Investigator-sponsored research (ISR) and investigator-initiated trials (IIT) are essential to expanding the drugs currently available or under investigation, either alone or in combination, to address unmet medical needs.
- What Can Digital Patient Twins Do For Clinical Research?
- What To Expect From An FDA Inspection
- Fortifying The 3 Cs With Strategic Approaches And Tools
- Assessing The 3Cs: Does Your Organization Have The Foundation For Clinical Trial Success?
- 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?
GUEST COLUMNISTS
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Will Today’s Clinical Trial Trends Become Tomorrow’s Routine?
Clinical trial trends can be divided into two groups — those related to changes in the conduct of clinical trials and those related to the changes in therapeutic areas. Will these trends hold steady as 2024 unfolds?
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For Veteran PI, Research Requires Motivation, Dedication, And CRO Support
Principal investigator Dr. Luke Twelves discusses how he remained motivated to continue conducting trials and shares insights into what he thinks will inspire others to do the same.
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Yes, Women’s Exclusion In Clinical Trials Is Still A Problem
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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Considering The Patient Experience Is Critical To Creating A Successful ICF
If an ICF is not written with the patient in mind — so that it truly facilitates an informed consent — a clinical trial runs the risk of losing viable study participants and derailing study start-up, even success.
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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.
CLINICAL TRIAL WHITE PAPERS
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Busting The Top 7 Data Quality Myths In Clinical Trials
Separate fact from fiction and dispel the myths about evolving clinical data collection, monitoring, and reporting by diving into this analysis of technology use in clinical trials.
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Maximize Your R&D Investment In DHTs Through The Use Of Raw Sensor Data7/19/2022
This white paper clarifies the myths about raw data and discuss why raw data is essential to maximize the clinical insights and the investment made into the clinical trials.
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2022 Completed Trials: A Roller Coaster Ride For Industry Sponsors6/15/2023
Dive into this analysis to better understand why the clinical trials landscape has not returned to its pre-pandemic level of momentum.
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Clinical Development Strategies For Western Biotech Companies In China9/22/2022
Delve into how China is now more aligned with international standards, enabling biotech firms to streamline processes and timelines, which has significantly recharged biotech innovation.
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Mobile Application Considerations For Clinical Trials And Beyond8/28/2023
Delve into fundamental definitions, navigate through the regulatory landscape, and examine common applications of mobile apps in research.
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How Sponsors And CROs Can Use Direct Patient Feedback To Improve Trial Engagement9/6/2022
Discover patient and public perceptions, and how the industry is evolving to deliver an improved clinical trial participant experience in this paper.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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CAR T Study For Blockbuster Drug Granted Therapy Designation2/28/2023
Discover how a pharmaceutical sponsor received support for an EDC and IRT database build and got help with data management and biostatistics.
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Solutions Support Endpoint Reliability In Pediatric Rare Disease Trial8/15/2023
Dive into this case study where a pharmaceutical sponsor running a trial for a new treatment for a rare pediatric disease employed solutions and services dedicated to enhancing endpoint reliability.
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Top-Tier University Stays Compliant With HRPP Assessment4/27/2023
Discover how one university was able to identify and resolve programmatic gaps in compliance with federal regulations and revitalize its Human Research Protection Program.
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Advancing From Single Country Phase 1 Success To Multinational Phase 1/2 Trial1/3/2024
Explore how this partnership aims to contribute to the success of the trial by leveraging global resources and streamlining processes for efficient and timely results.
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Optimizing Startup And Payment Processes While Reducing Time And Costs8/31/2023
Delve deep into the collaborative journey between global contract research organization Linical and Greenphire, and how the CRO was able to revolutionize its financial lifecycle of clinical trials—from initial budgeting to seamless site payments.
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Completing Recruitment In 4 Countries In A Study For ED11/10/2023
Uncover how a leading Eastern European CRO completed patient recruitment ahead of schedule in an erectile dysfunction study involving the evaluation of an innovative MED3000 topical gel.
NEWSLETTER ARCHIVE
- 05.03.24 -- Shorter, Faster, Cheaper: Powerful New Data On Digital Endpoints
- 05.03.24 -- Clinical Trial Software And Service Partners Ready To Help
- 05.02.24 -- ICH E6(R3): Defining What's Critical To TMF Quality
- 05.01.24 -- Seeking Clarity With DCT Guidance
- 04.30.24 -- Optimizing Clinical Operations: Digital Transformation Tips
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.