The Amgen team focused on three main tactics to expedite enrollment:

1. Good site selection. Amgen ensured that initial outreach to countries and sites focused on robust feasibility and evaluations. It was critical to ensure that the requirements for study procedures, the patient journey, as well as any challenges that sites and patients face from the protocol were fully assessed. The study team put together questions for sites to comment on upfront to mitigate any risks.  Feasibility in countries and certain sites was conducted to inform on country and site selection after which more in depth site level evaluations took place to understand each site’s ability to conduct the study per the protocol, ICF-GCP and regulations

2. Introducing efficiencies in study start up. Amgen ensured prompt vendor set up and expedited submissions and approvals where possible. Study start up encompasses many different activities, and it was important to ensure adequate resources were available, especially in the midst of the pandemic.

3. Deploying StudyTeam. Amgen deployed StudyTeam to support screening and recruitment activities at site following activation. StudyTeam, developed by Reify Health.

StudyTeam proved to be a valuable tool for the study; the Amgen team had real-time access to screening and enrollment activities on a site level and at a country level whenever needed. Amgen was able to use this information to make early and informed decisions about site management, recruitment tactics, and protocol design, which led to improvements on enrollment performance. 

StudyTeam supported early identification of trends that resulted in pre-screening failures, which allowed Amgen to implement prompt mitigation plans.

Using real-time data, Amgen was also able to follow up promptly with sites that showed limited activity, which meant that sites got support in a timely manner from CRAs. Amgen was able to use the data to project future trends in screening and enrollment activity, which is critical for resourcing and planning ahead for study level activities. 

Prior site workflow: 

New site workflow:

Amgen’s target enrollment period was nine months. Due to the hard work of site staff and all key stakeholders, the enrollment into the study was accelerated by approximately 2 weeks. This was an incredible achievement for the team not only due to the acceleration of timelines, but to achieve this during a pandemic was truly remarkable.

There were three key enrollment goals that Amgen had for this trial:

1. Increase enrolled patients per site per month. Data shows an approximate 44% increase in patients enrolled per site per month for Amgen’s sites that used StudyTeam in the trial versus those that did not use the tool.

2. Decrease the number of sites that enroll zero patients.  Data shows that Amgen’s sites using StudyTeam in the trial were approximately 60% less likely to be zero-enrollers.

3. Provide sites with a preferred tool that alleviates burden. Data shows that 89% of Amgen’s sites that were offered use of StudyTeam for the trial chose it over other methods to manage screening and enrollment activities.

“StudyTeam proved to be a valuable tool for the study. The team had real-time access to screening and enrollment activities [...] whenever we needed it. We were able to utilize this information to make early and informed decisions [...] which led to improvements to enrollment performance.”

— Riddhi Channa, Sr. Manager, Global Clinical Program Management, Amgen

Key software features

Automatically Share Data

StudyTeam automatically shares de-identified recruitment and enrollment activity and data, saving the sites from having to duplicate work and enter redundant data into traditional pre-screening logs.

Easy to Use Interface

The drag-and-drop interface gets sites operational in less than 60 minutes. Sites are more productive and more engaged in the study.

Patient Log Tracking 

Single system for sites to track patients through the enrollment funnel, across all sponsors, and CROs, reducing site burden.