This section will consider the supply of the trial intervention plus other materials for the trial and the logistics surrounding them. The considerations for the supply of Investigational Medicinal Products (IMPs) is outside of the scope of this toolkit.

In running international surgery trials, there are a range of trial supplies that may have to be sourced and supplied to collaborating sites. These supplies could include the intervention (e.g. wound dressings, sutures, surgical instruments) and also the materials necessary to help conduct the trial, for example the Investigator Site File (ISF), patient Case Report Forms (CRFs), trial promotional material.

The initial and ongoing supply of trial materials should be considered as early as possible in the trial planning stage.

Access to the trial intervention is essential for sites to be able to take part in the trial.  The trial intervention(s) may include operative techniques, devices, wound dressing, sutures, surgical instruments e.t.c.  It may be that sites already have access to the trial intervention e.g. they may already be able to perform both trial interventions as they already have the surgical equipment required, or a trial specific supply may be required e.g. a new surgical device not currently available as part of standard of care.
Funding for the Intervention
This should be established at the trial planning stage. Sites are already able to perform the trial interventions, therefore funding is not an issues as these interventions are already in place/being funded. Where the intervention is not already available, there are different possibilities to fund the intervention supply in a surgical trial:
  1. Each collaborating country may fund the cost of the intervention from a local funding source.
  2. The company which manufactures the intervention may supply the product free of charge, or at a reduced rate for use within the trial.
  3. The UK research grant may fund the cost for all of the interventions.
Procurement of the Intervention
Once the funding method has been agreed, the source of the products must be determined. Will the interventions be supplied:
  1. Directly from the manufacturer in each collaborating country?
  1. From the UK and shipped to each collaborating country?
For both options of sourcing the intervention, the following should be considered:
  • how will the interventions be transported?
  • Are there any requirements for shipping packaging? Are there any clinical trial-specific packaging requirements? E.g. thermally insulated box to help keep temperature stable; trial-specific e.g. labels for specifying “clinical trial use only”
  • Who will be the named individual(s) at site that the interventions will be shipped to?
  • The cost for transport and shipping (and possible returns of unused product) must be costed in the grant application and taking into consideration the varying costs for each collaborating country.
If the interventions are to be purchased directly from the manufacturer at each collaborating site, the following points must be considered:
  • Is the intervention routinely available in the country?
  • Is the intervention exactly the same in each collaborating country?
  • Is there a reliable method for supply and resupply?
    • Consider putting a contingency plan in place in the event that the in-country supply fails.
If the interventions are to be shipped from the UK to each collaborating country, the following points must be considered:
  • Will the interventions be subject to any customs checks and will costs be incurred?
  • What quantity of interventions will be shipped each time, or will the initial supply suffice for the entire trial?
  • If a re-supply is required, how will this be managed between the UK and the collaborating site? How will the resupply be triggered? Who will be responsible for initiation of re-supply; site or the UK trial team?
  • How will accurate accountability and reconciliation of the supply be managed in each site/ country?
Labelling Requirements
Ideally, trial interventions should be labelled ‘For Clinical Trials Use Only’. Who will ensure this labelling? If the collaborating country is non-English speaking, who will ensure the labels are in the appropriate language?
Storage and Distribution at Site
  • Who at site will be responsible for the storage and management of trial supplies?
    • Ideally, there should be one named person at site who the clinical trials unit/manufacturer can communicate with to organise and manage the trial supplies.
  • Where will the trial supplies be stored?
    • The supplies must be accessible to those who need to use them. A process should be put into place so that trial supplies are used only for the clinical trial they have been supplied for.
  • Who will be responsible for accountability of trial supplies and how will this be documented and managed?
    • Accountability is necessary in order to monitor stock levels and any expiry dates. Accountability monitoring will also ensure that adequate supplies of supplied materials are available for trial patients and ensure that supplies are used only for the clinical trial they have been provided for.
  • What will happen to unused trial supplies at the end of the trial?
    • Will the unused interventions be returned to the UK or to the manufacturer?
    • Or will the unused interventions be retained (and destroyed) at site?