Full Phase IIIb BATURA Trial Results Show Airsupra Cuts Severe Exacerbations by 47% in Mild Asthma
Credit: Sebastian Kaulitzki | stock.adobe.com Key Takeaways from the BATURA Trial Airsupra Reduces Severe Exacerbations by 47%In the Phase IIIb…
Category: Medicine
Nerandomilast Meets Primary Endpoints in Phase III IPF and PPF Trials, Shows Significant Lung Function Preservation
Credit: mi_viri | stock.adobe.com Key Takeaways: Nerandomilast Phase III Trial Data Nerandomilast Demonstrates Statistically Significant FVC Preservation in IPF and…
The Role of AI in Solving Clinical Trial Diversity and Access Challenges
In a recent video interview with Applied Clinical Trials, Michel van Harten, MD, CEO, myTomorrows, discussed the integration of artificial…
ARCHES and ENZAMET Trials Confirm Long-Term Xtandi Efficacy in Metastatic Hormone-Sensitive Prostate Cancer
Credit: Dr_Microbe | stock.adobe.com. Key Takeaways: Xtandi in mHSPC Long-Term Survival Confirmed. Five-year results from the Phase III ARCHES trial…
Harnessing Technology and Adopting Unified Approaches to Optimize Pharmacovigilance Activities
Image Credit: © NicoElNino – stock.adobe.com Key takeaways Digital intake must be the default to ensure quality and efficiency: Prioritizing…
How AI Lowers the Real-World Barriers to Trial Participation
In a recent video interview with Applied Clinical Trials, Michel van Harten, MD, CEO, myTomorrows, discussed the integration of artificial…
Roche’s Susvimo Lands FDA Approval for Diabetic Retinopathy Based on Phase III Pavilion Trial Data
Image Credit: © Pixel-Shot – stock.adobe.com Key takeaways Susvimo sets a new standard for long-acting ophthalmic treatments: With FDA approval…
FDA Panel Votes Against Columvi-GemOx sBLA for R/R DLBCL Over Regional Data Concerns from STARGLO Trial
Credit: Araki Illustrations | stock.adobe.com Key Takeaways FDA Panel Votes Against Columvi-GemOx sBLAThe FDA’s Oncologic Drugs Advisory Committee (ODAC) declined…
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
Image Credit: © JHVEPhoto – stock.adobe.com Key takeaways Placebo-controlled trials now required for low-risk groups: FDA will require placebo-controlled trials…
Bridging Innovation and Trust with Artificial Intelligence
In a recent video interview with Applied Clinical Trials, Michel van Harten, MD, CEO, myTomorrows, discussed the integration of artificial…
The Road to Simpler and Better Trials
Image Credit: © photon_photo – stock.adobe.com Key takeaways Simplify with purpose: prioritize what adds value: Modern trials are overloaded with…
Monitoring NIH Funding Cuts
In a recent video interview with Applied Clinical Trials, Michael Liu, medical student and researcher at Harvard Medical School, discussed…
Advancing Patient Engagement in Community-Based Oncology Research
Image Credit: © putilov_denis – stock.adobe.com Key Takeaways Community trials drive access and diversity: Embedding clinical trials in local oncology…
A Disruption in the Clinical Research Enterprise
In a recent video interview with Applied Clinical Trials, Michael Liu, medical student and researcher at Harvard Medical School, discussed…
KEYNOTE-B96 Trial Shows Keytruda is First Immunotherapy to Improve Overall Survival in Platinum-Resistant Ovarian Cancer
Credit: MohammedElAmine | stock.adobe.com Key Takeaways from the Phase III KEYNOTE-B96/ENGOT-ov65 Trial Keytruda Shows First OS Benefit in Ovarian Cancer:…
How NIH Funding Cuts are Affecting Academic Research
In a recent video interview with Applied Clinical Trials, Michael Liu, medical student and researcher at Harvard Medical School, discussed…
Oveporexton Shows Superior Efficacy in Phase II Narcolepsy Type 1 Trial Without Hepatotoxicity
Credit: GoodIdeas | stock.adobe.com Key Takeaways of the TAK-861-2001 Trial Clinically Meaningful Efficacy: In the Phase II TAK-861-2001 trial, oveporexton…
Phase II Data Land Merck’s Welireg FDA Approval for Advanced, Unresectable, or Metastatic Pheochromocytoma or Paraganglioma
Image Credit: © JHVEPhoto – stock.adobe.com Key takeaways 1. Regulatory milestone for rare tumors: Merck’s Welireg received FDA approval for…
FDA Grants Accelerated Approval to AbbVie’s Emrelis for the Treatment of NSCLC Based on Phase II Trial Results
Credit: Sebastian Kaulitzki | stock.adobe.com Key takeaways 1. Accelerated approval based on Phase II data: Emrelis received FDA accelerated approval…
A Closer Look at NIH Grant Terminations
In a recent video interview with Applied Clinical Trials, Michael Liu, medical student and researcher at Harvard Medical School, discussed…
3 Perspectives on Medical Research Funding Cuts
The calendar year of 2025 has brought many new challenges to the clinical research industry. Earlier in the year, several…
Novo Nordisk’s Sogroya Demonstrates Favorable Outcomes in Phase III Trial for Children’s Growth Disorders
Image Credit: © photon_photo – stock.adobe.com Novo Nordisk has shared positive trial results from the Phase III REAL8 basket study…
APHINITY Trial Shows Perjeta-Based Regimen Improves 10-Year Overall Survival in HER2-Positive Early Breast Cancer
Credit: David A Litman | stock.adobe.com Long-term overall survival (OS) data from the Phase III APHINITY trial (NCT01358877) show a…
3 Common eCOA Implementation Challenges and How to Solve Them
Image Credit: © putilov_denis – stock.adobe.com eCOA (electronic clinical outcome assessment) systems have become essential in modern clinical trials, offering…
Public Perception of Clinical Research Amidst Policy Changes
In a recent video interview with Applied Clinical Trials, Krinx Kong, chief commercial officer, Cognivia, discussed the potential impacts of…
Four Strategic Considerations to Choose an EDC
Image Credit: © putilov_denis – stock.adobe.com The role of electronic data capture (EDC) systems in clinical trials looks very different…
DESTINY-Breast11 Trial Shows Enhertu Plus THP Significantly Improves Response Rates in High-Risk HER2-Positive Early Breast Cancer
Credit: Valerii Apetroaiei | stock.adobe.com Topline results from the Phase III DESTINY-Breast11 trial (NCT05113251) show that Enhertu (trastuzumab deruxtecan; AstraZeneca…
Iqirvo Shows Significant Fatigue Improvement in Patients with Primary Biliary Cholangitis After 52 Weeks in Phase III ELATIVE Trial
Credit: syahrir | stock.adobe.com Updated data from the pivotal Phase III ELATIVE trial (NCT04526665) show Iqirvo (elafibranor) significantly improved fatigue…
The Potential for Stricter Regulations in Vaccine Trials
In a recent video interview with Applied Clinical Trials, Krinx Kong, chief commercial officer, Cognivia, discussed the potential impacts of…
Imfinzi Regimen Demonstrates Positive, Meaningful Outcomes in Phase III Bladder Cancer Trial
Image Credit: © Matthieu – stock.adobe.com AstraZeneca has shared positive results from its Phase III POTOMAC trial of Imfinzi (durvalumab)…
Linerixibat Demonstrates Statistically Significant Reduction in Pruritus in Phase III GLISTEN Trial for PBC
Credit: Yurii Kibalnik | stock.adobe.com Top-line results from the Phase III GLISTEN trial (NCT04950127) show that the novel therapy linerixibat…
How Vaccine Trials Could be Affected by Potential Policy Changes
In a recent video interview with Applied Clinical Trials, Krinx Kong, chief commercial officer, Cognivia, discussed the potential impacts of…
Boehringer Announces Start of Phase II Geographic Atrophy Trial of Potential First-in-Class Therapy
Image Credit: © Pixel-Shot – stock.adobe.com Boehringer Ingelheim has announced the start of the JADE Phase II clinical trial (NCT06769048),…
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
Image Credit: © photon_photo – stock.adobe.com Gilead has announced final data from its Phase III MYR301 clinical trial of bulevirtide…
Unifying Industry to Better Understand GCP Guidance
David Nickerson, head of clinical quality management at EMD Serono, executive sponsor of TransCelerate’s ICH E6(R3) Initiative & PhRMA topic…
Phase III MUSA Trial Finds Similar Six-Month Outcomes Between Botox, Midurethral Sling in Patients with Mixed Urinary Incontinence
Credit: ibreakstock | stock.adobe.com Results from the Phase III MUSA trial show that in women with moderate to severe mixed…
Nanobiotix Shares Positive Data from MD Anderson-Led Phase I Study in Pancreatic Cancer
Image Credit: © Matthieu – stock.adobe.com Nanobiotix has announced full results from a Phase I study evaluating its novel therapy,…
QUASAR LTE Trial Shows Tremfya Produces Sustained Clinical, Endoscopic Remission Through 92 Weeks in Ulcerative Colitis
Credit: Sebastian Kaulitzki | stock.adobe.com Long-term extension (LTE) data from the Phase IIb/III QUASAR trial (NCT04033445) program show adult patients…
AstraZeneca’s Breztri Meets Primary Endpoints in Duo of Phase III Asthma Trials
Image Credit: © Sebastian Kaulitzki – stock.adobe.com AstraZeneca has announced positive results from the Phase III KALOS and LOGOS clinical…
Challenges in Bringing Effective Therapies to Cancer Patients
In a recent video interview with Applied Clinical Trials, C.K. Wang, MD, chief medical officer, COTA, discussed a recent study…
Unlock Commercial Growth through Data-Driven Patient and HCP Insights
Leveraging data-driven patient and healthcare provider (HCP) insights, including social drivers of health (SDOH), is essential for life sciences companies…
The Growing Roles of RWD and RWE in Oncology
In a recent video interview with Applied Clinical Trials, C.K. Wang, MD, chief medical officer, COTA, discussed a recent study…
Semaglutide Significantly Improves Steatohepatitis, Fibrosis in Phase III MASH Trial
Credit: Peter Hansen | stock.adobe.com Weekly semaglutide was found to significantly improve steatohepatitis and fibrosis while enhancing metabolic markers and…
Improving Clinical Trial Reporting with CONSORT 2025 Updates
Image Credit: © photon_photo – stock.adobe.com Clinical trials are responsible for generating some of the most important evidence in evaluating…
Unlock Commercial Growth through Data-Driven Patient and HCP Insights Podcast
Unlock Commercial Growth through Data-Driven Patient and HCP Insights Podcast
FDA Approves Satsuma’s STS101 Nasal Powder for Acute Migraine
Image Credit: © yodiyim – stock.adobe.com The FDA has approved Satsuma’s STS101 dihydroergotamine (DHE) nasal powder under the name of…
MATINEE Trial Shows Nucala Significantly Reduces COPD Exacerbations in Patients With Eosinophilic Inflammation on Triple Therapy
Credit: peterschreiber.media | stock.adobe.com Results of the Phase III MATINEE trial (NCT04133909) show that Nucala (mepolizumab) produced a significant reduction…
Phase III SELECT-GCA Trial Results Lead to FDA Approval of Rinvoq for Giant Cell Arteritis
Credit: Yurii Kibalnik | stock.adobe.com The FDA has approved AbbVie’s Rinvoq (upadacitinib) 15 mg once daily for the treatment of…
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
Image Credit: © JHVEPhoto – stock.adobe.com The FDA has approved Johnson & Johnson’s IMAAVY (nipocalimab-aahu) for the treatment of treatment…
New Zongertinib Data from Boehringer Shows Sustained, Clinically Meaningful Results in Advanced NSCLC Patients
Image Credit: © Sebastian Kaulitzki – stock.adobe.com Boehringer Ingelheim has shared new data from the Phase Ib Beamion LUNG-1 clinical…
Johnson & Johnson’s TAR-200 for Bladder Cancer Shows High Rates of Disease-Free Survival, Bladder Preservation
Credit: Sebastian Kaulitzki | stock.adobe.com Early interim data from cohort 4 of the Phase IIb SunRISe-1 trial (NCT04640623) evaluating the…
Pivotal Phase III Trial Data Show Pfizer’s Sasanlimab with BCG Significantly Improves Event-Free Survival in Bladder Cancer
Image Credit: © Matthieu – stock.adobe.com Pfizer has shared new data from the Phase III CREST clinical trial of sasanlimab…
Landmark Phase III Trial Shows Keytruda Significantly Improves Event-Free Survival in LA-HNSCC
Credit: Lars Neumann | stock.adobe.com Interim data from the Phase III KEYNOTE-689 trial (NCT03765918) show that perioperative treatment with Keytruda…
Elevated Kitting Strategies for Clinical Trials
Industry experts from Precision for Medicine will share practical strategies for navigating the complexities of sample management in early-phase trials.…
Bridging the Gap Between Legacy Measures and Contemporary Healthcare
Image Credit: © photon_photo – stock.adobe.com Patient-reported outcomes (PROs) have long served as an essential tool for understanding how patients…
Understanding the True Meaning of Risk in Clinical Trial Operations
In a recent video interview with Applied Clinical Trials, Rob Jones, product manager, TMF practice area, Pharmalex, discussed challenges in…
The Importance of Clinical Trial Oversight when Outsourcing
In a recent video interview with Applied Clinical Trials, Rob Jones, product manager, TMF practice area, Pharmalex, discussed challenges in…
Phase III Trial Data Show Roche’s Xofluza Significantly Reduces Flu Transmission
Image Credit: © Dr_Microbe – stock.adobe.com Roche has shared additional findings from the Phase III CENTERSTONE clinical trial of Xofluza…
Phase II Advance-HTN Trial Shows Lorundrostat Significantly Lowers Blood Pressure in Treatment-Resistant Hypertension
Credit: Andrey Popov | stock.adobe.com Findings from the 12-week Phase II Advance-HTN trial (NCT05769608) show that lorundrostat significantly lowered systolic blood…
Embracing Risk-Based Approaches with Clinical Trial Oversight
In a recent video interview with Applied Clinical Trials, Rob Jones, product manager, TMF practice area, Pharmalex, discussed challenges in…
Phase III ASPEN Trial Shows Brensocatib Reduces Exacerbations, Lung Function Decline in Bronchiectasis
Credit: Thipphaphone | stock.adobe.com Brensocatib was found to significantly lower the annualized rate of pulmonary exacerbations and lung function decline…
Cobenfy Falls Short of Statistical Significance as Additional Treatment for Schizophrenia in Phase III Clinical Trial
Image Credit: © freshidea – stock.adobe.com Bristol Myers Squibb has shared results from its Phase III ARISE trial evaluating Cobenfy…
Rinvoq Shows Superior Remission Rates in Giant-Cell Arteritis With Reduced Steroid Use, Phase III Trial Finds
Credit: Yurii Kibalnik | stock.adobe.com A regimen of Rinvoq (upadacitinib) with a 26-week glucocorticoid taper showed superior efficacy in producing…
A Roadmap for the Use of Artificial Intelligence in Managing Trial Master Files
In a recent video interview with Applied Clinical Trials, Rob Jones, product manager, TMF practice area, Pharmalex, discussed challenges in…
Tolebrutinib Falls Short of Superiority vs. Aubagio Treating Relapsing Multiple Sclerosis in GEMINI Trials
Credit: freshidea | stock.adobe.com Data from the Phase III GEMINI 1 (NCT04410978) and GEMINI 2 trials (NCT04410991) show that compared to…
DESTINY-Breast09 Trial Shows Enhertu Plus Perjeta Significantly Improves Survival in HER2-Positive Metastatic Breast Cancer
Credit: Sebastian Kaulitzki | stock.adobe.com Interim data from the Phase III DESTINY-Breast09 trial (NCT04784715) found that the combination of Enhertu…
Gilead’s Trodelvy Plus Keytruda Significantly Improves Progression-Free Survival in PD-L1-Positive Metastatic Triple-Negative Breast Cancer
Image Credit: Adobe Stock Images/Lars Neumann Topline findings from Gilead’s Phase III ASCENT-04/KEYNOTE-D19 study found that the combination of Trodelvy…
Bridging Data & Disparities: The Power of SDOH in the Life Sciences Industry
Bridging Data & Disparities: The Power of SDOH in the Life Sciences Industry
Bringing the Rare Disease Community Together
In a recent video interview with Applied Clinical Trials, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical…
Improving Relationships and Diversifying the Site Selection Process
In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number…
Leading the Technology and Innovation Front Through Rare Disease Research
In a recent video interview with Applied Clinical Trials, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical…
Alector Completes Enrollment for Phase II Trial of Investigational Alzheimer’s Disease Therapy
Image Credit: © Aerial Mike – stock.adobe.com Alector has announced the completion of enrollment for its Phase II clinical trial,…
Uplizna Shows Significant Efficacy, Safety Treating Generalized Myasthenia Gravis in Phase III MINT Trial
Credit: wutipong | stock.adobe.com Findings from the Phase III MINT clinical trial (NCT04524273) show that Uplizna (inebilizumab) produced significant short-term…
Eli Lilly’s Oral GLP-1, Orforglipron, Demonstrates Efficacy and Safety Consistent with Injectable GLP-1s in Phase III Trial
Image Credit: © Mnt – stock.adobe.com Eli Lilly has shared positive Phase III clinical trial data of its investigational, oral…
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
Credit: MarijaBazarova | stock.adobe.com Long-term safety and efficacy clinical trial data (NCT03307980) for patients with hemophilia B administered the recombinant…
Clinical Strategies to Optimize Software as a Medical Device to treat Mental Health
Devin Ridgley, PhD, Director, Project Management, Medical Device and Diagnostics Research, ICON JoAnne Bronikowski, BSCS, RAC, Senior Manager, Regulatory Affairs,…
DapaTAVI Trial Shows Farxiga Significantly Lowers Risk of Death After Transcatheter Aortic-Valve Implantation in Older Patients
Credit: blacksalmon | stock.adobe.com Results from the Phase IV DapaTAVI trial (NCT04696185) show that the addition of Farxiga (dapagliflozin) to…
Johnson & Johnson’s Icotrokinra Succeeds in Phase III Trial for Plaque Psoriasis in Adolescents
Credit: Milan Lipowski | stock.adobe.com Johnson & Johnson has shared positive data from a subgroup analysis of the Phase III…
Phase III HERCULES Trial Shows Tolebrutinib Significantly Slows Disability Progression in Non-Relapsing Secondary Progressive MS
Credit: ralwel | stock.adobe.com Findings from the Phase III HERCULES trial (NCT04411641) published by The New England Journal of Medicine…
Unique Challenges in Rare Disease Research
In a recent video interview with Applied Clinical Trials, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical…
Phase III EXPECTS Trial Finds Alteplase Boosts 90-Day Recovery in Posterior Circulation Stroke Patients
Credit: Iqbal | stock.adobe.com Findings from the Phase III EXPECTS clinical trial (NCT05429476) show that in patients experiencing a mostly…
Patient Centricity, Data Collection, and the Role of AI
February 13th 2025 Article Dr. Peter Wahl, MLA, MS, ScD, VP and Global Head of Scientific Affairs at CorEvitas, part…
Sustainability by Design
In a recent video interview with Applied Clinical Trials, Theirry Escudier, Portfolio Lead, Pistoia Alliance, discussed the alliance’s newest initiative…
Maintaining Regulatory Adherence with Clinical Technology
In a recent video interview with Applied Clinical Trials, Theirry Escudier, Portfolio Lead, Pistoia Alliance, discussed the alliance’s newest initiative…
What’s Next for DEI?
Amid new government directives around diversity, equity, and inclusion programs in the US, our April issue explores the pivots and…
April 2025 Interactive Digital Edition
Applied Clinical Trials: April 2025 Interactive Digital Edition The Impact of DEI Ban On Clinical Research Ecosystem Tapping the Patient…
The Impact of DEI Ban On Clinical Research Ecosystem
Rebecca Johnson, PhD, Clinical Research Recruitment and Inclusion Executive and Strategist Efforts to make sustainable change toward more inclusive clinical…
Tapping the Patient Voice as a Strategic Differentiator
Stacy Hurt, Chief Patient Officer, Parexel As a patient advocate and caregiver, I’m excited and bullish about the significant progress…
Benchmarking Risks Across Therapeutic Areas
Image Credit: © Murrstock – stock.adobe.com The monitoring of key risk indicators (KRIs) is an established form of risk control…
Scaling eSource-Enabled Clinical Trials: Hospital Perspectives
Oncology clinical trials are increasingly complex, driven by rising data volumes, regulatory requirements, and inefficiencies in manual data handling. Current…
The Hard Truth About Rare Disease and Gene Therapy Drug Development
Ken Getz, MBA, Executive Director and Research Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine…
What’s Next for Digital Patient Engagement?
Hugo Stephenson, MD, Co-Founder and Executive Chair, TrialScreen With 40% of young people now getting their news from platforms such…
What’s in it for Patients?
Digital measures offer new insights into human health but require complex, multi-stakeholder development. Are they worth the effort? Can they…
High-Dose Ocrevus Falls Short of Primary Endpoint in Relapsing Multiple Sclerosis Trial
Credit: ralwel | stock.adobe.com Roche has announced results from the Phase III MUSETTE clinical trial of high-dose Ocrevus (ocrelizumab) intravenous…
Topline Results from Phase IIIb APEX Trial Shows Efficacy of Tremfya for Active Psoriatic Arthritis
Credit: fusssergei | stock.adobe.com Findings from the Phase IIIb APEX trial (NCT04882098) found that Tremfya (guselkumab) produced a significant reduction…
Addressing Current Regulatory Challenges with Diversity in Clinical Trials
In a recent video interview with Applied Clinical Trials, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discussed the…
Resource Reallocation in Clinical Research
In a recent video interview with Applied Clinical Trials, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discussed the…
Industry’s Response to Recent Government Research Changes
In a recent video interview with Applied Clinical Trials, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discussed the…
Filling the Void for Clinical Research Leadership Amidst Political Headwinds
In a recent video interview with Applied Clinical Trials, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discussed the…
Areas of Focus for Clinical Operations Leaders in the Current Research Climate
In a recent video interview with Applied Clinical Trials, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discussed the…
Thermocool Smarttouch SF Catheter Demonstrates High Efficacy in Patients with Atrial Fibrillation
Image Credit: © ckybe – stock.adobe.com One-year data from the SmartfIRE trial show that Johnson & Johnson’s (J&J) dual energy…
What Does Racial Color-Blindness Mean for Clinical Trial Participation?
Image Credit: © Jakub Krechowicz – stock.adobe.com Healthcare research represents a frontier where new drugs, behavioral interventions, diagnostics, and screening…
SOUL Trial Shows Oral Semaglutide Significantly Reduces Cardiovascular Risk in Type 2 Diabetes
Credit: santoelia | stock.adobe.com Results from the Phase III SOUL trial (NCT03914326) published by The New England Journal of Medicine…
Palatin Announces Results from Phase II Obesity Study of MC4R Bremelanotide Plus GLP-1/GIP Tirzepatide
Image Credit: © Egor – stock.adobe.com Palatin has announced positive results from its BMT-801 Phase II clinical trial of co-administered…
API-CAT Trial Shows Reduced-Dose Eliquis Matches Full Dose in Preventing Venous Thromboembolism, Lowers Bleeding Risk in Cancer Patients
Credit: Artur | stock.adobe.com Findings from the Phase III API-CAT trial (NCT03692065) show that extended anticoagulant therapy with reduced-dose Eliquis…
Merck Shares Results from Phase III Clinical Trial of Winrevair in Pulmonary Arterial Hypertension
Image Credit: © photon_photo – stock.adobe.com Merck has announced positive results from the Phase III ZENITH clinical trial of Winrevair…
Novel PCSK9 Inhibitor Achieves Significant Reduction in LDL Cholesterol Levels in Phase IIb Trial
Credit: Rasi | stock.adobe.com Data from the Phase IIb PURSUIT trial (NCT06173570) found that AZD0780, a novel proprotein convertase subtilisin–kexin…
Phase III Trial Data Show Subcutaneous Pembrolizumab as Noninferior to IV Keytruda
Image Credit: © putilov_denis – stock.adobe.com Merck has shared data from the 3475A-D77 Phase III clinical trial of the subcutaneous…
Phase II ALPACA Trial Shows Lepodisiran Produces Significant, Sustained Lipoprotein(a) Reductions
Credit: Chudapa | stock.adobe.com Results from the Phase II ALPACA trial (NCT05565742) published by The New England Journal of Medicine…
Reliance on Traditional Research Methods
In a recent video interview with Applied Clinical Trials, Rachael Higgins, chief commercial officer, PicnicHealth, discussed the company’s recently released…
The Leap from Deterministic to AI-Powered Stochastic Methods
Credit: ra2 studio | stock.adobe.com Clinical data is the cornerstone of progress in high-stakes pharmaceutical research and development. This vital…
Executing with Clinical Technology
In a recent video interview with Applied Clinical Trials, Rachael Higgins, chief commercial officer, PicnicHealth, discussed the company’s recently released…
MITIGATE Trial Shows Uplizna Significantly Lowers Flare Risk, Glucocorticoid Dependence in IgG4-Related Disease
Credit: Naeblys | stock.adobe.com Findings from the Phase III MITIGATE trial (NCT04540497) show the efficacy of Uplizna (inebilizumab) in lowering…
FDA Approves Expanded Label of Novartis’ Prostate Cancer Treatment, Pluvicto
Image Credit: © Dr_Microbe – stock.adobe.com The FDA has approved Novartis’ radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for…
The Impact of Funding Cuts on Medical Research
In a recent video interview with Applied Clinical Trials, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discussed the…
Addressing Clinical Trial Challenges Through AI and Scalable Solutions
ACT: What advancements do you foresee for Medable AI and Medable Studio, and how might these innovations change the way…
FOCUS Trial Results Show Solriamfetol Significantly Reduces ADHD Symptoms, Severity in Adults
Credit: adrian_ilie825 | stock.adobe.com Findings from the Phase III FOCUS trial (NCT05972044) show solriamfetol produced a significant reduction in the…
Johnson & Johnson Releases New Data from Phase III MARIPOSA Trial of Rybrevant-Lazcluze Combination in Non-Small Cell Lung Cancer
Image Credit: © iDoPixBox – stock.adobe.com Johnson & Johnson has shared new, positive data from the Phase III MARIPOSA clinical…
Addressing Data and Patient Retention Challenges
In a recent video interview with Applied Clinical Trials, Rachael Higgins, chief commercial officer, PicnicHealth, discussed the company’s recently released…
Medable Eyes Expanded Presence in Europe with New Approval for Digital Trials
ACT: Medable has played a pivotal role in decentralized and digital clinical trials globally. How do you see the company…
Results of Phase III HERCULES, GEMINI 1 and 2 Trials Lead to FDA Priority Review for Tolebrutinib for Non-Relapsing Secondary Progressive MS
Credit: ralwel | stock.adobe.com Results from the Phase III HERCULES (NCT04411641) trial and Phase III GEMINI 1 (NCT04410978) and GEMINI…
Understanding Study Coordinator Work Quality
The quality of study coordinator work is important to investigative sites, study sponsors, CROs, regulators, and patients. Site quality management…
VERITAC-2 Trial Shows Vepdegestrant Significantly Improves Survival in ESR1-Mutant Breast Cancer
Credit: Axel Kock | stock.adobe.com Data from the Phase III VERITAC-2 trial (NCT05654623) found that vepdegestrant (ARV-471) monotherapy produced a…
The Role of Quality Data in Utilizing Machine Learning Models
In a recent video interview with Applied Clinical Trials, Cameron Breze, product manager, Inovalon, discussed challenges in patient recruitment for…
The Impact on Drug Discovery
Credit: bizoo_n | stock.adobe.com The New Normal Five years ago, COVID-19 was declared a global pandemic, marking the official onset…
Connecting the Right Patients to the Right Trial
February 13th 2025 Article Dr. Peter Wahl, MLA, MS, ScD, VP and Global Head of Scientific Affairs at CorEvitas, part…
Tecentriq Falls Short of Primary Endpoint in IMvoke010 Trial for Locally Advanced Head and Neck Cancer
Credit: urwa | stock.adobe.com Maintenance treatment with Tecentriq (atezolizumab) was not found to produce a significant improvement in event-free survival…
The Backbone of Innovation: High Quality Datasets
Paul Mancinelli, PhD, is the Chief Technology Officer of WCG In today’s rapidly evolving technological landscape, robust datasets have become…
Enhancing Patient Engagement and Data Accuracy in Decentralized Trials
ACT: Medable has achieved impressive results, such as 90% eCOA adherence. How do you ensure such high levels of participant…
Novartis Shares Positive Phase III Data for Spinal Muscular Atrophy Therapy
Image Credit: © Rochu_2008 – stock.adobe.com Novartis has announced positive results from its Phase III clinical trial program evaluating intrathecal…
Determining the Effectiveness of Decentralization Across Different Trials
In a recent video interview with Applied Clinical Trials, Cameron Breze, product manager, Inovalon, discussed challenges in patient recruitment for…
Immunovant’s Batoclimab Excels in Clinical Trials for Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy
Image Credit: Adobe Stock Images/Lila Patel Immunovant has shared positive results of its batoclimab in a Phase III clinical trial…
Phase III DIPPER Trial Shows Camrelizumab Boosts Event-Free Survival in Advanced Nasopharyngeal Carcinoma
Credit: Matthieu | stock.adobe.com Findings from the Phase III DIPPER trial (NCT03427827) published by JAMA show that adjuvant camrelizumab administered…
An Underrepresented Group in Clinical Trials
Kristin Tolbert, Associate VP of Health Equity Strategy at Jumo Health Pregnant women have long been excluded from clinical trials.…
Phase II DAHLIAS Trial Results Lead to Fast Track Designation for Nipocalimab for Sjögren’s Disease
Credit: Yurii Kibalnik | stock.adobe.com Based on data from the Phase II DAHLIAS (NCT04968912) trial, the FDA has granted Fast…
Genmab’s Rinatabart Sesutecan Continues Success in Advanced Ovarian Cancer Clinical Trials
Image Credit: © Dr_Microbe – stock.adobe.com Genmab has shared positive results from the Phase I/II RAINFOL-01 clinical trial showing that…
Integrated Multi-Omic Data: Powering Precision Medicine
Credit: Toowongsa | stock.adobe.com Precision medicine is poised to transform healthcare as we’ve known it, from the earliest R&D efforts…
POETYK PsA-2 Trial Shows Efficacy of Sotyktu as an Oral Therapy for Psoriatic Arthritis
Credit: Milan Lipowski | stock.adobe.com Findings from the Phase III POETYK PsA-2 trial (NCT04908189) show Sotyktu (deucravacitinib) produced a significant…
Pooled Clinical Trial Meta-Analysis Shows Superior Response Rates with Padcev Plus Keytruda Treating Metastatic Urothelial Carcinoma
Credit: Lisa | stock.adobe.com A meta-analysis of 11 randomized and nonrandomized clinical trials shows significant benefits with Padcev (enfortumab vedotin-ejfv)…
Phase I Trial Supports Development of Once-Yearly Lenacapavir as Long-Acting HIV PrEP Option
Credit: RAJCREATIONZS | stock.adobe.com Results from an ongoing Phase I trial have shown the potential of once-yearly intramuscular administration of…
Phase III Trial Finds Baricitinib Boosts Hair Regrowth in Adolescents With Severe Alopecia Areata
Credit: Alex Papp | stock.adobe.com Data from the Phase III BRAVE-AA-PEDS (NCT05723198) trial show that adolescents with severe alopecia areata (AA)…
Collaborative Strategies for Technology Integration in Clinical Studies
Image Credit: © putilov_denis – stock.adobe.com Digital technologies have significantly transformed the landscape of clinical trials, revolutionizing the way they…
Leading with the Patient Voice
In a recent video interview with Applied Clinical Trials, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced…
Doravirine/Islatravir Regimen Shows Promise in Multiple Phase III Trials for the Treatment of HIV
Image Credit: © Ezume Images – stock.adobe.com Merck has announced positive results from two Phase III clinical trials of the…
Streamlining Patient Recruitment with Technology
In a recent video interview with Applied Clinical Trials, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced…
Johnson & Johnson’s Icotrokinra Succeeds Across Multiple Trials in Moderate-to-Severe Plaque Psoriasis, Ulcerative Colitis
Image Credit: © Sebastian Kaulitzki – stock.adobe.com Johnson & Johnson has shared positive results from multiple clinical trials of icotrokinra…
Strategies to Improve Patient Engagement
In a recent video interview with Applied Clinical Trials, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced…
Aiming to Calculate, Accommodate, and Innovate for Enhanced Drug Development
Zahiah (Zee Zee) Gueddar, Senior Director, Commercialization, IQVIA Technologies Melissa Mooney, Director Solution Engineering, IQVIA Patient Suite, IQVIA Technologies Katie Shaw,…
Accelerating Drug Development with Faster Patient Enrollment
In a recent video interview with Applied Clinical Trials, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced…
It’s Time for the Life Sciences Industry to Accelerate Action for Gender Equality
Vicky Marriott, Head of Statistics at Phastar As we marked International Women’s Day on March 8, we all need to…
A New Era for Faster, Smarter Clinical Trials
Image Credit: © photon_photo – stock.adobe.com Obstacles for pharma, biotech, and CROs Contract research organizations (CROs), biotech companies, and pharmaceutical…
Phase III Data Show Efficacy of Tezspire Treating Chronic Rhinosinusitis with Nasal Polyps
Credit: Prostock-studio | stock.adobe.com Tezspire (tezepelumab-ekko; Amgen and AstraZeneca) was found to significantly decrease the size of nasal polyps while…
Analysis of KEYNOTE-A18 Trial Finds Keytruda is Not Cost-Effective at Current Prices
Credit: stas_malyarevsky | stock.adobe.com A cost-effectiveness analysis of results from the Phase III ENGOT-cx11/GOG-3407/KEYNOTE-A18 clinical trial (NCT04221945) found that the addition…
Phase III Trials Confirm Remibrutinib Effectively Reduces Chronic Spontaneous Urticaria Symptoms
Credit: ABUL | stock.adobe.com Findings from the Phase III REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) clinical trials show that remibrutinib reduces…
MATTERHORN Trial Shows Imfinzi Plus Chemotherapy Produces Significant Event-Free Survival Gains in Resectable Gastric & GEJ Cancer
Credit: Crystal light | stock.adobe.com Results from the Phase III MATTERHORN trial (NCT04592913) found that perioperative treatment with Imfinzi (durvalumab)…
Leveraging Technology for Efficient Trial Design
Image Credit: © putilov_denis – stock.adobe.com Clinical trials are becoming increasingly complex, with trial cycle times rising by over 30%…
Ensuring the Long-Term Effectiveness of Clinical Trials
In a recent video interview with Applied Clinical Trials, Iddo Peleg, CEO and co-founder at Yonalink, discussed the impact of…
Investigational Pain Therapy Cebranopadol Succeeds in Second Phase III Clinical Trial
Image Credit: © photon_photo – stock.adobe.com Tris Pharma has announced positive, topline results from its ALLEVIATE-2 Phase III clinical trial…
Opportunities Amidst Recent Research Policy Challenges
In a recent video interview with Applied Clinical Trials, Iddo Peleg, CEO and co-founder at Yonalink, discussed the impact of…
Increasing Clinical Trial Diversity with a Satellite Model
In a recent video interview with Applied Clinical Trials, Iddo Peleg, CEO and co-founder at Yonalink, discussed the impact of…
Legal and Political Implications of the NIH Funding Freeze
ACT: With some judges indicating that the NIH funding freeze may be illegal, are there grounds for the NIH to…
The Impact of NIH Funding Cuts and Diversity Bans on Research and Talent Retention
ACT: In addition to the NIH funding cuts, how do you see the clinical trials industry navigating other political challenges,…
Making Clinical Trials More Accessible in Light of Recent FDA, NIH Policy Changes
In a recent video interview with Applied Clinical Trials, Iddo Peleg, CEO and co-founder at Yonalink, discussed the impact of…
Adapting to Funding Shifts and Policy Challenges
ACT: What should stakeholders have top of mind as they find new ways to effectively navigate and continue medical research?…
Positive Results from CheckMate -8HW Trial Lead to Priority Review, Breakthrough Therapy Designation for Opdivo Plus Yervoy in MSI-H/dMMR Colorectal Cancer
Credit: Sebastian Kaulitzki | stock.adobe.com Positive findings from the ongoing Phase III CheckMate -8HW trial (NCT04008030) resulted in the FDA granting…
GEMSTONE-303 Trial Shows Sugemalimab Plus Chemotherapy Significantly Improves Survival in Advanced Gastric Cancer
Credit: David A Litman | stock.adobe.com Results from the Phase III GEMSTONE-303 trial (NCT03802591) show that sugemalimab combined with chemotherapy…
Three Ways AI is Revolutionizing Clinical Development
Image Credit: © Egor – stock.adobe.com Artificial intelligence (AI) is the biggest transformation in life sciences in the last 25…
PRESTIGE-AF Trial Shows DOACs Reduce Ischemic Stroke Risk in Intracerebral Hemorrhage Survivors, Heighten Bleeding Complications
Credit: magicmine | stock.adobe.com Results from the Phase III PRESTIGE-AF trial (NCT03996772) found that treatment with direct oral anticoagulants (DOACs)…
Opdualag Misses Primary Endpoint in Phase III RELATIVITY-098 Trial for Melanoma
Credit: Ocskay Mark | stock.adobe.com The Phase III RELATIVITY-098 trial (NCT05002569) of Opdualag (nivolumab and relatlimab-rmbw) in the adjuvant treatment…
AI and Digital Technology in Regulatory Submissions
Credit: Tierney | stock.adobe.com The pharmaceutical industry is making significant strides driven by digital innovation and artificial intelligence (AI). As…
Potential Updates to FDA’s Protocol Deviations Guidance
In a recent video interview with Applied Clinical Trials, Vera Pomerantseva, director of product management, RBQM, eClinical Solutions, discussed FDA’s…
NIH Partially Lifts Hold on Medical Funding
Image Credit: © Tada Images – stock.adobe.com The National Institutes of Health (NIH) has partially lifted a freeze on its…
Strategies for Embedding Protocol Flexibility
In a recent video interview with Applied Clinical Trials, Vera Pomerantseva, director of product management, RBQM, eClinical Solutions, discussed FDA’s…
Set the Course for a More Engaging & Productive Patient & Clinical Trial Site Journey
Sponsored by uMotif In this video, uMotif CEO Steve Rosenberg discusses key trends shaping the clinical trial landscape, including CRO…
Reinforcing Quality by Design in Clinical Trials
In a recent video interview with Applied Clinical Trials, Vera Pomerantseva, director of product management, RBQM, eClinical Solutions, discussed FDA’s…
New Data Emerges from Phase IIb RELIEVE UCCD Study in Ulcerative Colitis and Crohn’s Disease
Image Credit: © Sebastian Kaulitzki – stock.adobe.com Teva and Sanofi have shared additional data from the Phase IIb RELIEVE UCCD…
Vera Pomerantseva of eClinical Solutions Reacts to FDA’s Recent Protocol Deviations Guidance
In a recent video interview with Applied Clinical Trials, Vera Pomerantseva, director of product management, RBQM, eClinical Solutions, discussed FDA’s…
Shakthi Kumar Talks Real-World Data Use in Clinical Development
ACT: Could you share real-world use cases where this technology has significantly accelerated clinical development, improved data integrity, or optimized…
Smarter Clinical Asset Evaluation Powered by Causal Machine Learning
Credit: WrightStudio | stock.adobe.com It is an old story in the pharmaceutical world. Every year, countless drugs are developed at…
Accelerate Inclusive Enrollment and Delivery with Lightship
Lightship focuses on patient accessibility and centricity in clinical trials, ensuring the patient experience is a positive one. Learn more…
Final Analysis of CheckMate -816 Trial Shows Opdivo Plus Chemotherapy Boosts Overall Survival in Resectable NSCLC
Credit: Sebastian Kaulitzki | stock.adobe.com A final analysis of survival data from the Phase III CheckMate -816 trial (NCT02998528) showed…
Sebastien Coppe Discusses Advancing Innovation in Clinical Trials
ACT: You were a part of panel discussion on start-up companies. Can you briefly discuss what the panel entailed? Coppe:…
Best Practices for Reducing Risk Upfront in a Clinical Trial
In a recent video interview with Applied Clinical Trials, Dominique Demolle, CEO of Cognivia, discussed challenges in improving patient adherence…
ASTRO Trial Shows SC Tremfya Provides Significant Clinical Benefits in Moderately to Severely Active Ulcerative Colitis
Credit: Saiful52 | stock.adobe.com Results from the Phase III ASTRO trial (NCT05528510) found that treatment with subcutaneous (SC) Tremfya (guselkumab;…
Graham Clark on Ensuring Data Consitency Amid the Rise of Real-World Evidence
ACT: What are Phastar’s key objectives for attending SCOPE 2025, and how do you see the conference shaping discussions on…
Phase III AMPLIFY Trial Shows Calquence Plus Venetoclax Significantly Improves Survival in Untreated CLL
Credit: jarun011 | stock.adobe.com A regimen of fixed-duration Calquence (acalabrutinib; AstraZeneca) plus venetoclax, with or without Gazyva (obinutuzumab), was found to…
Using AI/ML to Improve Patient Adherence
In a recent video interview with Applied Clinical Trials, Dominique Demolle, CEO of Cognivia, discussed challenges in improving patient adherence…
The Impact of Non-Adherence on Study Protocols
In a recent video interview with Applied Clinical Trials, Dominique Demolle, CEO of Cognivia, discussed challenges in improving patient adherence…
The Importance of Real-World Evidence in Medical Research and Drug Development
Credit: putilov_denis | stock.adobe.com Introduction As the gold standard for clinical research, randomized controlled trials (RCTs) are central to scientific…
Samuel Salvaggio Discusses Crucial Partnerships for Trial Efficiency
ACT: What types of partnerships—whether with CROs, technology vendors, or patient advocacy groups—do you see as crucial for improving trial…
Improving Patient Adherence
In a recent video interview with Applied Clinical Trials, Dominique Demolle, CEO of Cognivia, discussed challenges in improving patient adherence…
Samuel Salvaggio Discusses One2Treat’s Primary Objectives for Attending SCOPE
ACT: What are your primary objectives for attending SCOPE 2025, and what insights are you hoping to gain regarding trial…
AI/ML’s Impact in Patient Care
ACT: At the end of the day, it has to matter how these artificial intelligence/machine learning (AI/ML)-driven solutions are aiding…
Registries as Sources of Regulatory-Grade Real-World Evidence (RWE)
February 3rd 2025 Article This white paper presents findings from the PurpleLab Migraine Study, which leverages real-world data to analyze…
Implementing Diversity, Equity, and Inclusion in Drug Development
February 13, 2025 Publication Video Sponsored Jennifer Kim, PhD, assistant research professor, Tufts School of Medicine, Tufts Center for the…
Zenocutuzumab Shows Durable Efficacy in NRG1 Fusion-Positive Cancers in Phase II eNRGy Trial
Credit: Juan Gärtner | stock.adobe.com Results of the multinational Phase II eNRGy trial (NCT02912949) show that zenocutuzumab (Bizengri) produced durable…
Updated TALAPRO-2 Trial Data Confirms Talzenna Plus Xtandi Significantly Improves Survival in Metastatic Castration-Resistant Prostate Cancer
Credit: Dr_Microbe | stock.adobe.com Updated data from the final analysis of the Phase III TALAPRO-2 trial (NCT03395197) show a statistically…
SCOPE Summit 2025: Outlook on Clinical Data
ACT: With Veeva’s 2025 Clinical Data Trend Report now available, what are some key trends in clinical data that you’re…
Lightship’s Approach to Accessible, Inclusive, and Impactful Clinical Trials
Lightship focuses on patient accessibility and centricity in clinical trials, ensuring the patient experience is a positive one. Learn more…
Clinical Research, DEI Initiatives Caught in Political Headwinds Amidst Funding Freeze
Image Credit: © WESTOCK – stock.adobe.com The clinical research industry finds itself at a crossroads, faced with difficult decisions amid…