As the NIH shapes its plain language summary policy, EU CTR experience offers practical lessons on clarity, privacy, consistency, and implementation.
- Is Moving From One-Off Solutions To A Technology Platform The Best Fit For Your R&D?
- How Digital Twins Are Reshaping Clinical R&D
- Why Are We Still Talking About Compensating Research Participants?
- Examining The Potential Of P-tau217 To Provide Earlier Diagnosis Of Alzheimer's
- The 50-Page Monitoring Report And The Illusion Of Control
- Autoimmune Drugs For Women: What To Bring To The Clinic
- Small Biotech Can Outsource The Work, But Not The Thinking
GUEST COLUMNISTS
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The 50-Page Monitoring Report And The Illusion Of Control
A massive decentralized trial showed why more monitoring doesn’t always mean more control — and how risk-based oversight can reveal what truly matters.
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Autoimmune Drugs For Women: What To Bring To The Clinic
Autoimmune disease is one of the most sex-skewed categories in medicine. Sex, reproductive status, and hormonal state should not be treated as background noise.
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The Real Cost Of Sites Working Without An Enforceable Agreement: Why Your Site's Quality Of Earnings Is Suspect
Starting site work before an enforceable agreement may look like flexibility, but it can drain leverage, create unrecoverable costs, and raise financial reporting and GCP concerns.
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The U.S. Clinical Trial Recruiting Pipeline Report – August 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 July and August.
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How VNS-REHAB Aims To Improve Stroke Recovery After Patients Have Plateaued
Learn how a stroke trial standardized intensive therapy, sustained patient adherence, and exposed access barriers after FDA approval.
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Resensitizing Treatment-Resistant Cancer Holds Promise Over Replacing Once-Efficacious Therapies
John Yu, MD, of Kairos Pharma, explains why reversing treatment resistance could extend the life of proven cancer therapies and improve patient outcomes.
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Why Oncology Programs Can't Rely On An Inside View Alone
Discover how looking outside a program can help oncology teams test assumptions, improve feasibility, and make stronger development decisions.
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In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene Therapies
I review 10 of the FDA’s guidances spanning the last 12 months, all of which aid cell and gene therapy companies to assure safety and efficacy of these medicines.
CLINICAL TRIAL WHITE PAPERS
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Clinical Trial Disclosure Noncompliance: What Is Its Impact On Pharma M&As?
Noncompliance with clinical trial disclosure regulations can jeopardize M&A deals. Understanding FDA and SEC requirements is critical to avoid red flags during due diligence.
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Antibody-Drug Conjugates: 'Magic Bullets' Become Reality2/19/2025
Cancer therapy has evolved from potent chemotherapy to targeted biological therapy, including antibody-drug conjugates (ADCs). Learn more about ADCs’ makeup, mechanisms, and the development landscape.
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Open-Label Study Assessing Relative And Absolute Bioavailability1/26/2026
Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions.
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The Complexities Of Effective Patient Retention In Clinical Trials11/7/2025
Identifying and enrolling the right-fit patients from the outset is essential, but so is implementing comprehensive retention strategies that prioritize patient comfort, trust, and ongoing engagement.
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Master Protocols: Implementing Effective Treatment Adaptations8/25/2025
From balancing treatment ratios and managing eligibility to accommodating site-specific readiness and protocol amendments, a well-designed IRT system enables seamless transitions.
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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.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Outgrowing Excel: Implementing RTSM In A Live Phase I Trial2/25/2026
Learn how a clinical-stage oncology biotech successfully transitioned a live Phase I trial from manual spreadsheets to RTSM without disrupting site momentum or patient enrollment.
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A Mission To Expand Recruitment Territory6/11/2026
Learn how a proactive feasibility approach helps sponsors strengthen enrollment forecasting, mitigate risk, and implement timely interventions that improve study execution and clinical development.
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Delivering A Registrational GI Trial Through Ongoing Protocol Shifts10/17/2025
A biotech developing bispecific antibodies partnered with a flexible CRO to launch its first U.S. GI oncology trial, requiring strategic insight and full-service clinical support.
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Redefining Accessibility For Pediatric Patients9/24/2025
Explore how meeting patients where they are can redefine what successful pediatric trial delivery looks like.
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How Pfizer Used Wearable DHTs To Reveal Meaningful Treatment Effects In Cancer Cachexia11/20/2024
Wearable digital health technologies (DHTs) played a crucial role in assessing patient-centric outcomes during pfizer's study into the benefits of using ponsegromab for treating cancer cachexia.
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Market Approval For A Novel Non-Hodgkin Lymphoma (NHL) Therapy4/11/2025
Explore a collaboration that underscores the importance of strategic planning and regulatory engagement in the approval process.
NEWSLETTER ARCHIVE
- 09.30.26 -- Old Trial Playbooks Are Breaking Under New Complexity
- 09.30.26 -- Inside: Patient Advocacy, Smarter RTSM Builds, And Tech That Cuts Costs
- 09.29.26 -- Sponsors Are Rethinking Payments, eSource, And Study Design — Are You?
- 09.28.26 -- The Pharmacy Benefit No One Is Managing: Clinical Research As A Care Option
- 09.25.26 -- Sponsors Trust AI To Match Patients — But Risk Still Needs Human Eyes
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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Patients want to hear about clinical trials from their doctors — but most learn out online. CISCRP explores how industry can change the referral pathway for better.
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Autoimmune disease is one of the most sex-skewed categories in medicine. Sex, reproductive status, and hormonal state should not be treated as background noise.
FOCUS ON PATIENTS
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Patients want to hear about clinical trials from their doctors — but most learn out online. CISCRP explores how industry can change the referral pathway for better.
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As the NIH shapes its plain language summary policy, EU CTR experience offers practical lessons on clarity, privacy, consistency, and implementation.