Aprea’s Gene Kennedy explains how smart dose escalation, next-gen sequencing, and combination planning are helping the company advance its oncology trial for multiple solid tumor types.
- Lessons In Forecasting Discipline From A $40B Supply Chain
- The Pharmacy Benefit No One Is Managing: Clinical Research As A Care Option
- Planning A Global Clinical Trial With The Right Sites, Not The Most Sites
- Turning Pediatric Cancer Discoveries Into Medicines Requires Better Connections
- Building SIP Was The Hard Part
- Turning A Historically Limited Modality Into A Respiratory Drug Opportunity
- It Is Time To Require Human-Relevant Efficacy Evidence Before First-In-Human Trials
GUEST COLUMNISTS
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It Is Time To Require Human-Relevant Efficacy Evidence Before First-In-Human Trials
Why, when human-relevant evidence of likely efficacy can be generated before a trial begins, is it not evaluated before patients are exposed?
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Immune Priming, Oncolytic Viruses, And The Next Phase Of Solid Tumor Immunotherapy
Can priming with oncolytic viruses be a better path to reeducating the immune system to recognize and attack cancer? Oncolytics Biotech advisor Richard Vile, Ph.D., says yes.
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4 Ways That AI And Point-Of-Care Diagnostics Are Redefining Clinical Trial Design And Operations
Discover how AI-enhanced point-of-care diagnostics are changing trial design and what ClinOps should do next.
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What BriaCell's Trial Design Says About Real-World Cancer Research
BriaCell President and CEO William Williams, MD, shares how broader eligibility criteria and physician’s choice controls can better reflect real-world cancer care.
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Accountability Gaps Can Break Clinical Supply Contracts
Contract gaps can create clinical supply failures when responsibilities differ across agreements. See how aligning obligations can prevent costly disputes, delays, and risks.
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'How Do You Feel?': Designing A Cardiac Trial With A Patient-Reported Primary Endpoint
Imbria Pharmaceuticals' Albert Kim, MD, Ph.D., shares why PROs are the point of the company's FORTITUDE-HCM trial for patients with non-obstructive hypertrophic cardiomyopathy.
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Sustainable Patient Engagement: Your Enrollment And Representation Depend On It
Early and ongoing patient engagement is a crucial component to staving off recruitment trouble and securing proper patient representation. Boehringer Ingelheim's Karen Correa, Ph.D., explains how.
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Building The Execution Architecture For Real-World Data To Have Real-World Impact
RWE's next challenge is execution. Learn how life sciences orgns can turn evidence into sustained business and clinical impact.
CLINICAL TRIAL WHITE PAPERS
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Safeguarding Personal Data: Protecting PII
Learn about a secure, patient-centric platform that enables individuals to participate in clinical trials and registries while maintaining lifelong access to their data.
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A New Era Of ADC Development Demands A New Kind Of Partner3/30/2026
Explore how to navigate the evolution of antibody-drug conjugates by mastering AI-driven selection, dose optimization, and new regulatory strategies for earlier-line clinical success.
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New Duke Research Shows Participants Prefer Enhanced eConsent10/7/2024
It’s apparent to those who have used it that the “e” in eConsent could stand for much more than 'electronic'. Duke’s new research shows why participants prefer an eConsent experience bolstered with videos, media, questions, and more.
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De-Risking Early-Stage Biotech: Turning Vision Into Venture Capital9/3/2025
For early-stage biotech companies, transforming a scientific breakthrough into an investable asset requires more than compelling data—it requires a clear product vision.
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ICH GCP E6(R3) Implementation: Practical Approaches And Real-World Considerations11/21/2025
Access the full brief to learn how a phased, 12–18-month approach can help you meet ICH GCP E6(R3) requirements with confidence and avoid the costly pitfalls many organizations overlook.
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Advancing Alzheimer's Disease Therapies9/3/2025
By uniting scientific innovation with patient-focused execution, the next generation of alzheimer’s disease (AD) therapies has the potential to deliver a transformative impact on global health.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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ICON And Medable Drive 85% eConsent Adoption In U.S. Menopause Study4/1/2026
A site-focused strategy drove strong eConsent adoption in a complex women’s health study, showing how tailored training and hands-on support boost engagement and compliance.
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Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning1/31/2025
The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.
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Advancing Neuromuscular Research with Digital Endpoints1/20/2026
Explore cutting-edge digital measures that capture peak mobility and activity in real-world settings, offering meaningful insights into disease progression in neuromuscular disorders.
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Successful EU MAA Submission Enabled By U.S.–EU Regulatory Collaboration5/27/2026
Facing EU MAA complexity? Learn how one oncology sponsor met a fixed EMA deadline through global regulatory coordination, rapid dossier adaptation, and real-time submission execution.
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Duchenne Muscular Dystrophy Trial In China9/17/2025
A global sponsor conducting a Duchenne Muscular Dystrophy trial in China required reliable patient travel solutions to support children and families.
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Participant Support In Oncology Trials With Cachexia-Related Burden4/21/2026
Coordinated travel, reimbursements, and visit logistics for oncology participants experiencing fatigue, weight loss, and reduced mobility, helping reduce dropouts and keep people engaged.
NEWSLETTER ARCHIVE
- 09.01.26 -- Cut The Chaos: Smarter Systems For Sites, Sponsors, And Data
- 08.31.26 -- Compassion Shaping Pediatric Rare Disease Trials
- 08.29.26 -- Understanding And Preserving Data Flow Integrity In AI-Assisted Clinical Trials
- 08.28.26 -- From Data To Detection: Smarter Systems Are Reshaping Trial Oversight
- 08.28.26 -- Community Engagement, Travel Logistics, And Technology Driving Trial Success
RECRUITMENT AND DIVERSITY
This section includes some helpful resources regarding patient recruitment and diversity in clinical trials, including this link to the FDA's guidance on diversity action plans.
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Early and ongoing patient engagement is a crucial component to staving off recruitment trouble and securing proper patient representation. Boehringer Ingelheim's Karen Correa, Ph.D., explains how.
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When designing and conducting trials for terminally ill patients, Kamila Novak reminds researchers to act and speak with respect, warmth, and thoughtfulness.
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Skyhawk’s patient-first approach shows how advocacy partnerships, site engagement, and operational quality can accelerate enrollment without losing focus on patients.
FOCUS ON PATIENTS
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Pharmacies could make trials more accessible — if they preserve patient trust while research partners handle the operational burden.
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Why, when human-relevant evidence of likely efficacy can be generated before a trial begins, is it not evaluated before patients are exposed?
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Early and ongoing patient engagement is a crucial component to staving off recruitment trouble and securing proper patient representation. Boehringer Ingelheim's Karen Correa, Ph.D., explains how.