37:12+00:00 https://ctti-clinicaltrials.org/topics/novel/real-world-data2/evaluating-feasibility-of-rwd-supported-recruitment/ 2025-02-10T17:38:36+00:00 https://ctti-clinicaltrials.org/topics/novel/real-world-data2/effective-rwd-supported-discussions-of-eligibility-criteria/ 2025-02-10T17:39:41+00:00 https://ctti-clinicaltrials.org/topics/novel/real-world-data2/evaluating-whether-rwd-is-suitable-for-planning-eligibility-criteria-and-supporting-recruitment/ 2025-02-10T17:40:42+00:00 https://ctti-clinicaltrials.org/topics/novel/real-world-data2/establishing-use-of-rwd-as-a-standard-process-in-study-planning-and-recruitment/ 2025-02-10T17:41:39+00:00 https://ctti-clinicaltrials.org/topics/novel/real-world-data2/planning-rwd-supported-recruitment-strategies/ 2025-02-10T17:42:55+00:00 https://ctti-clinicaltrials.org/topics/novel/real-world-data2/case-study-using-real-world-data-to-solve-mid-study-recruitment-challenges-for-phase-ib-ii-breast-cancer-trial/ 2025-02-10T17:43:59+00:00 https://ctti-clinicaltrials.org/topics/novel/real-world-data2/case-study-using-real-world-data-to-expand-eligibility-criteria-for-phase-iii-endocrinology-study/ 2025-02-10T17:45:25+00:00 https://ctti-clinicaltrials.org/topics/novel/real-world-data2/case-study-using-real-world-data-to-expand-eligibility-criteria-for-phase-ii-inflammation-trial/ 2025-02-10T17:46:27+00:00 https://ctti-clinicaltrials.org/topics/novel/real-world-data2/real-world-data-for-planning-eligibility-criteria-and-enhancing-recruitment-recommendations-from-the-clinical-trials-transformation-initiative/ 2025-02-10T17:50:34+00:00 https://ctti-clinicaltrials.org/type/press-release/ctti-releases-new-recommendations-and-resources-for-using-real-world-data-to-plan-trial-eligibility-criteria-and-recruit-participants/ 2025-02-10T18:21:17+00:00 https://ctti-clinicaltrials.org/topics/quality/recruitment/recommendations-for-planning-for-successful-trial-recruitment/ 2025-02-10T18:31:07+00:00 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https://ctti-clinicaltrials.org/topics/ethics/safety-reporting2/clinical-trial-electronic-portals-for-expedited-safety-reporting-recommendations-from-the-clinical-trials-transformation-initiative-investigational-new-drug-safety-advancement-project/ 2025-02-11T17:49:53+00:00 https://ctti-clinicaltrials.org/topics/ethics/safety-reporting2/the-fdas-final-rule-on-expedited-safety-reporting-statistical-considerations/ 2025-02-11T17:51:22+00:00 https://ctti-clinicaltrials.org/topics/ethics/safety-reporting2/industry-practices-for-expedited-reporting-to-investigators-conducting-research-under-an-ind/ 2025-02-11T17:52:36+00:00 https://ctti-clinicaltrials.org/topics/ethics/safety-reporting2/investigators-experience-with-expedited-safety-reports-prior-to-the-fdas-final-ind-safety-reporting-rule/ 2025-02-11T17:53:47+00:00 https://ctti-clinicaltrials.org/topics/ethics/safety-reporting2/optimizing-expedited-safety-reporting-for-drugs-and-biologics-subject-to-an-investigational-new-drug-application/ 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