Category: Medicine

Image Credit: Adobe Stock Images/toa555 Topline Findings Rapid LDL-C Goal Achievement: Leqvio (inclisiran) enabled 84.9% of high-risk hypercholesterolemia patients to reach guideline-recommended LDL-C targets within […]

Jim Reilly, president, Development Cloud, and EVP, global strategy, Veeva Image Credit: Andy Studna In the opening keynote of the clinical operations zone, Jim Reilly, […]

In a recent video interview with Applied Clinical Trials, Sunny Kumar, MD, partner, Informed Ventures, discussed the slow adoption of DCT models despite their benefits […]

Image Credit: Adobe Stock Images/wutzkoh Roche and Alnylam are launching the Phase III ZENITH cardiovascular outcomes trial (CVOT) to evaluate zilebesiran in patients with uncontrolled […]

In a recent video interview with Applied Clinical Trials, Sunny Kumar, MD, partner, Informed Ventures, discussed the slow adoption of DCT models despite their benefits […]

This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, […]

Image Credit: Adobe Stock Images/Fitry Topline Findings Phase III CYPRESS Enrollment Completed: Theravance Biopharma finishes open-label patient enrollment in the pivotal trial evaluating ampreloxetine for […]

Lipset: Clearly, this is a very polarizing time politically for a lot of folks, but I think objectively, most would say that efficiencies are needed, […]

Credit: Dzmitry | stock.adobe.com Infants with spinal muscular atrophy (SMA) administered early treatment with Evrysdi (risdiplam) demonstrated motor milestone achievements that would not have been reached […]

Credit: photon_photo | stock.adobe.com Background Clinical trial success depends on selecting appropriate clinical sites. Poor site selection can lead to delayed recruitment, compromised data quality, […]

Image Credit: Adobe Stock Images/Robin What clinops professionals need to know The Phase III NIMBLE trial demonstrated that cemdisiran, given once every 12 weeks, achieved […]

In a recent video interview with Applied Clinical Trials, Sunny Kumar, MD, partner, Informed Ventures, discussed the slow adoption of DCT models despite their benefits […]

Credit: kentoh | stock.adobe.com Decentralized clinic trials are more than a mere trend, they are a revolution in the ways we support, reach and retain […]

Credit: Proxima Studio | stock.adobe.com As GLP-1 therapies expand from diabetes into obesity, cardiovascular disease, and rare conditions, clinical trial teams face a broader choice […]

In a recent video interview with Applied Clinical Trials, Sunny Kumar, MD, partner, Informed Ventures, discussed the slow adoption of DCT models despite their benefits […]

Image Credit: © JHVEPhoto – stock.adobe.com For individuals who fall outside of the conditions listed under the new CDC recommendations, the cost of updated vaccines […]

Image Credit: Adobe Stock Images/MKS The FDA has granted Breakthrough Therapy Designation (BTD) to Genmab’s Rina-S (rinatabart sesutecan) for the treatment of advanced endometrial cancer […]

In a recent video interview with Applied Clinical Trials, Sunny Kumar, MD, partner, Informed Ventures, discussed the slow adoption of DCT models despite their benefits […]

Image Credit: © JHVEPhoto – stock.adobe.com What clinops professionals need to know The FDA will now publish FAERS adverse event data daily, a shift aimed […]

Image Credit: © Shuo – stock.adobe.com What clinops professionals need to know Early-stage research is vulnerable to bias due to the vast volume of biomedical […]

In a recent video interview Applied Clinical Trials, Caroline Potts, general manager of sites and patient services, Medical Research Network (MRN), discussed operational flexibility in […]

Image Credit: © Pixel-Shot – stock.adobe.com Nicox has shared positive results from the Phase III Denali clinical trial (NCT04630808) evaluating its NCX 470 0.1%, a […]

In a recent video interview Applied Clinical Trials, Caroline Potts, general manager of sites and patient services, Medical Research Network (MRN), discussed operational flexibility in […]

Image Credit: © WESTOCK – stock.adobe.com What clinops professionals need to know Recent NIH funding cuts tied to DEI policies are creating uncertainty across the […]

Image Credit: Adobe Stock Images/Suriyawut Topline Findings Z-1018 Shingles Vaccine Shows Comparable Immunity: In part 1 of the Phase I/II trial (NCT06569823), Dynavax’s Z-1018 achieved […]

This presentation was generated based on two articles written by Rebecca Johnson, PhD: The Impact of DEI Ban On Clinical Research Ecosystem The Mandate Myth: […]

Image Credit: © Production Perig – stock.adobe.com ImmunityBio has initiated a new Phase II study, COVID-4.019-Long (NCT07123727), to evaluate the safety and effectiveness of Anktiva […]

Image Credit: Adobe Stock Images/Ti Studio Topline Findings Primary Endpoint Not Met: Barzolvolimab did not improve eosinophilic esophagitis (EoE) symptoms, endoscopic scores, or eosinophil infiltration […]

This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, […]

Image Credit: Adobe Stock Images/nature_photo by ice Topline Findings FDA lifts clinical hold on RP-A501 trial: Rocket Pharmaceuticals’ pivotal Phase II study for Danon disease […]

In a recent video interview Applied Clinical Trials, Caroline Potts, general manager of sites and patient services, Medical Research Network (MRN), discussed operational flexibility in […]

Image Credit: © Dr_Microbe – stock.adobe.com What clinops professionals need to know The Phase II trial is evaluating Hepzato in combination with trifluridine-tipiracil and bevacizumab […]

In a recent video interview Applied Clinical Trials, Caroline Potts, general manager of sites and patient services, Medical Research Network (MRN), discussed operational flexibility in […]

Image Credit: Adobe Stock Images/Bartek Topline Findings FDA Breakthrough Therapy Designation (BTD): I-DXd (ifinatamab deruxtecan) receives FDA BTD for pretreated extensive-stage small cell lung cancer, […]

Rohit Nambisan, CEO, Lokavant Jonathan Crowther, head of predictive analytics, Pfizer Summary AI adoption in clinical operations is accelerating, with growing optimism about its potential […]

In a recent video interview with Applied Clinical Trials, Meri Beckwith, Co-CEO, Lindus Health, discussed the evolving perception of breakthrough designation amid the FDA’s recent […]

In a recent interview with Applied Clinical Trials, Ron Lanton, partner at Lanton Law, discussed the pivotal role clinical operations professionals play in maintaining the […]

Alan Baldridge, MD, Senior Director, Gastroenterology and Hepatology, Drug Development Solutions, ICON What clinops professionals need to know A 2025 survey of cardiometabolic drug developers […]

Image Credit: Adobe Stock Images/Vii Topline Findings First Patient Treated: Apreo Health has enrolled the first patient in the pivotal BREATHE-3 trial testing the BREATHE […]

Image Credit: © Pixel-Shot – stock.adobe.com What clinops professionals need to know The Phase II STARLIGHT trial evaluated a single intravitreal injection of MCO-010 in […]

Image credit: © Destina – stock.adobe.com What clinops professionals need to know The Phase II B-SUPREME trial is evaluating ALG-000184, a first-in-class oral capsid assembly […]

Image Credit: Adobe Stock Images/Sean Topline Findings VE202 Phase II Results: Vedanta Biosciences’ VE202 did not meet the trial’s primary endpoints treating mild-to-moderate ulcerative colitis […]

This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, […]

In a recent interview with Applied Clinical Trials, Jon Walsh, founder and chief scientific officer of Unlearn, discussed how AI-designed therapies and digital twin technologies […]

Image Credit: © AkuAku – stock.adobe.com Summary The Phase III VAYHIT2 trial evaluated ianalumab plus eltrombopag versus placebo plus eltrombopag in adults with primary ITP […]

Image Credit: © Matthieu – stock.adobe.com Summary The Phase III EV-303/KEYNOTE-905 trial showed that Padcev (enfortumab vedotin) plus Keytruda (pembrolizumab), given before and after surgery, […]

In a recent interview with Applied Clinical Trials, Jon Walsh, founder and chief scientific officer of Unlearn, discussed how AI-designed therapies and digital twin technologies […]

Image Credit: Adobe Stock Images/Magnimage Topline Findings First Patient Dosed: Biogen and Stoke Therapeutics initiate Phase III EMPEROR trial of zorevunersen for Dravet syndrome across […]

Image Credit: © Satjawat – stock.adobe.com Summary The TRIUMpH Phase III program demonstrated that tegoprazan maintained healing in GERD patients over 24 weeks with statistical […]

Image Credit: Adobe Stock Images/freebird7977 Topline Findings Orforglipron delivers strong weight loss results: Lilly’s oral GLP-1 candidate achieved up to 12.4% average weight reduction in […]

In a recent video interview with Applied Clinical Trials, Luke Wilson, senior director, biotech, pharma services, Thermo Fisher Scientific, discussed the role of data visibility […]

Image Credit: © Kaikoro – stock.adobe.com Summary AI-powered, unified digital platforms are streamlining non-interventional studies by removing site dependencies, accelerating study start-up, and enabling continuous […]

Image Credit: Adobe Stock Images/Johannes Topline Findings Positive Phase III Trial Results: Genmab’s Epkinly (epcoritamab) combined with Rituxan (rituximab) and Revlimid (lenalidomide) (R2) showed promising […]

Image Credit: © Matthieu – stock.adobe.com Summary The Phase III ENVISION trial 24-month update shows Zusduri maintained a 72.2% duration of response in patients with […]

In a recent interview with Applied Clinical Trials, Jon Walsh, founder and chief scientific officer of Unlearn, discussed how AI-designed therapies and digital twin technologies […]

In a recent video interview with Applied Clinical Trials, Luke Wilson, senior director, biotech, pharma services, Thermo Fisher Scientific, discussed the role of data visibility […]

Credit: Lars Neumann | stock.adobe.com Summary The FDA has endorsed further development of Immutep’s eftilagimod alfa (efti) in combination with Keytruda for first-line HNSCC patients […]

Image Credit: © Tada Images – stock.adobe.com Summary HHS has canceled 22 BARDA-funded mRNA vaccine contracts, totaling $500 million, as part of a broader shift […]

Cindy Henderson, chief strategy officer, Veristat Summary Protocol complexity is rising across therapeutic areas, driving costly delays and frequent amendments—now affecting 76% of trials. New […]

Image Credit: Adobe Stock Images/Issara Topline Findings VX-993 misses endpoint in Phase II trial: Vertex’s selective NaV1.8 inhibitor failed to outperform placebo or hydrocodone/acetaminophen in […]

In a recent video interview with Applied Clinical Trials, Luke Wilson, senior director, biotech, pharma services, Thermo Fisher Scientific, discussed the role of data visibility […]

Image Credit: © photon_photo – stock.adobe.com Key takeaways Nearly 70% of Phase II trials fail, often due to preventable issues like restrictive endpoints or recruitment […]

This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, […]

Image Credit: Adobe Stock Images/Orawan Key Takeaways Sustained Benefit Over Three Years: Kisunla continued to slow cognitive and functional decline in patients with early Alzheimer […]

In a recent video interview with Applied Clinical Trials, Michael Miller, chief operating officer, Quanterix, discussed how the clinical research industry is increasingly integrating biomarkers. […]

Image Credit: Adobe Stock Images/Pete Key Takeaways FDA Approval for JSKN003 Trial: Alphamab Oncology received FDA approval to start a Phase II trial for the […]

Image Credit: © Dr_Microbe – stock.adobe.com Key takeaways Monthly ivermectin administration reduced malaria incidence by 26% versus albendazole, meeting WHO efficacy thresholds and demonstrating potential […]

Image Credit: Adobe Stock Images/MUdaylah Key takeaways Obicetrapib 10 mg significantly reduced plasma p-tau217 levels over 12 months in both the full analysis set and […]

AI Summary Test

Image Credit: © Sebastian Kaulitzki – stock.adobe.com Key takeaways The 30 mg onvansertib arm demonstrated a 49% confirmed ORR versus 30% with standard-of-care alone, with […]

Image Credit: © Axel Bueckert – stock.adobe.com Key takeaways Repibresib missed both primary and key secondary endpoints in Phase IIb, but showed nominally significant improvements […]

Credit: Alex Papp | stock.adobe.com Key takeaways Robust primary endpoint success: Upadacitinib achieved ≥80% scalp hair coverage in over half of patients at the 30 […]

Image Credit: © chayantorn – stock.adobe.com Key takeaways The AMPLIFY trial supports a fixed-duration, all-oral regimen of venetoclax and acalabrutinib, showing a 35% reduction in […]

Credit: and.one | stock.adobe.com Key takeaways J&J has submitted an sBLA to the FDA seeking to update Tremfya’s label to include data on inhibiting structural […]

Credit: Andrii | stock.adobe.com Key takeaways Ilumya demonstrated statistically significant ACR20 responses at Week 24 in both biologic-experienced and biologic-naïve patients with psoriatic arthritis. Safety […]

Rudradev Sengupta, Senior Trial Design Lead at One2Treat Key takeaways Net treatment benefit (NTB) provides a more holistic, multidimensional assessment of treatment efficacy by integrating […]

In a recent video interview with Applied Clinical Trials, Kate Gallin Heffernan, life sciences attorney, Epstein Becker Green, discussed the challenges clinical research teams face […]

Image Credit: Adobe Stock Images/jam Key Takeaways Clinical trial searches are delaying treatment: Around 72% of physicians in the United States say finding relevant trials […]

In a recent video interview with Applied Clinical Trials, Kate Gallin Heffernan, life sciences attorney, Epstein Becker Green, discussed the challenges clinical research teams face […]

In a recent video interview with Applied Clinical Trials, Kate Gallin Heffernan, life sciences attorney, Epstein Becker Green, discussed the challenges clinical research teams face […]

Image Credit: Adobe Stock Images/Robin Key Takeaways Gefurulimab shows promise in generalized myasthenia gravis (gMG) treatment: Phase III PREVAIL trial results demonstrate statistically significant and […]

Image Credit: © JHVEPhoto – stock.adobe.com Key takeaways Expect heightened scrutiny of trial design: Recent CRLs underscore that even previously aligned study protocols can be […]

Image Credit: Adobe Stock Images/Bungon Key Takeaways Obefazimod delivers statistically significant clinical remission in Ulcerative Colitis (UC): The 50 mg oral dose met the primary […]

Image Credit: © peterschreiber.media – stock.adobe.com Key takeaways The ALIENTO Phase IIb study met its primary endpoint, demonstrating a 15.4% reduction in annualized exacerbation rate […]

Image Credit: © JHVEPhoto – stock.adobe.com Key takeaways FDA’s internal AI assistant, Elsa, has experienced accuracy issues, including generating false citations and data hallucinations. While […]

Image Credit: Adobe Stock Images/Markus Key Takeaways FDA cites trial design concerns in Complete Response Letter (CRL) to Replimune: The agency rejected the RP1 Biologics […]

In a recent video interview with Applied Clinical Trials, Kate Gallin, Heffernan, life sciences attorney, Epstein Becker Green, discussed the challenges clinical research teams face […]

In an interview with Applied Clinical Trials, Shipra Patel, global therapeutic area section head for endocrinology and global head of pediatrics at Parexel, discussed the evolving […]

Image Credit: © Pixel-Shot – stock.adobe.com Key takeaways The MR-139 blepharitis trial missed its primary endpoint, prompting reevaluation of future study plans. Positive outcomes from […]

Image Credit: Adobe Stock Images/Jorm Sangsorn Key Takeaways Online recruitment boosts trial efficiency and diversity: Social media platforms such as Instagram and Facebook enabled faster […]

In an interview with Applied Clinical Trials, Shipra Patel, global therapeutic area section head for endocrinology and global head of pediatrics at Parexel, discussed the […]

Image Crddit: © yanapopovaiv – stock.adobe.com Key takeaways The Phase III CARES program evaluating anselamimab did not meet its primary endpoint in the overall population […]

In a recent video interview with Applied Clinical Trials, Ramita Tandon, chief biopharma officer, Walgreens, discussed the company’s three-year milestone of leading clinical trials. Tandon […]

In an interview with Applied Clinical Trials, Shipra Patel, global therapeutic area section head for endocrinology and global head of pediatrics at Parexel, discussed the […]

Image Credit: Adobe Stock Images/Khella Key Takeaways ODAC vote raises safety concerns over Blenrep combinations: FDA advisory panel cited significant ocular adverse events and voted […]

Image Credit: © Ezume Images – stock.adobe.com Key takeaways 89% of eligible participants in the VOLITION trial chose to switch from daily oral treatment to […]

Image Credit: Adobe Stock Images/Nurillo Key Takeaways Twice-yearly pre-exposure prophylaxis (PrEP) shows strong efficacy: Yeztugo prevented HIV infections in pregnant women and young people across […]

In a recent video interview with Applied Clinical Trials, Ramita Tandon, chief biopharma officer, Walgreens, discussed the company’s three-year milestone of leading clinical trials. Tandon […]

Image Credit: © stockdevil – stock.adobe.com Key takeaways Interim analysis from the randomized Phase IIb SURVIVE trial supports continued evaluation of SurVaxM in newly diagnosed […]

In an interview with Applied Clinical Trials, Shipra Patel, global therapeutic area section head for endocrinology and global head of pediatrics at Parexel, discussed the […]

Image Credit: © cacaroot – stock.adobe.com Key takeaways Phase II data show avexitide significantly reduces Level 2 and 3 hypoglycemic events in patients with post-bariatric […]

In a recent video interview with Applied Clinical Trials, Ramita Tandon, chief biopharma officer, Walgreens, discussed the company’s three-year milestone of leading clinical trials. Tandon […]

Image Credit: © Ezume Images – stock.adobe.com Key takeaways Merck has launched the Phase III EXPrESSIVE program to evaluate MK-8527, a once-monthly oral PrEP candidate, […]

Credit: steph photographies | stock.adobe.com Key Takeaways Perioperative Immunotherapy Boosts EFS. The KEYNOTE-689 trial demonstrated that adding neoadjuvant and adjuvant Keytruda to standard-of-care (SOC) radiotherapy […]

Image Credit: © Proxima Studio – stock.adobe.com Key takeaways Once-weekly efsitora may streamline insulin initiation for insulin-naïve type 2 diabetes patients, with comparable glycemic control […]

Image Credit: Adobe Stock Images/MohammedElAmine Key Takeaways Xtandi plus leuprolide significantly improves overall survival: In patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) and high-risk biochemical […]

Image Credit: © Matthieu – stock.adobe.com Key takeaways Orphan drug designation for quemliclustat highlights regulatory momentum and unmet need in pancreatic cancer treatment development. PRISM-1 […]

Image Credit: Adobe Stock Images/Tada Images Key Takeaways FDA publishes over 200 complete response letters (CRLs): The agency released CRLs from 2020 to 2024 to […]

Gaurav Bhatnagar, Chief Growth Officer, Tilda Research In an era where artificial intelligence (AI) writes poetry, self-driving cars navigate complex city streets, and algorithms predict […]

In a recent video interview with Applied Clinical Trials, Heather Horville, solutions consultant, Greenphire, discussed the challenges of retention and trial timelines due to increasing […]

Image Credit: © Dr_Microbe – stock.adobe.com Key takeaways Large-Scale, Multinational Trial Design: The P304 study enrolled over 40,000 participants across 11 countries, showcasing the complexity […]

In a recent video interview with Applied Clinical Trials, Heather Horville, solutions consultant, Greenphire, discussed the challenges of retention and trial timelines due to increasing […]

Image Credit: © Aerial Mike – stock.adobe.com Key takeaways Long-term ENLIVEN data reinforce the value of extended follow-up in rare disease trials, especially for demonstrating […]

In a recent video interview with Applied Clinical Trials, Heather Horville, solutions consultant, Greenphire, discussed the challenges of retention and trial timelines due to increasing […]

Christine Senn, PhD, FACRP is the SVP of Site-Sponsor Innovation at Advarra Key takeaways Modernize processes for site-initiated ads: Sponsors and CROs must establish clear, […]

In a recent video interview with Applied Clinical Trials, Heather Horville, solutions consultant, Greenphire, discussed the challenges of retention and trial timelines due to increasing […]

Credit: magicmine | stock.adobe.com Key takeaways The expanded FDA approval of Farapulse introduces a non-thermal ablation option for persistent AF, potentially shifting treatment pathways and […]

Credit: New Africa | stock.adobe.com Key Takeaways Up to 20% Weight Loss Achieved with Monthly Dosing. MariTide demonstrated mean weight reductions of up to 20% […]

With the EMA adopting ICH E6(R3) in July, sponsors with EU trial operations must now meet stricter regulations that directly impact sample management; this demands […]

In a recent video interview with Applied Clinical Trials, Judith Ng-Cashin, MD, chief medical officer, Novotech discussed the company’s recent accomplishment of winning the Citeline […]

Credit: Crystal light | stock.adobe.com Key Takeaways First Phase III Trial for Felzartamab in PMN: Biogen has initiated dosing in the global PROMINENT study, evaluating […]

Image Credit: © rost9 – stock.adobe.com Key takeaways Rare disease trial design requires careful structuring: The GEMZ trial’s two-part, multi-phase design highlights the complexity of […]

Credit: Daniel Krasoń | stock.adobe.com. Key Takeaways Unprecedented Weight Loss Outcomes. In the REDEFINE 1 trial, 60% of participants receiving once-weekly CagriSema (cagrilintide–semaglutide) achieved at […]

Credit: samunella | stock.adobe.com Key takeaways Early trial termination for efficacy signals strong clinical benefit: The ZENITH trial was halted ahead of schedule due to […]

Image Credit: © putilov_denis – stock.adobe.com Key takeaways Automation must evolve into intelligence: Traditional automation has reached its limits—future-ready trials require self-adjusting, data-driven systems that […]

In a recent video interview with Applied Clinical Trials, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts on underrepresented populations in medical […]

Image Credit: Adobe Stock Images/mi_viri Key Takeaways Bemarituzumab Shows Survival Benefit: The Phase III FORTITUDE-101 trial met its primary endpoint, with bemarituzumab plus chemotherapy significantly […]

In a recent video interview with Applied Clinical Trials, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts on underrepresented populations in medical […]

Image Credit: © photon_photo – stock.adobe.com Key takeaways Clinical trial populations often don’t reflect the diversity or complexity of real-world patients, particularly in community care […]

In a recent video interview with Applied Clinical Trials, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts on underrepresented populations in medical […]

In a recent video interview with Applied Clinical Trials, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts on underrepresented populations in medical […]

April 30th 2025 Article We are amidst a data revolution in healthcare and the life sciences. With advances in DNA sequencing, multiomics, wearables, imaging, and […]

April 30th 2025 Article We are amidst a data revolution in healthcare and the life sciences. With advances in DNA sequencing, multiomics, wearables, imaging, and […]

April 30th 2025 Article We are amidst a data revolution in healthcare and the life sciences. With advances in DNA sequencing, multiomics, wearables, imaging, and […]

Credit: Sebastian Kaulitzki | stock.adobe.com Key Takeaways Missed Primary Endpoint at 36 Weeks. Efruxifermin did not significantly reduce fibrosis without worsening of MASH at week […]

Credit: David A Litman | stock.adobe.com. Key Takeaways High Overall Response Rate. Talvey and Tecvayli combination achieved a 78.9% overall response rate in patients with […]

Shadi Cinpinski, MHA, Director, Therapeutic Strategy, Oncology, IQVIA Jim Routt, Vice President and Unit Head, Oncology Global Therapeutic Delivery, IQVIA Jennifer Underwood, MSc, Senior Director, […]

In a recent video interview with Applied Clinical Trials, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts on underrepresented populations in medical […]

Image Credit: © Design Cells – stock.adobe.com Key takeaways Strong Prophylactic Efficacy: Hympavzi achieved a 93% reduction in annualized bleeding rate versus on-demand treatment in […]

Key takeaways Data and AI are redefining clinical trial operations, requiring end-to-end data strategies, trustworthy AI frameworks, and a shift toward data-centric approaches aligned with […]

Credit: Key design | stock.adobe.com. Higher-Dose Semaglutide Shows Enhanced Efficacy Key Takeaways Higher-Dose Semaglutide Shows Enhanced Efficacy. The investigational 7.2 mg dose of Wegovy (semaglutide) […]

In an interview with Applied Clinical Trials, Brian Ongioni, chief product officer, uMotif, discussed how the company actively incorporates patient and site feedback throughout the […]

Image Credit: © putilov_denis – stock.adobe.com Key takeaways Tokenization enhances real-world evidence integration: Tokenization enables researchers to securely link clinical trial data with real-world data […]

In an interview with Applied Clinical Trials, Brian Ongioni, chief product officer, uMotif, discussed how the company actively incorporates patient and site feedback throughout the […]

Eric Karofsky is an award-winning CX, UX, and employee engagement industry expert who leads VectorHX, a human experience agency. Key Takeaways Human-Centered AI Design Drives […]

In an interview with Applied Clinical Trials, Brian Ongioni, chief product officer, uMotif, discussed how the company actively incorporates patient and site feedback throughout the […]

Credit: Tada Images | stock.adobe.com Key Takeaways FDA fast-tracks reviews for priority drugs: The new Commissioner’s National Priority Voucher (CNPV) program reduces review times from […]

Credit: Lisa | stock.adobe.com Key Takeaways Breyanzi Achieves High Overall Response Rate in R/R MZL. In the Phase II TRANSCEND FL trial, Breyanzi demonstrated a 95.5% […]

At the DIA Annual Meeting, Peter Ronco, CEO, Emmes, emphasized the under-recognized but impactful role of the public sector—particularly the NIH and FDA—in advancing tech-enabled […]

Credit: steph photographies | stock.adobe.com Key Takeaways Elinzanetant Significantly Reduces Vasomotor Symptoms. Patients receiving elinzanetant experienced a statistically significant reduction in moderate-to-severe vasomotor symptoms at […]

In a recent video interview with Applied Clinical Trials, Judith Ng-Cashin, MD, chief medical officer, Novotech discussed the company’s recent accomplishment of winning the Citeline […]

In a recent video interview with Applied Clinical Trials, Judith Ng-Cashin, MD, chief medical officer, Novotech discussed the company’s recent accomplishment of winning the Citeline […]

At the DIA Annual Meeting, Peter Ronco, CEO, Emmes, emphasized the underrecognized but impactful role of the public sector—particularly the NIH and FDA—in advancing tech-enabled […]

At the DIA Annual Meeting, Peter Ronco, CEO, Emmes, emphasized the underrecognized but impactful role of the public sector—particularly the NIH and FDA—in advancing tech-enabled […]

In an interview with Applied Clinical Trials, Brian Ongioni, chief product officer, uMotif, discussed how the company actively incorporates patient and site feedback throughout the […]

ACT: Looking back on the first half of the year, what are some achievements or advancements from the industry that have excited you most? Is […]

At the DIA Annual Meeting, Peter Ronco, CEO, Emmes, emphasized the underrecognized but impactful role of the public sector—particularly the NIH and FDA—in advancing tech-enabled […]

ACT: What are some of the most exciting themes or trends in clinical research you’re looking to explore at this year’s Global Annual Meeting? Pierce: […]

Image Credit: Andy Studna Key takeaways Global regulatory collaboration is strengthening to ensure faster, safer delivery of innovative therapies worldwide, with an emphasis on mutual […]

In a recent video interview with Applied Clinical Trials, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), discussed the current […]

Hugo Stephenson, MD, Co-Founder and Executive Chair, TrialScreen Key Takeaways Eligibility ≠ participation. While many users meet trial eligibility criteria, a significant drop-off occurs when […]

In a recent video interview with Applied Clinical Trials, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), discussed the current […]

Credit: Andrii | stock.adobe.com Key Takeaways Sotyktu Meets Primary Endpoint in POETYK PsA-1 Trial. In the Phase III POETYK PsA-1 trial, 54.2% of patients receiving […]

Allison Cuff Shimooka, Chief Operating Officer, TransCelerate BioPharma Key Takeaways Clinical trial processes lag behind scientific and technological advances. While the science and tools exist […]

Rebecca Johnson, PhD, Clinical Research Recruitment and Inclusion Executive and Strategist Key Takeaways Progress toward inclusive trials without mandates. Even before federal mandates such as […]

Image Credit: © Murrstock – stock.adobe.com “Identifying … potential data manipulation and data integrity problems” are an International Council for Harmonization of Technical Requirements for […]

Over the last half a century or so, clinical research has progressively shifted from a somewhat paternalistic focus on physiological or surrogate endpoints such as […]

Ken Getz, MBA, Executive Director and Research Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine Key Takeaways AI/ML adoption in […]

Graham Bell Director, Global Regulatory Strategy, ICON plc Key Takeaways Joint Clinical Assessment is now a parallel requirement under HTAR.Health technology developers must prepare for […]

Image Credit: © LASZLO – stock.adobe.com Key takeaways Phase III Trial Explores Enhertu Combo in Endometrial Cancer: DESTINY-Endometrial01 is assessing Enhertu with rilvegostomig or Keytruda […]

Credit: Dr_Microbe | stock.adobe.com Key Takeaways Imdelltra Outperforms Chemotherapy in SCLC. In the Phase III DeLLphi-304 trial, Imdelltra (tarlatamab) significantly improved overall survival (13.6 months […]

Credit: Crystal light | stock.adobe.com Key Takeaways Early Combination Therapy Achieves Superior UACR Reduction. Simultaneous initiation of Kerendia (finerenone) and Jardiance (empagliflozin) led to a […]

Image Credit: © putilov_denis – stock.adobe.com Key takeaways Transparent FMV practices are critical: Open and collaborative FMV calculations help build trust and reduce negotiation friction […]

Credit: Crystal light | stock.adobe.com. Key Takeaways First Immunotherapy to Achieve Statistically Significant EFS in Resectable Gastric and GEJ Cancers. Imfinzi (durvalumab) combined with FLOT […]

In a recent video interview with Applied Clinical Trials, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discussed the Trump Administration’s ‘Most Favored […]

Join us for an insightful session IQVIA experts Anthony Mikulaschek and Michael Bruhns will share their experience on harnessing the power of eCOA and digital […]

In a recent video interview with Applied Clinical Trials, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discussed the Trump Administration’s ‘Most Favored […]

Credit: Saiful52 | stock.adobe.com Key Takeaways On-body delivery system (OBDS) proves non-inferior to IV Sarclisa in multiple myeloma treatment. Data from the Phase III IRAKLIA […]

Image Credit: © Crystal light – stock.adobe.com Key takeaways Promising interim results support APRIL inhibition as a viable IgAN strategy: Sibeprenlimab achieved a 51.2% reduction […]

Image Credit: © photon_photo – stock.adobe.com Key takeaways Early regulatory engagement prevents delays: Proactively managing protocol amendments and aligning with regulatory authorities in advance can […]

Image Credit: Adobe Stock Images/freshidea Key Takeaways Carvykti Delivers Long-Term Remission: One-third of patients in the CARTITUDE-1 trial achieved at least five years of treatment-free […]

Image Credit: © Tada Images – stock.adobe.com Key takeaways HHS has pulled a $590M grant from Moderna’s H5N1 mRNA flu vaccine, citing scientific and ethical […]

In a recent video interview with Applied Clinical Trials, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discussed the Trump Administration’s ‘Most Favored […]

Image Credit: © iDoPixBox – stock.adobe.com Key takeaways Tecentriq plus Zepzelca significantly improved both PFS and OS in ES-SCLC maintenance therapy versus Tecentriq alone. IMforte’s […]

Credit: Sebastian Kaulitzki | stock.adobe.com Key Takeaways First-Line Survival Milestone in BRAF V600E mCRCThe Braftovi (encorafenib) combination regimen is the first to show a statistically […]

Image Credit: © Crystal light – stock.adobe.com Key takeaways Enhertu plus pertuzumab showed a 44% reduction in disease progression or death versus the current standard-of-care […]

In a recent video interview with Applied Clinical Trials, Ron Lanton, partner, Lanton Law, discussed the impact of drug cost increases on clinical research, predicting […]

Introduction Paper-based data capture has been the standard in clinical trials since their inception. In the 1990s, the FDA kicked off the digital era in […]

Image Credit: © Sebastian Kaulitzki – stock.adobe.com Key takeaways BLA withdrawn due to lack of OS benefit: The Phase III HERTHENA-Lung02 trial failed to meet […]

In a recent video interview with Applied Clinical Trials, Ron Lanton, partner, Lanton Law, discussed the impact of drug cost increases on clinical research, predicting […]

Image Credit: © Dr_Microbe – stock.adobe.com Key takeaways Early-phase trial design should anticipate combination therapy pathways, as seen with MK-1084 across multiple arms. Safety and […]

© photon_photo – © photon_photo – stock.adobe.com. Key takeaways AI and tech expertise are becoming core clin ops requirements: Success increasingly depends on integrating AI, […]

Jennifer Ross, director of biostatistics, and Kevin Venner, group leader, biostatisticians; both with Almac Clinical Technologies Developing a clinical trial’s effective monitoring plan can be […]

Image Credit: © Aerial Mike – stock.adobe.com Key takeaways Strong ORR validates trial design and execution: The trial achieved a 54% objective response rate vs. […]

Image Credit: © Crystal light – stock.adobe.com Key takeaways Trodelvy achieves primary endpoint in first-line mTNBC: The ASCENT-03 Phase III trial demonstrated a statistically significant […]

Image Credit: © Dr_Microbe – stock.adobe.com Key takeaways Quality of life metrics matter in mCSPC trials: Post-hoc ARANOTE data shows that Nubeqa + ADT significantly […]

In a recent video interview with Applied Clinical Trials, Michel van Harten, MD, CEO, myTomorrows, discussed the integration of artificial intelligence (AI) in clinical trials, […]

Don’t miss IQVIA Technologies’ webinar on clinical trial budgeting. Gain insights into effective budget-building techniques and explore how IQVIA GrantPlan can help you finalize budgets […]

Credit: Johannes | stock.adobe.com Key Takeaways Phase III IDeate-Esophageal01 Trial LaunchesMerck and Daiichi Sankyo have initiated a global, multicenter Phase III trial evaluating ifinatamab deruxtecan […]

Credit: Sebastian Kaulitzki | stock.adobe.com Key Takeaways from the BATURA Trial Airsupra Reduces Severe Exacerbations by 47%In the Phase IIIb BATURA trial, Airsupra (albuterol/budesonide) significantly […]