To commemorate Clinical Trials Day 2024, Clinical Leader tapped its community of clinical research professionals to share their experiences with and praise for working with one another across the industry.
- How Are PIs Paid? All The Options For Clinical Research Investigator Compensation
- Finding The Right Patients For Ketamine Clinical Trials
- Competitors Need To Collaborate On Digital Biomarkers
- Best Practices For Trial Design And Site Selection In Pediatric Clinical Trials
- $25 Million Awards Help Cancer Researchers Make Clinical Trial Inroads
- For Hybrid Trials, Have Some Faith … In Sites
- Multidisciplinary Collaborations Fuel New Glioma Treatment Breakthroughs
GUEST COLUMNISTS
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Meaningful Industry Change Means Balancing Tech And Human Touch
Technology and AI/ML are advancing at an unprecedented pace, and we must not lose sight of our industry's core: human-to-human interaction.
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Multidisciplinary Collaborations Fuel New Glioma Treatment Breakthroughs
Servier's Susan Pandya, MD, vice president of clinical development, shares what can be achieved when scientists, patients, investigators, and advocacy groups collaborate to create an innovative trial design for a potential breakthrough therapy.
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Unleashing The Power Of Investigator-Sponsored Research (ISR) And Investigator-Initiated Trials (IIT)
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.
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Early Exposure & Site Network Support Enable PI’s Enduring Interest In Research
Seasoned Phase 1 principal investigator and site co-director Manish Sharma, MD, recounts his career thus far as a PI, offering insights into PI motivation, retention, and satisfaction.
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Take-Home Microdosing Trial Studies Sub-Hallucinogenic For Depression
MindBio Therapeutics CEO Justin Hanka details the company’s Phase 2a clinical trial investigating the use of a take-home microdosing regimen for depression.
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What Can Digital Patient Twins Do For Clinical Research?
Digital patient twins have the potential to vastly improve our current healthcare systems by offering personalized therapeutics, enhanced health monitoring, and streamlined pharmaceutical manufacturing, including clinical trials.
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Fortifying The 3 Cs With Strategic Approaches And Tools
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.
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Assessing The 3Cs: Does Your Organization Have The Foundation For Clinical Trial Success?
In part one of this series on exploring the importance of culture, communication, and collaboration, the authors discuss the makings of a strong company foundation and offer an assessment plan meant to reveal strengths and weaknesses in those three areas.
CLINICAL TRIAL WHITE PAPERS
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Optimizing Your Clinical To Commercial Journey
How should you think about optimizing the journey from the development stage of clinical trials to commercialization? Review considerations to eliminate avoidable delays and have a seamless transition.
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Achieving Harmonious and Optimized Site Budget Negotiations4/13/2023
Review findings from research efforts into how principal investigators survive the complex process, identify coping strategies, and combat budget negotiation challenges.
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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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The EU MDR Is In Effect. Now What?11/15/2022
In May 2021, the EU MDR replaced the EU's Medical Device Directive and Directive on Active Implantable Medical Devices. Learn about the basics of this regulation, who it impacts, and how to collect EU MDR-compliant clinical data.
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A Guide To Patient-Centric Digital Endpoints In Heart Failure Trials7/18/2023
Unearth the ways actigraphy can objectively measure treatment effects on a variable that drives patient outcomes and prepare trials to better align with the FDA’s position on patient-centric drug development.
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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.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Supporting Utilization & Recruitment Through COVID-196/7/2023
Supporting one of the world's largest pharmaceutical research organizations, MRN has more than doubled patient recruitment rates and quadrupled home visit referrals during the global outbreak of COVID-19.
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Essity Uses eConsent To Optimize Enrollment8/15/2023
See how a global hygiene and health company was able to deploy virtual methods through a strategic partnership to recruit and retain participants, streamline consent, and analyze patient data.
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Patient Caregiver Network Improves Post-Seizure Trial Data3/26/2024
Discover how a pharmaceutical CRO addressed concerns about seizure diary timing in a rare disease study, leveraging insights from Medable's Patient Community Network to optimize data collection.
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Data Management Solution For A Clinical-Stage Cancer Immunotherapy Study2/9/2023
Check out the results from a clinical first-in-human study evaluating the safety and tolerability of an investigational cancer immunotherapy in patients with advanced melanoma.
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Retention Improved In A Pompe Disease Clinical Trial4/18/2023
Explore the ways one double-blind, randomized Phase 3 study was able to boost the participant’s overall adherence to the protocol and increase their willingness to continue with the trial.
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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
- 05.20.24 -- Enhancing Oncology Drug Development For Patient Safety
- 05.17.24 -- It's Crucial Role: Development Risk Management Plans For Small Clinical-Stage Companies
- 05.16.24 -- Multidisciplinary Collaborations Fuel New Glioma Treatment Breakthroughs
- 05.15.24 -- Unleashing The Power Of ISR And IIT
- 05.15.24 -- Unlocking Innovation: 6 Decades Of DIA's Global Journey
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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Are you truly listening to patients? Discover what it means to be a good listener in the clinical trial setting with The Crohn’s & Colitis Foundation Associate Director of Research Engagement Carol Chapman, MPH.
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“Children are not small adults," reminds Katie Smentek, MD, a PI at Mankato Clinic. Here, Smentek shares her advice for designing trials and selecting sites for pediatric patients.
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Technology and AI/ML are advancing at an unprecedented pace, and we must not lose sight of our industry's core: human-to-human interaction.
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.