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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Developing A Strategy To Optimize Study Supplies
Discover how the optimization of a clinical supply strategy can decrease wasted supplies, drive down costs, and ensure supplies reach the sites on time and in the correct quantities.
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Operationalizing Disclosure Intelligence For Go-To-Market Success12/16/2022
Regulatory intelligence goes beyond ensuring compliance. By monitoring and understanding these integral disclosure obligations, sponsors can position clinical trials for seamless completion from the start, and position themselves as industry leaders.
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Considerations For Plain Language Summaries4/22/2024
Recent FDA emphasis on plain language underscores a shift towards greater transparency and patient understanding, highlighted in the joint FDA and Office for Human Research Protections (OHRP) draft guidance.
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Direct-From-Patient Data Capture With eCOA5/2/2022
Learn how an eCOA tool can provide patients a chance to be heard while giving sponsors quantitative and qualitative data to track the efficacy of a treatment.
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Rare Disease – 2018-2022 Global Clinical Trial Landscape11/7/2023
Discover why the collaboration and expertise of organizations are vital in advancing rare disease research and improving the lives of millions affected.
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Synthetic Control Arm In Clinical Trials12/8/2022
Get an overview of the SCA, an external control generated with the goal of improving the interpretation of uncontrolled trials, which can enable better product development decisions.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Navigating Sensitive Country Requirements2/1/2024
See how Scout expertly navigated complex regional laws and regulations to allow study patients in Iran access to treatment in Turkey.
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Using IRT Data To Automate And Optimize Clinical Supply4/17/2023
Learn how clinical teams can save between $150,000 and $1 million in annual drug and shipping costs through automated supply optimization.
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From Paper To Digital Study Management In Large Patient Registries2/13/2024
Uncover how this sponsor was able to independently design and oversee its clinical study, minimizing external assistance, and easing the workload for their sites through mobile app accessibility.
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Biopharma In Non-Footprint Countries Gets Support11/22/2023
Uncover how this tailored solution helped a multinational pharmaceutical and biotechnology firm to develop an in-country presence and expertise, which was critical to meeting their study timelines.
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Patient Insights Informed Consent Engagement9/18/2023
By incorporating the patient viewpoint throughout the informed consent process, discover how this technical solution enhanced the overall patient experience within clinical research operations.
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Flexible, Global Delivery For Alzheimer’s Patients7/10/2023
Learn how MRN was able to take charge of overseeing clinical trial nurses and participants and work with Washington University to deliver clinical services to over 100 participants worldwide.
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.