Don’t Overlook a Critical Component to Study Start-up

Working at a clinical trial site early in my career, I remember the frustration felt by both the sponsor and site when we did not enroll a patient within a few days of receiving the go-ahead to start recruiting.  After weeks of contract negotiations, drug shipment confirmations and CRF development the sponsor believed we had everything needed to enroll a patient immediately. Often times the sponsor had failed to provide us with a recruitment plan and the enrollment materials until after the study started, which greatly impacted our patient recruitment efforts in the first few weeks.

The study start-up phase of a clinical trial can be chaotic with vendor set-up, budget negotiations, contract finalizations and investigator meeting preparation.  Of course, all of these factors are critical for the launch of the clinical trial but frequently a key component is overlooked, patient recruitment.

During the initial set-up of a clinical trial, it can be very beneficial to include patient recruitment in your early planning. When developing your study start-up checklist ask yourself the following patient recruitment questions:

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• What database query resources can be deployed to help sites proactively start identifying patients before the investigator meeting?
• What recruitment materials can the site use to reach out to their current patients?
• When and how can you use site communications to roll out a recruitment plan prior to the investigator meeting?

After a successful investigator meeting, the expectation is for sites to go home and immediately screen their first patient. But for many studies it can take a few weeks for the study to gain momentum and enrollment to really take-off.  Sites usually wait until after the investigator meeting to even start identifying potential patients.  Sites may need a couple of weeks to go through their database, send out an email blast and put an advertising plan together.  By the time all of this is done, it has been 3 weeks since the investigator meeting and the site may only have one or two patients scheduled.

Also, sites can be hesitant to screen their first patient in a study, as they want to avoid any errors, which may result with some back and forth with the sponsor and CRO.  If a recruitment plan is in place before the investigator meeting, these questions can be addressed via in-person conversations at the meeting.

• Launching a recruitment plan prior to the investigator meeting can help jump start enrollment and boost enthusiasm for the study. 
• Be upfront with sites about the recruitment plan timeline, including dates and expectations
• Work backwards from the investigator meeting, to see when you need to have your study materials IRB approved and sent to the sites
• Find additional resources, if needed, to roll out the plan, to conduct one-on-one site phone calls and/or scheduling of webinars
• Share the results of the patient recruitment efforts at the investigator meeting so sites can see the benefit of the early planning

The biggest challenge of early recruitment planning is carving out the time and resources when everyone is already stretched thin.  Identifying a dedicated team member or vendor to the task can greatly help the team and end result.  Another issue you may encounter is sites not wanting to start identifying patients prior to the investigator meeting.  If you can lay out the entire plan, highlighting the end objective such as a desired number of patients scheduled, it makes the plan much easier for the site to grasp.

For a cardiovascular study with very aggressive timelines, CAHG rolled out a comprehensive recruitment plan one month prior to the investigator meeting.  The study was going to be heavily reliant on patient recruitment within the site’s practice. We sent the essential recruitment materials and conducted webinars and one-on-one enrollment plan calls with all of the sites to introduce the recruitment campaign and educate them on how to best utilize the patient recruitment tools.

The communications outlined the recruitment expectations and set the goal for sites to have at least one patient scheduled by the time they attended the investigator meeting. To hold sites accountable, they were asked to complete a simple form detailing all of their patient identification efforts and how many patients were screened.

The study had its first screened patient the day after the investigator meeting and screening activity quickly gained momentum within the first few weeks. The sites maintained robust screening activity the entire study which led to the study exceeding the original enrollment goal almost four months ahead of schedule.  The early recruitment planning not only impacted the first few weeks but set the bar for the entire study duration.

The early recruitment planning led to several successful outcomes:

• Patients were scheduled for screening immediately after the investigator meeting
• The sites engaged in more productive patient recruitment discussions at the investigator meeting since sites already were in the middle of identifying patients
• Sites came to the investigator meeting very motivated and enthused about the study
• The enrollment rate immediately jumped up and held at a steady rate for the entire study

For your next trial, do not overlook patient recruitment in your study start-up planning.  Spending some time laying out an early patient recruitment plan can go a long way towards meeting your enrollment timelines.