Conducting clinical trials in tough times

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.