Studies by Swissmedic, University Hospital Zurich and the University of Zurich have analysed the assessment of cancer drugs

08.06.2026

A collaborative venture between Swissmedic, University Hospital Zurich (USZ) and the University of Zurich (UZH) has produced new insights into the efficacy and study quality of medicines used to treat cancer. The resulting study-level database has improved the basis for regulatory decisions and the assessment of new cancer treatments.

How well do new cancer drugs work, and how robust is the scientific basis underlying their authorisation? These questions were the focus of a successful collaboration between Swissmedic, USZ and UZH. Over a three-year period, the three institutions processed and harmonised authorisation data relating to oncology drugs obtained over the last two decades. Their aim was to produce a structured and a quality-assured database that systematically links regulatory decisions with clinical trial data.

The project involved the analysis of authorisation data from the years 2001 to 2020 and processed the data into a standardised form that would facilitate comparisons. The results of clinical trials were systematically entered and consolidated. At the same time, clear rules were drawn up for handling the data, and suitable structures were established to ensure data quality and management. For the first time, this project enabled cancer drugs authorised in Switzerland to be analysed retrospectively over a prolonged period.

The resulting scientific analyses were published in two international specialist journals. They provide important insights into the quality of the scientific studies, the robustness of the data basis for authorisation, and the use of specific biological features (termed biomarkers) in the development and assessment of cancer drugs.

First study: Analysis of the efficacy and safety of pivotal clinical trials

The first study (Rahimzadeh P et al., 2026) analysed the efficacy and safety of pivotal clinical trials. The results showed the following: New cancer drugs can prolong patients' lives and slow the progression of the disease. It also emerged that certain indirect indicators, for example how quickly a tumour grows or how quickly it returns, should generally be assessed in conjunction with overall survival. The authors showed that the correlation between these indirect indicators and patient survival is highly dependent on the type of tumour and the type of treatment. These individual findings for each tumour are helpful in assessing the benefit of new treatments.

Second study: Analysis of the designs of clinical trials

The second study (Rahimzadeh P et al., 2025) investigated trends in the design of clinical trials and the increasing use of biomarkers in oncology drug development. One interesting finding is the fact that clinical trials nowadays focus more often, and to a greater extent, on the individual characteristics of the patients, including, for example, the biological attributes of the tumour (biomarkers). The analysis showed that clinical trials in oncology have evolved substantially over the last 20 years. The current focus is no longer on a single standardised approach, but increasingly on personalised cancer medicine, in which the treatments are tailored to the patient's individual situation.

Proven collaboration to be continued

The results of both studies underline the added value of structured data analysis between regulatory authorities and clinical partner institutions. They also help improve the assessment of new cancer drugs and innovative cancer treatments.

Swissmedic, USZ and UZH plan to continue this collaboration and the targeted expansion of the joint database, enabling future regulatory and scientific questions to be answered with even greater precision and robustness.

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