More than 60 million Americans are caregivers, holding up a system and clinical research enterprise, yet they are mostly uncompensated for their efforts. That needs to change, says Denise N. Bronner and Marsha Calloway-Campbell.
- Reminder: FDA Approval Is Not Synonymous With Commercial Success
- What Sites, Sponsors, Vendors, And CROs Can All Agree On
- AI Amplifies Capabilities But Also Risks: Learn The Legal Consequences Of AI In Clinical Research
- Is It Time To Replace RECIST — Or Just Add AI?
- India Opens The Fast Lane For Drug Development
- U.S. Pharma Tariffs And MFN Become Law After April 2 Update
- Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem Listens
GUEST COLUMNISTS
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![India MAP-GettyImages-1195985043]( "India Opens The Fast Lane For Drug Development")
India Opens The Fast Lane For Drug DevelopmentNew in 2026, extensive reforms to India’s clinical trial rules are slashing approval timelines in half and eliminating licenses that once took months to obtain.
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![Finance business trade economy-GettyImages-2230458034]( "U.S. Pharma Tariffs And MFN Become Law After April 2 Update")
U.S. Pharma Tariffs And MFN Become Law After April 2 UpdateBeginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.
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![Hospital, holding hands and kid in bed, healthcare, cancer-GettyImages-2120554524]( "Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem Listens")
Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem ListensPatient advocate and founder of MIB Agents Ann Graham knows intimately the importance of including patient feedback into trial design. She explains value of — and offers practical advice — for doing just that.
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![Young female scientist works at work bench in laboratory-GettyImages-899074182]( "What Really Moves The Needle In Primary Immunodeficiency Research And Treatment")
What Really Moves The Needle In Primary Immunodeficiency Research And TreatmentKedrion Biopharma's Nisha Jain details how researchers can improve trials for primary immunodeficiency and shares four factors for improvement.
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![Kidney issues, medical-GettyImages-1360864678]( "First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access Success")
First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access SuccesseGenesis CEO Mike Curtis discusses the first-in-human trial of EGEN-2784, which they're studying whether a porcine kidney can restore near-normal quality of life while awaiting a human transplant.
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![Elderly man sitting in hospital-GettyImages-1740621426]( "Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)")
Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)In part two of this series on slot allocation, Nehal Lakhani, MD, Ph.D. proposes assigned slot allocation as an alternative to competitive placement and discusses how the approach might benefit patients and sites.
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![Patient sitting in waiting room-GettyImages-629772380]( "Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1)")
Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1)Given the shift in the size and scope of oncology Phase 1 trials, cohort management and slot allocation strategies must change, too. Nehal Lakhani, MD, Ph.D. explains why competitive slot allocation is no longer optimal for patients or PIs.
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![MRI scanning in control room-GettyImages-2176245578]( "There's A Gap In Brain Tumor Research — Here's How We Fix It")
There's A Gap In Brain Tumor Research — Here's How We Fix ItBrain tumors are some of the most biologically complex and least improved indications. Biochemistry researcher and scientist Catherine Bladen, Ph.D., argues sustained focus is a key to driving real-world progress.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1316437398-planning-strategy-data]( "Phase 1 Clinical Trial Designs And Strategies")
Phase 1 Clinical Trial Designs And StrategiesWith tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.
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What Is Healthcare Data Interoperability And Why Does It Matter For Clinical Research?1/28/2025
Explore how healthcare data interoperability can transform patient outcomes, streamline clinical research, and enhance efficiencies while addressing key challenges and global initiatives.
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Ensuring A Diverse Patient Population In Clinical Trials12/13/2024
In 2025, the FDA will require pharmaceutical companies to include diversity action plans (DAPs) for Phase II and pivotal studies.
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Designing More Representative Trials Through Strategic Planning5/28/2025
Strategic planning for representative clinical trials improves outcomes, regulatory alignment, recruitment efficiency, and commercial value by ensuring study populations mirror real-world patients.
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Combination Therapy Dose Optimization In Oncology Trials3/30/2026
Optimize dose selection in oncology trials by moving beyond toxicity limits. Use advanced modeling and benefit-risk analysis to improve efficacy and meet modern regulatory standards.
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Strategies For Post-Approval Lifecycle Management And Local PV7/12/2024
If you are unsure of how to navigate your post-approval regulatory journey, an experienced regulatory services partner can provide support to help you identify and achieve post-approval goals.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Digital Outcome Measures Approved As Primary Endpoint In Cardiopulmonary Study4/15/2025
Discover how a clinical development program was saved using objective, continuous digital outcome measures.
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How Sponsors Can Leverage New Technologies To Lower Trial Costs1/6/2025
This study introduces sponsors to an innovative, lean, and efficient approach to data management that integrates site-facing technologies to streamline trial operations.
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Achieving A 2.67x Reduction In Study Build Time For An Innovative Neuromodulation Study12/20/2024
This study explores the potential of Focused Ultrasound Neuromodulation in deepening meditative states, and the platform that helps enhance the overall experience for researchers and participants alike.
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How Syneos Health Tackles Protocol Complexities1/7/2025
Explore solutions employed by Syneos Health, a global contract research organization, to optimize Phase I-IV clinical trials, particularly under a complex adaptive trial protocol.
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What Unified eCOA And IRT Can Unlock4/6/2026
See how real-time scoring and automated eligibility checks helped a global dermatology study reduce site burden, avoid manual errors, and move participants through screening with greater speed.
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Preparing The Next Generation Of Clinical Research Professionals9/4/2025
Explore the live EDC platform that enabled Durham Tech to create a model for future-forward, hands-on education in clinical research.
NEWSLETTER ARCHIVE
- 04.20.26 -- Bridging Language And Medicine
- 04.20.26 -- Rethinking Rare Disease Recruitment
- 04.17.26 -- Continue To Choose New AI-Related Projects
- 04.16.26 -- Lessons Learned While Taking Glioblastoma Drug From Bench To Clinic
- 04.15.26 -- Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology Trial
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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![Elderly man sitting in hospital-GettyImages-1740621426]( "Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)")
In part two of this series on slot allocation, Nehal Lakhani, MD, Ph.D. proposes assigned slot allocation as an alternative to competitive placement and discusses how the approach might benefit patients and sites.
-
![Patient sitting in waiting room-GettyImages-629772380]( "Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1)")
Given the shift in the size and scope of oncology Phase 1 trials, cohort management and slot allocation strategies must change, too. Nehal Lakhani, MD, Ph.D. explains why competitive slot allocation is no longer optimal for patients or PIs.
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![translate foreign language with internet software-GettyImages-2215567295]( "Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing")
Poor translations are not just clunky. They can be risky. Medical-linguistic consultant Farah Ayadi, PharmD, explains its implications for safety, regulatory submissions, and downstream operational or financial outcomes.
FOCUS ON PATIENTS
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![Senior man with daughter at doctors office-GettyImages-1837504525]( "Caregivers: The Missing Line Item In Trial Budgets")
More than 60 million Americans are caregivers, holding up a system and clinical research enterprise, yet they are mostly uncompensated for their efforts. That needs to change, says Denise N. Bronner and Marsha Calloway-Campbell.
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![Insulin pen, medical equipment-GettyImages-1447329677]( "Reformulating An In-Clinic IV To At-Home Injection Puts Patients At The Center")
For Soligenix, reformulation was not a detour but a necessary step toward optimizing a therapy for real-world use. Discover how the team reformulated its drug delivery from in-clinic to at-home administration.
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![Hospital, holding hands and kid in bed, healthcare, cancer-GettyImages-2120554524]( "Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem Listens")
Patient advocate and founder of MIB Agents Ann Graham knows intimately the importance of including patient feedback into trial design. She explains value of — and offers practical advice — for doing just that.
