Investigator selection is arguably the most important driver of any trial’s success, especially in oncology. However, not every site is capable of running a study, even if they claim to have plenty of experience or treat a large number of eligible patients. Based on our experience here are five (very) important considerations to evaluate when qualifying sites:
- Patients: Select an investigator with access to the specific types of patients needed for your trial. Since oncology trial patient inclusion and exclusion criteria can be very limiting, this is of the utmost importance.
- Infrastructure: It’s important that every site have the appropriate infrastructure to support the study. Depending on the study design, this could mean many different things.
- Staff: Finding investigators where the staff are engaged in the clinical research process and are well-educated on good clinical practices (GCP) makes a big difference in how well the study is run. It will also aid in getting patients enrolled if the staff believe in the benefits of clinical research.
- Relationships: Consider how you’ll be treating study participants and what testing may need to be done throughout the course of the study. If you know you’ll need tissue samples, find an investigator with access to a credible pathologist. A relationship with a respected radiology department is essential for many oncology trials in order to achieve timely and consistent tumor evaluations. And, most importantly, a team environment between the investigators’ research nurses and coordinators always yields the most successful sites.
- Location, Location, Location: Geography plays a key role in investigator selection. If you need tissue samples to be processed within 48 hours from when they are collected, considering airline schedules will be critical to the study design. If your sites can’t get necessary specimens delivered within that window of time, it doesn’t matter if they have the best staff or most appropriate patient population. It’s also important to consider competition for patients – if there are numerous studies recruiting patients with a rare diagnosis from the same investigator site, it’s probably best to consider other investigators.