It’s common for sponsors to miss their patient enrollment targets during their first oncology study in the United States. It doesn’t matter whether you’re a venture-funded biotech or pharma startup, an established company entering oncology for the first time, or a European or Asian company bringing your oncology drug to the U.S.
The most common cause of low or slow patient enrollment boils down to site selection. Everyone wants to have the top research sites on their study – M.D. Anderson, Johns Hopkins, Sloan Kettering, Dana Farber. However, these large academic sites present significant administrative hurdles that are not always clear to the clinical operations executive who hasn’t navigated the hurdles in a previous study.
Here are three key points to consider when launching your first oncology study in the U.S. While most sponsors address all at the high level, we’ve seen many over the years not get granular enough in the planning which leads to missed enrollment targets.
As stated above, most sponsors desire to have a prestigious academic center on the study to bring valuable recognition. However, if that’s your only site, or if you have two academic centers as your sites, you’re likely to miss your targets.
Truly identifying the right investigator mix is the first step to deliver the right patients to meet the timeline in your protocol. Using another local community site that can get ramped up quickly in addition to the academic center is a solution that Medelis uses. This enables us to get the first patients in quickly while we ramp up the academic center.
If you’re running an immunotherapy study, it’s common for sites to have limited experience in complex immuno-oncology trials. Immuno-oncology studies have a steep learning curve, so selecting a site with prior clinical trial experience in immunotherapies relieves the burden of training the site from scratch.
In addition, it’s important to understand the volume of studies at a site and the site’s ability to promote it to patients. Participation fatigue is real, and a site running too many studies can cause enrollment delays. Make sure to understand how to structure the cadence of your communication to investigators, patients and all site staff to keep your study top-of-mind.
Turnover is common at sites, so comprehensive training, even for experienced sites, is critical. If a site is new to clinical research, additional time for start-up, comprehensive training, and constant communication and support are essential to success.
Even the most experienced sites may not fully understand how to budget for these types of new immunotherapy trials. Here’s more detail about how Medelis trains and manages sites for a CAR T-cell therapy study.
When sponsors are new to oncology studies in the U.S., or perhaps their first immuno-oncology study, it’s common to hear pushback when we present realistic timelines. Sponsors want to move quickly, but meeting timelines requires a complete understanding of all of the operational elements of a study.
As an example, one sponsor that came to Medelis for a rescue study did not factor in the cost and time to identify a central lab that was necessary to ship a drug on their behalf and prepare the necessary drug kits. One of the sites involved placed a hold on the study because the lab manual was considered incomplete. The study site would not submit to the IRB until this step was complete and placed the study on hold causing the sponsor an unexpected 8-week delay. There is time involved to perform due diligence in obtaining quotes and approving vendors. Once qualified, the details need to be incorporated into the lab manual. Cutting corners leads to the sticker shock of unforeseen costs and delays on the back end of a study. Even worse, delays can lead to potential patient safety issues.
Understanding all of the above is necessary to properly evaluate the timelines of a complex oncology study.
Transparency is important, so we make sure to educate sponsors about the details of their study timeline, so you don’t get unexpected delays and change orders. With our partner-like approach, we deliver accurate timelines and cost estimates instead of presenting overly aggressive timeframes just to win the study.
Connect with us if you’d like to discuss your upcoming study plan.