If you drive a car without a dashboard and GPS, you may able to reach your destination, but how safe will you be and how long will your trip last? The same applies to endpoint adjudication process: without the proper tools, you cannot win the race. This is exactly what Key Performance Metrics (KPM) are for.
Adjudication Process best KPMs?
By KPMs, we refer to the overall statistics of a study, the time-related Key Performance Indicators (KPIs), and the quality control measures. Altogether, these KPMs allow the clinical team to effectively steer the adjudication process.
Frequently used Key Performance Metrics
Which KPMs are mostly used in an endpoint adjudication process? Here’s a non-exhaustive list of some of Ethical’s eAdjudication® electronic platform Key Performance Metrics to help you effectively steer your clinical adjudication study*
Study statistics
Study statistics, such as the number of recorded events versus the number of expected events are helpful for keeping track of the study overall progress. Other frequently used statistics include:
- List of pending cases between two given dates:
Knowing how many cases are pending within a timeframe is helpful for tracking the performance of the site study coordinators or the individual reviewers and understand the difficulties they may be facing. Tracking deviations from the expected numbers allows to take corrective actions. - New events and closed events by time period (e.g. per month):
Two helpful KPMs to help keep oversight of the overall performance of the adjudication process. - Events by type:
If the study is measuring different types of events, the clinical team also needs to track the events by type. - Events by status (e.g. “more data request”, “pending review” or “to be discussed”):
This KPM reflects the advancement of the adjudication process and may indicate a difficulty at a particular point. - Pending events by reviewer:
If a reviewer has more pending events than another, this may indicate a difficulty. The adjudication coordinator can then take appropriate action, e.g. send a notification to the reviewer or alert the clinical team. - Closed events by disagreement (Agreed/Major/Minor):
Tracking the progress of disagreement resolution gives a good estimate of the efficiency of the adjudication committee. - Closed events by event type:
A very useful KPM for tracking progress towards full completion of the study. Can be tracked as number of events and percentage of total. - Disagreements by period:
The rate of disagreements may remain constant, diminish, increase or show variability during the adjudication process. The reasons may be known or the evolution may deserve a discussion with the reviewers. The study team will judge whether this KPM is flagging a potential difficulty. - Disagreements by reviewer:
If, for example, a study has three reviewers and disagreement tends to come mainly from the same one, it may indicate that action is needed.
Time-related Key Performance Indicators
KPIs refer to different measurements within a given process. Among the most useful KPIs are those pertaining to the time necessary to accomplish each step of the adjudication process.
Most frequently used time KPIs are:
- Time from creation of an event to submission for review.
- Time from creation of an event to closing.
- Time from submission of an event to closing.
- Time from notification of “minor” or “major” deviation to closing.
- Time for coordinator’s review of an event.
- Time from creation of an event to completion of translation.
- Time for translation of an event.
- Time for general query resolution.
- Time for query escalation resolution.
- Time for site to upload medical records of an event.
- Time for site to answer query about medical record.
- Time from completion of event package to submission for review.
Other important KPIs include:
- Percentage of medical records files accepted/refused per site/country.
- Number of queries per site/country.
These KPIs help the clinical team and adjudication coordinator detect if there is a difficulty, and at which step. The difficulty may lie with the coordinator, the translator, a reviewer or a particular site or country.
Quality Control (Q.C.)
Quality control in an endpoint adjudication process can be described as the sum of the procedures, measurements and metrics used to control and maintain the quality of the adjudication. It is usually performed by collecting and evaluating specific and pre-defined metrics (Intra-Variability, Inter Variability, etc.) throughout the study. The study team needs to track the following:
- QC events versus total study events.
- Number of events closed with and without discrepancies.
- Discrepancies by event type.
- Major deviations reported per QC round.
If the discrepancies or deviations identified are above a pre-defined threshold, the study team must take corrective and preventive actions to preserve the quality of the adjudication process.
The importance of monitoring KPMs
Closely monitoring the KPMs from the onset of the endpoint adjudication process will help the study team solve any issues without delay. In most cases, a complementary training of the site coordinator, the reviewer or other staff involved (depending on where the problem lies) to clarify the endpoint adjudication electronic platform settings and endpoint adjudication charter requirements will solve the issue.
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