DIA Global Head of Growth Highlights Variety of Sessions at the 2024 Global Annual Meeting
admin ACT: What were your impressions of the sessions at DIA? Pierce: The sessions that I saw that were…
Medicine
LEO Pharma Reveals Groundbreaking Data From Duo of Chronic Hand Eczema Phase III Clinical Trials
Image Credit: © Ольга Тернавская – stock.adobe.com Emerging data from the Phase III DELTA 1 (NCT04871711) and DELTA…
DIA Global Head of Growth, Carie Pierce Discusses 2024 Global Annual Meeting
ACT: What were your greatest takeaways from this year’s DIA Global Annual Meeting in San Diego? Pierce: This…
Phase III Trial Shows Older Patients with Atrial Fibrillation May Benefit From Lower-Dose Anticoagulants
Image credit: magicmine | stock.adobe.com Patients aged 80 years and above with atrial fibrillation (AF) may gain a…
PurpleLab Accelerates Clinical Trial Lifecycle with Real-World-Data
A large percentage of clinical trials are unable to stay on track. Jason Gagner talked with ACT about…
Altuviiio Shows Sustained Protection Against Bleeding Episodes in Children with Severe Hemophilia A
Image credit: Svetlana | stock.adobe.com Results from the Phase III XTEND-Kids trial (NCT04759131) found that once-weekly Altuviiio (efanesoctocog…
Digital Technology’s Impact on Rett Syndrome Management
Image Credit: © Blue Planet Studio – stock.adobe.com Rett syndrome, a rare genetic neurological and developmental disorder that…
Paxlovid Postexposure Prophylaxis Not Found to Significantly Lower Risk of Symptomatic SARS-CoV-2
Image credit: JeromeCronenberger | stock.adobe.com Findings from a Phase II/III study show postexposure prophylaxis with Paxlovid (nirmatrelvir–ritonavir; Pfizer)…
Results From Phase III SPACE Trial of AJOVY Show Promise in Episodic Migraine Prevention
Image Credit: © yodiyim – stock.adobe.com Teva Pharmaceuticals has shared new results from the Phase III SPACE clinical…
Phase III Data for Susvimo Show Promise in the Treatment of Two Diabetic Eye Conditions
Image Credit: © Pixel-Shot – stock.adobe.com Emerging two-year data from a pair of Phase III studies—Pagoda (NCT04108156) and…
NUBEQA Meets Primary Endpoint for Phase III ARANOTE Trial in Men with Prostate Cancer
Image Credit: © Dr_Microbe – stock.adobe.com The Phase III ARANOTE trial (NCT04736199) of Bayer’s NUBEQA (darolutamide) plus androgen…
Decentralized Technologies See Growth in Life Sciences Industry
Image Credit: © Andrii Yalanskyi – stock.adobe.com The newly released 2024 ISG Provider Lens global Life Sciences Digital…
Overcoming Challenges with Critical Care Trials During COVID-19
Image Credit: © NicoElNino – stock.adobe.com There is no doubting the impact of the COVID-19 pandemic on clinical…
Octreotide CAM2029 Returns Positive Results for the Treatment of Acromegaly in ACROINNOVA 2 Phase III Study
Image Credit: © jarun011 – stock.adobe.com Camurus has shared positive, final, topline results from the ACROINNOVA 2 Phase…
Q&A with Tom deLaubenfels, PhD, Director of Data Science, Strados Labs
Tom deLaubenfels, PhD, Director of Data Science, Strados Labs In respiratory clinical trials, cough frequency monitoring can serve…
Novel Anti-CD38 Targeted Therapy Shows Promise Treating Immune Thrombocytopenia in Phase II Trial
Image credit: Andrew Dorey | stock.adobe.com Findings from the Phase I-II 2022-CM313-ITP trial (NCT05694767) show that an investigational…
FDA Clears IND for Selective Fatty Acid Binding Protein 5 Inhibitor, ART26.12, Phase I Study to Commence
Image Credit: © Aerial Mike – stock.adobe.com The FDA has cleared Artelo Biosciences’ Investigational New Drug application (IND)…
What Sponsors Can Expect From FDA’s Diversity Action Plan Guidance
ACT: Does the FDA’s Diversity Action Plan guidance create any additional challenges for sponsors? How can they be…
Tivdak Shows Significantly Greater Efficacy vs. Chemotherapy in Second-, Third-Line Treatment of Recurrent Cervical Cancer
Image credit: Crystal light | stock.adobe.com Data from the Phase III innovaTV 301/ENGOT-cx12/GOG-3057 trial (NCT04697628) show second- or…
Patient-centric Approaches in Designing and Creating Products
ACT: How can sponsors embed patient and caregiver insights into product vision and design? Birchard: I’m currently a…
Real–World Data Show Efficacy of Beyfortus Against Hospitalization for RSV-Associated Bronchiolitis
Image credit: PH alex aviles | stock.adobe.com An observational study (NCT06030505) in a real-world setting found that Beyfortus…
FDA Grants Fast Track Designation for OBX-115 for the Treatment of Advanced Melanoma
Image Credit: © Christoph Burgstedt – stock.adobe.com The FDA has granted Fast Track Designation to Obsidian Therapeutics’ OBX-115,…
Brigatinib Shows Clinical Benefit Across Multiple Tumor Types in Patients with NF2-Related Schwannomatosis with Progressive Tumors
Image credit: kh_art | stock.adobe.com Results from the Phase II INTUITT-NF2 trial (NCT04374305) show brigatinib produced radiographic responses…
Acclinate CEO Del Smith Discusses FDA’s Recently Released Diversity Action Plan Guidance
ACT: What are your initial thoughts on FDA releasing the Diversity Action Plan guidance? Smith: My initial thoughts…
Pfizer Selects Once-daily Modified-release Formulation for Danuglipron Following Analysis of Ongoing Clinical Trial
Image Credit: © VadimGuzhva – stock.adobe.com Pfizer announced it has selected its preferred once-daily modified release formulation for…
Prelude Therapeutics Collaborates With Merck to Evaluate PRT3789 in Combination With KEYTRUDA
Image Credit: © peterschreiber.media – stock.adobe.com Prelude Therapeutics has announced a new clinical trial collaboration and supply agreement…
Leveraging eCOA Technologies to Create Greater Patient Centricity
ACT: How can sponsors leverage electronic clinical outcome assessment (eCOA) technologies to facilitate the collection and management of…
Positive Interim Phase II Data Show Strong Overall Response and Disease Control Rates for MAT2A Inhibitor, IDE397
Image Credit: © iDoPixBox – stock.adobe.com IDEAYA Biosciences has shared positive clinical data for the IDE397 Phase II…
Strategies to Bridge Gaps Between Study Participants and Industry
ACT: What strategies can sponsors employ to bridge the gaps between study participants and the industry, ensuring open…
Phase I/II Clinical Trial of JCXH-211 IV to Begin Following FDA Investigational New Drug Clearance
Image Credit: © putilov_denis – stock.adobe.com The FDA has cleared Immorna Biotherapeutics’ Investigational New Drug Application (IND) for…
Incorporating Patient and Caregiver Perspectives
ACT: Why should sponsors prioritize incorporating patient and caregiver perspectives into clinical trial design and conduct? Birchard: I…
More Data, More Insights, More Progress
June 27th 2024 Article AI can be applied to patient data in real time, allowing medical reviewer teams…
The Role of Artificial Intelligence in Medical Review
June 27th 2024 Article AI can be applied to patient data in real time, allowing medical reviewer teams…
Future Use of Artificial Intelligence in Clinical Trials
ACT: Looking forward, where do you see the use of artificial intelligence (AI) in clinical trials in five…
Navigating the Complexities of Patient Screening: Streamlining the Process for Accelerated Clinical Trials
Discover how streamlining patient screening can help accelerate clinical trials. Simplifying and improving the patient journey and optimized…
Industry Leaders React to FDA’s Newly Announced Diversity Action Plan Guidance
Tenaerts: It was awaited, so we’re all happy it came out and I think it’s going in the…
Hepatitis Delta Treatment Combination Receives FDA IND Clearance and Fast Track Designation Following Positive Phase II Results
Image Credit: © photon_photo – stock.adobe.com The FDA has cleared Vir Biotechnology’s investigational new drug (IND) application and…
FDA Clears Investigational New Drug Application for Potential Leukemia Treatment, GTB-3650
Image Credit: © Aerial Mike – stock.adobe.com The FDA has cleared GT Biopharma’s Investigational New Drug (IND) application…
Emerging Data From Phase I Clinical Study for Pancreatic Cancer Show Stable Disease Activity
Image Credit: © Matthieu – stock.adobe.com Sirnaomics has announced its small interfering RNA (siRNA) drug candidate, STP707, showed…
Q&A with Nick Slack, Chairman and CEO of START Center for Cancer Research
Nick Slack, Chairman and CEO, START Center for Cancer Research Clinical trials can offer patients who have run…
Boehringer Ingelheim, Gubra Initiate Phase I Clinical Trial for BI 3034701, a Potential Obesity Treatment
Image Credit: Adobe Stock Images/Hunterframe Boehringer Ingelheim and Gubra have launched a Phase I clinical trial for BI…
Industry Leaders Discuss the Impact of FDA’s Diversity Action Plan
Tenaerts: I think it’ll help the industry get more data, actionable data on a diverse population—there’s different ways…
National Institutes of Health Initiates Phase I Trial to Test the Safety of an Experimental Nasal COVID-19 Vaccine
Image Credit: Adobe Stock Images/fotoyou The National Institutes of Health (NIH) has begun a Phase I clinical trial…
New Phase II Data Shows Frexalimab Reduced Nerve Cell Damage in Relapsing Multiple Sclerosis
Image Credit: © Aerial Mike – stock.adobe.com Emerging data released from Sanofi show its CD40L monoclonal antibody, frexalimab,…
Phase III Vivacity-MG3 Trial Demonstrates Superiority of Nipocalimab Over Placebo in Treating Patients with Generalized Myasthenia Gravis
Image Credit: Adobe Stock Images/Lila Patel Results from the Phase III Vivacity-MG3 trial show that Johnson & Johnson’s…
Advancing Medical reviews with AI
AI can be applied to patient data in real time, allowing medical reviewer teams to actively monitor patient…
OpenBioLLM
Introducing OpenBioLLM-Llama3-70B & 8B: Saama’s AI Research Lab Released the Most Openly Available Medical-Domain LLMs to Date
Pediatric Patients with Eosinophilic Esophagitis Administered Dupixent Achieve Significant Improvements Across Multiple Disease Measures
Image credit: shidlovski | stock.adobe.com Phase III trial data published by The New England Journal of Medicine (NEJM)…
Rybrevant with Leclaza Shows Significantly Improved Progression-Free Survival vs. Tagrisso Treating EGFR-Mutated Advanced NSCLC
Image credit: Sebastian Kaulitzki | stock.adobe.com The combination of Rybrevant (amivantamab-vmjw; Janssen Pharmaceutical) with Leclaza (lazertinib; Johnson &…
Expanding Conceptual Model of Disease into Conceptual Model of Patient Experience for Designing, Interpreting Medication Effects
Image credit: Deemerwha studio | stock.adobe.com Patient experience data (PED) are no longer a nice to have; it…
Considerations for Integrating Artificial Intelligence
ACT: What should industry stakeholders be keeping top of mind when implementing artificial intelligence (AI) into their workflows?…
Benefits of Using AI in Data Management
ACT: What are the greatest benefits to utilizing artificial intelligence (AI) in data management? Lacroix: Coming from a…
New Results From National Comprehensive Cancer Network Survey Show Drug Shortages are Impacting Clinical Trials
Image Credit: © Andrii Yalanskyi – stock.adobe.com The National Comprehensive Cancer Network (NCCN) has published new results for…
Addressing Data Management Challenges With Automation
ACT: How can data management challenges be addressed? Specifically, is there any opportunity to address them with artificial…
FDA Issues Draft Guidance on the Submission of Diversity Action Plans
Image Credit: © Jakub Krechowicz – stock.adobe.com The FDA has issued a draft guidance which provides details to…
Complexities in Data Management
ACT: What are some of the biggest challenges you are currently seeing with data management in clinical trials?…
FDA Clears Adicet Bio’s IND Application for ADI-270 in Renal Cell Carcinoma, Phase I Study to Begin in 2024
Image Credit: © Crystal light – stock.adobe.com Adicet Bio has announced that the FDA has cleared its Investigational…
Results from Phase III Trials Show Eli Lilly’s Tirzepatide Reduces Obstructive Sleep Apnea Severity
Image Credit: © terovesalainen – stock.adobe.com Eli Lilly has announced results from its Phase III clinical trials of…
Usage of Patient-Reported Outcomes in Blood Cancer Clinical Trials
Image Credit: © putilov_denis – stock.adobe.com In recent years, there has been a growing interest in the use…
Accelerating the Use of RWD for Oncology Clinical Trial Planning
As medical facilities become more equipped to handle different telemedicine platforms and procedures, more clinical trials are back…
Emerging Biosimilars and the Importance of Identifying Experienced Providers
Although biologics and biosimilar drugs only represent 2% of U.S. prescription volume, these naturally sourced medications have recently…
DIA 2024: Improving Patient Access to Clinical Trials Through Decentralization and Flexible Design: Lessons from Oncology
Image Credit: Andy Studna In a session at the 2024 DIA Global Annual meeting in San Diego, CA,…
Phase III GRAVITI Trial Data Power sBLA Submission for Tremfya to Treat Crohn Disease
Image credit: Matthieu | stock.adobe.com Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the…
Accelerating Clinical Trial Activation
Sandra Smith, RN, MSN, AOCN, Senior Vice President, Clinical Solutions and Strategic Partnerships at WCG. Site activation of…
Ginny Beakes-Read of Johnson & Johnson Discusses Regulatory Challenges
ACT: What are currently some of the greatest regulatory challenges industry stakeholders such as CROs and sponsors should…
Pivoting Toward Sustainable Supply Chains in Clinical Research
Image credit: Corona Borealis | stock.adobe.com The clinical research industry has historically operated with a focus on effectively…
Allison Cuff Shimooka of TransCelerate Biopharma Discusses Innovation in Clinical Research
ACT: How is FDA promoting innovation in clinical trial design and conduct? Cuff Shimooka: It’s a timely question,…
Rob DiCicco of TransCelerate Biopharma Discusses the State of AI in Clinical Research
ACT: What do you think are some of the greatest opportunities for integrating artificial intelligence (AI) into clinical…
Elrexfio Shows Deep and Durable Responses Extending Survival in Relapsed or Refractory Multiple Myeloma
Image credit: LASZLO | stock.adobe.com Findings from the Phase II MagnetisMM-3 trial (NCT04649359) showed a significant survival benefit…
Improving Quality of Care for Cancer Patients
ACT: How can we improve shared decision-making practices as ways to improve the quality of care for cancer…
EQT Acquires Majority Stake in CluePoints
Image Credit: © lidiia – stock.adobe.com EQT has announced that the EQT Healthcare Growth Strategy and the EQT…
Designing Trials to Consider the Full Spectrum of Patient Outcomes
ACT: How is clinical trial design and analysis changing in response to more comprehensive evaluation methods (methods that…
Bimzelx Shows Long-Term Efficacy Treating Non-Radiographic Axial Spondyloarthritis, Ankylosing Spondylitis
Image credit: Sweettymojidesign | stock.adobe.com Two-year data from the Phase III BE MOBILE 1, BE MOBILE 2, and…
Transforming Cancer Care Through Patient-Centered Research
ACT: How can we transform cancer care through more patient-centered research and treatment analysis? Buyse: Just building on…
Two-year Interim Analysis of Trial Data Show Sustained Efficacy of Seladelpar Treating Primary Biliary Cholangitis
Image credit: Crystal light | stock.adobe.com Two-year interim data from the Phase III ASSURE trial (NCT03301506) show sustained…
Challenges in Oncology Trials: Analyzing Endpoints
ACT: What are some of the unique challenges facing oncology trials today? Buyse: Well, I think there are…
Applied Clinical Trials June 2024 Issue (PDF)
Applied Clinical Trials June 2024 Issue (PDF) Sustainability: More than Meets the Eye Status Check: Science & Sustainability…
Can Large Language Models Accurately Assess Risk of Bias in Randomized Clinical Trials?
Image Credit: © putilov_denis – stock.adobe.com Systematic reviews are a key element of clinical research. While these reviews…
An Updated View of Industry Trends
Image Credit: © Murrstock – stock.adobe.com We presented an initial review of quality tolerance limit (QTL) adoption trends…
Elahere Achieves Primary, Key Secondary Endpoint in Phase II Trial Treating Platinum-Sensitive Ovarian Cancer
Image credit: Dr_Microbe | stock.adobe.com Elahere (mirvetuximab soravtansine; AbbVie) achieved both the primary and secondary endpoints of the…
Amid Heightened Industry Rules on Sustainability, How are CROs Faring?
Image Credit: © Supapeach – stock.adobe.com A few points to review before we reach the heart of this…
First Patient Treated With Investigational ABBV-383 in CERVINO Phase III Study for Multiple Myeloma
Image Credit: © Катерина Євтехова – stock.adobe.com AbbVie has announced that the first patient has been treated with…
Sustainability in Clinical Trials: Purposeful Digitalization is Key
Julia Sundari, Senior Director of Clinical Design and Analytics, IQVIA In 2023, clinical development productivity rose the highest…
Aligning Patient Burden with Planetary Burden
Michael Cohen, Senior Director, Lead, Environmental Sustainability Robyn Owens, Manager, Recruitment and Engagement Both with the PPD clinical…
Understanding Heuristics and Biases in Clinical Trial Decision-Making
Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder, ArcheMedX, Inc. In our journey through the lessons…
How Much Does a Day of Delay in a Clinical Trial Really Cost?
Ken Getz, MBA, Executive Director and Research Professor, Tufts Center for the Study of Drug Development, Tufts University…
FDA and CluePoints Extend Existing Collaboration to Include AI/ML for Quality Assessment
Image Credit: © Murrstock – stock.adobe.com FDA and CluePoints have announced a new 3-year extension to their long-standing…
New Data From Phase III MARIPOSA Study Presented at ASCO Show Groundbreaking Results for RYBREVANT Combination in NSCLC Patients
Image Credit: © Sebastian Kaulitzki – stock.adobe.com Johnson & Johnson has announced new data from the Phase III…
Data From Phase III PALOMA-3 Study for NSCLC Presented at ASCO Show Five-Fold Reduction in Infusion-Related Reactions
Image Credit: © iDoPixBox – stock.adobe.com Johnson & Johnson has announced first data from the Phase III PALOMA-3…
The Future of BYOD Adoption
ACT: Looking forward, what does the future of bring-your-own-device (BYOD) adoption look like? Liu: I think it’s already…
Differentiating Consumer- and Medical-Grade Wearables
ACT: What are the differences between consumer- and medical- grade wearables and their uses in clinical settings? Liu:…
A Multiomic Roadmap to Success
Image Credit: © Kaikoro – stock.adobe.com Conversations around the impact of artificial intelligence (AI) in the pharmaceutical industry…
Quickly connect the right participants to your trial
Meet your enrollment goals faster by recruiting from Evidation’s engaged, highly characterized health community.
Datopotamab Deruxtecan Achieves Superior Survival Compared to Chemo in Advanced Nonsquamous NSCLC
Image credit: Axel Kock | stock.adobe.com Results from the TROPION-Lung01 Phase III trial (NCT04656652) show datopotamab deruxtecan (Dato-DXd)…
Optimizing Remote Monitoring With FSP: Adapting to the New Normal
Webinar Date/Time: Tuesday, June 25th, 2024 at 11am EDT|8am PDT|4pm BST|5pm CEST
FDA Extends PDUFA Date for Dupixent in COPD, Requesting Additional Data From BOREAS and NOTUS Trials
Image credit: art4stock | stock.adobe.com The FDA has extended the Prescription Drug User Fee Act (PDUFA) target action…
Breyanzi Gets FDA Approval to Treat Relapsed/Refractory Mantle Cell Lymphoma
Image credit: David A Litman | stock.adobe.com The FDA has approved Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel)…
ConcertAI Introduces New Artificial Intelligence Solutions Powered by Real-World Data
Image Credit: © Shuo – stock.adobe.com ConcertAI has announced its first-in-category predictive and generative artificial intelligence (AI) solutions.…
Optimizing Technology Implementation to Improve Diversity in Clinical Research
Image Credit: © Jakub Krechowicz – stock.adobe.com Inclusion of diverse populations continues to lag in clinical research. In…
Challenges With BYOD in Clinical Trials
ACT: What are some challenges we are currently seeing with data security and accuracy in bring-your-own-device (BYOD) models?…
An Overview of FDA Diversity-Related Documents for Clinical Trials
Image credit: GraphicPapa | stock.adobe.com Since 2016, the FDA has released various guidance documents intended to promote diversity…
Lexicon Pharmaceuticals Selects Medidata to Aid in Advancing Phase IIb Trial of Non-Opioid Drug for Neuropathic Pain
Image Credit: © photon_photo – stock.adobe.com Medidata has announced it has been selected by Lexicon Pharmaceuticals to help…
Navigating Robotic Process Automation, ICH E6(R3) Changes, and Outsourcing in Clinical Trials
Image Credit: © Murrstock – stock.adobe.com With ambitious goals to accelerate clinical trials, increase efficiency, and lower costs,…
Phase II Triple Combo Trial of Osemitamab for Gastric/Gastroesophageal Adenocarcinoma Produces Encouraging Results
Image Credit: © PIC4U – stock.adobe.com Transcenta has announced results from the Phase I/IIa Cohort-G data for Osemitamab…
Eisai and Biogen Start Rolling Biologics License Application Submission to FDA for Subcutaneous Version of Alzheimer Disease Drug Leqembi
Image credit: Dr_Microbe | stock.adobe.com Eisai and Biogen Inc. have initiated a rolling FDA submission for a subcutaneous…
Comparing End Points Between Non-Small Cell Lung Cancer Clinical Trials, Observational Studies
Image Credit: © iDoPixBox – stock.adobe.com A study recently published in JAMA Network Open compared response- and progression-based…
Q&A with Jeremy Wyatt, CEO of ActiGraph
Jeremy Wyatt, CEO of ActiGraph The technology that goes into wearable health monitoring devices has advanced by leaps…
Strategies and eCOA Best Practices in Drug Development
Mike Hughes, Chief Product Officer, YPrime The field of drug development is placing a growing emphasis on the…
Phastar and Beaconcure Announce Partnership, Enhance Data Review in Clinical Trials
Image Credit: © Murrstock – stock.adobe.com Beaconcure, a provider of artificial intelligence-enabled clinical data validation and automation, has…
Nimbus’ Phase 1/2 Trial for NDI-101150 Shows Promise in Treating Advanced Solid Tumors
Image Credit: Adobe Stock Images/Hero Design Nimbus Therapeutics presented promising data from its Phase 1/2 clinical trial of…
Clario Partners With Emsere, Extends Ophthalmic Medical Imaging Capabilities
Image Credit: © lidiia – stock.adobe.com Clario has announced a strategic partnership with medical equipment supplier for clinical…
The Critical Role of Contracting in Research
Image Credit: © ipopba – stock.adobe.com From the promise of shrinking pancreatic tumors to a vaccine for Alzheimer’s,…
Sanofi’s Phase II Trial of Rilzabrutinib Shows Clinically Meaningful Reduction in Loss of Asthma Control
Image Credit: Adobe Stock Images/Antonioguillem Sanofi announced positive results from a Phase II study for rilzabrutinib, a promising…
Boehringer Ingelheim and OSE Immunotherapeutics Announce Expansion of Two Solid Tumor Programs
Image Credit: © Aerial Mike – stock.adobe.com Boehringer Ingelheim and OSE Immunotherapeutics have announced a major expansion of…
Edgewood Oncology Doses First Two Patients in Phase IIa Study for BTX-A51, a Potential Treatment for Metastatic Breast Cancer
Image Credit: Adobe Stock Images/Oksana Smyshliaeva Edgewood Oncology announced that it has begun dosing patients as part of…
Identifying Relevant Randomized Clinical Trial Questions for Hospitalized Children
Image Credit: © Egor – stock.adobe.com While the number of randomized clinical trials (RCTs) for adult participants has…
US Pharma and Biotech Summit 2024: Evolving Clinical Research
Image Credit: © Aerial Mike – stock.adobe.com In a presentation at the 2024 US Pharma and Biotech Summit,…
GSK Presents Positive Results from SWIFT-1 and SWIFT-2, Phase III Trials Evaluating Depemokimab in Adults and Adolescents with Severe Asthma
Image Credit: Adobe Stock Images/Sebastian Kaulitzki GSK announced promising results from its Phase III clinical trials, SWIFT-1 and…
Mapping Baseline ChatGPT Usage to Support Drug Development
Image credit: Tierney | stock.adobe.com Abstract Background: ChatGPT usage remains limited to administrative and support work among drug…
Eli Lilly Reveals Promising Results from QWINT-2 and QWINT-4 Phase III Trials for Efsitora Alfa, a Weekly Insulin Treatment for Adults with Type 2 Diabetes
Image Credit: Adobe Stock Images/Robert Kneschke Eli Lilly announced promising results from the QWINT-2 and QWINT-4 Phase III…
What’s Complicating Good Data Practices and Data Integrity?
Image credit: metamorworks | stock.adobe.com Data integrity is an ongoing concern across all R&D organizations, no matter what…
Where Innovation and Patients Meet to Improve Cancer Care
David Alsadius, MD, PhD, Senior Medical Director, Oncology Center of Excellence, IQVIA Sergio Sánchez-Gambetta Director, Design Analytics, IQVIA…
Roche’s Novel Dual GLP-1/GIP Receptor Agonist Produces Clinically Meaningful Weight Loss in Phase Ib Trial
Image credit: 9dreamstudio | stock.adobe.com Roche’s dual GLP-1/GIP receptor agonist CT-388 produced positive findings treating obesity and type…
A Promising Future for Oncology R&D
Mike Hennessy Jr, president and CEO, MJH Life Sciences® Oncology clinical trials have always been a unique area…
Putting LP-284 on the Industry RADR
Panna Sharma, CEO, Lantern Pharma ACT: While reaching the first-in-human stage is a significant achievement, what specific endpoints…
Four-Year Data from Long-Term Extension Trial Show Efficacy of Sotyktu Treating Moderate-to-Severe Plaque Psoriasis
Image credit: Ban | stock.adobe.com Four-year data from the long-term extension (LTE) of the POETYK PSO clinical trial…
The Future of RBQM Adoption
ACT: What do you think the RBQM space will look like in five years? Will we see any…
Applied Clinical Trials May 2024 Issue (PDF)
Applied Clinical Trials May 2024 Issue (PDF) A Promising Future for Oncology R&D Where Innovation and Patients Meet…
Potential Pitfalls Without RBQM Adoption
ACT: If companies choose not to adopt risk-based approaches, what are some of the largest risks they leave…
A Fun and Insightful Exploration of Behavioral Science
Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder, ArcheMedX, Inc. This installment of my column is…
Medidata Expands Agreement With Worldwide Clinical Trials
Image Credit: © lidiia – stock.adobe.com Medidata and Worldwide Clinical Trials have announced an expansion of their existing…
Accelerating the Progress of Kinase Inhibitors in Oncology
Hannah Jones, PhD, Senior Vice President, PBPK Consultancy Services, Certara Masoud Jamei, PhD, Senior Vice President, Research and…
Increasing Comfortability With Adopting Risk-Based Approaches
ACT: How do you think industry can increase the level of comfortability with adopting risk-based approaches? Getz: I’ll…
Opdivo and Yervoy Combination Misses Primary Endpoint in Phase III Trial for NSCLC
Image Credit: © iDoPixBox – stock.adobe.com In an update on the Phase III CheckMate -73L trial, Bristol Myers…
Ken Getz of Tufts CSDD and Steve Young of CluePoints Discuss Stand Out Results from Recent RBQM Study
ACT: What do you make of the results of the study? Was there anything that stood out? Young:…
Keytruda Combination Falls Short of Disease-Free Survival Primary Endpoint in Phase III Trial for High-Risk Endometrial Cancer
Image credit: MdBabul | stock.adobe.com Keytruda (pembrolizumab; Merck) plus chemotherapy as adjuvant therapy, with or without radiotherapy, in…
The Role of Social Determinants of Health in Cancer Clinical Trial Availability
Image Credit: © putilov_denis – stock.adobe.com Patient enrollment has been a persistent challenge in clinical trials over the…
Ken Getz of Tufts CSDD Discusses RBQM Study Conducted with CluePoints and PwC
ACT: Ken, could you give us an overview of the risk-based quality management (RBQM) study conducted by Tufts?…
Can You Use a Torch Disposable For Cooking?
Torch Disposable For Cooking A culinary torch is a handy kitchen tool that’s often seen on TV cooking…
FDA Delays Review of BLA Submission for Moderna’s Novel Respiratory Syncytial Virus Vaccine
Image credit: JHVEPhoto | stock.adobe.com The FDA has notified Moderna that it will be unable to finish reviewing…
Tufts CSDD Vendor Qualification Survey
Image Credit: © NicoElNino – stock.adobe.com The Tufts Center for the Study of Drug Development (Tufts CSDD) is…
Ken Getz of Tufts CSDD Discusses Results of RBQM Study Conducted with CluePoints and PwC
ACT: Ken, could you give us an overview of the risk-based quality management (RBQM) study conducted by Tufts?…
Conference Calls for Unity in Addressing Artificial Intelligence Regulation in Life Sciences Research and Development
Image Credit: Adobe Stock Images/_veiksme_ The Pistoia Alliance, a prominent non-profit advocating for increased collaboration in life sciences…
Challenges in Conducting Multicentric Infectious Giardia Diarrhea Clinical Studies in India
Image credit: Jafree | stock.adobe.com Diarrheal diseases place a significant burden on public health in India, particularly among…
FDA Grants Breakthrough Device Designation for At-Home Self-Collect Cervical Cancer Screening Device
Image Credit: © ibreakstock | stock.adobe.com The FDA has granted Breakthrough Device Designation for Teal Health’s Teal Wand,…
First Worldwide Clinical Trial for Diabetic Macular Ischemia Treatment Achieves Primary Safety Endpoints
Image credit: koolsabuy | stock.adobe.com The first ever clinical trial conducted to evaluate an experimental treatment for diabetic…
FDA Clears Investigational New Drug Application for Novel BD2-Selective BET Inhibitor, VYN202
Image Credit: © Murrstock – stock.adobe.com The FDA has cleared an Investigational New Drug Application (IND) for VYNE…
Novel Therapy Achieves Durable Complete Response Rate Treating High-Risk Bladder Cancer in Phase II Trial
Image credit: magicmine | stock.adobe.com Data from a Phase II trial for Johnson & Johnson’s novel targeted therapy…
Are Event Rates and Effect Sizes Reported Accurately in Cardiovascular Trials?
Image Credit: © Tierney – stock.adobe.com In the design of a randomized clinical trial (RCT), estimations for expected…
A New Approach for Sponsors and Sites
Are you interested in learning about clinical trial participant payment best practices? Join IQVIA Technologies to learn how…
Ensuring Patient Centricity With AI
ACT: How is artificial intelligence (AI) currently being used in clinical trials to ensure patient centricity? Nambisan: I…
Safeguarding Against Trial Complexities With Feasibility Studies
ACT: How can feasibility studies be used to safeguard against trial complexities? Nambisan: So I touched on this…
Challenges With Feasibility Studies
ACT: What are some of the biggest mistakes stakeholders tend to make with their feasibility studies? How can…
Tips to Rescue a Clinical Trial Before It’s Too Late
Elizabeth Kelchner is the Associate Director of Data Management at Rho Sometimes relationships can continue even when things…
Leveraging Innovative Trial Designs and Advanced Imaging Techniques
Image credit: Juan Gärtner | stock.adobe.com The landscape of oncology drug development is rapidly evolving, particularly in the…
First-Line Treatment with Calquence Plus Chemoimmunotherapy Found to Improve Survival in Patients with Mantle Cell Lymphoma
Image credit: David A Litman | stock.adobe.com Calquence (acalabrutinib; AstraZeneca) plus standard-of-care chemoimmunotherapy produced a statistically significant and…
Walgreens, Boehringer Ingelheim Agree to Collaboration on Enhancing Clinical Trial Diversity
Image Credit: Adobe Stock Images/freshidea Walgreens and Boehringer Ingelheim have announced a joint venture, which will focus on…
Keytruda Combination Achieves Overall Survival Improvement in HER2-Positive Advanced Gastric or GEJ Adenocarcinoma
Image credit: Crystal light | stock.adobe.com Merck’s Keytruda (pembrolizumab) combined with trastuzumab, plus fluoropyrimidine- and platinum-containing chemotherapy, demonstrated…
What are the Most Common Barriers to Community Cancer Centers Engaging in Clinical Trials?
Image Credit: © peshkova – stock.adobe.com An overwhelming amount of cancer patients express willingness to participate in clinical…
Novel 21-Valent Pneumococcal Conjugate Vaccine for Adults Shows Positive Data in Phase III Trial
Image credit: Jezper | stock.adobe.com Data from the Phase III STRIDE-10 trial show the promise of Merck’s novel…
Tailoring AI Regulation in Healthcare
Image Credit: © Shuo – stock.adobe.com As artificial intelligence (AI) technology rapidly evolves, regulators around the world are…
Parexel and Palantir Expand Collaboration to Leverage AI Capabilities in Clinical Trials
Image Credit: © lidiia – stock.adobe.com Parexel and Palantir Technologies have announced a new multi-year strategic partnership to…
The Future of Drug Discovery
Image credit: NicoElNino | stock.adobe.com Artificial intelligence (AI) has become a cornerstone in the healthcare and pharmaceutical industry.…
Creating Standardized eCOA Solutions
ACT: How can differences across therapeutic areas be used to create more standardized electronic clinical outcome assessment (eCOA)…
FDA Grants Priority Review to sBLA for Jemperli plus Chemotherapy for Adults with Primary Advanced, Recurrent Endometrial Cancer
Image credit: Crystal light | stock.adobe.com The FDA has granted Priority Review to GSK’s supplemental Biologics License Application…
Using Patient Reported Outcomes in Dermatology Trials
ACT: Specifically in dermatology trials, which provide a lot of unique challenges, could you discuss some of the…
Regulatory Compliance With eCOAs
ACT: Are there currently any regulatory challenges with the use of electronic clinical outcome assessments (eCOAs)? If so,…
FDA Grants Fast Track Designation to Novel Bispecific Antibody Plus Paclitaxel for Advanced Biliary Tract Cancer
Image credit: Matthieu | stock.adobe.com Compass Therapeutics, Inc’s novel bispecific antibody CTX-009 was granted Fast Track Designation (FTD)…
Why We Need to Harness Real-Time Data to Truly Drive Diversity in Clinical Trials
Monique Adams, PhD, Executive Director, Global Head of Diversity & Inclusion in Clinical Trials, Sanofi The lack of…
Rinvoq Found Superior to Dupixent in Key Endpoints of Open-Label Trial Treating Atopic Dermatitis
Image credit: InfiniteStudio | stock.adobe.com Findings from the Phase IIIb/IV LEVEL UP (NCT05601882) trial demonstrated the superiority of…
Do Assigned Roles in Clinical Trials Affect Patient-Reported Outcomes?
Image Credit: © Andrii Yalanskyi – stock.adobe.com A study recently published on JAMA Network Open examined a single…
Q&A With Rust Felix, CEO and Co-founder of Slope
Rust Felix, CEO and Co-founder of Slope While the potential of artificial intelligence (AI) has become more popular…
Comparing the Characteristics of Type 2 Diabetes Patients in General Practices and Those in Randomized Controlled Trials
Image Credit: © Proxima Studio – stock.adobe.com A study recently published in BMJ Open has identified differences in…
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
Image credit: MdBabul | stock.adobe.com Kura Oncology’s ziftomenib has been granted Breakthrough Therapy Designation (BTD) by the FDA…
The Consequences of Underrepresentation in Clinical Trial Design
Image credit: Pixel-Shot | stock.adobe.com Clinical trials are opportunities to advance how we diagnose, treat, and prevent disease,…
CDC Case Data Highlight Importance of Children and Adolescents Remaining Up to Date with COVID-19 Vaccinations
Image credit: neirfy | stock.adobe.com A new report from the Centers for Disease Control and Prevention (CDC) demonstrates…
Utilizing COAs Across Different Therapeutic Areas
ACT: How does the utilization of clinical outcome assessments (COAs) differ across the various therapeutic areas? Mooney: That’s…
Long-Term Treatment with Kesimpta Shows Sustained Efficacy in Recently Diagnosed, Treatment-Naïve Patients with Relapsing MS
Image credit: Nathan Devery com | stock.adobe.com Results from the open-label ALITHIOS extension study demonstrated the long-term efficacy…
To be, or not to be, that is the Question
Image Credit: © Sergey Nivens – stock.adobe.com Generating insights from data based on structured patients’ reports dates back…
Enabling Evidence-Based Study Endpoint Selection
Marcelo Alves Favaro, Associate Outcomes Researcher, MAPI Research Trust Caprice Sassano, Research Lead – Applied Sciences, HumanFirst, an…
Analysis of Randomized Clinical Trials Show Improved Survival with Neoadjuvant Immune Checkpoint Inhibitors Plus Chemotherapy for NSCLC
Image credit: mi_viri | stock.adobe.com An analysis of eight randomized clinical trials (RCTs) found that the use of…
Is Japan Leading a New Digital Health Movement?
Dave Hanaman, President, Chief Commercial Officer, Co-Founder, Curavit Clinical Research. Japan’s digital health market is expected to show…
The Evolving Landscape of DHTs
Jill Sommerville, Senior Director Lauren Flood, Associate Director Matthew Ryan, Associate Director All with the digital and decentralized…
Navigating a Digital-Era Shift to Patient-Mediated Research
Vincent Keunen, Founder and CEO, Andaman7 New digital technologies are transforming possibilities in clinical research and driving a…
What is the Current State of Remote Monitoring in Oncology Clinical Trials?
Image Credit: © Blue Planet Studio – stock.adobe.com A recent survey study published on JAMA Network Open sought…
The Future Fit of Wearables for Patient-Centric Clinical Trials
Todd Rudo, MD, Chief Medical Officer, Clario Luc Dekie, PhD, Director of Scientific Affairs, Cardiology, Clario In an…
Patient Centricity: The Journey Matters
Bruce Hellman, Chief Patient Officer and Co-Founder, uMotif You’re setting forth on a long journey; you have your…
Utilizing a Large Language Model to Answer Questions From Oncology Patients
Image Credit: © Shuo – stock.adobe.com A cross-sectional study recently published on JAMA Network Open analyzed the quality…
FDA Accepts Phase III RECOVER-2 Study for Brilaroxazine in Schizophrenia
Image Credit: © Egor – stock.adobe.com Reviva Pharmaceuticals has gained alignment from the FDA on its registrational Phase…
Columvi Combination for Diffuse Large B-Cell Lymphoma Achieves Primary Endpoint of Overall Survival in Phase III Trial
Image credit: David A Litman | stock.adobe.com Data from the Phase III STARGLO trial (NCT04408638) show the combination…
New Site Added to Phase I Trial of Lymphir for the Treatment of B-Cell Lymphoma
Image Credit: © peshkova – © peshkova – stock.adobe.com The University of Minnesota (UMN) Masonic Cancer Center is…
Trial Data Show Potential Benefit of Krazati Plus Cetuximab in KRAS-Mutated Locally Advanced or Metastatic Colorectal Cancer
Image credit: Dr_Microbe | stock.adobe.com The combination of Krazati (adagrasib) plus cetuximab showed promise in patients with previously…
Benefits Patients Will See With the Integration of AI Into Clinical Research
ACT: How much of a game-changer are artificial intelligence (AI) solutions to patients participating in clinical research? What…
Does Your eCOA Reduce Clinical Trial Risk?
April 5th 2024 Article Digital biomarkers, smartphones, and wearables are transforming clinical trials by revolutionizing remote data collection…
The Role of Human Oversight With Artificial Intelligence in Clinical Research
ACT: How important is it that a level of human intervention remains with the oversight of these artificial…
Taking eCOA Delivery Off the Critical Path to First Patient In
Meeting the first patient in (FPI) deadline is a critical milestone for study teams who must first implement…
Data From Phase III Extension Trial Show Long-Term Safety, Efficacy of Qulipta in Migraine Prevention
Image credit: peterschreiber.media | stock.adobe.com Results from an interim analysis of an ongoing Phase III trial demonstrated the…
Meta-Analysis of Randomized Clinical Trials Show Psilocybin for Depression, Anxiety Has Tolerable Adverse Effects
Image credit: cendeced | stock.adobe.com An analysis of randomized, double-blind clinical trials found that psilocybin has a manageable…
Generative AI-Enabled/Augmented Clinical Trials: The Road Ahead
Image credit: Kaikoro | stock.adobe.com With the recent advances in generative AI (GenAI) with large language models (LLMs),…
Q&A With Flo Mowlem of ObvioHealth
Flo Mowlem, PhD, VP of Science, ObvioHealth On March 25, ObvioHealth hosted a webinar on the execution of…