Site selection is a key decision at the start of any phase I oncology trial. Good sites start your trial off right; early site challenges put you behind schedule and over budget.
When investigating sites, we look for a site that has
Over the years we’ve evaluated and selected many investigative sites for phase I oncology trials. We have found that the most effective sites have dedicated phase I oncology teams. In many cases, they also have a dedicated phase I clinical research space within the cancer center or clinic.
A dedicated team provides the structure to efficiently facilitate these key activities:
The smoothest-running sites have a specialized team that includes experienced study coordinators, research nurses, data managers and other personnel dedicated to running the phase I trials at the site. With the intense biospecimen collections and safety monitoring, the collective efforts and experience of a dedicated phase I team increase the chance of protocol compliance and quality data.
A dedicated phase I team typically uses a system to support regular patient toxicity review meetings with investigators, sub-investigators, and research nurses. This is critical for accurately monitoring patient responses and making dose escalation decisions. Also, these routine patient review meetings ensure that all appropriate team members, especially the principal investigator, are engaged in patient monitoring.
Another key consideration is how the team manages the logistics of the serial biospecimen collections and additional radiographical studies. A dedicated phase I team is usually better prepared to handle the special sample collection, processing and shipping requirements, especially for the collection of samples after clinic hours. They’re also better at working with in-patient hospital staff, or GCRC staff, to ensure the collection of key samples throughout the night.
We believe that the structure brought by a dedicated team is a better qualifier for a site than, say, the number of years of experience. A dedicated phase I study coordinator with only a few years of research experience may have handled ten phase I studies in twelve months. That’s a strong experience base. Another study coordinator might have ten year’s experience but only completed one phase I trial. We always feel more comfortable with the former coordinator.
The ultimate benefit of a dedicated phase I oncology team is focus. Focus ensures familiarity, precision and efficiency. Look for it when evaluating sites for your trial, and feel confident that they’ll handle all the nuances that occur.