Applied Clinical Trials Online articleshttps://www.appliedclinicaltrialsonline.com/newsApplied Clinical Trials Online articles© 2026 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.Tue, 13 Oct 2026 05:57:37 +00005en-us14447https://www.appliedclinicaltrialsonline.com/newshttps://www.appliedclinicaltrialsonline.com/logo.webphttps://www.appliedclinicaltrialsonline.com/view/flexible-clinical-operations-site-management-quality-design-risk-based-oversighthttps://www.appliedclinicaltrialsonline.com/view/flexible-clinical-operations-site-management-quality-design-risk-based-oversight<![CDATA[How a phased CRO partnership built on ICH E6(R2) and E6(R3) principles supported a multi-indication biotech portfolio.]]>Mon, 12 Oct 2026 19:16:45 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/outreach-structural-drivers-representation-clinical-trialshttps://www.appliedclinicaltrialsonline.com/view/outreach-structural-drivers-representation-clinical-trials<![CDATA[The second of a two-part perspective examining why clinical trial enrollment and representation outcomes are shaped long before the first patient is screened.]]>Mon, 12 Oct 2026 15:11:41 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/what-practical-roadmap-fda-ema-quality-frameworks-actually-looks-likehttps://www.appliedclinicaltrialsonline.com/view/what-practical-roadmap-fda-ema-quality-frameworks-actually-looks-like<![CDATA[In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, describe what operationalizing regulatory-grade quality frameworks requires—and why fit-for-purpose evidence generation is a transparency and documentation discipline, not just a data cleanliness exercise.]]>Mon, 12 Oct 2026 11:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/start-study-budgets-ai-enabled-protocol-translationhttps://www.appliedclinicaltrialsonline.com/view/start-study-budgets-ai-enabled-protocol-translation<![CDATA[AI can turn complex protocols into first-pass budget inputs, letting sponsors start budgeting sooner while budget builders shift from data entry to review.]]>Fri, 09 Oct 2026 18:01:44 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/ai-and-patient-recruitment-can-predictive-promise-drive-true-transformation-https://www.appliedclinicaltrialsonline.com/view/ai-and-patient-recruitment-can-predictive-promise-drive-true-transformation-<![CDATA[Trialbee CEO Matt Walz explores the current impact of AI in delivering practical gains in clinical development and reflects on its future potential, where enrollment predictability may be the biggest prize of all.]]>Fri, 09 Oct 2026 14:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/how-routine-lab-markers-missing-functional-status-datahttps://www.appliedclinicaltrialsonline.com/view/how-routine-lab-markers-missing-functional-status-data<![CDATA[In this video interview, Carole Berini, PhD, of Ontada, explains how validated proxies for variables like ECOG performance status can recover not just sample size but the representativeness of hard-to-reach patient populations in real-world oncology studies.]]>Fri, 09 Oct 2026 11:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/test-smarter-pathways-clinical-trial-participationhttps://www.appliedclinicaltrialsonline.com/view/test-smarter-pathways-clinical-trial-participation<![CDATA[A biomarker test now decides who enters a precision medicine trial, yet results often go unused and assays are not ready when screening opens.]]>Fri, 09 Oct 2026 10:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/rbqm-analysis-frequency-building-trust-oncology-data-rare-pediatric-prv-monetizationhttps://www.appliedclinicaltrialsonline.com/view/rbqm-analysis-frequency-building-trust-oncology-data-rare-pediatric-prv-monetization<![CDATA[In today's ACT Brief, we examine proportionate analysis frequency in RBQM, how to build trust into real-world evidence foundations for cancer trials, and how rare disease developers monetize regulatory success.]]>Fri, 09 Oct 2026 10:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/real-time-data-right-time-decisions-rethinking-analysis-frequency-rbqmhttps://www.appliedclinicaltrialsonline.com/view/real-time-data-right-time-decisions-rethinking-analysis-frequency-rbqm<![CDATA[Real-time RBQM requires proportionate analysis frequency matched to data arrival and issue criticality, not continuous reanalysis, because signal churn from over-frequent runs creates alert fatigue and operational noise that obscures meaningful deterioration.]]>Thu, 08 Oct 2026 15:16:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/what-takes-harmonize-ai-across-fragmented-oncology-health-systemshttps://www.appliedclinicaltrialsonline.com/view/what-takes-harmonize-ai-across-fragmented-oncology-health-systems<![CDATA[In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, explain how building trust into the data foundation—through source lineage, standardization, and reconciliation—is what makes reliable real-world evidence generation in oncology possible.]]>Thu, 08 Oct 2026 14:57:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/ai-protocol-design-site-training-readiness-glp-1-unmet-needshttps://www.appliedclinicaltrialsonline.com/view/ai-protocol-design-site-training-readiness-glp-1-unmet-needs<![CDATA[In today's ACT Brief, we examine how AI surfaces design flaws before enrollment, why site training readiness depends on learning science, and the priorities defining next-generation weight-loss therapies.]]>Thu, 08 Oct 2026 10:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/better-site-training-starts-five-simple-questionshttps://www.appliedclinicaltrialsonline.com/view/better-site-training-starts-five-simple-questions<![CDATA[Site training effectiveness depends on readiness at first-patient-in, requiring learning-science design principles around performance focus, cognitive load reduction, progressive sequencing, and spaced retrieval practice rather than training completion metrics or content volume.]]>Wed, 07 Oct 2026 15:37:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/using-ai-design-better-trials-before-first-patient-enrolls-claire-riches-citelinehttps://www.appliedclinicaltrialsonline.com/view/using-ai-design-better-trials-before-first-patient-enrolls-claire-riches-citeline<![CDATA[In this Q&amp;A, Claire Riches, VP of clinical solutions at Citeline, discusses how AI is transforming endpoint selection and protocol pressure-testing, what data inputs matter most for realistic enrollment planning, and why the tools are more accessible than most sponsors assume.]]>Wed, 07 Oct 2026 15:22:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/fda-transparency-roadmap-radiopharmaceutical-trial-operations-ai-powered-enrollment-predictionhttps://www.appliedclinicaltrialsonline.com/view/fda-transparency-roadmap-radiopharmaceutical-trial-operations-ai-powered-enrollment-prediction<![CDATA[In today's ACT Brief, we examine the FDA's multi-domain transparency priorities, why radiopharmaceutical trials need redesigned infrastructure, and how AI can make enrollment more predictable.]]>Wed, 07 Oct 2026 10:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/beyond-recruitment-the-future-of-patient-and-site-engagement-in-oncology-clinical-trialshttps://www.appliedclinicaltrialsonline.com/view/beyond-recruitment-the-future-of-patient-and-site-engagement-in-oncology-clinical-trials<![CDATA[Webinar Date/Time: Tue, Nov 17, 2026 11:00 AM EST]]>Wed, 07 Oct 2026 04:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/beyond-molecule-why-radiopharmaceutical-trials-require-new-operating-modelhttps://www.appliedclinicaltrialsonline.com/view/beyond-molecule-why-radiopharmaceutical-trials-require-new-operating-model<![CDATA[Radiopharmaceutical therapy is exposing a broader challenge for clinical development: scientific innovation can advance only as fast as the infrastructure, data, and cross-functional decisions required to deliver it.]]>Tue, 06 Oct 2026 19:24:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/fda-releases-transparency-roadmap-outlining-disclosure-priorities-drug-development-regulatory-reviewhttps://www.appliedclinicaltrialsonline.com/view/fda-releases-transparency-roadmap-outlining-disclosure-priorities-drug-development-regulatory-review<![CDATA[A new FDA Voices post from the agency's acting chief of staff details completed milestones and upcoming priorities across complete response letter disclosure, application lifecycle transparency, new approach methodologies, labeling, and inspectional records.]]>Tue, 06 Oct 2026 15:28:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/ibogaine-trial-design-guidance-outsourcing-model-oversight-gaps-kidney-disease-partnershiphttps://www.appliedclinicaltrialsonline.com/view/ibogaine-trial-design-guidance-outsourcing-model-oversight-gaps-kidney-disease-partnership<![CDATA[In today's ACT Brief, we examine FDA input sought on early-phase ibogaine protocols, why mixed outsourcing models spread faster than oversight infrastructure, and a major partnership for a rare kidney disease treatment.]]>Tue, 06 Oct 2026 10:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/operation-trialblazer-leveraging-new-and-anticipated-us-policy-changes-in-early-developmenthttps://www.appliedclinicaltrialsonline.com/view/operation-trialblazer-leveraging-new-and-anticipated-us-policy-changes-in-early-development<![CDATA[Webinar Date/Time: Wed, Oct 28, 2026 10:00 AM EDT]]>Tue, 06 Oct 2026 04:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/mixed-outsourcing-models-spreading-sponsor-oversight-keeping-uphttps://www.appliedclinicaltrialsonline.com/view/mixed-outsourcing-models-spreading-sponsor-oversight-keeping-up<![CDATA[Mixed FSP and FSO models are gaining ground as sponsors seek agility and resource flexibility, but the oversight infrastructure, audit trails, and accountability structures needed to run them well and survive regulatory inspection are consistently lagging behind the model itself.]]>Mon, 05 Oct 2026 18:34:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/fda-seeks-public-input-early-phase-clinical-trial-design-ibogainehttps://www.appliedclinicaltrialsonline.com/view/fda-seeks-public-input-early-phase-clinical-trial-design-ibogaine<![CDATA[A new request for information asks for comments on dose selection, safety monitoring, eligibility criteria, and oversight approaches to support the responsible development of ibogaine drug products.]]>Mon, 05 Oct 2026 16:08:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/ai-adoption-starting-points-hierarchical-endpoints-patient-priorities-early-stage-program-terminationhttps://www.appliedclinicaltrialsonline.com/view/ai-adoption-starting-points-hierarchical-endpoints-patient-priorities-early-stage-program-termination<![CDATA[In today's ACT Brief, we examine practical guidance for clinical operations teams beginning AI adoption, how hierarchical endpoints better reflect treatment benefit, and why early-stage program failures signal smarter pipeline management.]]>Mon, 05 Oct 2026 10:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/hierarchical-endpoints-cardiology-treatment-benefithttps://www.appliedclinicaltrialsonline.com/view/hierarchical-endpoints-cardiology-treatment-benefit<![CDATA[Hierarchical composite endpoints analyzed through pairwise comparisons more accurately reflect multifaceted treatment benefit than time-to-first-event composites, but transparent outcome prioritization, patient involvement in ranking, and reporting of Net Treatment Benefit remain underutilized despite their importance to interpretation.]]>Fri, 02 Oct 2026 16:05:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/clinops-professionals-starting-ai-should-keep-top-mindhttps://www.appliedclinicaltrialsonline.com/view/clinops-professionals-starting-ai-should-keep-top-mind<![CDATA[In this video interview, Claire Riches, VP of clinical solutions at Citeline, offers practical guidance for clinical operations teams beginning their AI journey—making the case that the tools are more accessible than many assume and that waiting to start is a competitive risk in itself.]]>Fri, 02 Oct 2026 11:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/proactive-trial-risk-management-federal-infrastructure-modernization-pediatric-heart-disease-treatmenthttps://www.appliedclinicaltrialsonline.com/view/proactive-trial-risk-management-federal-infrastructure-modernization-pediatric-heart-disease-treatment<![CDATA[In today's ACT Brief, we examine how AI enables sponsors to pressure-test protocols before enrollment, HHS's multi-initiative effort to accelerate trial design and execution, and FDA approval expanding heart disease therapy to adolescents.]]>Fri, 02 Oct 2026 10:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/hhs-launches-surpass-program-three-complementary-initiatives-transform-clinical-trial-design-infrastructurehttps://www.appliedclinicaltrialsonline.com/view/hhs-launches-surpass-program-three-complementary-initiatives-transform-clinical-trial-design-infrastructure<![CDATA[The new effort combines adaptive platform trial design, AI-enabled site activation, nationwide data infrastructure, and patient data contribution tools to reduce timelines, costs, and patient burden across clinical development.]]>Thu, 01 Oct 2026 16:15:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/from-engagement-to-enterprise-value-reframing-community-as-a-growth-segmenthttps://www.appliedclinicaltrialsonline.com/view/from-engagement-to-enterprise-value-reframing-community-as-a-growth-segment<![CDATA[Community engagement is a powerful tool but its impact depends on how it is done. When it begins early, is sustained over time, and is built through organizations and individuals communities already trust, it can expand access to historically overlooked and medically underserved populations worldwide. The result is more representative science, stronger participation across the drug-development lifecycle, and a sustainable pathway to commercial growth. Inside Edge’s proprietary global Trustmaker Network turns trusted community relationships into meaningful action helping people make informed health decisions while delivering measurable outcomes across R&amp;D and commercial.]]>Thu, 01 Oct 2026 13:29:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/ai-informed-approach-means-how-sponsors-think-about-riskhttps://www.appliedclinicaltrialsonline.com/view/ai-informed-approach-means-how-sponsors-think-about-risk<![CDATA[In this video interview, Claire Riches, VP of clinical solutions at Citeline, explains how AI is shifting trial risk management from reactive to proactive—enabling sponsors to pressure-test protocols and anticipate pivots before a single patient is enrolled.]]>Thu, 01 Oct 2026 11:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/ai-design-advisor-autonomous-agent-governance-oral-weight-loss-therapyhttps://www.appliedclinicaltrialsonline.com/view/ai-design-advisor-autonomous-agent-governance-oral-weight-loss-therapy<![CDATA[In today's ACT Brief, we examine AI's role as trial design advisor with human leadership, how to govern autonomous agents in regulated operations, and real-world outcomes from switching to oral weight-loss therapy.]]>Thu, 01 Oct 2026 10:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/control-plane-agentic-clinical-operations-governing-autonomous-digital-actors-regulated-trialshttps://www.appliedclinicaltrialsonline.com/view/control-plane-agentic-clinical-operations-governing-autonomous-digital-actors-regulated-trials<![CDATA[AI agents in clinical operations acquire broader autonomous capability through expanded permissions, tools, memory, and delegated authority, requiring governance focused on whether effective capability has shifted outside approved boundaries rather than whether software has changed.]]>Wed, 30 Sep 2026 18:22:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articles