Explorez tous les épisodes du podcast Applied Clinical Trials

In today's ACT Brief, we examine why real-time monitoring scales only through coordinated ecosystem efforts, how organizational failures not models explain weak AI results, and FDA's advisory panel peptide compounding decision.

In today's ACT Brief, we examine how sustainability is shifting from compliance to a procurement driver, what infrastructure gaps remain in FDA's real-time pilot model, and regulatory guidance targeting unnecessarily restrictive cancer trial criteria.

In today's ACT Brief, we examine how programmatic recruitment requires portfolio funding and behavioral readiness integration, why clinical R&D modernization stalls without systems-level thinking, and FDA's traditional approval of a kidney function-preserving therapy.

In today’s ACT Brief, we examine how site-level data capture is becoming central to trial execution, how Merck and Mayo Clinic are scaling AI-driven discovery, and how Gilead’s latest acquisition strengthens its position in cell therapy for multiple myeloma.

In today’s ACT Brief, we examine how Evinova is scaling AI-driven clinical development through industry collaboration, how the clinical trial project manager role is evolving amid growing complexity, and how FDA scrutiny of compounded GLP-1s could reshape market dynamics.

In today’s ACT Brief, we examine how SCOPE 2026 reinforced the link between speed and strategy, how AI adoption is driving real-world efficiency gains, and how FDA’s evolving evidence standards could reshape approval pathways.

In today’s ACT Brief, we examine how predictive analytics are shaping portfolio decisions, how industry collaboration is scaling digital data standards, and how FDA review of an mRNA flu vaccine candidate is back on track.

In today’s ACT Brief, we examine how AI is enabling continuous trial monitoring and faster site decisions, how provider participation influences recruitment in pragmatic trials, and how leadership restructuring at HHS may shape health policy execution.

In today’s ACT Brief, we examine how AI is shifting from pilot programs into daily development workflows, how a new adoption platform is helping sponsors integrate digital measurement tools, and how global competition and data-driven site selection are reshaping clinical trial activity.

In today’s ACT Brief, we explore how eSource adoption is advancing with AI-enabled validation and interoperability, examine how flexible outsourcing models are helping sponsors balance control and efficiency, and highlight why adaptive, simulation-driven trial design is becoming essential to improving study success.

In today’s ACT Brief, we examine new data on regional variation in clinical trial risk, why patient experience must move from intent to execution, and how digital endpoints are advancing efficiency and regulatory alignment in oncology trials.

In today’s ACT Brief, we cover a new real-world data collaboration aimed at scalable interoperability, how AI fits into modern data capture and quality oversight, and what leaders say must change to move diversity efforts forward in clinical trials.

In today’s ACT Brief, we cover how AI is being deployed to optimize global trial design, why ESG performance is emerging as a core vendor qualification signal, and how sites are becoming more selective as payment practices come under scrutiny.

In today's ACT Brief, we examine how local-first approaches can redesign clinical trial communication, quantitative evidence on risk-based quality management returns, and FDA approval of an oral cholesterol-lowering therapy.

In today’s ACT Brief, we highlight how purpose-driven efficiency is reshaping clinical development priorities, where leaders see the greatest opportunity for accelerating trial timelines, and how artificial intelligence is already influencing decisions across the R&D lifecycle.

In today’s ACT Brief, we look at how real-world evidence is reshaping trial design rather than replacing trials, what Worldwide Clinical Trials’ acquisition of Catalyst Clinical Research signals for oncology-focused CRO models, and new data showing feasibility and enrollment challenges remain stubborn across global trials.

In today’s ACT Brief, we examine why ESG efforts in clinical development are shifting into vendor oversight, what data and governance barriers still limit broader use of de-identified RWE in submissions, and new Phase II obesity data from Roche as its program moves toward Phase III.

In today’s ACT Brief, we explore why decentralized trial innovations struggle to scale without better change management, where real-world evidence most realistically complements traditional trials, and how efficiency, AI, and platformization are expected to reshape clinical operations in 2026.

In today’s ACT Brief, we examine how large de-identified datasets are reshaping trial design and site strategy, why global pharmaceutical production is expected to cool after a tariff-driven surge, and what FDA’s new M4Q(R2) draft guidance means for quality submissions.

In today’s ACT Brief, we look at how FDA policy is accelerating the use of de-identified real-world evidence in clinical development, why a new bipartisan funding package could stabilize federal research agencies, and how the US withdrawal from the World Health Organization reshapes global health coordination.

In today’s ACT Brief, we look at how global clinical development is evolving through decentralized models and emerging markets, why site-centric practices are becoming critical to faster study activation, and how a new Pfizer–Novavax agreement reflects shifting vaccine development strategies.

 In today’s ACT Brief, we examine why life sciences companies are maintaining DEI commitments amid political pressure, what’s driving longer site activation timelines and how sponsors can reverse the trend, and how FDA and EMA are aligning on principles for AI use in drug development.

In today’s ACT Brief, we look at why durable signal closure is emerging as a defining metric in risk-based quality management, how AI can reduce startup delays without burdening sites, and how patient-centric drug design is reshaping the CDMO landscape.

In today's ACT Brief, we examine CRO success through program-level partnership, FDA guidance addressing psychedelic trial design challenges, and approval of a comprehensive cancer pathway inhibitor.

In today’s ACT Brief, we look at efforts to address sex-based evidence gaps in Parkinson’s disease research, why communication failures continue to delay study startup, and how a new White House healthcare plan aims to reduce drug and insurance costs.

In today’s ACT Brief, we look at how AI is reshaping clinical trial registries into discovery tools, why contract and budget negotiations remain the biggest drag on site activation timelines, and how integrated data platforms are closing gaps across payer, provider, and patient care.

In today’s ACT Brief, we examine what will separate sponsors that scale AI beyond pilots in 2026, break down the FDA’s new draft guidance on Bayesian statistical methods in clinical trials, and explore how poor planning and trial design continue to place operational strain on research sites.

In today’s ACT Brief, we look at how community research sites can stay competitive under efficiency pressure, why 2026 is shaping up as a turning point for platform-based clinical operations, and how AI is being positioned to better match patients to therapies.

In today’s ACT Brief, we examine how community research sites can stay competitive under rising efficiency pressures, why clinical outcome assessment licensing remains a drag on trial start-up, and what’s holding back AI-driven pharmacovigilance at scale.

In today’s ACT Brief, we look at how growing trial competition is undermining AI-driven efficiency gains, why pharmacovigilance is shifting toward patient-level causal reasoning, and what AI life sciences companies must demonstrate to stand out in a crowded market.

In today’s ACT Brief, we hear how sponsors may redefine efficiency to protect patient access in 2026, review Verana Health’s merger with COTA to expand real-world evidence capabilities, and examine FDA’s latest decision on Vanda’s Hetlioz for jet lag disorder.

In today’s ACT Brief, we examine the growing challenges of sourcing comparator drugs across the EU, highlight a new AI-driven oncology collaboration between BostonGene and AstraZeneca, and explore why AI life sciences companies are being pushed to prove real operational value beyond hype.

In today’s ACT Brief, we examine why representative enrollment remains a barrier in US cancer trials, review Johnson & Johnson’s positive Phase IIb results for nipocalimab in systemic lupus erythematosus, and break down a new multibillion-dollar research and licensing agreement between Nimbus Therapeutics and Eli Lilly targeting oral obesity treatments.

In today’s ACT Brief, we explore how site initiation can be leveraged to improve early trial performance through demonstrated readiness, examine how AI and decentralized infrastructure are reshaping clinical operations strategy, and review FDA’s approval of the first new pharmacologic motion sickness treatment in more than four decades.

In today's ACT Brief, we examine how organizational silos block programmatic recruitment strategies, why regulatory collaboration on selective safety data enables scalability, and FDA approval of an at-home Alzheimer's therapy option.

In today’s ACT Brief, we examine persistent barriers limiting cancer trial participation and emerging approaches to address them, outline new guidance clarifying investigator versus sponsor ownership of IRT data, and review evidence highlighting sub-Saharan Africa’s capacity to support controlled clinical trials.

In today’s ACT Brief, we examine new data from the American Cancer Society on how transportation and lodging support affect cancer trial participation, review the most-viewed Applied Clinical Trials video interviews of 2025, and break down key trial results supporting the FDA approval of narsoplimab for transplant-associated thrombotic microangiopathy.

In today’s ACT Brief, we cover the FDA approval of oral Wegovy based on Phase III OASIS 4 results, recap the most-read Applied Clinical Trials articles of 2025, and examine why data quality remains critical to enabling AI in clinical trials.

In today’s ACT Brief, we look at how AI-enabled workflows can automate existing site processes, review the FDA approval of subcutaneous Lunsumio VELO for relapsed or refractory follicular lymphoma, and examine early clinical development activity for a pan-KRAS inhibitor licensed by AstraZeneca.

In today’s ACT Brief, we examine why fragmented data systems continue to slow life sciences research, review how sponsor sourcing decisions may affect site experience and study execution, and report on topline Phase III results for Eli Lilly’s oral GLP-1 therapy orforglipron.

In today’s ACT Brief, we examine how sponsors are reassessing new engagement technologies to avoid increasing site burden, review new research on integrating unstructured health data to scale eSource-enabled trials, and cover Novo Nordisk’s NDA submission for its fixed-dose amylin–GLP-1 obesity therapy, CagriSema.

In today’s ACT Brief, we look at emerging operational changes aimed at reducing site burden, review the FDA approval of GSK’s twice-yearly biologic for severe asthma, and examine a national priority voucher granted for a new multiple myeloma treatment combination.

In today’s ACT Brief, we examine new survey data revealing what patients value most in remote clinical trials, break down Sanofi’s latest partnerships aimed at advancing Alzheimer’s and autoimmune therapies, and look at how AI-powered digital pathology is being integrated into oncology research through a new biopharma collaboration.

In today’s ACT Brief, we close out our McKinsey interview series with a look at how AI could transform clinical trials end to end, review new Phase III data supporting Gilead’s investigational HIV regimen, and examine an FDA approval that reshapes first-line treatment for HER2-positive metastatic breast cancer.

In today’s ACT Brief, we look at new evidence showing how targeted training can build research readiness at community cancer centers, explore McKinsey’s view on how digital tools can make trials more patient-centric and geographically inclusive, and review new Phase III results that could reshape obesity and osteoarthritis treatment.

In today's ACT Brief, we examine how sponsors can shift to portfolio-level recruitment strategies, why real-time burden sampling captures operational friction before it becomes risk, and FDA approval of a platinum-free bladder cancer combination.

In today’s ACT Brief, we examine new data on how AI is improving the accuracy and speed of COA localization, break down McKinsey’s perspective on why trials must expand beyond AMCs and into routine care settings, and highlight the FDA’s latest approval of a targeted biologic for generalized myasthenia gravis.

In today’s ACT Brief, we highlight new insights from McKinsey on where AI can meaningfully accelerate clinical development, break down the emerging design and regulatory forces reshaping obesity drug development, and examine why human-centered clinical guidance is becoming essential within an increasingly fragmented pharmacy system.

In today’s ACT Brief, we break down FDA’s new superiority requirement reshaping CAR-T development, examine Pfizer’s global move into oral small-molecule GLP-1 therapy, and highlight new MONALEESA findings that reinforce long-term disease control with Kisqali.