The United States Food and Drug Administration (FDA) have released their latest guidance, with accompanying question and answers document, regarding the topic of conducting clinical trials during the COVID-19 pandemic, with the aim to aid industry and institutional professionals with the safe and effective continuation of clinical trials within the current climate.
The purpose for releasing this guidance is due to the FDA recognising that the current pandemic has and will continue to impact the manner in which clinical trials are conducted, in addition to the belief that any potential decisions or indecisions, regarding the continuation of clinical trials, can have a significant, detrimental impact to both trial participant’s and investigator’s safety.
As a result, the FDA chose to assess the approach for both ongoing and upcoming clinical trials, in addition to trials already impacted by COVID-19, with key considerations towards the safety of trial participants and investigators; the responsibility of trial sponsors; site protocols; processes and procedures, and data management.
To summarise their guidance, the FDA communicated that the safety and well-being of trial participants and investigators remains paramount and, ultimately, any decisions made, with regards to potential changes/deviations to regulations, will always require the prioritised assessment of impact for this very factor. Further to this, the FDA has also emphasised the importance of communicating any and all decisions made, promptly and directly, to the trial participant – whether it be the deviation or continuation of the trial – in addition to communicating this to the appropriate authoritative body.
Regarding the continuation of clinical trials, the FDA has communicated that sponsors should evaluate the safety of the site itself, due to concerns over the inability of participants being able to safely access a specific site, and therefore, to ensure both participant safety and trial efficacy, have recommended that alternative methods be considered, in addition to assessing the potential necessity for any additional monitoring requirements.
Moreover, when addressing the topic of potential revisions and changes made to existing protocol, processes or procedures, the FDA have informed sponsors that these should be made in direct consultation with their appropriate authoritative body, in addition to keeping documentation of justification and execution for the purpose of future inspections.
However, whilst the FDA have notified that this guidance document is not to be regarded as legally enforceable, PharSafer recommends that sponsors who are unable to safely adapt and implement the necessary measures extending from this guidance document, to help ensure trial participant and investigator safety, should contact their appropriate authoritative body as the earliest opportunity.
In addition to this, PharSafer will continue to monitor this topic, for any further information, and will communicate this once this becomes available.
This policy, although just approved, covers the period from January 2020 when the COVID-19 crisis began.
The main aim of this guidance is to ensure patient safety; allow existing trials to continue where possible; advise on trials yet to begin and how to manage safety items and protocol amendments.
For on-going trials, safety is of paramount importance but recruitment, site visits, CLINICAL TRIAL patients contracting COVID-19 and supply of investigational medicines are all considerations for the Sponsor; together with any clinical trial protocol amendments.
With such protocol amendments, requiring review and acceptance by IRBs and the FDA normally, the guidance recognises the difficulty in getting such amendments approved quickly for trial continuance and do understand that such amendments may be implemented before such review, but should be prioritised according to the extent of protocol revisions – especially if the safety of patients is concerned.
Documenting such deviations and actions is paramount (as a GCP auditor) in order to satisfy any Regulatory GCP inspection, to justify the actions taken at that time and the detailed recording of how this was implemented and trained out to everyone.
The document is a pragmatic approach to try to maintain existing trials, allow new trials to start and closure of existing trials, such that the patients are not compromised from a safety perspective and the data generated from the trials can be utilised for any Regulatory submissions because data has not been compromised.Share this News item: