16-18 November 2021
Ireland’s Health Products Regulatory Authority (HPRA) recently shared an advice for Academic Sponsors and has updated its guide to clinical trial applications. The guide now features new sections to help academic and other noncommercial organizations sponsor trials and prepare for good clinical practice (GCP) inspections.
Sponsors should take into account European and International Council for Harmonization (ICH) GCP documents to ensure they comply with all their obligations. New sponsors should also have an expert to assess their systems and procedures before starting a clinical trial.
Academic sponsors are subject to the same regulations as commercial drug developers, but they face some unique challenges. Many academic groups have less experience in applying to run clinical trials and ensuring studies are compliant. The effect of this inexperience is compounded by the fact that some regulatory documents are written primarily for companies that are advancing pipeline candidates toward marketing authorization applications. Therefore, the agency recommends noncommercial organizations and their investigators to assess whether they have the resources, infrastructure, systems and procedures to run GCP compliant trials. As HPRA states, sponsoring a trial entails assuming legal responsibilities such as safety reporting that necessitate a certain level of preparedness.
In some rare cases, HPRA will help academic sponsors make submissions to the EudraVigilance safety database. Sponsors that want such support must request it when submitting their clinical trial applications. If HPRA agrees to help, the timelines for submission will be truncated so the agency can process cases before filing. As part of the broader agreement on the collaboration the sponsor will decide together with HPRA on the timelines.
The other new, academic-focused section, addresses GCP inspections. Academic sponsors can draw on existing European documents to help prepare for inspections (see also GCP - Implementing Regulation on Inspection Procedures). However, while these documents apply to all sponsors, HPRA thinks they are tailored to commercial organizations. Hence, HPRA has shared descriptions of the key systems inspectors will check when inspecting an academic sponsor.
The descriptions cover organization, personnel, facilities, quality risk management (QRM), data integrity and other factors that are important to GCP compliant running of all clinical trials. In each case, HPRA focuses on details of particular significance for academic sponsors. For example, the section on organization and personnel states principal investigators, safety committees and other noncommercial entities often serve as the medical expert in academic-sponsored trials. According to HPRA this is acceptable, but the sponsor must be able to show inspectors the organization was considered as part of its QRM.
HPRA also used the update to change sections of the guide about end of trial declarations, substantial amendments to trials and other topics (see HPRA Guide).