We, at COREX Logistics are only too well aware that the current geopolitical turmoil in Eastern Europe has presented clinical trials organisations with unprecedented challenges. Continuing to conduct trials, however, remains as vital as ever to the future of healthcare and the wellbeing of patients so it’s essential to observe some modifications to existing practices for the health, safety and wellbeing of all.
ACTO – the Association of Clinical Trials Organisations – calls first to focus on the principles of the Helsinki Declaration and on ICH-GCP standards while ensuring that the welfare and rights of patients remain paramount.
ACTO also recommends the following:
The postponement of launching new projects, opening new sites and enrolling new patients into existing trials until all risks can be clarified and ascertained.
Approving protocol amendments where necessary concerning patient safety, after taking specific patient safety measures.
Continued, thorough recording, in accordance with the procedure, of all deviations from protocols.
Switching, where possible, to working with available laboratories (ideally local, or based in countries where bio materials can be delivered) and postponing, whenever feasible, the collection of those materials until logistical issues have been clarified.
Arranging any possible new routes for shipping medicinal products, lab kits, and other trial supplies and equipment where transportation requirements can be ensured.
Where feasible, considering investigational product delivery to the patient by a sponsor-engaged distributor, with detailed instructions prepared by the sponsor for provision to the patient.
Pre-arranged alternative communication channels between trial organisers, research teams and patients incase of problems with existing channels.
With forward planning, care, and prioritisation of patients above all, the advancements in healthcare that clinical trials help to create can continue to weather the storm and continue to benefit people worldwide
Suggested bullet points for info-on-graphic presentation of tweet
ACTO also recommends the following:
Postponing new projects, new sites and new patients until all risks can be clarified and ascertained.
Protocol amendments concerning patient safety
Thorough recording of all deviations from protocols.
Working with available laboratories (ideally local, or based in countries where bio materials can be delivered) and postponing collection of materials until logistical issues have been clarified.
Arranging new routes for shipping where transportation requirements can be ensured.
Considering product delivery to the patient by sponsor-engaged distributor, with detailed patient instructions provided.
Alternative communication channels incase of problems with existing channels.
COREX Logistics is a supply and logistics company with headquarters in Ireland, working with pharma and patients to facilitate improved healthcare worldwide.
Our expert international team works across an 80-country network, specialising in the EMEA region, providing the latest in clinical trial logistics technology and systems, cold-chain delivery, temperature-controlled transportation and storage services. From sourcing, procurement and customs clearance, to labelling, returns and destruction, we cover every link in the supply chain. We also run an established Named Patient Programme and provide Patient-Oriented services. With extensive knowledge and on-the-ground insight into our markets, we create innovative solutions with the ultimate goal of improving the lives of patients.