| dc.description.abstract | Introduction: Components of so-called decentralized clinical trials (DCTs), such as technological tools like wearable devices, smartphones, video calling, and apps, do allow for less in-person contact between trial patients and investigators/research staff. These innovations are generally considered to facilitate patients' accessibility to and participation in clinical trials. Whereas these components were explored prior to the arrival of the COVID-19 pandemic in March 2020, this public health crisis accelerated the introduction of DCT-components.
This review aimed to assess the legal and regulatory "landscape" pertaining to the specific component of direct-to-patient (DtP) supply of an investigational medicinal product (IMP). This is one of the components used in the concept of DCTs and involves supplying an IMP (or placebo) directly to the patient/participant or to their local setting (local community pharmacy, local hospital pharmacy). This eliminates the need for - or at least would significantly reduce the time spent on - travel to the investigative/clinical site and limits in person visits.
Methodology:
We searched the databases and websites of 11 selected (with the largest numbers of clinical trials as criterion) European Union (EU) member states (MSs) to evaluate the legislations and regulations, both outlined by the EU/European Medicines Agency (EMA) and their own national legislature, pertaining to DtP supply of IMP which were in place in the pre-COVID-19 pandemic era, during the pandemic, and in the post-COVID-19 era.
Results:
Our findings demonstrate a clear absence of uniformity of the pertinent regulations and legislations between these 11 EU MSs in the pre-COVID-19 era at a national level. This only changed in a time of severe crisis (the COVID-19 pandemic) and was replaced rapidly by complete uniformity or permission to integrate DtP supply of IMP as all MSs adopted the "flexibilities" granted in an EMA document on 20 March 2020.
We found that only 2 of the 11 MSs still explicitly allow DtP supply of IMP in the post-COVID era (and only 1 of these 2 did so in the pre-COVID era). It remains unclear if the hesitancy towards the incorporation of DtP supply of IMP in the remaining 9 MSs is based on poor experiences with this component during the COVID-19 pandemic, on persistent safety concerns or on bureaucratic tardiness in updating the relevant websites with new legislature or guidance.
Conclusion:
The mechanism of DtP supply of IMP, an important component of DCT, while slowly gaining ground in the pre-COVID pandemic era, was rapidly accepted by 11 EU MSs at the onset of this pandemic in March 2020 as legal and regulatory "flexibilities" were introduced by the EMA. However, this has not (yet) resulted in permanent changes of the pertinent legal framework regarding DtP supply of IMP in these MSs in the post-COVID pandemic era. As more stakeholders (sponsors/manufacturers, investigators/research staff, clinical research organizations [CROs], patients/participants) are increasingly supportive of the use of this component of DCT (and of several other ones), we would expect that harmonization of regulations and legislations with respect to DtP supply of IMP (and extending this to | |
