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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The Importance Of An Implementation Lead Within FSP Models
Uncover how the role of the Implementation Lead from PPD™ FSP ensures streamlined and expertly managed onboarding and resource allocation for FSP clinical research projects.
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Accelerate Clinical Development With Patient-Centered Digital Endpoints12/16/2022
While biomarkers have improved trial efficiency in some cases, patient-centered clinical outcome assessments remain essential – the lack of which can lead to commercial catastrophe.
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Solving The EHR-To-EDC Challenge: A Scalable-First Approach8/14/2023
Unearth how industry shifts, technology adoption, and interoperability openness are paving the way for scalable solutions.
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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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Clinical Trials Are Better, Faster, Cheaper With Big Data12/8/2022
The path from study design to approval is long, winding, and expensive. Explore how researchers are using artificial intelligence and advanced analytics to speed up the process, reduce costs, and get effective treatments swiftly to those who need them while tapping into data on patients from past trials.
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Still Using Paper Diaries To Capture PRO Data? Read This.1/8/2024
Access real-world examples of how electronic patient-reported outcome measures (PROMs) optimize data quality and reliability and improve the statistical power of trial data.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Integrating Early-Phase Clinical Supply Manufacturing & Distribution5/10/2022
A tablet formulation was a solution when developing a new class of anti-infective medicine, allowing the integration of formulation development, clinical trial material (CTM) manufacturing, and supply and distribution to patients.
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Blinded Randomization And Trial Supply Management Gets Support11/17/2023
Uncover how this global specialty pharmaceutical company was able to ensure the confidentiality of its blinded study data while receiving flexible and scalable unblinded support.
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Global CRO Streamlines Study Startup By Centralizing IRB Review5/17/2023
See how PRA Health Sciences was able to convert to a central IRB to improve the overall study startup processes and timelines.
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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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ClinCard Supports Tufts Medical Center’s Commitment To Care And Research2/17/2023
Administrative work is to be expected at any site. Explore how improved and efficient administrative processes can ensure a better experience for patients and the team.
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How A Top 3 Global CRO Reduced The Impact Of CRA Hiring And Retention Challenges8/22/2022
Learn how a top 3 global CRO implemented technology to remotely connect with their research sites and can now monitor up to 50 sites per week, compared to the former average of two on-site monitoring visits per week.
NEWSLETTER ARCHIVE
- 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
- 04.23.24 -- Revolutionizing Healthcare: AI, RWD, Cloud Tech, And Automation
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.