Key Performance Indicators in Clinical Research

Are Key Performance Indicators (KPIs) necessary in clinical research?

KPIs are often used in clinical research, e.g. in:

• budget planning
• contract creation
• submissions to authorities and ethics committees
• project management
• Sponsor Oversight
• quality

KPIs are used for individual areas or for the entire development program to monitor the quality of work, timelines, patient safety, data integrity and financial scope. To define and monitor KPIs together with the vendors, especially for sponsor oversight and to ensure quality in clinical trials.

For sponsor oversight, it is recommended to define (and monitor) the following KPIs:

• Timelines for creating plans and manuals
• Compliance with the training plan
• Selection of Study Centers
• Activation of the study centers in comparison of the actual activation of study centers versus planning applies
• Inclusion of study subjects in comparison of the actual inclusion rate versus the planning also applies here
• Open action items from monitoring visits at the study centers
• Timeline for the creation of the monitoring report - here it is necessary to define and track the percentage of the reports which were created within the timeline
• Number of protocol deviations
• Query status in case report forms - here the total number of queries and also the time for answering the queries is observed
• Number of SAEs and whether these were reported in a timely manner
• Timely confirmation of the acknowledgement of receipt of the safety letters by the investigators
• Quality of the TMF and whether it is " inspection-ready ", including the timely upload of the documents
• Timely tracking and completion of CAPAs
• Budget - on the one hand, the current budget status is compared to plan and, on the other hand, the time required to finalize the budget is also important

KPIs help ensure that both the sponsor and the vendor have an equal understanding of the common goals. And of course, it is also about transparency and a metric-based evaluation of the vendor's performance. It is therefore also advisable to implement the fulfillment of certain KPIs in the contract. For each study, the KPIs should be adjusted to the study-specific requirements and this should also be done using a risk-based approach. In reality, not all KPIs listed above have to be used in one trial. Another advantage of establishing KPIs for Sponsor Oversight is the monitoring of risks.

It is also advantageous to define KPIs for Quality Assurance (QA). These can be:

• Completion of the audit reports within the timeline
• Completion of the CAPA within the timeline and here it should be noted that this KPI is within the responsibility of the operational team and within the responsibility of QA. A strong and close cooperation between the operational team and the QA is substantial. Ultimately, it can be assumed that both departments have the same goal - namely ensuring patient safety and data integrity within clinical trials.
• Number of all deviations - whereby this KPI must be precisely defined
• Timely fulfilling of training of the SOPs
• Audit findings - divided into the types and severity of the findings

However, defining KPIs is not enough. The development of the KPIs should also be constantly monitored in order to identify a trend and possibly initiate countermeasures. A definition of KPIs without a constant analysis does not make any sense. There are some electronic systems that can display the status or history of KPIs via dashboards and graphics. This enables a quick and good overview of the individual KPIs and their progress. It is possible to zoom into the individual graphics to being able to look at individual study centers, for example. In addition, reports can be created which facilitate e.g. reporting to senior management in a simple and transparent way. However, there is the disadvantage that KPIs are often the same for all studies without any study-specific adjustment. As already mentioned above, KPIs should be adapted to the requirements of each study in order to ensure a good overview. If the vendor maintains an electronic system and the sponsor wants to use this system to keep track on the KPIs for his study(s) it is essential that the sponsor receives access to the system. This especially applies to smaller sponsors, who usually do not have their own electronic system for monitoring the KPIs. In addition, it is important that for those KPIs which are in the responsibility of the vendor, regular reports should be made available. These can be simple excel exports or documents into which graphics can been inserted. Here, too, the type of data and the frequency of the reports should be defined at the beginning of the study to ensure that these reports are of good quality. As part of the sponsor oversight, KPIs should be integrated into the corresponding SOP on sponsor oversight. A transparent and clear definition of KPIs is documented in the sponsor oversight plan to being able to provide clarity for the implementation of the sponsor oversight activities. Furthermore, necessary corrective measures can be identified and implemented at an early stage. If a governance structure is also in place, the establishment of KPIs will support with the to senior management from both sponsor and CRO, as described above, and assessing the progress of the clinical trials in an easy and transparent way. An associated governance plan also offers the possibility of a joint agreement on the KPIs, as this is usually signed by representatives of the sponsor and representatives of the CRO.

With this the initial question can be finally answered that KPIs are essential in clinical research.

If you have any questions about sponsor oversight, governance structure or KPIs, please do not hesitate to contact us. We will be happy to support you.