Diverse range of skills and experience

Site staff must have a broad range of skills and experience to effectively implement a phase III clinical trial.

Good clinicians are essential for successful trial implementation, but a wide range of other skills are needed, including project management skills, ethics and regulatory expertise, and data management experience. Sponsors should ensure the breadth of trial requirements is clear to participating trial sites so that appropriate staff are available and trained. This is particularly the case in the two areas outlined below – project management and regulatory expertise.

Project management is especially important in clinical trials, with a strong need to coordinate diverse activity streams – for example, clinical care, laboratory assessments, regulatory compliance, and financial compliance (among others). Equally, a focal point for communication with the trial sponsor is essential. Therefore, every site should aim to have a very strong trial coordinator.

Ideally, given the range of issues they need to manage, trial coordinators will be as comfortable in high-level meetings with regulators as they are managing the details of procurement. In addition, trial coordinators should be good communicators who can “translate” clinical concepts for non-clinical staff and vice versa, as well as communicate with the sponsor (which often requires English fluency). In STREAM, sites that had trial coordinators with strong communication skills whose role was defined as overall trial implementation and management, rather than only clinical care, performed very well.

At first, we thought the study coordinator should be chosen based on their excellent patient management skills. Soon into the trial, we understood that the role should be more focused on the overall coordination and administration of the trial.

Site Principal Investigator, STREAM Trial

In-depth regulatory expertise is also important, and critical to navigating initial approval of the study by local ethics committees and regulators, as well as ongoing regulatory compliance. Where STREAM study teams did not have significant regulatory expertise, the trial experienced delays in approvals for the initial submission as well as subsequent amendments and the trial was forced to rely on external parties (CRO or local consultants) to understand and comply with regulatory requirements. Access to regulatory expertise was especially important in locations with more complex or less developed regulatory regimes, for example India and Mongolia.

Ideally, sites will recruit staff that have the diverse experience and expertise required by the trial. However, where that is not possible, Sponsors will need to identify local consultants to fill gaps and/or provide appropriate training and support to build expertise in existing staff.

Recommended best practices

Ensure sites are equipped to manage the broad range of issues that arise in connection with clinical trials through the following measures:

  • Provide sites with standard Terms of Reference for key positions to inform hiring decisions

  • Invest in key non-clinical staff positions, including a trial coordinator with strong project management and communication skills and a regulatory lead with the experience required to navigate local and international requirements

  • Work with sites to identify local consultants to fill gaps in staff experience/expertise

  • Support capacity building for site staff throughout the trial, especially on non-clinical aspects such as project management, operations, and financial management.