Site Training

Oncology Expertise – Site Training

Medelis has been managing checkpoint inhibitors and CAR T-cell therapy studies since 2008 – so we’ve been able to work with many sites in the U.S. and Europe to develop the safety SOPs and train them.

Proper site selection is critical to the success of any oncology study. It’s even more critical in the rapidly expanding area of cancer immunotherapy.

To get the right data within your timelines, you need:

• The investigators who have access to the patients your study requires
• The right mix of sites (academic, government and community-based) that are able to get patients enrolled within your timeline
• Sites that are skilled and experienced in handling the type of treatment being administered
• Sites that understand how to deal with the differences in how the immune system reacts to these types of treatments

These variables directly affect your study cost and data quality. In addition, if your study is phase I, you will also have to evaluate their dose-escalation experience (and we address that here).

Communication with the nurses is an ongoing process, not a one-and-done process (like some big CROs use). We meet with the site before the initial infusions to coach them through the side effects. We hold continuing team meetings with site physicians and coordinators, so we can debrief and help to anticipate what may happen with other patients. From our experience, this constant communication process does improve safety.

For every study, we:

• Record the audio of the meetings
• Maintain a list of FAQ that we send back to sites
• Take detailed minutes
• Save meeting recordings and share with the team
• Share everyone’s cell phone numbers to enable real-time communication
• Communicate one-on-one with each nurse

This last point isn’t common in all studies, but it’s important, because at times coordinators aren’t that forthcoming in group calls / phone meetings due to a fear of not wanting to sound “dumb” in front of their colleagues. It’s human nature. One-on-one communication allows them to ask the important questions.

Rigorous communication enables us to detect problems early. It helps to reduce deviations. For example, we had an SAE in one of our CAR T-cell studies recently: a patient contracted hypoxia due to the drug. The patient had lung cancer and some hypotension, and the question was this: Did the lung cancer exacerbate the SAE, or was it the other way around? The communication plan enabled the team to determine the result.

With cytokine release syndrome, we often speak to a research nurse and ask them about their pre-med cocktail, researching on PubMed and evaluating the risk / benefit ratio to determine if it’s in balance. Moreover, sharing the collective experiences across the organization speeds the learning curve. We’re managing a number of CAR T-cell studies and update SOPs with new learnings. For example, one of our current studies is utilizing a novel approach of laparoscopy into the abdomen to treat malignant ascites. The PI is an innovator, and it requires new and specific training and techniques.