Challenge

 

Clients challenged Prelude Dynamics to develop customizable enrollment graphs and tables in order to quickly reflect current enrollment rates and/or adjusted projected enrollment at any point, per site or across the whole study.  In evaluating this challenge, Prelude anticipated the need for a highly customizable function for creating the enrollment graph to accommodate a variety of different studies and sponsors. Additionally, field names may vary from study to study and different studies have different criteria for actual enrollment. For example, some studies may determine enrollment by if a treatment group has been assigned while others may use screening results as enrollment criteria, and still others may not consider a subject fully enrolled until the first dose is administered.

 

Proposal

 

Prelude Dynamics proposed to add an enrollment graph module to VISION™, an electronic data capture system built explicitly to support clinical research.  In particular, Prelude proposed development of an administrative panel where enrollment graphing information could be set up. A separate form would be employed for graphical display of the specified information. Prelude Project Managers would determine initial settings with the study project manager. Then study project managers would be trained on how to change the criteria if necessary.

 

Background

 

Successful tracking of enrollment for a clinical study is imperative in order to maintain study schedule and budget. When multiple sites are involved, this can be complex, particularly because some studies have sites location across the globe. A single location within the EDC where enrollment could be monitored would be very helpful in tracking study progress.

 

Solution

 

Prelude developed an enrollment graph and table settings panel and a corresponding results display section. The enrollment settings allow the selection of the form and field to be used as an indication of successful enrollment. The expected and projected total and monthly enrollment can be put into the settings and changed at any time. The project manager can choose to view graphs, tables or both for each site, all sites or a combination.

 

Results & Benefits

 

The Prelude project manager worked with the study project manager to input initial enrollment settings. As data was collected, the enrollment graph and tables were used to quickly view the progress of the study. The project managers using this feature found it helpful to be able to track the study progress, and reported that the location of enrollment information in a single location better facilitated planning subject recruitment activities and working with the clinics experiencing difficulty meeting monthly enrollment goals.

 

The study project manager was able to modify projected enrollment settings mid-study to address realistic enrollment. The project managers were quickly able to identify which sites were successful at enrollment and which were struggling, which contributed to beneficial strategic planning sessions to improve enrollment at low-enrollment sites. Project managers used this information to communicate with the sponsor to decide if successful enrollment sites could enroll additional subjects to mitigate the reduced enrollment at other sites. This allowed them to stay on track and meet the study enrollment projections.

 

About Prelude Dynamics & VISION™

 

Prelude Dynamics is a global provider of customized web-based software systems for data collection, analysis and management of clinical trials, studies and registries. We streamline eClinical operations through our unique and innovative VISION software system, which allows us to rapidly configure data collection solutions for pharmaceutical, CRO, medical device, animal health, and university organizations.