Itovebi Combo Boosts Progression-Free Survival in PIK3CA-Mutated HR-Positive, HER2-Negative Metastatic Breast Cancer
admin Credit: Sara_P | stock.adobe.com Data from the Phase III INAVO120 trial (NCT04191499) published in The New England Journal…
Medicine
Applied Clinical Trials October Recap
This October, Applied Clinical Trials focused on the topic of new-age outsourcing. Led by the rise of integrated…
EMPA-KIDNEY Trial Shows Jardiance Reduces Chronic Kidney Disease Progression, Cardiovascular Death Risk, with Benefits Lasting Up to One Year Post-Treatment
Credit: mi_viri | stock.adobe.com Long-term results of the Phase III EMPA-KIDNEY trial (NCT03594110) demonstrate that two years of…
Eli Lilly Shares Positive Phase III Data of Mirikizumab for the Treatment of Crohn’s Disease
Image Credit: © Sebastian Kaulitzki – stock.adobe.com Eli Lilly has shared results from two Phase III clinical trials…
Tremfya Achieves Significant Clinical Remission, Endoscopic Response in Moderate to Severe Crohn Disease at 48 Weeks
Credit: Uladzislau | stock.adobe.com Patients with moderate to severe Crohn disease (CD) administered treatment with subcutaneous (SC) Tremfya…
Merck and Moderna Initiate Phase III Study of mRNA-4157 and Keytruda Combination for Non-Small Cell Lung Cancer
Image Credit: © iDoPixBox – stock.adobe.com Merck and Moderna have announced the initiation of a Phase III clinical…
Omvoh Achieves Long-Term Remission, Symptom Improvement for Ulcerative Colitis, Crohn Disease in Phase III Trials
Credit: antkevyv | stock.adobe.com A pair of multiyear Phase III trials show that Eli Lilly’s Omvoh (mirikizumab) produced…
4 Perspectives on Sustainability in Clinical Research
Sustainability in clinical research is key. As complexity and productivity in the industry continue to rise, so does…
EHR-to-EDC Technology for Cancer Clinical Trials: Review of Research Webinar
October 16th 2024 Podcast Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and…
Prioritizing Data Quality Amidst Complexity in Clinical Trials
In a recent video interview with Applied Clinical Trials, Silvio Galea, chief data & analytics officer, WCG, discussed…
RSV Vaccine Arexvy Shows Potential for Expanded Use in At-Risk Adults Aged 18-49, Including Immunocompromised
Credit: Julia | stock.adobe.com A pair of clinical trials demonstrated that GSK’s respiratory syncytial virus (RSV) vaccine Arexvy…
Uncertainty With Artificial Intelligence at the Site-Level
In a recent video interview with Applied Clinical Trials, Jimmy Bechtel, vice president, site engagement, SCRS, discussed key…
Ebglyss Shows Significant Improvement in Skin Symptoms, Itch for Moderate-to-Severe Atopic Dermatitis
Credit: ltyuan | stock.adobe.com Ebglyss (lebrikizumab-lbkz) was found to significantly improve skin symptoms and decrease itching in patients…
4 Key Themes From Industry Conferences in 2024
Conferences offer the clinical research industry a fantastic opportunity to meet face-to-face. Between friendly conversations and interactive sessions,…
Improving Site-Sponsor Collaboration in Clinical Trial Startup
Christine Senn, Vice President, Site/Sponsor Innovation, Advarra Clinical research is more complicated and expensive than ever. That means…
4 Challenges With Technology in Clinical Trials
The shift towards technology and other decentralized approaches in clinical trials has been occurring for years now. The…
Oral Semaglutide Lowers Cardiovascular Events by 14% in Type 2 Diabetes Patients with Heart, Kidney Disease
Credit: santoelia | stock.adobe.com Headline data from the Phase III SOUL trial found that oral semaglutide (Rybelsus) lowered…
4 Areas of Interest for Artificial Intelligence in Clinical Research
In recent years, the artificial intelligence (AI)-hype train has picked up steam. Its promise has caught the attention…
Vabysmo Shows Significant Vision Improvement for Diabetic Macular Edema in Underrepresented Patients
Credit: Dr_Microbe | stock.adobe.com One year of treatment with Vabysmo (faricimab-svoa) for diabetic macular edema (DME) produced significantly…
Re-imagining the Labs
Pharmaceutical companies face numerous drug development challenges today, including low drug approval rates, rising drug discovery costs, pressure…
Novel Once-Weekly HIV Treatment with Islatravir and Lenacapavir Shows Promising 94% Viral Suppression at 48 Weeks
Credit: artegorov3@gmail | stock.adobe.com The novel combination of islatravir (Merck) and lenacapavir (Gilead) maintained high rates of viral…
4 Perspectives on FDA’s Diversity Action Plan Guidance
In June, the FDA released its Diversity Action Plan guidance. The document outlines requirements for sponsors on submitting…
Implementing a Gold Standard FSP Strategic Partnership
Elisa Mansfield, Vice President, FSP, Phastar The drug development landscape is continuously evolving. This evolution is ushering in…
Driving Diversity with the Integrated Research Model
Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses: Current trends and challenges with achieving greater…
Opdivo Combination Shows Superior Survival, Fewer Adverse Effects in Advanced Hodgkin Lymphoma
Credit: Dzmitry | stock.adobe.com The combination of Opdivo (nivolumab) plus chemotherapy was found to significantly improve progression-free survival…
Clesrovimab Shows Significant Reduction in RSV Infections, Hospitalizations in Infants
Credit: kitsawet | stock.adobe.com The results of the Phase IIb/III MK-1654-004 trial (NCT04767373) show that clesrovimab (Merck) produced…
AI Already Starting to Deliver Faster, Safer, More Effective Clinical Trials
Credit: Shuo | stock.adobe.com Artificial intelligence (AI) has had an undeniable impact on society in the past few…
Navigating the Complexities of Patient Data in Clinical Trials
In a recent video interview with Applied Clinical Trials, Silvio Galea, chief data & analytics officer, WCG, discussed…
How Digital Health Technologies are Addressing Unmet Measurement Needs in Parkinson’s Disease
Image Credit: © Pixel-Shot – stock.adobe.com Clinical development in Parkinson’s disease (PD) faces numerous challenges and pitfalls. There…
The Need for Clinical Trial Awareness
In a recent video interview with Applied Clinical Trials, Silvio Galea, chief data & analytics officer, WCG, discussed…
Real-World Data Show 99% Efficacy for Apretude in HIV Prevention with High Adherence, Reduced Stigma
Credit: jarun011 | stock.adobe.com Real-world data demonstrated that Apretude (cabotegravir long-acting ; ViiV Healthcare) for HIV pre-exposure prophylaxis…
Tina Bowdish Highlights the Importance of Site-Sponsor Relationships
ACT: You’ve been in the clinical research industry for more than 25 years. Can you please tell us…
New Trends and Tactics in Outsourcing
Mike Hennessy Jr, president and CEO, MJH Life Sciences® Within the push for greater diversity of patient populations…
Achieving Optimal Adoption of Risk-Based Quality Management
Steve Young, Chief Scientific Officer, CluePoints For more than a decade, the FDA and European Medicines Agency have…
New Two-Year Data Shows Early Evrysdi Treatment Significantly Improves Motor Milestones in Infants with Spinal Muscular Atrophy
Credit: Dzmitry | stock.adobe.com Two-year data from the Phase II RAINBOWFISH trial (NCT03779334) demonstrated that early treatment with…
The Strategic Emergence of Site Networks in Clinical Research
Gerri Gallagher, Head, US Site Engagement, GSK Adam Kinsey, Associate VP, Clinical Operations and Regional Head, North America,…
Talzenna Plus Xtandi Shows Significant Overall Survival Improvement in Metastatic Castration-Resistant Prostate Cancer
Credit: Dr_Microbe | stock.adobe.com The combination of Talzenna (talazoparib; Pfizer) plus Xtandi (enzalutamide; Astellas and Pfizer) produced a…
A New Approach to Global Participant Payments
Discover how to handle participant payments in global studies with ease. Join us to learn practical tips and…
Elevating Patient Centricity in Clinical Trials
Join experts from IQVIA Biotech and IQVIA in a webinar focused on enhancing clinical trial conduct by prioritizing…
Planning Ahead for FDA’s Multiregional Clinical Trials Guidance
In a recent video interview with Applied Clinical Trials, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel,…
Tremfya Shows Superior Endoscopic Remission Rates in Crohn Disease, Ulcerative Colitis
Credit: luchschenF | stock.adobe.com Pooled data from the Phase III GALAXI trial (NCT03466411) and the Phase III QUASAR…
Understanding Acceptability of eConsent from a Global, Ethical, and Industry Perspective
To date, there is limited insight into the perspectives on eConsent in clinical trials of Independent Ethics Committees/Institutional…
Ensuring Greater Access and Diverse Patient Populations
In a recent video interview with Applied Clinical Trials, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel,…
New Phase III Data of RSV Vaccine Arexvy Shows Efficacy Through Three Full Seasons
Image Credit: © Aerial Mike – stock.adobe.com GSK has shared positive Phase III data from its AReSVi-006 trial…
Industry Perspectives on the Key Challenges in Trial Optimization
The holy trinity of trial optimization At the core of trial optimization lies what the authors call the…
Mwango Kashoki of Parexel Shares Initial Reaction to FDA Guidance on Conducting Multiregional Clinical Trials in Oncology
ACT: What is your initial reaction to the FDA’s latest guidance on conducting multiregional clinical trials in oncology?…
Trial Site Engagement Models are Poised for Disruption
Image Credit: © Egor – stock.adobe.com We’re witnessing significant changes in how trial sites interact with biopharmaceutical organizations.The…
New Phase III Data Show Twice-Yearly Lenacapavir Reduces HIV Infections by 96% in Gender-Diverse Populations, Cisgender Men
Credit: RAJCREATIONZS | stock.adobe.com Additional data released from the Phase III PURPOSE 2 trial (NCT04925752) demonstrated that twice-yearly…
BATURA Trial Shows Airsupra Reduces Severe Asthma Exacerbation Risk in Patients with Mild, Intermittent Asthma
Credit: Sebastian Kaulitzki | stock.adobe.com Treatment with Airsupra (albuterol/budesonide; AstraZeneca, Avillion) as a rescue medication was found to…
NIH Selects T Cell-Priming Vaccine Candidate to be Included in Clinical Trials Under Project NextGen
Image Credit: © Production Perig – stock.adobe.com Emergex Vaccines has announced that the National Institute of Allergy and…
Regulatory Challenges With Data Collection
In a recent video interview with Applied Clinical Trials, Erin Erginer, director of product, Certara discussed the growing…
Ziresovir Significantly Improves RSV Outcomes in Infants and Children, Reducing Viral Load and Symptoms in Phase 3 AIRFLO Trial
Credit: kitsawet | stock.adobe.com Ziresovir produced significantly greater clinical improvement, decreased viral load, and reduced the Wang bronchiolitis…
Evolving With Your Needs Now and in the Future
• A one-size-fits-all model no longer exists. Because of this, Parexel’s models are flexible and agile, designed to…
Ensuring Proper Data Collection
In a recent video interview with Applied Clinical Trials, Erin Erginer, director of product, Certara discussed the growing…
Pomalidomide Significantly Reduces Bleeding, Improves Quality of Life in Hereditary Hemorrhagic Telangiectasia
Credit: luchschenF | stock.adobe.com Findings from the Phase II PATH-HHT trial (NCT03910244) show that pomalidomide significantly lowered the…
Blending Models for Better Sourcing Solutions
Tony Southers, Executive Vice President, Head of ICON Strategic Solutions In the new age of sourcing, sponsors are…
FSP Partnership: A Foundation for Innovation and Patient-Guided Development
Liz Rogers, VP and Head of Global Site and Study Operations at Pfizer, discusses Pfizer’s partnership with Parexel…
Arcus and AstraZeneca Enter Collaboration for Clinical Trial in Renal Cell Carcinoma
Image Credit: © Crystal light – stock.adobe.com Arcus Biosciences has announced a clinical trial collaboration agreement with AstraZeneca…
Tulisokibart Shows Superior Efficacy in Achieving Clinical Remission for Ulcerative Colitis Patients
Credit: Sebastian Kaulitzki | stock.adobe.com Tulisokibart (Merck) showed superior efficacy to placebo in achieving clinical remission in patients…
New Survey Uncovers Distrust as Key Factor in Enrollment Declines Among Black Patients
Image Credit: © Andrii Yalanskyi – stock.adobe.com Results from a survey conducted by two Baltimore medical centers suggest…
Phase III BENEGENE-2 Trial Shows Beqvez Significantly Reduces Bleeding in Hemophilia B
Credit: nobeastsofierce | stock.adobe.com Results from the Phase III BENEGENE-2 trial (NCT03861273) show that Beqvez (fidanacogene elaparvovec) administered…
Moving Beyond Claims Data in Clinical Trials
Image Credit: © ipopba – stock.adobe.com The pharmaceutical industry is facing a challenging landscape where the cost of…
Carvykti Significantly Improves Overall Survival in Relapsed Multiple Myeloma in Phase III Trial
Credit: abdelaziz@771 | stock.adobe.com Carvykti (ciltacabtagene autoleucel) was found to produce a significant improvement in overall survival (OS)…
Cancer Clinical Research Sees Shift Toward Industry-Sponsored Trials
Image Credit: © FlowStudio – stock.adobe.com Cancer incidence in the United States is on the rise. According to…
Trends in Patient Recruitment Advertising From 2012-2019
Credit: photon_photo | stock.adobe.com Clinical trial advertisements are a significant way through which prospective patients learn about and…
Bristol Myers Squibb and 2seventy bio Halt KarMMa-9 Trial in Patients with Newly Diagnosed Multiple Myeloma
Credit: Saiful52 | stock.adobe.com Bristol Myers Squibb (BMS) and 2seventy bio announced the discontinuation of enrollment in the…
A Site Roadmap for Sponsors and CROs
This webinar, hosted by Avacare Clinical Research Network, will provide a comprehensive understanding of why clinical trial diversity…
Regulatory Concerns Associated With Utilizing RWD
ACT: What are some key regulatory requirements or challenges that need to be addressed when using real-world data…
Advancing Safeguards for Innovative Clinical Research
Image Credit: © NicoElNino – stock.adobe.com As the field of clinical research undergoes rapid evolution, so too must…
Gazyva/Gazyvaro Shows Improved Complete Renal Response Among Patients with Lupus Nephritis
Credit: GoodIdeas | stock.adobe.com Findings from the Phase III REGENCY trial (NCT04221477) demonstrated that Gazyva/Gazyvaro (obinutuzumab; Roche) in…
Medidata Launches New Patient Payment Solution
Image Credit: © Blue Planet Studio – stock.adobe.com Medidata has announced the launch of its newest solution, Patient…
Reducing Burden With RWD
ACT: How can the integration of real-world data (RWD) reduce burden for key stakeholders in a trial such…
Long-Term Extension Trial Shows Ebglyss Maintains Skin Clearance in Over 80% of Moderate-to-Severe Atopic Dermatitis Patients
Results from the ADjoin long-term extension study (NCT04392154) show that more than 80% of patients with moderate-to-severe atopic…
Racial Disparities in Late-Stage Cancer Diagnosis for Adolescents and Young Adults
Image Credit: © Jakub Krechowicz – stock.adobe.com While cancer affects all demographics, there is a noticeable difference in…
The Importance of RWD in Rare Disease Research
ACT: How important is the role of real-world data (RWD) in clinical research for cancer and other rare…
IDEAYA Shares Positive Phase II Data for Darovasertib and Plans for Future Phase III Trial
Image Credit: © Christoph Burgstedt – stock.adobe.com IDEAYA Biosciences has shared positive interim Phase II data for darovasertib…
Developing AI/ML Models for Clinical Trials
ACT: You have an upcoming session on “Transforming Clinical Trials: From Reactive to Predictive.” What are some of…
Phase II AGAVE-201 Trial Shows Efficacy of Niktimvo for Refractory Chronic GVHD
Credit: gpointstudio | stock.adobe.com Results from the Phase II AGAVE-201 trial (NCT04710576) show that (Niktimvo) axatilimab monotherapy is…
Kesimpta Shows Promise in Reducing Relapsing Multiple Sclerosis Disability, Progression
Image credit: Artur | stock.adobe.com Data from the ALITHIOS open-label extension and Phase IIIb OLIKOS trials demonstrated the…
Aligning Decisions with Clinical Trial Timelines
ACT: What are some key considerations sponsors should be mindful of when aligning their decision-making process with the…
The Benefit to Adapting Operating Models
DPHARM’s “How Pharma is Shifting Operating Models for More Efficient Clinical Trials” session Sometimes, the innovation in things…
AutoCruitment CEO Jill Pellegrino Discusses Patient Recruitment
ACT: You hosted a session on how to “Unlock the Power of the Patient for Better Patient Recruitment…
Insights on the FDA’s Project Optimus and Dose Optimization
Matt Cooper, PhD is an Executive Director and Therapeutic Strategy Lead, Oncology, at Worldwide Clinical Trials Jim Eamma…
Cabozantinib Shows Significant Progression-Free Survival Benefits in Phase III Trial for Advanced Neuroendocrine Tumors
Image credit: THITIPORN | stock.adobe.com Results from the Phase III CABINET trial (NCT03375320) demonstrated that cabozantinib (Cabometyx, Cometriq)…
Imfinzi Treatment Regimen Shows Promise for Muscle-Invasive Bladder Cancer
Image credit: freshidea | stock.adobe.com Findings from the Phase III NIAGARA trial (NCT03732677) show that Imfinzi (durvalumab) in…
DPHARM 2024: eSource EHR Requirements
DPHARM’s “How Do You Make Scaling eSource EHR a Reality?” session Along its “New Approaches to Scale eSource…
Problem Solving in the Clinical Trial Realm
DPHARM’s “Aligning Innovations to Solve the Big Problems in Clinical Trials in a Resource-Constrained Environment” session When it…
Acclinate CEO Del Smith Highlights the Roles of Technology and Engagement in Clinical Research
ACT: You have an upcoming session on “Harnessing AI/ML to Drive Sustained Community Engagement for Diverse Clinical Trial…
Enhertu Shows Promising Results in Treating HER2-Positive Metastatic Breast Cancer with Brain Metastases, Extending Progression-Free Survival
Image credit: Nathan Devery com | stock.adobe.com Findings from the Phase IIIb/IV DESTINY-Breast12 trial (NCT04739761) show Enhertu (trastuzumab…
DPHARM 2024: Analyzing DCT Deployments
DPHARM’s “Examining Short and Long-Term ROI of DCT Deployment” session One of the first presentations to kick off…
The Importance of Relationships Between CROs and Clinical Trial Sites
ACT: How important is it for CROs to form strong relationships with sites, especially in the rare disease…
Imfinzi Plus Imjudo Shows Significant Five-Year Survival Improvement in Unresectable Liver Cancer
Image credit: Matthieu | stock.adobe.com Updated data from the Phase III HIMALAYA trial (NCT03298451) show the combination of…
Regulatory CMC: Enhancing Biologics Development
Gabriel Bohl, PharmD, FTOPRA, Director, Regulatory Affairs, ICON plc In the rapidly evolving field of biologics, strategic chemistry,…
AI Adoption for Clinical Trial Design, Planning
Image credit: Tierney | stock.adobe.com Human-centered artificial intelligence (AI), which emphasizes harmoniously integrating technology and predictive analyses with…
Imfinzi Shows Significant Survival Benefits in Limited-Stage Small-Cell Lung Cancer in Phase III ADRIATIC Trial
Image credit: Dr_Microbe | stock.adobe.com Results from the first planned interim analysis of the Phase III ADRIATIC trial…
Aligning Technology and Oversight
Mike Hennessy Jr, president and CEO, MJH Life Sciences® Throughout 2024, we have witnessed a multitude of advancements…
Navigating The New EU Clinical Trial Framework
ACT: As the deadline for legal transition for EU clinical trials approaches, what strategies can companies deploy to…
Applied Clinical Trials September 2024 Issue (PDF)
Applied Clinical Trials September 2024 Issue (PDF) Aligning Technology and Oversight A New Regulatory Road in Clinical Trials:…
A New Regulatory Road in Clinical Trials: Digital Twins
Gen Li, PhD, MBA, CEO and Founder, Phesi In recent decades, the complexity of clinical development has grown…
Impactful EU Clinical Trial Regulation Changes
ACT: What are the most impactful changes that companies need to be aware of? Neuberger: It was a…
Bridging Patient Support Gaps While Navigating Global Regulations
Craig Popovich, Associate Director, Implementation CIPP/E, Greenphire Solving site and sponsor clinical trial pain points with technology is…
What Does it Aim to Achieve?
ACT: What does the EU’s clinical trial regulation aim to achieve? Neuberger: That is an important part. Why…
2024 Veeva R&D and Quality Summit: Q&A with Dee DeOliviera
Dee DeOliviera, senior director, global regulatory operations, Cerevel (now part of AbbVie) The evolving regulatory landscape in clinical…
Top Takeaways from FDA Final Guidance on Real-World Evidence
Image Credit: © Supapeach – stock.adobe.com The FDA’s latest guidance on how trial sponsors should use real-world evidence…
Bree Burks of Veeva Discusses Site-Sponsor Relationships
ACT: To get started, could you give us an overview of your focus area at Veeva? Burks: I…
Rybrevant, Lazcluze Combination Demonstrates Improvement in Patients with Advanced Non-Small Cell Lung Cancer
Image Credit: Adobe Stock Images/Sweetrose official Results from the Phase III MARIPOSA trial demonstrated improved outcomes with Johnson…
Empowering Sponsors to Drive Trial Success
Attend this new, interactive webinar and join experts who reveal how sponsors can leverage technology to drive study…
How Pharma is Tackling DE&I in the Workplace
Katsuyoshi Sugita, chief people officer and chief ethics & compliance officer at Astellas Pharma. Katsuyoshi Sugita, the chief…
Edoxaban Monotherapy Outperforms Dual Antithrombotic Therapy for Atrial Fibrillation, Stable Coronary Artery Disease
Image credit: magicmine | stock.adobe.com Trial results show that edoxaban monotherapy reduced the risk of the primary net…
Novel Agent Shows Superiority Over Placebo in Reducing Monthly Migraine Days
Image credit: Damir Khabirov | stock.adobe.com A single intravenous (IV) infusion of Lundbeck’s investigational agent Lu AG09222 achieved…
Eli Lilly’s Insulin Efsitora Alfa Succeeds in Duo of Type 2 Diabetes Phase III Studies
Image Credit: © Minerva Studio – stock.adobe.com Eli Lilly has shared positive study data from its QWINT clinical…
Real-World Data Show Efficacy of PCSK9 Inhibitors in Lowering LDL-C in HeFH Patients with Statin Intolerance
Image credit: Rasi | stock.adobe.com Real world data demonstrated the efficacy of PCSK9 inhibitors in reducing low-density lipoprotein…
Gaps and Opportunities in Qualitative Systematic Reviews
Image Credit: Adobe Stock Images/Generative AI In the past few years, there has been more of a focus…
Veeva Adds New Capabilities to Veeva Site Connect
Image Credit: © NicoElNino – stock.adobe.com Veeva Systems has announced the newest release of Veeva Site Connect. New…
Take Control of Site Costs with Clinical Research Terminology Codes
Norman M. Goldfarb, executive director of the Site Council and executive director of the Clinical Research Interoperability Standards…
Medidata and Aixial Group Partner to Achieve Streamlined Database Lock
Image Credit: © nespix – stock.adobe.com Medidata and Aixial Group have announced a new partnership to streamline clinical…
Lyme Disease Vaccine Candidate Continues to Show Strong Immune Response Following Second Booster Dose
Image Credit: © fotovapl – stock.adobe.com Valneva and Pfizer have shared positive Phase II results from their study…
Plozasiran Reduces Triglycerides, Pancreatitis Risk in Persistent Chylomicronemia
Image credit: alexlmx | stock.adobe.com Data from the Phase III PALISADE trial (NCT05089084) demonstrated that plozasiran (Arrowhead) significantly…
Using AI to drive successful clinical development planning
Do you know how AI can inform clinical development planning and drive competitive advantage? In this webinar, learn…
Johnson & Johnson Seeks FDA Approval for Nipocalimab in Generalized Myasthenia Gravis
Image Credit: Adobe Stock Images/Lila Patel Johnson & Johnson has announced the submission of a Biologics License Application…
5 essential capabilities for decentralized clinical trials (DCT)
July 30th 2024 Article Do you leverage a quality-first mindset as you evaluate clinical trial technology? When you…
Four Hundred Scientists Share Secrets to Maximizing R&D Data
Image credit: Molnia | stock.adobe.com Data is more important than ever in today’s challenging R&D environment, but as…
DVCR is Designed Differently
Zach Bader (Vice President, Business Development) talked with ACT about how Dr. Vince Clinical Research (DVCR) is challenging…
DVCR’s Multi-Site Model
Korey Nevitt (Executive Director, Site Partnerships) talked with ACT about what makes Dr. Vince Clinical Research (DVCR) solutions…
Olaparib Demonstrates Efficiency in Biochemically Recurrent Prostate Cancer
Image Credit: Adobe Stock Images/Best Results from a recent Phase II clinical trial conducted by Johns Hopkins Kimmel…
Current Trends in Patient Reimbursement
ACT: What are some trends that you’re currently seeing with patient reimbursement? I mentioned the cost of travel…
Crinecerfont Found to Lower Androstenedione Levels in Pediatric Patients with Congenital Adrenal Hyperplasia
Image credit: growth.co | stock.adobe.com Findings from the Phase III CAHtalyst Pediatric Study (NCT04806451) show that crinecerfont (Neurocrine…
Leqvio Achieves Statistically Significant LDL-C Lowering in Phase III Study
Image Credit: © Rasi – stock.adobe.com Novartis has shared positive results from its Phase III study of Leqvio…
The Impact of Patient Data Access
ACT: What impact does patient data access have on elements such as forecasting, budgeting, and enrollment? Murphy: Well,…
Comparison of Androgen Receptor Inhibitors for Nonmetastatic Castration-Resistant Prostate Cancer Shows Advantage with Darolutamide
Image credit: Dr_Microbe | stock.adobe.com A cohort study comparing outcomes with the use of darolutamide (Nubeqa), enzalutamide (Xtandi),…
Challenges with Budgeting and Analytics in Trials
ACT: What are some challenges that stakeholders are currently seeing with budgeting and analytics in their trials? Murphy:…
Analysis Shows Diabetes Mellitus May Increase Risk of Developing Tuberculosis
Image credit: Dr_Microbe | stock.adobe.com An analysis of retrospective and prospective cohort studies finds that diabetes likely elevates…
Identifying the Most Common Symptoms of Long COVID in Children and Adolescents
Image Credit: © AntonioDiaz – stock.adobe.com While the height of the COVID-19 pandemic is well behind us, its…
OASIS Trials Show Efficacy of Elinzanetant in Reducing Hot Flashes in Postmenopausal Individuals
Image credit: fizkes | stock.adobe.com In the pivotal Phase III OASIS 1 and 2 trials, elinzanetant achieved a…
Walgreens and BARDA Partner to Increase DCT Innovation
Image Credit: © peshkova – stock.adobe.com Walgreens and the Biomedical Advanced Research and Development Authority (BARDA) have announced…
Welireg Shows Survival Advantage Over Everolimus Treating Advanced Clear-Cell Renal Cell Carcinoma
Image credit: MdBabul | stock.adobe.com Welireg (belzutifan) produced a significant benefit compared to everolimus (Afintior; Afinitor Disperz; Zortress)…
Ashley Moultrie of Javara Shares Thoughts on FDA’s Diversity Action Plan Guidance
ACT: What are your thoughts on the FDA’s recently released Diversity Action Plan Guidance? How will this affect…
The Role of Collaboration in Achieving Greater Diversity in Clinical Research
ACT: What areas of trial design should stakeholders be focusing on the most to increase diversity within their…
FDA Clears IND for Phase I/II Study in Relapsed/Refractory Non-Hodgkin Lymphoma
Image Credit: © Dr_Microbe – stock.adobe.com The FDA has cleared an Investigational New Drug (IND) application for an…
Study Shows Infusion of Amino Acids Reduces Risk of Acute Kidney Injury Following Cardiac Surgery
Image credit: Crystal light | stock.adobe.com Findings from a Phase III trial (NCT03709264) show that intravenous (IV) infusion…
Results from Phase III Duo Show Elinzanetant Significantly Reduced Frequency and Severity of Hot Flashes Associated with Menopause
Image Credit: © ArtyKris99 – stock.adobe.com Full data for the duo of Phase III studies—OASIS 1 and 2—has…
Tufts CSDD Site Experience Survey
Image Credit: © Andrii Yalanskyi – stock.adobe.com Researchers at Tufts CSDD at the Tufts University School of Medicine,…
Increasing Diversity with the Integrated Research Model
ACT: What do you think are currently industry’s greatest obstacles in achieving more diversity in trials? Moultrie: I…
Lumryz Associated with Weight Loss in Patients with Narcolepsy
Image credit: Laflor/peopleimages.com | stock.adobe.com Findings from a post-hoc analysis of the pivotal Phase III REST-ON trial (NCT02720744)…
FDA Approves Rybrevant Combination for Advanced Non-Small Cell Lung Cancer
Image Credit: © iDoPixBox – stock.adobe.com The FDA has approved Johnson & Johnson’s Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib)…
What’s Next for DCTs?
Mike Hennessy Jr, president and CEO, MJH Life Sciences® One of the most prominent areas of discussion in…
Applied Clinical Trials July/August 2024 Issue (PDF)
Applied Clinical Trials July/August 2024 Issue (PDF) Streamlining Clinical Trials with eSource: Insights from MSK Decentralized Clinical Trials:…
Streamlining Clinical Trials with eSource: Insights from MSK
Mats Sundgren, PhD, Industry Science Director, i-HD Gynet Santiago, Clinical Research Coordinator, Memorial Sloan Kettering Cancer Center (MSK)…
‘Fit-for-Purpose’ Considerations for Remote Trials
Joachim Lövin, Workstream Lead on Modernizing Clinical Trial Conduct, TransCelerate BioPharma Inc., and DCT Specialist, Novo Nordisk In…
Choosing the Best Clinical Technology for Your Study
What should be top of mind for stakeholders when they are deciding what clinical technology is best for…
FDA Grants Breakthrough Therapy Designation, Priority Review to AstraZeneca’s Imfinzi for the Treatment of Limited-Stage Small Cell Lung Cancer
Image Credit: Adobe Stock Images/pakbung The FDA has granted Breakthrough Therapy Designation and Priority Review to AstraZeneca’s Infimzi…
Pfizer and BioNTech’s mRNA-Based Combination Vaccine Demonstrates Strong Immune Responses to Influenza A
Image Credit: Adobe Stock Images/arti om Pfizer and BioNTech announced that their mRNA-based combination vaccine program aimed at…
Monjuvi Succeeds in Phase III Trial of Patients with Relapsed or Refractory Follicular Lymphoma
Image Credit: © Aerial Mike – stock.adobe.com Incyte has shared positive Phase III results of its CD19-targeting monoclonal…
How Regulators are Viewing the Current Landscape of Clinical Technology
ACT: How are the regulators viewing this current “boom” in clinical technology? How has their stance on it…
Decentralized Clinical Trials: Bust or Breakthrough?
Decentralized clinical trials (DCTs) are shapeshifting. Originally piloted 15 years ago and more recently catalyzed by the COVID-19…
The Evolution of CRAACO: Gains and Lessons Learned
Tracking efforts to advance the mission and concept of “clinical research as a care option.”
Integrating Clinical Technology
ACT: What are some challenges you are currently seeing with the integration of clinical technology? Easy: That is…
Engaging Emerging Clinical Investigators Yields Unique Benefits for All
Benjamin Marcum, MD, family practitioner, Stephenville Medical and Surgical Clinic, Privia Health Emerging investigators play a vital role…
Abrysvo Demonstrates Safety and Efficacy as an RSV Vaccine in Immunocompromised Adults
Image Credit: Adobe Stock Images/Mahmud Pfizer announced top-line results from the ongoing Phase III MONeT (RSV IMmunizatiON Study…
Reproxalap Significantly Reduces Ocular Discomfort in a Phase III Clincal Trial for the Treatment of Dry Eye Disease
Image Credit: Adobe Stock Images/Media Srock Results from a Phase III clinical trial demonstrated that Aldeyra Therapeutics’ Reproxalap…
Utilizing the eConsent Fit-for-Purpose Study Framework
Image Credit: © photon_photo – stock.adobe.com To date, eConsent adoption and tangible study data about eConsent outcomes are…
Potential Advancements in Patient Centricity
ACT: What are some patient-centric advancements you are looking forward to seeing in the next five years? Keunen:…
Addition of Olanzapine Improves Complete Response, Nausea and Vomiting Prevention in Chemotherapy-Naive Patients
Image credit: 9nong | stock.adobe.com A Phase III trial found that adding olanzapine to moderately emetogenic chemotherapy (MEC)…
Building Patient-centric Technology
ACT: What do technology vendors need to focus on most when creating patient-centric solutions? Keunen: It seems obvious,…
Nipocalimab Shows Significant Promise Treating Early-Onset Severe Hemolytic Disease of the Fetus and Newborn
Image credit: adimas | stock.adobe.com Results from the Phase II UNITY trial demonstrated that nipocalimab delayed or stopped…
Identifying the Most Useful Features in Solutions from a Patient POV
ACT: As a patient yourself, what specific features or functions do you look for in technology? Keunen: I…
Sarclisa Combination Produces Significantly Improved Progression-Free Survival in Newly Diagnosed Multiple Myeloma
Image credit: Saiful52 | stock.adobe.com The results of a Phase III trial show that the combination of Sarclisa…
Delivering Operational Excellence in a Complex Environment of CAR-Directed Cell Therapies
Vito Romita, PhD, MSc, Senior Director, Global Project Management, Hematology/Oncology Therapeutic Unit, PPD clinical research business, Thermo Fisher…
Merck Discontinues Phase III Trial of Keytruda Combination for SCLC
Image Credit: © iDoPixBox – stock.adobe.com Merck has announced the discontinuation of the Phase III KeyVibe-008 trial evaluating…
Reducing Patient Dropout Rates and Accelerating Trial Completion
Jon Ernst talked with ACT about how PCM Trials are harmonizing various elements in the decentralized clinical trial…
Postsurgical Pain Candidate Vocacapsaicin Demonstrates Efficacy in Reducing Opioid Use
Image Credit: © Egor – stock.adobe.com Concentric Analgesics has shared positive Phase II data for its leading postsurgical…
Current Challenges in Patient Centricity
ACT: What do you think are currently industry’s greatest challenges in patient centricity? Keunen: Patient centricity—that’s a big…
Kerendia Achieves Reduction in Risk of Cardiovascular Death and Heart Failure
Image Credit: © Africa Studio – stock.adobe.com Bayer has shared new data from the Phase III FINEARTS-HF clinical…
Delivering Better Outcomes for Patients with LLMs
ACT: Where do you see the use of large language models (LLMs) in clinical trials in five years?…
Eli Lilly’s Tirzepatide Shows Reduction in Risk of Heart Failure Outcomes
Image Credit: © ckybe – stock.adobe.com According to new data revealed by Eli Lilly, tirzepatide significantly improved heart…
Being Responsible with Artificial Intelligence Solutions
When vendors are evaluating which artificial intelligence (AI) solutions are best for them, what should they be keeping…
Current Uses of LLMs in Clinical Trials
ACT: What is the current state of the use of large language models (LLMs) in clinical trials? Kondru:…
Blenrep Combo Shows Significant Survival Benefit Over Darzalex Combo in Patients with Relapsed or Refractory Multiple Myeloma
Image credit: LASZLO | stock.adobe.com The combination of Blenrep (belantamab mafodotin), bortezomib, and dexamethasone (BVd) demonstrated a significant…
Strategies From Design to Delivery
Join experts to explore regulatory strategies, clinical challenges, and operational models that speed up trials and bring patient…
Leveraging Real-World Evidence to Optimize Trial Design
ACT: Are there any opportunities for these AI models to leverage data such as real-world data (RWD)? If…
Antihypertensive Treatment May Improve Target Organ Damage in Patients with Masked Hypertension
Image credit: grinny | stock.adobe.com Antihypertensive medications may improve target organ damage (TOD) in patients with masked hypertension…
A New Tool for Optimizing Site Payments
Norman M. Goldfarb, executive director of the Site Council and executive director of the Clinical Research Interoperability Standards…
Emerging Phase II Data Show Evorpacept Improved Tumor Response in Patients with Gastric Cancer
Image Credit: © PIC4U – stock.adobe.com Evorpacept, a CD47 blocker, has returned positive data from the Phase II…
Improving Trial Design with LLMs
ACT: Specifically, how can these large language models (LLMs) improve trial design, recruitment, and analysis? Kondru: I want…
PGN-EDO51 for the Treatment of Duchenne Muscular Dystrophy Demonstrates Higher Levels of Exon Skipping in Phase II Trial
Image Credit: © Aerial Mike – stock.adobe.com PepGen has shared positive data from the CONNECT1-EDO51 Phase II trial…
You Are Forgetting the Patient, but You’re Not Alone
Vincent Keunen, founder and CEO of Andaman7 shares his thoughts on how industry can achieve true patient centricity…
Emerging Phase III Results Show CALQUENCE Regimen Significantly Improved Progression-free Survival in Leukemia Patients
Image Credit: © chayantorn – stock.adobe.com AstraZeneca has shared positive, interim results from the AMPLIFY Phase III trial…
Lomecel-B Meets Key Objectives in Phase IIa Alzheimer’s Study
Image Credit: © LIGHTFIELD STUDIOS – stock.adobe.com Lomecel-B, a living cell product for the treatment of Alzheimer’s Disease,…
Phase III BROOKLYN Trial Evaluating Obicetrapib in Patients with Heterozygous Familial Hypercholesterolemia Meets Primary Endpoint
Image Credit: © photon_photo – stock.adobe.com NewAmsterdam Pharma has shared positive results from its pivotal Phase III BROOKLYN…
Felzartamab Shows Potential Therapeutic Benefit, Acceptable Safety for Late Antibody-Mediated Rejection
Image credit: Crystal light | stock.adobe.com Felzartamab demonstrated a potential therapeutic benefit and an acceptable safety and adverse…
Dovato Demonstrates Non-Inferior Efficacy to Biktarvy in Head-to-Head Phase IV Trial
Image Credit: © Ezume Images – stock.adobe.com ViiV Healthcare has shared initial results from the 48-week Phase IV…
Pair of Randomized Clinical Trials Show Skyrizi Improves Clinical Remission in Moderately to Severely Active Ulcerative Colitis
Image credit: Sebastian Kaulitzki | stock.adobe.com An analysis of two randomized clinical trials (NCT03398148 and NCT03398135) found that…
Blincyto Plus Consolidation Chemotherapy Produces Significant Survival Improvement in MRD-Negative Acute Lymphoblastic Leukemia
Image credit: MdBabul | stock.adobe.com Blincyto (blinatumomab; Amgen) added to consolidation chemotherapy produced a significant improvement in overall…
DIA’s Impact on the Clinical Research Industry
ACT: What kind of impact do you hope DIA and its conferences have within the clinical trials industry?…
Undue Burden Created by Protocol Deviations
Jim Wahl, vice president, client services, TruLab In the clinical trial ecosystem these days, patient-centricity has become quite…
Early-Phase Trial Indicates Potential of Fecal Microbiota Transplant in Overcoming Resistance to Immune Checkpoint Inhibitors
Image credit: drimafilm | stock.adobe.com An early-phase clinical trial (NCT04264975) suggests that patients with cancer who have shown…
Investigational Gene Therapy for Hemophilia A Shows Positive Results in Phase III Clinical Trial
Image Credit: © Design Cells – stock.adobe.com Giroctocogene fitelparvovec, an investigational gene therapy for the treatment of adults…
DIA’s Objectives for the Remainder of 2024
ACT: What are your goals or objectives for DIA for the remainder of the year? Pierce: There are…
Topline Results from Phase IIb/Phase III Trial of Clesrovimab Show Reduction in Attended Lower Respiratory Infection in Infants
Image Credit: © Gary – stock.adobe.com Clesrovimab (MK-1654), Merck’s investigational prophylactic monoclonal antibody designed to protect infants from…
Themes Involving Clinical Trials at the 2024 DIA Global Annual Meeting
ACT: When it comes to clinical trials specifically, what do you think some of the most relevant themes…