This month we’ve been writing about selecting sites for phase I oncology trials. Our first recommendation is to use a dedicated oncology team. Then we provide pros and cons of academic versus private sites. Now we’ll move to evaluating potential sites.
Without a doubt, your direct experience with a site is the best predictor of future success. You know what type of service, results, and responsiveness to expect. But what if you haven’t worked with a site before? How do you evaluate them?
Thoroughly.
Step one: Determine how many phase I studies the site has completed in the last 12 to 24 months. Look for the details such as the number of patients enrolled in each study, enrollment rates, and data collection.
You’re always looking for a dedicated phase I oncology team. But sometimes we’re given sites that don’t have a dedicated team, so we have to make the best with what we have.
Since phase I oncology studies typically follow a standard approach, site comparisons are pretty straightforward. Talk directly with the site’s nurse to validate her experience. If she has hands-on phase I experience, you can be more comfortable that she understands the fast-changing nature of a phase I oncology trial and will handle the curveballs that always appear. It’s a red flag a nurse isn’t familiar with the phase I oncology process or feels that certain steps or frequencies of meetings are excessive.
It’s also important to understand the investigator’s experience level. Senior investigators are great because of their experience. Inexperienced investigators might require more hands-on trial management.
Something we look out for is a senior investigator that likes to assign a junior faculty member to a study. While the junior member might bring enthusiasm to the study and enroll patients ahead of schedule (which of course sponsors love), his/her lack of experience can sometimes lead to trial problems later on.
For instance, overshooting patient enrollment rates can backfire if the structure and site staff aren’t in place to handle the impending avalanche of data. An experienced investigator will know that pacing patients is critical for staying responsive and keeping data processing manageable.
If "over-enrollment" occurs, it can become a challenging situation for you as a sponsor. You’re excited about being ahead of schedule, which sends a positive signal to management. But you also know that the faster patients go on study, the harder it becomes to manage the future data — especially if the right site staffing infrastructure isn’t in place.
Data managers or monitors are the people that understand the volume of work involved with getting data collected, reviewed, and entered into the database. "Over-enrollment" often leads to later delays, which wipes out the previous gains and makes it difficult to continue work with that site on the next trial.
Assessing a site’s track record is important when determining if you’re going to select it for your study. It’s also important to understand what’s in store for you if the site has already been selected for your trial. Dive deep into the details. Understand the site’s true experience, the nurse’s hands-on experience level, the lead investigator, and the site’s ability to manage resources. It’s well worth it and will help you keep your trial on track and on budget.