Based on Real World Evidence (RWE)

We’ve summarized for you four different RBQM case studies that illustrate how our intelligent EarlyBird system forecasts future events and detects suspicious activity, to subsequently trigger on time preventive and corrective actions.

1. Permissible Clarifications

After checking the audit trail for those who entered the data, the RBQM system revealed that at two sites in Japan, instead of site personnel, the sponsor company monitor entered the majority of the data into the EDC system using his user ID for ‘permissible clarifications’ or ‘type 1 error correction’ – something that is not supposed to happen in a trial.

CS Permissible Clarifications

2. Data Cleaning before Christmas

Data Cleaning before Christmas

In an Oncology trial the prediction in the RQBM system showed that a number of required events were to take place around Christmas time. This helped the sponsor to proactively intensify the data cleaning just before Christmas so – in case the required number of events would have taken place – the data were already cleaned. This prospective learning resulted in all queries responding to “on schedule” for an interim analysis, which then even resulted in stopping the study early due to a positive outcome – without spoiling Christmas time…

3. Late Data Entry and Delayed Responses

A long term study with many patients was supposed to be completed prior to summer break avoiding the analysis being postponed until after summer. The system had been set up to also highlight the risks around late data entry and delayed responses to queries. It turned out that the study lock would be delayed by one country in particular together with the sites with many open queries, which also were not addressed by the site monitor. Still on time, both the study monitor and the central monitor successfully addressed the situation. A second site monitor was hired to assist with the data cleaning at those sites – eventually supporting the timely availability of a clean database.

Late Data Entry and Delayed Responses

4. Lost-to-follow-up or IC-withdrawn

Lost-to-follow-up or IC-withdrawn

In a large CardioVascular outcome trial with 8000 patients, very early on EarlyBird® predicted that – if the informed consent withdrawn cases and the Lost-to-follow-up cases would continue to accrue at the current level – the study would end up with 1300 cases of Lost-to-follow-up or informed-consent-withdrawn cases.

This high number would have resulted in a non-acceptance by the health authorities and so preventive measures were taken to ensure the number of those particular drop out cases remained at an acceptable level, so that sufficient information about the outcome could still be collected for the analysis – without jeopardizing a non-acceptance of the study data by the health authorities.