key: cord-0776876-b30shyhk
authors: Flet, Laurent; Tching-Sin, Martine; Chanat, Adeline; Gendre, Pauline; Tibi, Annick
title: Clinical trials: management of investigational products during the coronavirus (COVID-19) pandemic
date: 2020-05-14
journal: Am J Health Syst Pharm
DOI: 10.1093/ajhp/zxaa146
sha: 2f8f1ac49b69d58cb08c39cdd18d39119cc89080
doc_id: 776876
cord_uid: b30shyhk

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The global COVID-19 pandemic has reached a critical stage, with several countries implementing strict lockdown procedures in light of the need to contain its spread. In response to the rapidly evolving situation, several key regulatory bodies have issued temporary guidelines regarding the conduct of clinical trials in this setting [1] [2] [3] [4] . Moreover, sponsors, contract research organizations, institutional review boards and ethics committees, and medical associations have developed a range of specific recommendations in this regard. In light of these, we wish to highlight the impact of this pandemic on the management of ongoing clinical trial investigational products (IPs).

Protecting the safety of study participants is a priority while also ensuring regulatory compliance, scientific integrity of the trial data, and the processes instituted in response to the COVID-19 pandemic. Prior to a scheduled patient visit, the investigator needs to weigh the public health considerations and the individual risk/benefit in treatment decisions for trial participants. This determination will vary by region and over time.

Numerous study centers have been instructed to halt in-office visits due to the risk of exposure to COVID-19 for their teams and study participants. To ensure the safety of these individuals, and ongoing patients who are unable or unwilling to attend protocol-specified visits and procedures, changes in IP management are needed, albeit while still maintaining compliance with sponsor requirements in order to avoid treatment discontinuation for patients. Firstly, the sponsors need to provide clear guidance regarding IP management, and they need to ensure the supply of the investigational drugs to the various trial sites. For IPs that are administered in a health care setting, alternative solutions should be investigated (e.g., home infusion by ambulant care service providers; alternative sites). For self-administered IPs, the sponsors should arrange secure direct-to-patient (DTP) delivery of medications from clinical or storage sites directly to the patients' homes. Clinical sites may also directly -4contract or use their usual qualified carriers to manage IP shipments. The DTP process has to be approved by the sponsor, be compliant with good clinical practices, and be approved by the patients and the investigator with regard to the relevant mandatory personal data protection regulations. The study procedures specified by the protocol (e.g., lab results; IP distribution by an electronic system) should have been implemented prior to deciding on DTP delivery.

Shipments should be temperature controlled, as required, and tracked. Finally, the patients should acknowledge receipt of their IP.

In practice, for sites handling numerous clinical trials, the challenge is to deal with a wide variety of guidelines for the management of IPs, with each study having specific processes, and to ensure traceability of all of the operations. This requires being very proactive and a high capacity for adaptation.

All of the above should be clearly documented in the patient file/record. The goal is to be able to continue to provide the investigational drug to patients included in ongoing clinical trials and to keep them enrolled in the study so as to avoid treatment interruption, while also ensuring patient safety and scientific integrity of clinical research throughout this period of uncertainty.

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

Guidance on clinical trial management during the COVID-19 pandemic (Version 2

Medicines & Healthcare products, Regulatory Agency. Managing clinical trials during Coronavirus (COVID-19

Agence nationale de sécurité du médicament et des produits de santé. COVID-19 -Essais cliniques en cours

Essais-cliniques-en-cours/(offset)/0#paragraph_172489 (updates

The authors received no specific funding for this work.

The authors declare that they have no competing interests.