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
-
$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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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
-
Site Perspectives On Decentralized Clinical Trials
Discover why understanding clinical research sites’ experiences and perspectives on DCTs will help industry stakeholders refine trial design, operational procedures, and regulatory policy to better serve patients and sites.
-
7 Considerations For eCOA Technology Solutions3/3/2023
Choosing the right vendor, solution, and deployment model is critical for a clinical trial to be successful. As a sponsor, consider these seven best practices when selecting the best eCOA.
-
Empowering Transformation Through Technology4/24/2024
By outlining the transformation of clinical data management into data science, this paper highlights the growing responsibility of data managers as stewards of all clinical trial data and its overall quality.
-
Clinical Trial Disclosure Compliance: A Moving Target10/19/2023
To date this year, 115 updates to clinical trial disclosure rules have been tracked across global regulatory agencies. See what types of changes have occurred, where they were, and how they are implemented.
-
The Shifting Paradigm Of Dose Selection In Oncology6/21/2023
Oncology drug development is undergoing a significant transformation. Explore strategies for integrating dose finding and optimization into early clinical development and how it could benefit oncology patients.
-
eTMF As A Factory: Elements For High-Volume, High-Quality Processing4/17/2023
In an ideal scenario, the eTMF would operate like a well-oiled factory. Examine some of the key factors that would support making “The eTMF Factory” a reality.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
RTSM: Randomization And Cohort Management, IP Inventory Management4/17/2024
Signant’s SmartSignals® RTSM solution helped an innovative biopharmaceutical company secure an FDA Orphan Drug designation for its cardiomyopathy drug.
-
eSource For A COVID Treatment Trial1/17/2024
Unearth how this emerging biopharmaceutical company was able to overcome challenges to successfully facilitate a Phase 2 trial for a COVID-19 treatment in critically ill patients.
-
Advancing Your API To First Human Dose Trials More Efficiently2/7/2024
Learn how end-to-end support for development and manufacturing, clinical trial services, advanced drug delivery, and commercial packaging can accelerate drug development and time to market.
-
An Exploration Of ICIs In Cancer Therapy1/31/2024
This collection of frequently asked questions highlights the remarkable efficacy of immune checkpoint inhibitors (ICIs) and the projected growth of the global ICI market.
-
Zero Disruptions: Migrating 14 Mid-Study Clinical Trials In 16 Months11/15/2023
Uncover how Imperial College London was able to effectively transfer 14 ongoing studies, encompassing over 1,700 patients and 150,000+ forms, onto a new EDC platform within 16 months.
-
Breaking The Mold: How R Is Revolutionizing CSR Generation4/22/2024
The open-source statistical programming language R is becoming more popular in the life sciences sector for clinical study report submissions due to its cost-effectiveness, inclusivity, and collaboration.
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
-
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.
-
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.
-
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
-
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.
-
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.
-
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.