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RWE Increasingly Supports Rare Disease Research As RCTs Alone Fall Short

Chiesi's Rachele Berria, MD, Ph.D., discusses how RWE is reshaping rare disease drug development strategies, from leveraging registries and patient-reported outcomes to navigating evolving regulatory expectations.

GUEST COLUMNISTS

A Sponsor Playbook For Matching AI Use Cases To Readiness, Risk, And ROI
Clinical technology consultant Karen Maduschke explains why your next AI investment should solve a problem you can articulate, with data you can access, in a process you can change.
One Drug, Three Indications: How Small ClinOps Teams Manage Multi-Trial Execution
Having the same number of clinical programs as team members might sound crazy, but for Step Pharma, it has become one of their biggest strengths.
Rare Disease Nonprofits: De-Risk Development With Orphan Drug Designation And Early Talks With The FDA
For nonprofit organizations, Orphan Drug Designation is the start of a disciplined, forward-looking regulatory strategy, but it's not the only factor in success. H. Greg Thomas, Ph.D., shares his advice for de-risking orphan drug development.
The Compliance Problem With Excel Trackers And Other Computational Tools — And How AI Can Help
Everyday computational tools such as Excel are simple and easy to use, but they carry risk. Learn how these tools might not adhere to 21 CFR Part 11, and discover how AI can help keep them compliant.
To Prevent Parkinson's Disease, We Need New Biomarkers
Parkinson's disease research has shifted toward prevention and prodromal intervention but success with disease-modifying and preventive therapies depends on validated PD-specific biomarkers. AC Immune Cofounder and CEO Andrea Pfeifer explains.
What It's Like To Advance A Cell Therapy Through The Japan Entry Acceleration Program
Ernexa Therapeutics President & CEO Sanjeev Luther details having one the of 10 coveted spots in the Japan Entry Acceleration Program (JEAP) that supports cell therapy development and market entry in Japan.
A Blueprint For Addressing Underserved Patient Populations
Does our current approach to clinical research truly serve the patients who face the greatest needs? Insmed Inc. CMO Martina Flammer, MD, MBA, explores how to better meet patient needs.
Why Clinical Data Standards Matter In An AI-Driven World
Novartis technology and scientific computing expert Bill Illis discusses what changes sponsors must make to the R&D data landscape to achieve sustained, meaningful progress — with the help of AI — to bring new therapies to patients faster.

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.

De-Risking Early-Stage Biotech: Turning Vision Into Venture Capital
9/3/2025

For early-stage biotech companies, transforming a scientific breakthrough into an investable asset requires more than compelling data—it requires a clear product vision.
Tracking Functional Capacity To Advance Neuromuscular Disease Research
2/6/2026

This presentation introduces a dual-endpoint approach to monitoring neuromuscular disease progression through two high-centile digital measures.
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.
Reimagining Medical Monitoring In Clinical Research
4/11/2025

Clinical trials are undergoing a transformative shift driven by evolving regulations, advanced technologies, and decentralized methodologies.
Potential Of eClinical Solutions To The Complexity Of Oncology Trials
7/31/2025

How are eClinical technologies—specifically IRT and eCOA— being leveraged to overcome patient recruitment difficulties, high mortality rates, and the intricacies of cancer treatments.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Tailored Approach Supports Bladder Cancer Breakthrough
3/5/2026

Discover how a flexible operational strategy and expert site management help bladder cancer programs overcome complex logistical hurdles and achieve critical regulatory milestones.
What Unified eCOA And IRT Can Unlock
4/6/2026

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.
Expand Bandwidth With A Trusted Regulatory Writing Partner
9/18/2025

Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.
Accelerating Early Phase Oncology Study Development
4/17/2025

Explore a close collaboration to co-develop a comprehensive, adaptive protocol designed to support key decisions across multiple trial phases for an innovative cancer therapy.
GSK And Medable Discuss The Next Phase Of DCTs
3/10/2025

GSK and Medable share the value of embedding DCTs into strategic goals to enhance trial accessibility, diversity, and efficiency.
Removing Translation Bottlenecks With AI
8/8/2025

See how an AI-enabled approach eliminated the manual, time-consuming translation bottlenecks that often delay clinical trial launches.

More Clinical Trial App Notes & Case Studies

NEWSLETTER ARCHIVE

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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.

AI Can Help Design Better Trials, But It Still Can't Tell You Whether Patients Will Join Them

AI is changing the way clinical trial trials are discussed, planned, and designed. But even with an improved protocol, are AI-enhanced trials driving better enrollment?
Lessons In Pivoting From A Clinical Trial Launch In Uganda

Gates MRI researchers share how they navigated supply chain challenges, an Ebola outbreak, and evolving regional malaria vaccination strategies to successfully execute a malaria clinical trial in Uganda.
Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community

CEO Paul J. Hastings discusses Nkarta's decision to bring outpatient dosing into the community setting, including how it communicated with the FDA on safety and how the changes will improve patient access.

FOCUS ON PATIENTS

The Next Chapter Of Obesity And Type 2 Diabetes Care: ADA 2026 Signals A More Personalized Future

The American Diabetes Association 2026 conference showed where we are and where we're going with GLP-1 therapies.
A Blueprint For Addressing Underserved Patient Populations

Does our current approach to clinical research truly serve the patients who face the greatest needs? Insmed Inc. CMO Martina Flammer, MD, MBA, explores how to better meet patient needs.
New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA

NervGen CEO Adam Rogers discussed why choosing a hand function endpoint for tetraplegia made sense for patients and how regulators helped guide and support the company's decision.