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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What Does The New FDA DHT Guidance Mean?
In December 2023, the FDA released the final version of its digital health technologies guidance, outlining the facilitated use of sensor-based DHTs and wearables in clinical investigations.
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Achieving Harmonious and Optimized Site Budget Negotiations4/13/2023
Review findings from research efforts into how principal investigators survive the complex process, identify coping strategies, and combat budget negotiation challenges.
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Beyond Integration: Flexible Orchestration Of IRT And eCOA Solutions4/25/2023
Consider how integrated response technologies and electronic clinical outcomes assessments can improve configurability, study start-up, and flexible mid-study changes.
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Pharma R&D Annual Review 20234/17/2023
Although COVID-19 has not quite finished its final act, it appears the industry is emerging from this tumultuous episode stronger and emboldened. Find out if the 2023 pipeline was a page-turner in this literary-themed Pharmaprojects’ 2023 review of trends in pharmaceutical R&D.
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Adaptive Designs Save Time And Money: Why Aren’t They Used More Often?3/14/2023
Get a brief introduction to adaptive designs, including their major benefits and challenges and best practices for operationalizing them. This foundation will help maximize the likelihood of success when implementing an adaptive trial design.
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The Essential Role Of Adjudication Technology In Clinical Trials10/19/2023
With adjudication, learn how teams can enhance the quality and integrity of their research, paving the way for impactful and reliable outcomes in clinical research.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Optimizing Direct-To-Patient Supply Management: ClinChoice And 89Bio9/1/2022
Learn how the CRO ClinChoice and the sponsor 89Bio were conducting a phase II, randomized, double-blind, placebo-controlled study that needed to pivot to a decentralized protocol during the pandemic or face trial disruption.
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EDC For Mid-Study Changes In Medical Device Clinical Trials6/21/2022
In this case study, discover how a company was pointed to an electronic data capture (EDC) system that was quick to adapt and easy to scale as the study changed.
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Partner Helps Biotech Organization Become Inspection Ready8/1/2023
Delve into the details of how after receiving proper consulting, this renowned biotech company was able to conduct thorough site inspection readiness activities and receive an accelerated FDA approval.
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Enhancing Oncology Trials With Clinical Platform Solutions10/18/2023
This example involves a top 10 pharmaceutical company and explores how they were able to improve oncology trial efficiency, safety, patient experience, and more using a platform approach.
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A Comprehensive Planning Approach For Cancer Antibody9/29/2023
Discover how a clinical-stage biotech company was able to accelerate pathways for development and regulatory review of their first Phase I protocol for an immuno-oncology antibody.
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Top Pharma Achieves Record-Breaking Enrollment In Weight Loss Trial10/18/2023
See how digital solutions enabled this top pharma’s fastest clinical trial enrollment period of all time.
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.