Once sponsors have generated a short list of investigative sites, the next step is to contact the sites to start the process of assessing their interest in participating in the study. While the process varies by sponsor/CRO, some type of communication is needed to alert the sites to the upcoming study opportunity.
Communication is typically handled via email, telephone, or even fax, with responses tracked using spreadsheets. This sounds simple, but it can quickly become cumbersome.
How requests are sent and tracked today
A sponsor that needs to engage 50 investigative sites to enroll patients for a Phase III trial would:
- Find the sites' contact information
- Send an email, fax or call
- Document/record when the inquiry was sent, which sites responded, the nature of interest (yes, I am interested in learning more or no, I am not interested) and how long it took the sites to respond
- Follow up based on the site's interest level
Most sponsors use spreadsheets and email folders to track all replies from sites. Though some sponsors have developed in-house systems to tackle this activity in study startup, most companies do not have the resources to build and implement an internal solution.
Spreadsheets can work, however they require a great deal of customization and are not the ideal solution for managing and documenting responses from multiple investigative sites. The major drawback to using spreadsheets is the amount of manual work needed to keep them updated. A clinical research assistant or clinical project manager must manually update the spreadsheet when responses from sites are received. This is not only tedious, but also leaves room for human error and mistakes.
How sponsors go about contacting sites can vary depending on the size of the sponsor, phase of the trial and CRO involvement, and they are not necessarily performed in a step-wise fashion. Sending requests to investigative sites can also happen at any point in the clinical trial, not just the study startup phase.
If enrollment for a clinical trial is falling behind and the sponsor needs to recruit sites quickly, the sponsor needs to perform the same steps, which adds even more complexity to the tracking procedures.
Tracking site responses is a time-consuming activity and every day saved represents a significant amount of money and helps pharmaceutical companies ultimately deliver therapies to those in need faster. Sponsors need to activate sites as quickly as possible so that they can move on with all the other activities and reach the first patient-in (FPI) milestone quicker.
Clinical Performance Partners, Inc
"The initial introduction a sponsor makes sets the tone for the entire relationship they will have with the sites over the course of the study. The more informative and user-friendly the initial exchanges are, can go a long way towards engaging the sites. Interactive tools and portals that enable two-way communication that facilitate transparency in the site selection process are becoming necessary techniques for fostering productive sponsor-site relationships."
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