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Problem Solvers – IHC Swat Visits (Case Studies)

Problem Solvers – IHC Swat Visits (Case Studies)

A clinical trial of over 70 hospital centers to enroll 180 subjects was 2 years into recruitment with only 30 subjects enrolled.  IHC was brought into perform SWAT visits to understand enrollment obstacles and to identify any other barriers to enrollment.  We discovered that site support was ending after normal business hours and the subject population was often identified after hours or over the weekend.  IHC bolstered recruitment support efforts during these hours and weekends to ensure no candidates missed the enrollment window.  These efforts were highly successful and enrollment was completed in under 17 months after IHC introduction into the project. 

A clinical trial of over 70 hospital centers to enroll 180 subjects was 2 years into recruitment with only 30 subjects enrolled.

IHC was brought into perform SWAT visits to understand enrollment obstacles and to identify any other barriers to enrollment. We discovered that site support was ending after normal business hours and the subject population was often identified after hours or over the weekend. IHC bolstered recruitment support efforts during these hours and weekends to ensure no candidates missed the enrollment window.

These efforts were highly successful and enrollment was completed in under 17 months after IHC introduction into the project. Weekend enrollment rates doubled with IHC’s help and after hours calls were addressed by SWAT members to ensure enrollment targets were met.

A clinical study of over 200 centers and 6600 patients were being poorly site-managed.

Electronic Data Capture was the means of managing all aspects of the clinical data (date entry, review by the monitors, and cleaning of the data by the study coordinators and data managers). Eighteen (18) sites with over 30% of the enrollment were very behind in entering and cleaning the data for over 1000 patients. This problem had been growing for over 9 months with no real movement resolving the issues.

IHC was called in to meet the sponsor's deadline of delivering a clean database of all patients within 4 months. The sponsor company needed to present results of this trial at a late breaking session of the AHA annual meeting. The IHC "SWAT" Team was brought in - we corrected the site problems, had all the clinical data entered, reviewed and cleaned with 2 weeks to spare.

This data was presented and very well received at the annual American Heart Association annual conference. Without this effort, a major marketing opportunity would have been lost.

A 200 patient pilot program using paper-based CRFs was over a year behind with enrollment and severely lacking CRF data entry.

IHC was brought in to monitor the program and provide separate "SWAT" support at sites where needed. The trial completed enrollment within 6 months after IHC was hired and data was cleaned and submitted by our "SWAT" Team ahead of the sponsor revised time lines.

An interim analysis conducted by the sponsor, before IHC was hired, predicted a 40% loss of quality data, due to site and data management problems. IHC was able to reduce that data loss to under 20%. Many data management and data cleaning issues were resolved and the study results were used as part of the pivotal submission of clinical support for the drug's new indication of use.

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