Former FDA inspector turned regulatory consultant, Patrick Stone, gives some valuable insights to what to expect when the FDA comes knocking at your clinical trial site. Here's a hint: make sure you PI knows the difference between presiding over and overseeing a study.
- Validating A Better ALS Biomarker With Coya’s Fred Grossman
- For Veteran PI, Research Requires Motivation, Dedication, And CRO Support
- Will Today’s Clinical Trial Trends Become Tomorrow’s Routine?
- Why Can’t We Compare Site Performance Measures?
- Yes, Women’s Exclusion In Clinical Trials Is Still A Problem
- Considering The Patient Experience Is Critical To Creating A Successful ICF
- $100M In Government Funding Helps, But What Can Really Be Done About Trial Diversity?
GUEST COLUMNISTS
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$100M In Government Funding Helps, But What Can Really Be Done About Trial Diversity?
Breast surgical oncologist and medical director Monique Gary, DO lists three steps to take right now to improve clinical trial patient diversity.
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Cell & Gene Therapies: An Overview Of FDA Regulatory Considerations For 2024
This article outlines key FDA regulatory developments from the past few months relevant to sponsors seeking approval of cell and gene therapies in the U.S.
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How To Determine Country Feasibility For Cell And Gene Therapy Clinical Trials
Learn how to choose the right location — globally — for your next cell and gene therapy clinical trial.
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Shorter, Faster, Cheaper: Powerful New Data On Digital Endpoints
The idea of leveraging novel, sensor-based measures to gather data for clinical trials is not new, but relevant evidence of their usefulness is. Here, DiMe experts discuss the impact of digital endpoints on trial success.
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Looking Back & Moving Forward With J&J’s Global Development Leader For Immunology
In this Q&A, David Gordon, M.B., Ch.B. recounts lessons learned from past clinical trial challenges and shares current-day strategies, like figuring out how to run a study that’s both scientifically sound and actually doable for patients and doctors.
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Mission: Remission — Patient Need For Durable Treatment Informs J&J’s Ulcerative Colitis Trial
J&J Global Therapeutic Area Head, Immunology, David M. Lee, MD, Ph.D., talks about the progression from treating PsO and PsA to UC, the importance of integrating patient needs into the trial’s design, and the quest for a durable treatment that lends itself to total remission.
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FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket Submissions
The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do.
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2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.
CLINICAL TRIAL WHITE PAPERS
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Achieving Statistical Significance With Limited Patient Populations
Explore highlights from a timely panel debate on emerging approaches to clinical research and data collection for advanced, novel and personalized therapies, especially linked to rare diseases.
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Facilitating Good Clinical Data Review In Your Clinical Trial6/7/2023
Learn how to create a system based on connectivity and automation, aggregated and usable data, flexible analysis, and methods of collaborative data review by centralizing analysis and communications.
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Antibody Drug Conjugates: Global Trial Landscape - Focus On Asia Pacific5/9/2023
Gain a better understanding of the global clinical trial landscape of antibody drug conjugates (ADCs) and their trends in the Asia Pacific.
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Establishing And Operating A DSMB5/23/2022
This white paper discusses the data safety monitoring board's (DSMB) role in research, the basics of setting up a DSMB, and why independence is so important.
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Study Start-Up Challenges: Hard Realities, Effective Strategies3/13/2024
Launching a study is complex, and the time between protocol approval and the first patient visit has increased dramatically. How can companies reverse this trend and accelerate study start-ups?
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Trial Summaries: Improving Patient-Centric Communications8/14/2023
Consider this alternative approach to distributing trial results summaries to participants that takes advantage of commonly used technologies.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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RWD For Early Clinical Development Planning And Strategy9/19/2023
Delve into this use case where Citeline’s Real-World Data was used to inform clinical development strategy and differentiate target product profiles through patient journey mapping.
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Navigating Sensitive Country Requirements2/1/2024
See how Scout expertly navigated complex regional laws and regulations to allow study patients in Iran access to treatment in Turkey.
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eCOA And Digital Platforms Reduce Diabetes Study Startup To 8 Weeks10/18/2023
See how digital solutions came together to enable faster study startup by 50% for this top pharma company conducting a Phase 3 diabetes study within the weight loss market.
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Atlantic Research Group Builds Competitive Advantage With Medrio EDC1/30/2023
By using Medrio’s EDC platform, learn how Atlantic Research Group was able to achieve the flexibility needed to span multiple therapeutic areas and eliminate redundancy in documentation.
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Moving From Clinical Development To BLA Through Strategic Planning10/23/2023
Uncover how a small biotechnology company was able to successfully file its Biologics License Application submission to the U.S. Food and Drug Administration after undergoing several personnel losses and shifts.
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Supporting Utilization & Recruitment Through COVID-196/7/2023
Supporting one of the world's largest pharmaceutical research organizations, MRN has more than doubled patient recruitment rates and quadrupled home visit referrals during the global outbreak of COVID-19.
NEWSLETTER ARCHIVE
- 04.26.24 -- The Challenges CRCs, CRAs, And CTMs Face
- 04.25.24 -- Reflection And Advancement: J&J's Global Immunology Leader
- 04.25.24 -- Insights From Across The Globe: Trends In Clinical Trials
- 04.24.24 -- 4 Takeaways From Building A Differentiated Franchise In Clinical Immunology
- 04.24.24 -- Crossing The FDA Bridge: Your Path To Success
CLINICAL LEADER CONTENT COLLECTIONS
With the advent of decentralized clinical trials and the increased fascination and exploration with technology-assisted processes bringing new data — and more of it — the importance of intentional data collection cannot be overstated. Our latest ebook from Clinical Leader brings you helpful articles on a topic that is arguably the most crucial part of the study process.
More Content CollectionsFOCUS ON PATIENTS
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Despite the progress made in including women in clinical trials, challenges persist. Hera Biotech CEO Somer Baburek explains why the fight for inclusion isn't over.
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Digital healthcare and AI technologies play a crucial role in exploring and treating a range of rare diseases as we welcome a new era of personalized care and potentially better patient outcomes.
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Results from the latest CISCRP “Perceptions & Insights” study reveal five opportunities to improve clinical trial recruitment and participation, especially among ethnic and racial minority groups.
EMBRACING DIVERSITY & INCLUSION
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Clinical trials are essential for evaluating the safety and efficacy of new treatments before they are approved for use by patients. However, a new report from the International Longevity Centre (ILC), in collaboration with RBW Consulting, highlights a significant problem in the clinical trial process: the underrepresentation of older adults.
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The Food and Drug Omnibus Reform Act, signed into law by President Biden on Dec. 29, 2022, includes provisions intended to modernize clinical trials and are broadly divided into two categories: encouraging the enrollment of diverse populations and facilitating novel clinical trial designs.
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The enthusiasm for the role of AI in upgrading global health and care provision is justified, provided we understand that the path to success is just as much about communication and collaborative development as it is about the raw potential of the technology itself. Because realizing this technological potential requires us to consider the role of people and processes in an integrated approach.