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.
- Accountability Gaps Can Break Clinical Supply Contracts
- 'How Do You Feel?': Designing A Cardiac Trial With A Patient-Reported Primary Endpoint
- Sustainable Patient Engagement: Your Enrollment And Representation Depend On It
- The Big Idea Behind The Creation Of SIP
- Building The Execution Architecture For Real-World Data To Have Real-World Impact
- Stock Options: Choosing The Right Viral Inoculum For An Early-Phase Norovirus Trial
- The Reality Of Clinical Research Federal Funding Cuts
GUEST COLUMNISTS
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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.
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The Reality Of Clinical Research Federal Funding Cuts
Although the most catastrophic federal funding cuts didn't come to fruition, Pamela Garzone discusses where some impacts are being felt now and will be felt for years to come.
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Everyone Is A Consultant Now
Jon Newton argues clinical research’s “vanishing middle” is giving rise to a more flexible workforce of consultants, specialists, and boutique firms.
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Rare Disease Study Gets A Boost From Crowdsourced Patient Reported Data
Jen A. Levitt, MD, explains how crowdsourced patient-reported data and AI tools can compress rare disease research timelines and surface new signals.
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What The Sponsor–CRO Relationship Gets Wrong — On Both Sides
The CRO's value is not execution alone. It is the depth of perspective that comes from having seen hundreds of trials across disease areas and regulatory environments.
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The U.S. Clinical Trial Recruiting Pipeline Report – July 2026
This WhichTrial report breaks down which drug trials are growing the most and the least, drugs that are no longer being studied, and new drugs to the clinic from June through July 2026.
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The Art And Skill Of Caring For Terminally Ill Patients In Clinical Research And Beyond
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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What The FDA's Latest Move On Psychedelics Means For Non-Hallucinogenic Drug Sponsors
Taking another angle to the FDA focus on psychedelic research, Enveric Biosciences CEO Joseph Tucker, Ph.D., explores what the FDA’s moves mean for non-hallucinogenic drug sponsors.
CLINICAL TRIAL WHITE PAPERS
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Navigating Complexity In Master Protocols With Key Operational Partners
Complex adaptive trials offer real efficiency gains, but success hinges on having experienced partners to manage the operational details.
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The Next Era Of eCOA Is AI4/15/2026
Discover how AI is moving beyond the hype to streamline clinical study builds. Explore practical ways to automate protocol digitization and UAT scripts while preparing for future patient tools.
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Best Practices In Rare Disease Patient Recruitment3/9/2026
Recruiting for rare disease clinical trials is daunting, and making patients aware of clinical trials, involving them in trial design, and building trust are a few ways sponsors can boost recruitment.
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Immunohistochemistry In Precision Medicine: From Biomarker To Clinical Trial Assay6/17/2025
From preclinical validation to clinical implementation, immunohistochemistry (IHC) is essential in understanding target biology and ensuring drug safety and efficacy.
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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 Patient Recruitment Shift: Navigating Disruption, Delivering Precision3/27/2025
Explore the four macro trends reshaping the recruitment space in 2025—each grounded in emerging data, technology, and behavior shifts.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Strategic Pre-IND Consulting For Gene Therapy In Rare Leukemia4/11/2025
Learn about the collaborative efforts of an innovative biotech startup and Ergomed Consulting to overcome challenges in the pre-IND phase for a novel gene therapy targeting a rare form of leukemia.
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How Compassion Shaped This Pediatric Rare Disease Trial6/11/2025
Learn how kindness transformed the clinical trial experience for pediatric rare disease participants in a global study.
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No More Swiss Holes: Filling The Gaps In Clinical Trial Disclosure1/14/2026
This use case shows how sponsors can gain clarity on disclosure requirements when entering a new country.
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Pioneering The End-To-End Decentralized Trial Experience4/16/2025
This collaboration highlights the potential of decentralized clinical trials (DCTs) to transform trial execution, as well as offering a replicable model for future research.
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Sensors And On-Demand eCOA7/13/2026
See how one rare disease trial eased caregiver burden by unifying glucose monitoring and patient diaries into a single app with real-time safety alerts.
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Scaling Global Vaccine Mega-Trials For A Top Five Pharma4/16/2026
See how high-volume enrollment, dynamic safety data capture, and rapid iteration can support global studies operating under intense timelines and scale.
NEWSLETTER ARCHIVE
- 08.24.26 -- Bridge The Gap Between Raw Data And Clinical Enrollment
- 08.21.26 -- Safeguarding Data Integrity And Exploring Agentic AI
- 08.21.26 -- From Oncology To Neuro-Science: Flexible CRO Support Built For Every Trial
- Take Another Angle To The FDA Focus On Psychedelic Research
- 08.19.26 -- Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors
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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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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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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When designing and conducting trials for terminally ill patients, Kamila Novak reminds researchers to act and speak with respect, warmth, and thoughtfulness.