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The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development

Discover how the new FDA Plausible Mechanism Framework changes the game for rare disease research by formalizing an approval pathway for individualized treatment of ultra-rare genetic diseases.

GUEST COLUMNISTS

When A Clinical Trial Surfaces In An AI Chat, What Happens Next?
AI is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.
The Cost Of Transactional Thinking In Clinical Research
Denise N. Bronner of Empactful Ventures explores the power dynamics at play in clinical research, picking apart the roles of sponsors, vendors, and sites and advocating for a better way to do business among them.
Enabling Cloud Computing In DCTs For Remote Data Capture, Monitoring, And More (Part 1)
Understand why cloud infrastructure is foundational to hybrid and decentralized trials and what critical trial activities it enables with reduced operational friction.
Safe And Sustainable DCTs and Hybrid Trials (Part 2)
In part two of this series, learn practical cloud architectural patterns, governance structures, and operating mechanisms that allow sponsors to run hybrid and decentralized trials.
Why Sponsors Should Share KPI Rationale With Sites
To build partnerships, foster transparency, and promote shared accountability, Curo Research CEO Amy Bland explains why sponsors need to communicate the utility of KPIs with sites.
Rethinking Clinical Trials In Rare Neurodegenerative Diseases: Lessons From Alterity's MSA Trial
Alterity Therapeutics CEO David Stamler shares how early diagnosis, biomarker-guided design, and precise patient selection positively impacted a trial in multiple system atrophy (MSA).
Breaking Through Tumor Defenses With Next-Generation Cell Therapy
Ernexa Therapeutics CEO Sanjeev Luther shares how clinical research has revealed why certain cancers resist treatment and how emerging cell therapies may help break through those defenses.
Reprogramming The Tumor Microenvironment: Bringing A Metabolic Checkpoint Therapy Into The Clinic
Pilatus Biosciences CEO Raven Lin shares learnings from his company's early-stage oncology program.

CLINICAL TRIAL WHITE PAPERS

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.

Phase 1 Clinical Trial Designs And Strategies
9/18/2025

With tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.
Endpoint Clinical RTSM: Getting The Job Done
12/5/2025

Explore how a Job-to-be-Done (JTBD)-focused RTSM approach reduces delays, optimizes costs, and accelerates trial success through predictive intelligence and streamlined global workflows.
Paper Vs ePRO: Clinical Data Collection Methods
7/16/2024

Patient-reported outcomes (PROs) assess patients' health without clinician interpretation. Traditional paper methods often result in missing data and quality issues, while electronic solutions enhance data accuracy and completeness.
Decentralized And Community-Based Solutions Driving Women's Healthcare
9/24/2025

Clinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.
Deriving Reliable Clinical Outcome Scores From Continuous DHT Data
6/10/2025

DHT-derived endpoints, especially percentile-based metrics, hold promise for robust, scalable measurement in clinical trials—provided they're chosen statistically and with adherence in mind.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Driving A High-Adherence LTFU Trial Without An EDC
10/29/2025

Discover how our partnership with a client was able to deliver a ten-year long-term follow-up (LTFU) trial that delivered an over 90% adherence rate while keeping trial costs low by not using an EDC.
Overcoming Unexpected Obstacles In A Phase 1 Study
1/29/2025

Discover how the implementation of mobile vision clinics (MVCs) was used to enhance efficiency in a Phase 1 clinical trial.
Optimizing Recruitment For Urgently Needed Vaccine
5/15/2024

Uncover how Citeline Connect helped a late-stage biotech sponsor expedite enrollment of a diverse population of eligible patients impacted by monkeypox for a large Phase 1 and Phase 2 trial of a next-generation vaccine.
Optimizing Chronic Cough Phase 3 Trials With Point-Of-Need Eye Assessments
1/15/2025

Collaboration was key for Company W to overcome challenges with an FDA-mandated ocular substudy, including limited resources for ocular assessments and logistical difficulties
Transforming Clinical Trial Sites With Research Study Rockstar
2/10/2025

This innovative platform addresses prevalent pain points faced by trial coordinators by streamlining workflows, automating patient communication, and providing intuitive dashboards that simplify trial management.
Meeting 100% Recruitment 7 Months Ahead Of Schedule
7/23/2024

Uncover the detailed outcomes of this extensive Phase 3 clinical trial on a new biosimilar for non-small cell lung cancer.

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.

When A Clinical Trial Surfaces In An AI Chat, What Happens Next?

AI is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.
The Problem With Excluding Children From GLP-1 Trials In The U.S.

In the U.S., roughly 15 million children are obese. But many are excluded from GLP-1 research. Obesity expert Evan Nadler, MD, explains why that's problematic.
How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows

Learn how AI-enabled personal health technologies are impacting key aspects of trial operations while also exploring operational challenges that clinical operations leaders must manage in this AI-driven era.

FOCUS ON PATIENTS

Time Is Lives: How Collaboration And Urgency Are Rewriting The Future Of Rare Disease

The inflection point has arrived, says Rob Freishtat, MD, MPH. Understand how collaboration will rewrite how we think of rare disease clinical research.
The Problem With Excluding Children From GLP-1 Trials In The U.S.

In the U.S., roughly 15 million children are obese. But many are excluded from GLP-1 research. Obesity expert Evan Nadler, MD, explains why that's problematic.
How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows

Learn how AI-enabled personal health technologies are impacting key aspects of trial operations while also exploring operational challenges that clinical operations leaders must manage in this AI-driven era.