Update of Phase 3 Clinical Trial Using eSource (Target e*CTR)
A phase 3 clinical trial started in August this year is using Target e*CTR™ (eClinical Trial Record), fully integrated with Target e*CRF, in lieu of paper source documents. Subject data are being entered at the time of the office visit in real team, thus the name eClinical Trial Record. Clearly, being alerted in real time when a subject signs informed consent, seeing data in real time, and being able to query almost immediately after entry, has revolutionized the way we now monitor our clinical trials. We met with FDA and shared our approach at a Type C Meeting under an IND. Interestingly, the sites are making very few errors. The majority of the database changes have to do with modifications of form properties based on requests from the sites, changes of online edit check specifications, and yes, “over-zealous” monitoring. Once we modified the Target e*CRF EDC application and retrained the monitors, query rates dropped.
Here are some metrics:
A. Query Rates
- At the time when 2,291 forms were entered the query rate was 8.3%. A week later, when 3,432 forms were entered, the query rate dropped to 7.6%.
- When there were 190 queries, 62% came from just 2 forms. A week later when there were 260 queries, those 2 forms represented 59% of total queries (sites retrained, EDC tweaked)
- Just 29 online edit checks fired from 2291 entered pages (forms) for a rate of 1.3%. This rate has stayed stable (1.4% a week later)
- Of the 29 edit checks, 15 were from one edit check which was modified. A week later when the edit check was modified, of the 49 edit check firing, there were still 15 from that edit check indicating that the problem was solved
B. Form Review: From the time of the office visit, of the entered forms:
- 1. 50% were reviewed in 4 hours
- 2. 75% were reviewed in 23 hours (<1 day)
- 3. 90% were reviewed in 45 hours (<2 days)
- 4. 95% were reviewed in 66 hours (<3 days)
Goodbye Paper: Time to go to the shredder
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