Phases of clinical research - Wikipedia
Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension | Nature Medicine
Design and Conduct Considerations for First‐in‐Human Trials - Shen - 2019 - Clinical and Translational Science - Wiley Online Library
Step 3: Clinical Research | FDA
En Route to Ethical Recommendations for Gene Transfer Clinical Trials: Molecular Therapy
Complimentary Webinar — Regulatory Submissions in Canada vs. the U.S | Altasciences
NIH's Definition of a Clinical Trial | grants.nih.gov
ClinicalTrials.gov Requirements - Center for Clinical and Translational Science | UAB
Downloading Content for Analysis - ClinicalTrials.gov
EMA publishes revised guidelines to reduce risk in first-in-human clinical trials - The Pharmaceutical Journal
1 Current regulatory guidance on FIH dose selection and preclinical... | Download Table
First-in-human Clinical Study in Drug Development Pathway | Download Scientific Diagram
Harmonization of U.S., European Union, and Canadian First-in-Human Regulatory Requirements for Radiopharmaceuticals: Is This Possible? | Journal of Nuclear Medicine
Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study - The Lancet
NEW EMA SAFETY GUIDELINES | Altasciences
The Next Phase of Human Gene-Therapy Oversight | NEJM
Clinical Trial Designs: Basket, Umbrella & Platform Trial Designs - Part II | Credevo Articles
Evaluating eligibility criteria of oncology trials using real-world data and AI | Nature
Estimating the Maximum Safe Starting Dose for First-in-Human Clinical…
Need for aligning the definition and reporting of cytokine release syndrome (CRS) in immuno-oncology clinical trials - Cytotherapy
Clinical Research Whitepapers (CRO) | Simbec-Orion
Harmonization of U.S., European Union, and Canadian First-in-Human Regulatory Requirements for Radiopharmaceuticals: Is This Possible? | Journal of Nuclear Medicine
Phase I and first-in-human Clinical Trials and FDA's CGMP Requirements
Early phase clinical trials extension to guidelines for the content of statistical analysis plans | The BMJ
Clinical trial - Wikipedia
Phase I and first-in-human Clinical Trials and FDA's CGMP Requirements
FDA draft guidance aims to expedite first-in-human clinical trials for oncology drugs and biologics - Pearl Pathways
