Clinical Leader - Helping clinical research professionals connect and collaborate

What It Takes To Validate A Biomarker For Real-World, Post-Transplant Care

Yelena Bushman, MBA, VP of cell therapy and transplant at CareDx, discusses the operational challenges of validating biomarkers for post-transplant care.

July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
C-Suite Changes Help Biotech Narrow Focus But Maintain Drive To Treat Fatal Neonatal Brain Injury

GUEST COLUMNISTS

To Take On Transverse Myelitis, Researchers Must First Address Heterogeneity And Misguided Outcome Measures
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.
From Signal To Strategy: What Oncology Basket Trials Can Teach Clinical Development Teams
AbbVie's Svetlana Kobina discusses how basket trials can help clinical development teams move from early clinical signals to a more disciplined strategy.
4 Hidden Gaps In Clinical Trial Preparation For Small Biotechs
Gaps are not always visible at the executive level, but their consequences are very real — affecting timelines, budgets, data quality, and ultimately the likelihood of regulatory success.
ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive Malignancies
ImvivaBio CMO Jan Davidson-Moncada, MD, Ph.D., discusses the company's Phase 1b/2 study for aggressive T-cell malignancies, explaining their unmet need, the rationale for an allogeneic approach, and how they plan to address immune rejection.
Clinical Trial Per-Patient Cost Analytics For Procurement And Sponsor Strategy
With the help of Beroe Inc.'s Surya Ponnam, discover how per-patient cost (PPC) analytics is evolving into a core capability for balancing cost, quality, speed, and patient outcomes.
Expanded Access And Rollover Design Help CytoDyn Reach High-Need Cancer Patients
CEO Jay Lalezari and CFO Robert E. Hoffman share how CytoDyn meet patient needs when they approach trial design for cancer trials.
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.
Delays At The Handoff: Where Breakdowns Occur Among The Sponsor, CRO, And Site
Consultant Jason C. Bork identifies 10 of the most common points at which a trial can break down before and after patient recruitment.

CLINICAL TRIAL WHITE PAPERS

New Duke Research Shows Participants Prefer Enhanced eConsent
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.

Navigating Adverse Immunostimulation: A Practical Guide For Clinical Researchers
9/30/2025

Explore a systematic approach to evaluate adverse immunostimulation (AIS) in drug development through standardized biomarker sampling and tailored management strategies.
How Remote Pharmacy Monitoring Improves Trial Compliance
6/10/2026

Explore how leading IDS pharmacies are using remote monitoring workflows and digital accountability systems to improve accuracy, reduce site burden, and maintain audit readiness.
Ensuring A Diverse Patient Population In Clinical Trials
12/13/2024

In 2025, the FDA will require pharmaceutical companies to include diversity action plans (DAPs) for Phase II and pivotal studies.
Five Preventable Clinical Design Pitfalls And How To Avoid Them
7/21/2026

While late-stage trial attrition is often attributed to inadequate safety or efficacy, the true failure may be insufficient upstream planning and/or misalignment between clinical and commercial goals.
Breaking Through Barriers With Integrated Trial Optimization
5/9/2025

In today’s complex clinical trial environment, optimizing trial design requires a multidimensional strategy that balances scientific rigor with real-world constraints.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Delivering Complex Oncology Trials At Scale
5/19/2026

Parexel delivered two complex, global Phase III prostate cancer trials by aligning site selection, logistics, imaging workflows, and RAM regulatory expertise—achieving faster enrollment and on‑time execution.
Incorrect Clinical Trial Enrollment Is Preventable. A Tale Of Three Case Studies
6/5/2026

See how three clinical trials used centralized eligibility review to accelerate enrollment, eliminate enrollment-based protocol deviations, and keep studies on track, even at a global scale.
Case Management Accelerates Shipment For SCN1A+ Dravet Syndrome Gene Therapy
3/12/2026

Consider this streamlined, end-to-end solution that helped safeguard study timelines and ensured that patients with urgent medical needs could receive treatment without delay.
Navigating Choppy Waters: Rapid Study Completion For An Anti-Nausea Compound
7/17/2026

See how strategic technology reuse and real-time query resolution allow study teams to successfully manage high-volume, rapid participant enrollment without compromising data quality.
Transforming European Case Intake Operations
5/26/2026

Centralized intake and semi‑automation brought clarity and control to European safety reporting, improving oversight, data quality, and compliance across multiple partners and countries.
Expanding Clinical Research In East Africa With Digital Innovation
12/11/2025

Africa carries 25% of the world’s disease burden but hosts only 1% of clinical trials. Discover technology-driven strategies that close this gap and transform research access in underserved regions.

More Clinical Trial App Notes & Case Studies

NEWSLETTER ARCHIVE

More Newsletters

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.

How Visible Is Your Clinical Trial To AI?

Ross Jacksons explores how clinical trials show up — it at all — in AI tools and what that means for sponsors' approach to publicizing trial information.
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.
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.

FOCUS ON PATIENTS

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.
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.
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.