Consider this scenario: You are the clinical trial manager for a new oncology study. You have recommended an investigator site for the study. After a comprehensive feasibility and site qualification process, your site was selected and eventually activated. Throughout the process the site has indicated that they have the patients for the trial, so you are confident in the site’s ability to recruit for the trial. Two months have gone by, and the site has not even pre-identified a subject. Finally, on your routine client call, your client counterpart asks the pointed question. “This was your hand selected site…what is going on here?”
Enrollment is the lifeblood of any clinical trial. The most cutting edge of trials will fail if potential patients are not enrolled. While it is impossible to predict every eventuality that could negatively influence enrollment on a trial, we do have the ability to predict risks and mitigate as much as possible. The main tool that we have is engagement. Successful enrollment at the site requires engagement at the site level, engagement at the client level, and engagement at the CRO level. Linical prides itself as being the hub of the clinical study team, working closely with both the client and the sites to ensure that the right patients are enrolled for our clinical trials.
Everything originates from the feasibility portion of the trial. The project team closely looks at the Feasibility Questionnaire responses and has the site manager vet these responses with all stakeholders. Often, we discover that the investigator’s thinking is incongruent with the thoughts of the site staff that are responsible for subject screening. By identifying this difference, we can take another look at sites to decide if they are a good fit.
In terms of client engagement, Linical encourages client attendance at the site initiation visits. This allows the client representative to demonstrate to the site that the client is fully engaged as well as provide the site with any late breaking new information on the study and or the Investigational Product (IP). In addition to startup activities, Linical also focuses on enrollment throughout the study startup process. The site initiation visit (SIV) serves as the final stop prior to the green light, thus ensuring that the expected parameters for enrollment are still in play. We look to identify if there have been team member changes that may need additional training or if there are blockades that had previously not been identified that could adversely affect recruitment.
Finally, we come to the recruitment phase of the study. Very often, just based on the design of the study, it is known that the recruitment could be protracted. At that time, it is incumbent on the site manager to come up with ways to keep the site engaged. In my previous days as a monitor, I’ll admit I often dreaded the weekly recruitment contact as often it was simply the same dialogue week after week and often bore little fruit. Over the years you learn new “tricks” to really help open the dialogue and promote collaboration.
- Set the stage early and prepare your site staff that there will be routine contact but that you consider yourself as part of the team.
- Email is often the easy path but set plans for phone calls. Actually speaking to a person often can lead to greater dialogue
- I routinely called my study contacts if he/she was coming back from vacation/long holiday just to see how their time off was. Often that discussion led to them providing information completely unsolicited.
At the study level, there are many ways to keep the sites engaged and to help boost enrollment. These range anywhere from developing patient facing materials, engaging in recruitment booster visits, and ranging all the way to having face to face study coordinator training and/or investigator meetings. While the efforts often can be effective, it is certainly not guaranteed, and can carry a significant price tag.
As I moved into the role of clinical trial manager and project manager, I found myself pivoting to come up with new ways to keep sites engaged that would cost very little in terms of time and money. I have often found that that if I am recognized for my work, that it will spur me to put in even more effort. I am also competitive by nature, so I have the natural tendency to want to close the gap if I am behind or maintain that gap if I am ahead. With the belief that most people are very similar, I have developed some tools that appeal directly to these natural instincts.
- On studies that have routine study coordinator or Principal Investigator (PI) teleconferences, I have often invited individuals at our sites that are having success to present. Often that can lead to great discussion and other sites can adopt best practices.
- On studies that have newsletters, I have worked to highlight a team member of the month. I request permission to post the individual’s picture and provided a short biography. I have found that doing these little things helps show that we are all people and not just a contact in an email.
- Probably the easiest tactic and the most successful tool was the creation of the study newsflash. Simply creating a weekly or biweekly email to the study team that can include any or all of the following:
- Welcome new sites that have been initiated
- Congratulations on first enrollment
- Adding a table highlighting/recognizing the high enrolling sites
Often, I found myself receiving feedback on the emails indicating that they were doing what they could to get on the high enrollers graph.
Here at Linical we are utilizing these tools and collaborating to share success stories, as often what works on one study can be used on another.
There is certainly no guarantee with any clinical trial in terms of enrollment, however ensuring engagement strategies are in place should help foster a positive study dynamic, which should in kind help maintain and possibly increase the overall study enrollment.
Author:
Doug Schallon
Linical Project Director, Oncology