Keep talking: The key to success in trial delivery

Zoe Boylan, Combinations Alliance (CA) Trial Manager within the ECMC Programme Office. The CA team have recently run a series of review meetings with Sponsor Clinical Trial Unit (CTU) teams and Chief Investigators to understand the key to sucess in trial delivery.

 

It’s clear, at the outset each team sets out with the very best intentions to open their trial to recruitment in the shortest amount of time possible. In reality, setup times vary greatly, based on external and internal processes that must be successfully navigated. 

 

Establishing good communication pathways from the outset of the trial emerged as a reoccurring theme, that formed the backbone of a successful collaborative trial. Not only can a good pathway ensure regular and timely flow of information on a day to day basis, more crucially it can save time and confusion when facing issues, to move forward in the smoothest and shortest time possible. 

 

Establishing roles and responsibilities also emerged as an important success factor. From the outset, partner company contacts (be that operational, legal, scientific, drug supply) and their roles and responsibilities in terms of meeting participation and within certain processes (e.g. regulatory application, protocol review) should be identified. 

 

Similarly, at a more local level, taking time to set out an agreed meeting structure between Sponsor CTU and Chief Investigator, to routinely discuss trial management, was commented as constructive in building a collaborative working environment. This is perhaps more critical when CTU and Chief Investigator do not benefit from the convenience of being co-located. 

 

Contracts were another heatedly discussed area, with many reflections of how to manage the process better. Besides having good communication channels, partners are often not familiar with the standard UK Co-Sponsorship setup (NHS Trust and University), and taking time to explain this can avoid later confusion and delays.

 

In trials, where two different partners are collaborating, it is highly recommended to facilitate the two partners talking together as early as possible (within a joint teleconference), and as regularly as needed to facilitate a smooth contractual finalisation process. It is recommended to pursue dual contract finalisation in parallel to ensure terminology is not in conflict, or alternatively via a tripartite agreement.

 

It’s clear that good site engagement by the sponsor with recruiting centres, established early and maintained throughout the trial, is key to facilitating recruitment, timely discussion of issues, and direction of the trial, but how did the study teams manage to engage sites?  A combination of factors was suggested including; setup and management of Investigator teleconferences (be that via a Trial Management Group or Scientific Review Committee), regularly, not just at key trial decision points;  Chief Investigator and Sponsor Trial Manager building good working relationships with Principal Investigators; awareness of how a site functions on a day to day basis, and the challenges they face, through establishing close contacts with site staff (e.g Lead Research Nurse) has empowered staff to approach specific site issues.

 

The use of regular study update emails or newsletters, including detailed recruitment updates and expectations of each site’s enrolment was also commented as a useful engagement tool.

 

The Combinations Alliance team support and encourage networking with other CTU Trial Managers of Combinations Alliance trials, to discuss common issues and share advice. This was felt particularly useful to teams new to the Alliance or those less experienced at managing early phase trials.