Valuing Local Expertise

Deep local knowledge needs to be valued when designing new data management tools and pharmacy plans.

STREAM was implemented across eight countries, all with vastly different experiences with clinical trial implementation. Given the wealth of knowledge required to work and operate in various countries worldwide, in-depth conversations with local pharmacy organizations, drug regulatory authorities, and trial pharmacists would have been useful in order to adapt the implementation strategy, and particularly data management systems, to fit the local context.

At one of the trial sites in South Africa, we found that one of the STREAM pharmacy logs designed for trial implementation was duplicative and ineffective. Given the robust pharmacy operations that already existed within the hospital at the trial site along with experienced clinical trial staff, we were able to adopt the existing system and apply it to the STREAM trial. However, for our trial sites in India, additional STREAM pharmacy logs were designed to more effectively document IMP dispensing to participants via field workers.

The Sponsor pharmacists worked very closely with site pharmacists. Close working relationships amongst team members were very important for the trial.

STREAM Stage 2 Pharmacist

There is a great deal of reliance on the site pharmacists to not only gather accurate data, but also to be able to review and interpret the data. The most effective data collection systems were in place when the site pharmacists understood exactly why the data were needed and they felt motivated and empowered as important members of the research team. Having a clear understanding of how data will be captured and utilized is critical to gain buy-in and establish trust amongst site pharmacists. In contrast, there was reluctance from site pharmacy staff when the Sponsor requested collection of data they felt were useless or redundant. Creating a collaborative environment amongst all site pharmacists and ensuring systems and processes are designed taking into consideration feedback from site pharmacists would benefit trial implementation and add tremendous value.

Recommended best practices

Value local knowledge when designing new data management tools and pharmacy plans through the following measures:

  • Allow site pharmacists sufficient time to provide comments and recommendations before pharmacy plans are finalized

  • Interview local pharmacists and professional pharmacy organizations to understand the scope of pharmacists’ practice and landscape within the country

  • Develop an electronic data management system in collaboration with local pharmacists to ensure efficiencies and leverage existing systems