On 12 July 2023, a study was published in the British Journal of Clinical Pharmacology on different models in Europe for directly shipping drugs to patients during decentralized clinical trials (DCTs ), which are conducted in environments such as a participant’s home or a local address, rather than investigative sites. This potentially grants improved accessibility to products and trials – and reduces burden on participants – as DCTs rely on direct-to-participant (DtP) supply of investigational medicinal products (IMPs).
Although the European Union lacks harmonised requirements related to the shipping of IMPs directly to study participants, trial sponsors have been experimenting with different approaches. DtP supply of IMPs and DCT models were important to on-going activities related to clinical trials conducted during the COVID-19 pandemic.
Previous research already suggested that EU law would not prohibit home shipping or administration of medicinal products for use in conducting a clinical trial. It also established that related national provisions in EU Member States can be limited, resulting in case-by-case decisions by regulatory bodies and ethics committees. The study published in July, conducted on behalf of Trials@Home consortium , investigated the different approaches used for DtP supply of IMPs during DCTs within the European Economic Area (EEA).
Study methodology
Research was based on interviews with staff at investigative sites, representatives from pharmaceutical companies, and courier services between the months of May and November 2021. Interviewees were questioned regarding their experiences or plans related to DtP supply of IMPs in the EEA.
Comparison of different models
The study identified three main DtP IMPs supply models used in the EEA – and considered the positive and negative elements of each. These models are investigative site-to-participant supply, central pharmacy or pharmacy depot-to-participant supply, and local pharmacy-to-participant supply. All these models involve supply of IMPs through courier post, a healthcare professional or collection at a local pharmacy. The study could not identify a sponsor-to-participant supply model in the EEA, however, which involves the shipping of IMPs from a private company sponsor or distributor depot to study participants. According to the researchers, a sponsor-to-participant model in the EEA raises concerns related to privacy and the need for pharmacy controls in the dispensing of IMPs.
Model 1: Investigative site-to-participant
IMPs are shipped from the investigative site to the local address.
Pros – There are few regulatory barriers and it’s easy to implement.
Cons – It brings an increased logistical burden for site staff.
Model 2: Central pharmacy or pharmacy depot-to-participant
- IMPs are shipped from a central pharmacy depot with distribution facilities under a pharmacist’s supervision.
- In multicentre clinical trials, one site’s pharmacy could act as a central pharmacy.
Pros
- Costs and IMPs spillage are reduced.
- It may facilitate supply of IMPs with stringent stability requirements.
Cons
- Distance between pharmacist and participant is increased.
- It is not accepted by all relevant authorities in the EU due to privacy concerns and lack of investigator oversight.
Model 3: Local pharmacy-to-participant
IMPs are collected by participants from, or delivered by, local pharmacies that are distinct from the investigative site’s pharmacy.
Pros – This is complementary to low-intervention trials under the EU Clinical Trials Regulation which involve the use of authorized IMPs – and are subject to less stringent rules regarding labelling and traceability of IMPs.
Cons – This may require training of local pharmacists in good clinical practice.
Basis for discussion
The researchers suggest that it is feasible to employ DtP IMPs supply models in the EEA, and that their findings can be used by trial sponsors to discuss supply models with regulatory bodies and ethics committees – or identity best practices regarding DtP supply of IMPs. The findings of this study are consistent with an EU recommendation paper on DCTs published on 13 December 2022, which includes an annex on the acceptability of various decentralized elements such as DtP delivery of IMPs in EU Member States.
Contributors
Jessica Koffel
Alix Vermulst
