Article Figures & Data
Figures
- FIGURE 1.
Phases of clinical trials for radiopharmaceuticals, from first-in-human to marketing authorization. RP = radiopharmaceutical.
- FIGURE 2.
Application process for clinical trial, comparing current situation in United States, Canada, and Europe.
Tables
Europe Parameter United States Canada Current Proposed Regulations Title 21 of CFR, parts 50, 54, 56, and 312 Food and Drug Regulations, part C, division 5 Directive 2001/20/EC, 2005/28/EC, 2003/94/EC Regulation (EU) 536/2014 Submission structure Single IND with clinical amendments for new protocols One CTA per study Per study Per study Submission format eCTD for commercial IND; non-eCTD for noncommercial IND Non-eCTD, electronic only (eCTD = pilot stage) Non-eCTD, electronic (paper cover letter plus compact disk) eCTD (EU portal) Regulatory approval time Initial study, 30 d; amendments, 0–30 d 30 d/study 60 d, variable for EC approval 10 + 50 d Labels Investigational use statement Investigational use statement (in English and French); sponsor and protocol number Sponsor, EudraCT number, investigational use statement Simplified for diagnostic radiopharmaceuticals Annual report Required NA NA NA Fees None None National National Ethics approval Required (institutional review board) Required (research ethics board) Required (EC) Integrated in centralized evaluation process Database www.clinicaltrials.gov Health Canada–managed database (www.clinicaltrials.gov recommended) EudraCT, EU Clinical Trials Register EudraCT, EU Clinical Trials Register Record retention 2 y after FDA approval or after last patient administration; notify FDA 25 y 5 y after completion of trial (in certain cases ≤30 y) 25 y (for advanced therapy medicinal products, 30 y) Financial disclosure Required NA NA NA Safety reporting to authority Life-threatening SUADR, 7 d; SUADR, 15 d Life-threatening SUADR, 7 d (+8 d follow-up); SUADR, 15 d Life-threatening SUADR, 7 d (+8 d follow-up); SUADR, 15 d Life-threatening SUADR, 7 d (+8 d follow-up); SUADR, 15 d CFR = Code of Federal Regulations; EC = European Commission; eCTD = electronic common technical document; NA = not applicable; SUADR = serious unexpected adverse drug reaction.
Parameter United States Canada Europe Submission name IND application CTA CTA General Form FDA 1571 Form HC-SC3011 EudraCT registration Table of contents; introductory statement Table of contents CTA application form for competent authority and ethics committee Related to clinical trial conduct General investigation plan PSEAT-CTA (protocol synopsis) Protocol synopsis Clinical protocol Clinical trial protocol Clinical trial protocol Informed consent form Informed consent form Informed consent form Case report forms, standard operating procedures, etc. Case report forms, standard operating procedures, etc. Related to radiopharmaceutical Investigator’s brochure Investigator’s brochure (including nonclinical and clinical data) Investigator`s brochure CMC CMC summary information; (module 2) and supplemental information (module 3) IMPD including quality, pharmacology, toxicology, and clinical data of investigational medicinal product Pharmacology and toxicology data Previous human experience clinical reports Others Dosimetry; letter of access to cross-referenced IND or master file (if applicable) Letter of access to cross-referenced master file (if applicable) Additional information (facility and staff, financial issues [insurance, compensations, agreements]) PSEST = protocol safety and efficacy assessment template.
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