One of the key indicators of a clinical trial’s success is if the First Patient In is enrolled on time, or close to the goal. This is an important milestone for patients, physicians, and the sponsor. It marks the culmination of “study start-up,”, an operationally intense period when the team is focused on pre-identifying patients, document review, contracting, user testing of software, and regulatory and ethics discussions.
If the First Patient In takes place 30 or 60 days after the initial goal, it could impact the overall success of a clinical trial by extending the timeline to complete enrollment. Study delays can also lead to significantly increased costs for the sponsor if they are behind in patient recruitment.
“Doing preparatory work before a study starts, including pre-identifying patients and activating sites, can help sponsors achieve the First Patient milestone on time, and just as important, line –up the Next Patient In,” said Preston Klassen, the President and Head of R&D at Regulus Therapeutics. “Without this, the patient recruitment campaign could be starting from scratch and study sites might not be activated on time, which can lead to avoidable delays in enrolling the First Patient In.”
Global Site Solutions Is a Proven Solution That Works Hand-in-Hand with Study Sites to Enroll the First Patient In and Avoid Patient Recruitment Delays.
For 10+ years, Continuum Clinical’s Global Site Solutions (GSS) team has been Going Beyond to provide comprehensive site support to more than 8,500 study sites around the world. This expertise has led to activating study sites and regularly enrolling the First Patient In on time or close to the goal. Our GSS team collaborates with staff at study sites to develop a personalized, actionable enrollment plan to maximize site-specific local recruitment efforts while encouraging site focus and accountability.
Upon site activation, quickly pre-identifying patients is a critical step to bringing that First Patient In on time. To achieve this, study coordinators can share their patient database with the GSS team, who can then help identify individuals that reside close to the clinical trial site and have expressed an interest in participating.
Just as important as pre-identifying patients is working with study sites to make sure they are activated on time. When a study site is active before a campaign starts, our GSS team will work with their staff to pre-identify patients whom they can contact to be the First Patient In as soon as patient recruitment begins. The GSS team also holds study sites accountable throughout the enrollment process by following a Communications Plan, which outlines how patient recruitment will be managed.
To learn more about how our Global Site Solutions team can assist your clinical trial in enrolling the First Patient In on time and meet its enrollment goals, please fill out the form on the bottom of this page.
