Back to Basics: Satellite Sites in Clinical Trials

In clinical trials, ensuring the consistency and reliability of research data often hinges on the ability to manage multiple study sites efficiency. One approach involves the use of satellite sites, which are linked to an existing parent site and share the same principal investigator. These satellite sites while maintaining close oversight and adherence to the study protocol.

Leveraging satellite sites can expand the reach of a clinical trial by allowing greater flexibility in subject visits. When trial participants can attend both the parent and satellite sites, they are more likely to adhere to protocols for the entirety of the study. However, maintaining a consistently high level of oversight and protocol adherence across all locations is crucial to the successful management of these satellite sites.

Key Considerations for Managing Satellite Sites

Tracking and protocol adherence are very important for a trial strategy involving satellite sites. All satellite sites must follow the same protocol guidelines as the parent site to ensure consistency in the study's conduct and data collection. Oversight into adherence to protocols can allow sponsors to flag non-functioning satellite sites early and make changes to avoid inspections findings or regulatory non-compliance down the line.

To achieve successful oversight, site and data management follows a hierarchical structure, with information rolling up and down between the parent and satellite sites. A typical hierarchy is as follows:  Protocol -> Region - > Site. While a site can have multiple satellite sites, each satellite site is linked to only one parent site.

Key data points such as subject enrollment, accrual payments, contract amounts, and payment amounts are consolidated from the parent site to the satellite site and vice versa. Bulk actions like activity tracking, account management, document tracking, and payment generation at the protocol and region levels for the parent site also apply to the satellite site. The satellite site inherits the parent site’s subject visit template, principal investigator, team, and currency information. Any changes in these attributes at the parent site are automatically applied to the satellite site. Subjects can be allocated to either the parent site or the satellite site. Depending on the study requirements, subjects may carry out visits at both locations.

Regulatory Considerations

In their October 2009 Guidance, the FDA outlined their understanding of adequate supervision for clinical trials. According to their guidance, each study site should have a distinct responsible investigator responsible. Sub-investigators are permitted, but must report directly to the primary investigator, who evaluates their performance and may terminate their involvement if necessary. The investigator must have sufficient time to conduct and supervise the trial properly. Factors affecting adequate supervision include conducting a study from a remote location or overseeing multiple sites.

Challenges and Recommendations

One common question is whether a satellite site can be a remote location. However, this question is difficult to answer as the FDA has declined to explicitly define the term “satellite site” in their guidance or regulations.  

Conducting a study from a remote location can compromise an investigator's ability to provide adequate supervision. If a satellite site is near its parent site, it may be feasible for the investigator to oversee both locations. However, for physically distant satellite sites, it is recommended to have a separate individual oversee the study to ensure proper supervision and adherence to the protocol.

Conclusion

Managing satellite sites in clinical trials requires careful planning and oversight to ensure protocol adherence and data consistency. By following regulatory guidelines and maintaining a robust system for tracking and data consolidation, satellite sites can effectively extend the reach of clinical trials without compromising on quality or oversight.