Update – eSource Pivotal Trial – WOW!!!

 

 

Target Health has begun to eliminate the use of paper records in the clinical trials it is managing. Target e*CTR (eClinical Trial Record; patent issued)™ is now being offered as part of our EDC and paperless clinical trial offering. And yes, it is compatible with any “modern” EDC system and does not change any of the interfaces or behavior of EDC systems. The following are contracted studies:

 

  1. 2 Phase I/II studies completed (IND Project 1)
  2. 2 Phase I studies to be completed December 2012 (IND Project 1)
  3. 1 Phase III pivotal study (n=200; 20 sites) to be completed Q1 2013; NDA to be submitted Q2 2013 (IND Project 1)
  4. 1 Phase IIIb open-label extension study to be completed Q4 2013 (IND Project 1)
  5. 1 Phase II study (n=120; 6 sites) to be completed December 2012 (IND Project 2)
  6. 1 Phase I study to be initiated January 2013 (IND Project 3)
  7. 5-year followup of a PMA device study

 

RESULTS: An analysis was performed of 10,458 pages entered in the first 3 months of an ongoing Phase 3 clinical trial using Target e*CTR and direct data entry at the time of the office visit. What is unique is that it is possible to review all monitoring metrics in real time and implement changes within hours of any real time observation.

 

Bottom Line:

  1. Of the 2,283 pages that were source document verified (SDV) because there were paper records in the patient’s chart, there were just 16 (0.7%) changes made to the database; 4 of the changes were 4 minor medical histories for 1 subject that was found by the CRA in the chart. None of the findings were critical.
  2. Initial form review from the time of data entry, which occurred in real time at the office visit:
    1. 50% of pages were reviewed within 11 hours
    2. 75% of pages were reviewed within 25 hours
    3. 90% of pages were reviewed within 54 hours
    4. 95% of pages were reviewed within 92 hours
    5. Just 4.2% of pages were queried
    6. Just 1.4% of pages had queries that were generated as a result of online edit checks (auto queries)
    7. Just 1.6% of pages were modified post query.
      1. Of those pages that were changed, at least 62% were non-significant changes to baseline medications and medical history.
      2. There were no changes made to the database that would have affected patient safety or the outcome of the trial.

 

# Pages Entered # Pages With Queries # Pages Modified Post Query
10,458 435 (4.2%) 164 (1.6%)

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com

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