In part two of this series, the authors continue the discussion by identifying specific tools and strategies that companies can use to improve communication and collaboration.
- 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?
- Cell & Gene Therapies: An Overview Of FDA Regulatory Considerations For 2024
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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Decision-Making For The Adoption Of A 'Bring Your Own Device' Strategy
Set explicit expectations about what "bring your own device" strategies should be, the associated risks, and propose structured help to support successful decision-making processes and implementation.
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Patient-Defined Recruitment: The Movement Advanced By COVID-194/17/2024
The pandemic forced the pharmaceutical industry to reimagine how we recruit patients to clinical trials – and it's delivering significant benefits to sponsors who embrace these changes.
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Unlock The Value Of Your Clinical Trial Data And Content With Big Data Discovery10/6/2022
Today, clinical trials are accommodating an incredible variety of data and content sources. This data explosion brings new and transformative opportunities, but learn why it also comes with additional risks.
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Navigating Key Complexities In The Development Of Cell & Gene Therapies5/17/2023
By engaging with the right partner, discover how biotech companies can navigate the full research and development continuum.
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Optimizing Generative AI In Clinical Operations4/17/2024
Crafting a thoughtful strategy to determine the optimal utilization of Generative AI in advancing medical research and enhancing patient well-being.
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eConsent Readiness In 24 Countries3/12/2024
Discover how regulatory bodies worldwide, including the U.S. Food and Drug Administration and the European Medicines Agency, are now championing the shift towards eConsent adoption.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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EU’s New Clinical Trial Regulation: What Does It Hold For Sponsors And Sites?5/16/2022
The Clinical Trials Information System (CTIS) is a centralized platform for Clinical Trial Application (CTA) and marketing authorization submissions, and supervision of clinical trials across the European Union/European Economic Area (EU/EEA). The regulation, which came into effect on January 31, 2022, aims to simplify and streamline routine clinical processes.
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A Smart Solution To Clinical Supply Management10/28/2022
Delve into a solution that ensures the efficient delivery of trial materials worldwide, while navigating the challenges of more complex study designs and the ever-evolving regulatory landscape.
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A Sponsor’s Commitment Drives Global Site Adoption & Process Optimization2/15/2023
A global top 10 pharma sponsor needed a provider whose core focus was on patient payments with heightened functionality and centrality. Find out the solution they turned to to solve this need.
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Tackling The Complexity Of Pediatric Clinical Trials1/18/2023
Understand why despite the evolution in pediatric legislation and a renewed interest in developing therapeutics for pediatric and rare diseases, pediatric clinical research remains deeply challenging.
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Validating New Identification Algorithms With Objective Criteria & Clinical Trial Data7/19/2023
Learn how researchers and clinicians can make better-informed decisions to advance patient care and enhance public health outcomes related to myocardial infarction.
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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.
NEWSLETTER ARCHIVE
- 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
- 04.23.24 -- Ignoring Digital Biomarkers Will Be Your Undoing
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.