UNC researcher Irena Dujmovic Basuroski, MD, Ph.D., discusses why transverse myelitis remains difficult to study, how multicenter collaboration and adaptive trial designs may help, and why better clinical, patient-reported, and biomarker-based measures are essential to advancing treatment.
- Clinical Trial Per-Patient Cost Analytics For Procurement And Sponsor Strategy
- Expanded Access And Rollover Design Help CytoDyn Reach High-Need Cancer Patients
- Why Protocol Complexity Is Slowing First Patient In — And How Small Sponsors Can Fix Start-Up Inefficiencies
- Delays At The Handoff: Where Breakdowns Occur Among The Sponsor, CRO, And Site
- The U.S. Clinical Trial Recruiting Pipeline Report – June 2026
- Pharma R&D Pipeline Productivity: Three Ways To Enhance Bandwidth And Efficiency
- When One Trial Leads To Rethinking Them All
GUEST COLUMNISTS
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![Lab Experiment-GettyImages-157697835]( "The U.S. Clinical Trial Recruiting Pipeline Report – June 2026")
The U.S. Clinical Trial Recruiting Pipeline Report – June 2026This 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 May 1 to June 30, 2026.
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![hand closing valve on gas pipeline-GettyImages-1450250263]( "Pharma R&D Pipeline Productivity: Three Ways To Enhance Bandwidth And Efficiency")
Pharma R&D Pipeline Productivity: Three Ways To Enhance Bandwidth And EfficiencyPA Consulting's Naveed Panjwani explores how to improve pipeline productivity via resource utilization, tech-enabled operations, and execution discipline.
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![navigating the future of healthcare-GettyImages-1785706755]( "Reduce Friction And Save Time: Revamp Site Training To Focus On Value Over Volume")
Reduce Friction And Save Time: Revamp Site Training To Focus On Value Over VolumeTransCelerate BioPharma members Ashlin Dunne, Anne Marie Inglis, and Ann Katrine Miranda assess the state of site training, examine how training affects trial execution, and discuss a better path forward.
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![Business finance-GettyImages-1503371245]( "The Cost And ROI Of Agentic AI In Clinical Trials: What Sponsors And CROs Need To Know")
The Cost And ROI Of Agentic AI In Clinical Trials: What Sponsors And CROs Need To KnowBeroe Inc. analyst T.G. Prasanna discusses agentic AI for clinical research and how it must be evaluated as a regulated operating cost transformation, with platform, orchestration, compliance, validation, and oversight costs modeled together.
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![Biological cancer cell disease-GettyImages-2161692091]( "Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors")
Unlocking Gentler, Cost-Efficient TIL Therapy For Cold TumorsCuraCell Head of Clinical Operations Torbjörn Ström discusses, in the context of CC-38 and CytoPLY-derived tumor-infiltrating lymphocytes (TILs), the utility of named-patient experience, dosing and preconditioning, and T-cell therapy capabilities in cold solid tumors.
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![Online testing, questionaire, voting-GettyImages-873499310]( "What Pistoia Alliance's AI Poll Reveals About Industry Readiness And Regulatory Confidence")
What Pistoia Alliance's AI Poll Reveals About Industry Readiness And Regulatory ConfidencePistoia Alliance President Becky Upton, Ph.D., reviews findings from a poll about AI use in clinical research conducted at Clinical Trials Technology Congress (CTTC) that revealed barriers to adoption, early ROI, emerging use cases, and the role of patient-generated data.
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![Busy surgery waiting room-GettyImages-1208597148]( "Early Patient Education And Community Outreach Are Advancing Representation In Clinical Trials")
Early Patient Education And Community Outreach Are Advancing Representation In Clinical TrialsMerck Executive Director, Clinical Trial Patient Representation, Adrelia Allen argues that patient awareness, access, early information, and trust shape are the pillars of patient representation in clinical trials.
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![woman receiving cancer treatment-GettyImages-1346190289]( "The Promise Of Bispecifics In The Quest For Outpatient Immunotherapy")
The Promise Of Bispecifics In The Quest For Outpatient ImmunotherapySTART San Antonio's Drew Rasco, MD, reflects on the evolution of immunotherapy and highlights how novel therapies such as bispecifics are both challenging and intriguing for principal investigators (PIs).
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-166539104-cell-petri-gloves-lab-research]( "Cell And Gene Therapy Field Quiet In Q2")
Cell And Gene Therapy Field Quiet In Q2While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.
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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 EMR Interoperability Dream Vs. Clinical Research Reality10/20/2025
Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.
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Sickle Cell Cure Within Reach, But At A Steep Cost7/10/2025
Treatment options for sickle cell disease (SCD) and newly available gene therapies represent a potential cure. However, the latter are costly and thus remain out of reach for many SCD patients.
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AI-Driven Signal Management: The Future Of Drug Safety12/19/2025
By combining autonomy with robust governance, agentic AI enables pharmacovigilance teams to move from reactive to proactive safety management, anticipating risks before they materialize.
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Patient-Focused Data Capture For Cancer Research8/21/2025
In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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AI In Clinical Data Management: How Does It Work?8/18/2024
AI is revolutionizing clinical data management by automating medical coding, data reconciliation, and audit trail reviews, significantly enhancing efficiency and accuracy.
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Use Case: How Consulting & Analytics Can Guide Clinical Strategy7/10/2025
A large European pharmaceutical company sought to benchmark a CRO’s suggestions involving a Phase III trial for a newly acquired asset.
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Rescuing Data Integrity: A Swift Transition And Quality Transformation11/14/2025
Uncover how this collaboration supported timely progress toward key study milestones, enabling smoother execution and more dependable output across data management and statistical activities.
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Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study1/6/2025
Explore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO.
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How Cara Therapeutics Increased Compliance And Reduced Study Team Burden7/31/2025
Delve into the partnership that helped Cara Therapeutics achieve a significant milestone in their clinical research efforts to transform the lives of chronic pruritus patients.
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Phase 1 Trial In Painful Diabetic Peripheral Neuropathy2/24/2026
A complex Phase 1 neuropathy study with overnight stays achieved full enrollment and retention through careful planning, strong participant engagement, and disciplined operational execution.
NEWSLETTER ARCHIVE
- 07.29.26 -- Hybrid Models, Disease Modification, And Comparator Sourcing: This Week In Clinical Trials
- 07.29.26 -- STREAM Edition: The Cost Of Late Engagement — In AI, Regulatory, And Supply Chain
- 07.28.26 -- When One Trial Leads To Rethinking Them All
- 07.27.26 -- Optimizing The Clinical Lifecycle: Evaluating Site Models, Unlocking Social RWD, And Elevating Representation
- 07.24.26 -- Turning RWD Into RWE That Works For Trials
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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![Inefficiency, delays, confusion, public administration-GettyImages-2213159033]( "Why Protocol Complexity Is Slowing First Patient In — And How Small Sponsors Can Fix Start-Up Inefficiencies")
Protocol complexity directly affects timelines, costs, and execution quality. Consultant Jessica Cordes explains why this challenge requires sponsors to change their approach to protocol design, feasibility, and start-up.
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![Busy surgery waiting room-GettyImages-1208597148]( "Early Patient Education And Community Outreach Are Advancing Representation In Clinical Trials")
Merck Executive Director, Clinical Trial Patient Representation, Adrelia Allen argues that patient awareness, access, early information, and trust shape are the pillars of patient representation in clinical trials.
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![Finance, data-GettyImages-2253914965]( "5 Informed Consent Fixes For Sponsors And Investigators")
Informed consent has never been solely about documentation, but some sponsors has treated it as a checkbox exercise. Here, consultant Tasha Mohseni shares tips and fixs for how best to approach informed consent.
FOCUS ON PATIENTS
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![Busy surgery waiting room-GettyImages-1208597148]( "Early Patient Education And Community Outreach Are Advancing Representation In Clinical Trials")
Merck Executive Director, Clinical Trial Patient Representation, Adrelia Allen argues that patient awareness, access, early information, and trust shape are the pillars of patient representation in clinical trials.
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![MRI_forPR_final-(4)-(1)]( "Digital Twins Enhance Disease Progression Measurements In FSHD")
Digital twins can transform trial design by making data more robust and alleviating patient burden. In this interview, Epicrispr CEO Amber Salzman, Ph.D., shares how the company's using it to reliably predict muscle volume change in their trial for a FSHD gene therapy.
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![kaniel_cassady_01_edit_stairs]( "How One Researcher's Personal Study Experience Is Helping Him Better Serve Patients")
Regeneron Executive Director in Clinical Sciences Kaniel Cassady, Ph.D., reflects on how his industry experience shaped his expectations, questions, and interactions as a patient in a clinical trial and how his patient experience is reshaping his clinical work going forward.
