Indicators for the quality of clinical studies

Various key performance indicators (KPIs) are used to measure the success of a contract research organisation (CRO) in clinical studies.

These KPIs help to evaluate the performance of the CRO in terms of the conduct and management of the study.

Important key performance indicators for the quality of clinical study conduct are:

• Data quality and protocol compliance: The accuracy, completeness and consistency of the data collected are critical. This is often checked by Source Data Verification (SDV) and other quality assurance measures. In addition, the specifications, processes and responsibilities set out in the protocol must be adhered to. This is the only way to ensure the validity of the results and the safety of all study participants.
• Recruitment (inclusion) and retention (keeping participants in the study) of study participants: In order for authorities to recognise the validity of study results, a retention rate of > 80% should be achieved.
• Time management: Adherence to timelines and the achievement of milestones according to the study plan are essential. Delays can increase costs and delay the launch of new therapies.
• Cost control: efficient use of resources to minimise costs per patient and the need to work within the agreed budget without compromising the quality of the trial.
• Regulatory compliance: all regulatory requirements and ethical standards must be adhered to throughout. This includes proper quality assurance, risk management, obtaining informed consent and compliance with data protection regulations
• Patient satisfaction: Patient satisfaction with the study processes, the questionnaires, the accessibility, competence and accessibility of the study assistance staff, the possibility of integrating the study-related procedures into the everyday life of the patient. This has a positive influence on recruitment and retention.
• Communication and collaboration: Regular and transparent communication with the sponsor, collaboration with and support of study centres.
• Safety and risk management: Effective monitoring and timely reporting of adverse events and side effects. Consistent risk management to avoid crisis situations, endangerment of study participants and even failure of the entire study.

These indicators are the basis for evaluating the performance of CROs and the quality of individual clinical studies and help to ensure that studies are conducted efficiently, cost-effectively and in compliance with all regulatory requirements.

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