We all know that delays in patient recruitment and enrollment can be costly, and it is critical to minimize as many delays as possible from study initiation to when the sites are actually able to enroll. If you don’t get a head start on site enrollment levels out of the gate, your study could be in jeopardy.
To emphasize this point, here are the latest stats:
If a site can enroll a patient within 30 days from when the site is initiated, the site has a 90-plus percent chance of success. If the enrollment gets pushed to 60 days, the site still has a fairly good chance. The site is at a 50 percent chance of success. But if enrollment gets pushed to 90 days or later, the site has a less than 10 percent chance of success.
That being said, what can you do to prepare your sites and get them enrolling out of the gate? Here are 8 critical factors to consider during the planning stages. Going through this checklist will help to make sure that your sites have the support that they need to be successful.
1. Patient Population: Are the patients needed for the study actually available and accessible to the site?
2. Disease Prevalence: What does the disease prevalence look like in the regions where you are conducting your trial?
3. Number of Patients: How many patients are required for your study? How many do you expect each site to enroll?
4. Enrollment Timeline: What is the length of enrollment? How many patients are you expecting sites to enroll each week?
5. Location of Sites: How well does the location of sites match up to the geographic locations of your target population of enrollees? Are your sites accessible to your target patient population?
6. Regulatory Agencies: Regulatory agencies, whether they are central IRBs, local IRBs, or even ethics committees, will be an additional element that you will need to include in your plan. This one criterion can have a significant impact on your timelines.
7. Communication with Sites: Do you have open communication with your sites? Is it a two-way communication or is it just you funneling information to them? When you need information back from the sites, how quickly and how readily are they able to provide it?
8. Metrics Tracking: Any time you plan to roll out initiatives to support the sites, you want to make sure there is a way to track metrics. Are your results not as successful as you planned? If so, what changes do you need to make? Metric tracking helps you measure your return on investment and determine whether the initiatives you put in place were successful.
Each study is different and needs a customized enrollment plan. Fully reviewing and evaluating each of these elements will help you determine where your energies will be best directed.
Contact us to discuss how we can help with your study.
