By pairing donor priorities with research needs at Children's National, Milken Institute SPARC is turning philanthropy into faster trials, stronger infrastructure, and long-term care goals.
- 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
- Immune Priming, Oncolytic Viruses, And The Next Phase Of Solid Tumor Immunotherapy
GUEST COLUMNISTS
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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.
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Stock Options: Choosing The Right Viral Inoculum For An Early-Phase Norovirus Trial
Viral stock can make or break a norovirus challenge study. Cocrystal Pharma's Sam Lee explains why inoculum quality, infectivity, and availability matter.
CLINICAL TRIAL WHITE PAPERS
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Innovating With Generative And Agentic Artificial Intelligence
Discover how specialized AI is revolutionizing clinical trials by enhancing data quality and operational speed through curated training, human oversight, and objective scientific analysis.
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Overcome Patient-Level Access Barriers For New Medicine3/23/2026
Explore market access from the patient’s perspective and identify five aspects of how people get hold of medicine that should inform commercialization.
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A 2025 Survey Report Uncovers The Top 5 Clinical Trial Cost Insights4/22/2025
In this 2025 survey of over 100 U.S. clinical trial participants and caregivers, we reveal that most individuals join trials seeking life-saving treatment, not financial gain.
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Completed Clinical Trials Continued To Climb In 20246/19/2025
Data collected in this report reflects a shift toward sustained growth, reflecting rapid advancement in therapeutic areas such as oncology, autoimmune/inflammation, and central nervous system studies.
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The Evolution Of SDV, SDR, And RBQM In Clinical Trial Data Quality11/18/2024
Explore the inefficiency of complete SDV and how the adoption of technologies like centralized monitoring, remote SDR, and targeted SDV can enhance data integrity and cost-effectiveness.
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The Renaissance Of Psychedelic Research: History, Protocols, And Forward Trajectories7/30/2026
Discover how clinical trial protocols are evolving to address unblinding, therapeutic support variables, and regulatory standards in modern psychedelic research.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Breaking Down Operational And Financial Complexity In Clinical Trials12/8/2025
Consider how factors like hybrid visits, enrollment patterns, and variable procedure volumes shape both the cadence and magnitude of site payments, supplier activity, and patient-related expenses.
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Increasing Efficiency And Reducing Drug Waste10/2/2025
Discover how streamlined clinical supply chain management helped accelerate study timelines, reduce costs, and support global treatment delivery through a strategic technology partnership.
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CRO Takes Trial Build Times From Weeks To Days5/27/2025
Recognizing the inefficiencies in traditional build processes, a top global CRO partnered with Medable to transform its approach to clinical trial launch.
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Turning Patient Advocacy Into Meaningful Trial Engagement8/18/2026
See how structured PAO engagement can inform protocol design, reduce participation barriers, and strengthen recruitment and retention.
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A Long COVID Study Sponsor Adopts Integrated eCOA And Cognitive Assessment Solution8/18/2025
eCOA tools used in a long COVID study enabled remote, real-time symptom tracking, cognitive testing, and patient-reported outcomes, ensuring high-quality data while minimizing patient burden.
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Optimizing Wearable Adherence In A Phase 3 Oncology Trial5/15/2026
Long-term wearable monitoring only works if patients keep wearing the device, and in oncology trials, that’s easier said than done.
NEWSLETTER ARCHIVE
- 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
- 08.27.26 -- What The FDA's Psychedelic Drug Focus Means For Classic Psychedelic Development
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.