Contributions
Abstract: P699
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - Clinical assessment tools
Introduction: To improve consistency of neurological assessments in clinical trials for Multiple Sclerosis the “Web Diary” (WD-EDSS) was developed by CRF Health (CRFH) in collaboration with the University Hospital Basel, providing the Neurostatus-EDSS electronically. The Web Diary is an algorithm-based electronic data capture and processing system. An automated consistency check can be run up to 4 times (one run is mandatory) providing real-time feedback on expanded disability status scale (EDSS) assessments. Unresolved inconsistencies are submitted to an EDSS Expert guided online query management and data clarification (DCF) system, the CRFH Trial-Manager.
Objective: To analyse the first experiences with the Web Diary in two global multi-centre phase 3 studies.
Methods: ASCLEPIOS I and II are phase 3, randomized, double-blind/double-dummy, active-controlled, multi-center trials comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing Multiple Sclerosis. Neurostatus-EDSS assessments of the first 8 study visits of 2368 patients were analyzed from 2016 to 2018, for number of inconsistencies and rounds of real-time feedback use, number of required expert reviews and query releases, Functional System (FS), Ambulation or EDSS step concerned and changed.
Results: Of 8174 completed EDSS assessments after first data entry by neurologist at site, 3375 were found with inconsistencies after the 1st feedback, from which the 3 most affected FS were: Pyramidal FS (49%), Sensory FS (24%) Visual FS (22%). Of the 8174 assessments, 3783 were signed off and submitted to the CRFH Trial-Manager after the 1st, 1213 after using a 2nd, 468 after a 3rd and 2710 after a 4th feedback. Of 8174 completed EDSS assessments, 6266 assessments were stored in the database without triggering an expert review, 1908 were submitted for expert review. From these, 1587 queries to sites were released and 321 assessments were accepted by the expert directly and stored in the database. Frequency of queries to site decreased during the observation time from 27% to 10%. Further analysis will be presented: affected FS after each feedback and expert review, rater-expert interaction and time from data entry to submission.
Conclusion: This first analysis shows that the Web Diary increases consistency of EDSS assessments based on real-time feedback function and EDSS Expert, and leads to a lower rate of queries during the observation time.
Disclosure: M. D`Souza has received travel support from Bayer AG, Teva Pharmaceuticals and Sanofi Genzyme and research support from the University Hospital Basel
S. Gysin has nothing to disclosure
A. Heikkilä is an employee of CRFH
J. Lorscheider has received a research grant from Biogen and has served on advisory boards for Roche
V. Haller has nothing to disclosure
K. Kravalis has nothing to disclosure
N. Norman is an employee of CRFH
P. Higgins is an employee of CRFH
E. Lam Novartis Pharmaceuticals Corporation
A. Kakarieka is an employee of Novartis Pharam AG
D. Tomic is an employee of Novartis Pharam AG
L. Kappos´ institution (University Hospital Basel) received in the last 3 years and used exclusively for research support at the Department: steering committee, advisory board and consultancy fees from Actelion, Alkermes, Almirall, Bayer, Biogen, Celgene/Receptos, df-mp, Excemed, GeNeuro SA, Genzyme, Japan Tobacco, Merck, Minoryx, Mitsubishi Pharma, Novartis, Roche, sanofi-aventis, Santhera, Teva, Vianex and royalties for Neurostatus-UHB products. The Research of the MS Center in Basel has been supported by grants from Bayer, Biogen, Novartis, the Swiss MS Society, the Swiss National Research Foundation, the European Union and Roche Research Foundations.
Abstract: P699
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - Clinical assessment tools
Introduction: To improve consistency of neurological assessments in clinical trials for Multiple Sclerosis the “Web Diary” (WD-EDSS) was developed by CRF Health (CRFH) in collaboration with the University Hospital Basel, providing the Neurostatus-EDSS electronically. The Web Diary is an algorithm-based electronic data capture and processing system. An automated consistency check can be run up to 4 times (one run is mandatory) providing real-time feedback on expanded disability status scale (EDSS) assessments. Unresolved inconsistencies are submitted to an EDSS Expert guided online query management and data clarification (DCF) system, the CRFH Trial-Manager.
Objective: To analyse the first experiences with the Web Diary in two global multi-centre phase 3 studies.
Methods: ASCLEPIOS I and II are phase 3, randomized, double-blind/double-dummy, active-controlled, multi-center trials comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing Multiple Sclerosis. Neurostatus-EDSS assessments of the first 8 study visits of 2368 patients were analyzed from 2016 to 2018, for number of inconsistencies and rounds of real-time feedback use, number of required expert reviews and query releases, Functional System (FS), Ambulation or EDSS step concerned and changed.
Results: Of 8174 completed EDSS assessments after first data entry by neurologist at site, 3375 were found with inconsistencies after the 1st feedback, from which the 3 most affected FS were: Pyramidal FS (49%), Sensory FS (24%) Visual FS (22%). Of the 8174 assessments, 3783 were signed off and submitted to the CRFH Trial-Manager after the 1st, 1213 after using a 2nd, 468 after a 3rd and 2710 after a 4th feedback. Of 8174 completed EDSS assessments, 6266 assessments were stored in the database without triggering an expert review, 1908 were submitted for expert review. From these, 1587 queries to sites were released and 321 assessments were accepted by the expert directly and stored in the database. Frequency of queries to site decreased during the observation time from 27% to 10%. Further analysis will be presented: affected FS after each feedback and expert review, rater-expert interaction and time from data entry to submission.
Conclusion: This first analysis shows that the Web Diary increases consistency of EDSS assessments based on real-time feedback function and EDSS Expert, and leads to a lower rate of queries during the observation time.
Disclosure: M. D`Souza has received travel support from Bayer AG, Teva Pharmaceuticals and Sanofi Genzyme and research support from the University Hospital Basel
S. Gysin has nothing to disclosure
A. Heikkilä is an employee of CRFH
J. Lorscheider has received a research grant from Biogen and has served on advisory boards for Roche
V. Haller has nothing to disclosure
K. Kravalis has nothing to disclosure
N. Norman is an employee of CRFH
P. Higgins is an employee of CRFH
E. Lam Novartis Pharmaceuticals Corporation
A. Kakarieka is an employee of Novartis Pharam AG
D. Tomic is an employee of Novartis Pharam AG
L. Kappos´ institution (University Hospital Basel) received in the last 3 years and used exclusively for research support at the Department: steering committee, advisory board and consultancy fees from Actelion, Alkermes, Almirall, Bayer, Biogen, Celgene/Receptos, df-mp, Excemed, GeNeuro SA, Genzyme, Japan Tobacco, Merck, Minoryx, Mitsubishi Pharma, Novartis, Roche, sanofi-aventis, Santhera, Teva, Vianex and royalties for Neurostatus-UHB products. The Research of the MS Center in Basel has been supported by grants from Bayer, Biogen, Novartis, the Swiss MS Society, the Swiss National Research Foundation, the European Union and Roche Research Foundations.