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.
- How To Determine Country Feasibility For Cell And Gene Therapy Clinical Trials
- Shorter, Faster, Cheaper: Powerful New Data On Digital Endpoints
- Looking Back & Moving Forward With J&J’s Global Development Leader For Immunology
- Mission: Remission — Patient Need For Durable Treatment Informs J&J’s Ulcerative Colitis Trial
- Ignoring Digital Biomarkers Will Be Your Undoing
- FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket Submissions
- ICH E6(R3) And Defining What Is Critical To TMF Quality
GUEST COLUMNISTS
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![Cyber Alert GettyImages-1185282377]( "FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket Submissions")
FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket SubmissionsThe 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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![Robot Arm holding microchip-GettyImages-1309584123]( "2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies")
2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences CompaniesClarkston 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.
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![standardization certification compliance-GettyImages-1733514056]( "ICH E6(R3) And Defining What Is Critical To TMF Quality")
ICH E6(R3) And Defining What Is Critical To TMF QualityBy applying Quality by Design to clinical trials, sponsor companies can rise to meet the elevated role and importance of the TMF in the face of ICH E6 (RF3).
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![World health organization-GettyImages-1209486927]( "AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance")
AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good GovernanceThe World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.
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![Find job candidates-GettyImages-1635746271]( "You’ve Chosen Your Vendor(s), But Have You Thought About Their Oversight?")
You’ve Chosen Your Vendor(s), But Have You Thought About Their Oversight?Vendor management has become an even more complex task involving multiple stakeholders, and it may often be overlooked, especially in the oversight of subcontracted vendors.
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![FDA]( "New FDA Draft Guidance: Data Monitoring Committees In Clinical Trials")
New FDA Draft Guidance: Data Monitoring Committees In Clinical TrialsIn a new draft guidance, the FDA describes expectations of data monitoring committees in clinical trials. The public comment period ends April 15, 2024.
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![USA UK Canada round flags-GettyImages-1438625936]( "FDA, MHRA, Health Canada Joint GCP Symposium Focuses On 3 Key Topics")
FDA, MHRA, Health Canada Joint GCP Symposium Focuses On 3 Key TopicsThe FDA, the U.K. MHRA, and Health Canada recently came together for a symposium on GCP with focus on the ICH E6 harmonized guideline and two other key topics.
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![diverse people-mixed reactions-GettyImages-1589930234]( "The Results Are In — Survey Reveals Barriers & Opportunities In Site Sustainability")
The Results Are In — Survey Reveals Barriers & Opportunities In Site SustainabilityGet a better understanding of site-level dynamics with 2024 release of the Society for Clinical Research Sites' (SCRS) Site Landscape Survey.
CLINICAL TRIAL WHITE PAPERS
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![Intelligent Automation AI]( "Operationalizing Disclosure Intelligence For Go-To-Market Success")
Operationalizing Disclosure Intelligence For Go-To-Market SuccessRegulatory 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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Accelerating Study Start Up Through An Electronic Clinical Outcome Assessment (eCOA) Library5/2/2022
Dive into how the shift to patient reported outcomes has made Clinical Outcome Assessments (COAs) an increasingly necessary and often required tool in the clinical research landscape.
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Risks To Sponsors Developing And Running Their Own DCT Technology8/24/2022
Delve into the considerations of inadequate data in DCTs and how a sponsor can ensure it exerts appropriate control over the DCT technologies in place.
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Navigating The Complex Oncology Landscape: Rethinking Trial Strategy10/27/2023
In the clinical trial space, it's important to stay informed about global oncology trends impacting sponsors. Utilize these valuable insights to strategically enhance your clinical study approach.
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2024 Safety And Regulatory Compliance Trends And Predictions12/26/2023
The introduction of artificial intelligence and machine learning into pharmacovigilance, safety, and regulatory workflows stands to have a major impact on process efficiency and employee workloads.
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The Role Of Real World Evidence To Support US FDA And TGA Registrations9/22/2022
Real world evidence (RWE) can contribute valuable information to new medicine registrations, in particular, for diseases that are difficult to assess in randomized clinical trials (RCTs) and for emerging technologies.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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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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Alliance Bolsters Patient Engagement And Data Insights9/19/2023
Learn how the Metastatic Breast Cancer Alliance’s desire for richer participant information and heightened patient engagement led them to create MBC Connect™.
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Fast-Tracking Your Product Development With An IDP10/30/2023
Explore how a customized Integrated Development Plan assisted in the removal of guesswork and obstacles from a startup's development roadmap, enabling it to move with speed and remain competitive.
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An Exploration Of ICIs In Cancer Therapy1/31/2024
This collection of frequently asked questions highlights the remarkable efficacy of immune checkpoint inhibitors (ICIs) and the projected growth of the global ICI market.
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Large NCI-Designated Hospital System Trains 400 End Users, Resulting In Increased Levels Of Efficiency And Consistency6/28/2022
Learn how an eLearning solution was used to help overburdened trainers from a large National Cancer Institute (NCI)-designated hospital system.
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Collaboration Delivers Agility & Results During COVID-196/6/2023
Learn how a European multinational pharmaceutical company gained support for several international studies to test its RBD dimer recombinant protein vaccine for SARS-CoV-2.
NEWSLETTER ARCHIVE
- 04.19.24 -- Strategic Approaches To TMF Management Amidst Workforce Reductions
- 04.18.24 -- You've Chosen Your Vendor(s), But Have You Thought About Their Oversight?
- 04.18.24 -- Your Approach To Managing Complex Clinical Trials
- 04.17.24 -- 4 Questions About A DTx Clinical Trial
- 04.17.24 -- Mobile Nurse Visits Can Transform Clinical Trials - Here's Why
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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![Control room-GettyImages-1074166486]( "AI Technologies Drive Drug Development And Enhance Patient Experience In Neurology & Rare Diseases")
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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![teamwork-multiracial hands-GettyImages-852285850]( "Latest CISCRP Patient Survey Reveals Diversity Gaps, Yields 5 Tips For Improvement")
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.
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![ear source pain-GettyImages-1383500021]( "What’s Needed To Keep Tinnitus Research From Going Quiet")
Finding effective treatments for tinnitus has often been circuitous and frustrating for many patients. Tinnitus expert Marc Fagelson, Ph.D., explores the current treatment landscape and what can be done to improve outcomes for patients.
EMBRACING DIVERSITY & INCLUSION
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![Eldersly-old age-GettyImages-1324246375]( "Age Diversity In Clinical Trials: Why It Matters")
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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![White House American flag GettyImages-918426992]( "Clinical Trial Diversity, Flexibility Championed By The Food And Drug Omnibus Reform Act")
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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![GettyImages-1282038137]( "AI And Healthcare Disparities: Driving A Wedge Or Closing The Gap?")
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.
