Pharmacists’ Input on Trial Design

Solicit pharmacists’ input during the pre-trial strategy and planning phase.

STREAM was implemented at trial sites across eight countries in Africa, Asia and Europe, each with vastly different experience and specific constraints requiring careful tailoring of how clinical supplies were delivered, documented, and monitored. This made the development of supply chain processes extremely complicated. The level of detail required was, however, not fully anticipated in the design phase of the trial. The trial would have benefited from greater input from Sponsor pharmacists in the design of the protocol and implementation strategy. Pharmacists are uniquely placed to inform the development of effective supply chains and if considered in this planning phase, potential inefficiencies could have been addressed rather than confronting them as they emerged. This is particularly important for regulatory trials.

One instance where earlier planning would have been beneficial was the development of a contingency strategy for local sourcing of supplies to avoid stock-outs. Minimizing potential disruptions is foundational to an agile clinical trial supply chain enabling a more rapid response to disruptions. Had the complexity of the supply needs been better anticipated, then relationships and arrangements for contingency plans could have been put in place in advance. For example, to lessen the impact of supply blockades caused by recalls, back orders, or stock outs, having existing contractual relationships with local vendors and suppliers directly would have been valuable in securing safe multisource supplies.

In addition to being included in planning to support the establishment of efficient supply chains, the involvement of pharmacists at this stage could also have supported site selection. In STREAM, site selection began with a desk-top analysis of recruitment potential based on burden of disease and competing trials and did not necessarily include an assessment of local pharmacy capacity and experience. At some sites, Sponsor pharmacists did conduct initial pharmacy assessments, and this proved to be extremely beneficial. This allowed the Sponsor to better understand the local pharmacy context and decide if more start-up capital would be required to ensure adequate systems were in place prior to trial implementation. The pharmacy assessments became more comprehensive over time taking into consideration themes, including infrastructure needs, identified from prior assessments. However, incorporating detailed, standardized pharmacy assessments from the outset at all sites would have informed the selection process with a clearer understanding of the requirements to ensure sites were prepared for trial implementation.

Recommended best practices

Increase efficiencies by including pharmacists’ input in the following areas:

  • The pharmacists’ input is needed from the beginning of the trial design and planning phase to determine possible sourcing, procurement, and supply strategies in line with the trial objectives

  • Considerations for regulatory trial requirements should be made during the trial design and protocol development phase

  • Considerations for regulatory trial requirements should be made during supply chain design to inform sourcing, procurement, and supply chain management strategy

  • Pharmacists should be included in site assessments to ensure sites have required infrastructure to meet regulatory requirements and anticipate potential infrastructure investments