How to design a dose-finding study using the continual reassessment method | BMC Medical Research Methodology | Full Text
Estimating the Maximum Safe Starting Dose for First-in-Human Clinical…
Immune checkpoint inhibitor-based combinations: is dose escalation mandatory for phase I trials? - Annals of Oncology
A new pragmatic design for dose escalation in phase 1 clinical trials using an adaptive continual reassessment method | BMC Cancer | Full Text
Starting dose selection and dose escalation for oncology small molecule first-in-patient trials: learnings from a survey of FDA-approved drugs | SpringerLink
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Frontiers | Predicting Approximate Clinically Effective Doses in Oncology Using Preclinical Efficacy and Body Surface Area Conversion: A Retrospective Analysis
Early phase clinical trials to identify optimal dosing and safety - ScienceDirect
FDA Issues Guidance On Expansion Cohorts In Clinical Trials Of Oncology Drugs
Initial Design Considerations of Trials of Immuno-Oncology: Domains and Elements
Groups suggest changes to FDA's guidance expanding eligibility criteria for oncology trials | RAPS
Starting dose selection and dose escalation for oncology small molecule first-in-patient trials: learnings from a survey of FDA-approved drugs | SpringerLink
5 Tips To Avoid An IND Clinical Hold: Regulatory Guidance And Insights | Premier Consulting
Considerations and Opportunities for Your Investigational Drug Service
Frontiers | Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA
On Biostatistics and Clinical Trials: Phase I Dose Escalation Study Design: "3 + 3 Design"
1 Current regulatory guidance on FIH dose selection and preclinical... | Download Table
Experts Seek Tweaks to FDA Draft Guidance on Clinical Trial Diversity | RAPS
EX-99.3
Design and Conduct Considerations for First‐in‐Human Trials - Shen - 2019 - Clinical and Translational Science - Wiley Online Library
Expansion Cohorts Guidance Balances Drug Development With Safety, Rigor
Phase 0/microdosing approaches: time for mainstream application in drug development? | Nature Reviews Drug Discovery
Moving Beyond 3+3: The Future of Clinical Trial Design | American Society of Clinical Oncology Educational Book
Early-drug development in the era of immuno-oncology: are we ready to face the challenges? - Annals of Oncology
10 tips for improved drug development
Statistical controversies in clinical research: building the bridge to phase II—efficacy estimation in dose-expansion cohorts - Annals of Oncology
FDA draft guidance aims to expedite first-in-human clinical trials for oncology drugs and biologics - Pearl Pathways
