Focus on safety Clinical trials and inspections

Swissmedic reviews and approves clinical trials before they start and subsequently monitors the conduct and management of these research projects. Visible tracked down and contacted Alexander Mion, Head of the Clinical Trials Department (CT), who drew back the curtain and, together with his colleagues Verena Gafner and Simone Ferbitz, introduced us to the world of clinical trials.

Simone Ferbitz

Alexander Mion

First of all: arrival

The Clinical Trials Department is located on Freiburgstrasse in the west of Bern. Although most of the open-plan offices on the third floor are currently unoccupied, Alexander Mion was able to call upon the services of two team members: Verena Gafner and Simone Ferbitz accompanied us on a tour of the building and the subsequent interview. Gafner works as a Clinical Study Reviewer, in which role she assesses and approves clinical trials with medicines. Ferbitz is responsible for checking whether the safety and rights of study participants and the integrity of the data obtained in connection with clinical trials are guaranteed.

Next: getting the facts

As the person in charge of the Clinical Trials Department at Swissmedic, Alexander Mion manages a team of 14 women and two men from numerous nations, including Croatia, the Netherlands, Sierra Leone, Spain, Germany and, primarily, Switzerland. What is striking is the high proportion of women. Whether biochemist, pharmacist, doctor or specialist assistant – what matters most to Alexander Mion is the cohesion and the willingness to work together in the team.

Not forgetting: team spirit

Personal interaction in particular is something that suffers enormously in these pandemic times – much to the regret of Alexander Mion, who attaches great importance to team spirit. The CTD Head realises that, "in the end, we have to manage the balancing act between general requirements, safety and our personal views of cooperation." Nevertheless, he very keen to maintain the community spirit, integrate the teams and keep them regularly updated about ongoing projects. "Ultimately, it's all a question of attitude. I am very pleased to receive excellent support from all my team", concludes Mion in an upbeat manner despite the current difficult conditions.

But also: changes

We’re now sitting where distancing works best: in the common room on the fourth floor – with a commanding view in all directions. The dedication and commitment shown by the three professionals immediately become apparent. Alexander Mion kicks off the discussion by referring to the latest developments in the market: "We find ourselves in a highly regulated state of affairs. As a result of the special situation during the COVID-19 pandemic, we are currently exploring new approaches that would have been inconceivable even a year ago." For example, medicines used for study purposes can now be sent directly to patients in their homes, or someone from the study team makes home visits to carry out simple investigations. "This enables us to minimise the risk of possible infection", explains Simone Ferbitz. And her colleague Verena Gafner adds: "Of course, this all has to be implemented by those responsible for the study in such a way as to comply with all legal requirements and ethical principles."

Down to business: example of an epilepsy study

Clinical trials are initiated by the pharmaceutical industry as part of drug development or by doctors pursuing clinical research. The requirements relating to clinical trials with medicinal products are specified at both national and international levels and are reviewed by various bodies (Swissmedic, ethics committee) before and during the trials. Swissmedic and the ethics committees are responsible for differing aspects of the trials. The practical implementation of a trial is complex and requires numerous logistical preparations, efficient management and meticulous documentation on the part of the companies, research groups and hospitals involved. Take the example of the epilepsy trial that has recently been thoroughly investigated by Verena Gafner. "First of all, we check the description of the clinical trial. The study is registered and assigned to a reviewer, who is then responsible for this study until approval. Over a period of seven days we check the completeness of the documentation and ask the applicant to submit any missing documents. After receiving all the documents, Swissmedic has exactly 30 calendar days to review the quality and safety profile of the test medication. The approval of the relevant ethics committee is also needed before a clinical trial can begin", explains Gafner. She adds: "The researchers must submit their application to the ethics committee responsible for their location. The committee checks whether a clinical trial satisfies scientific and ethical criteria. Only when the study has been approved by both authorities can it be conducted at the relevant sites – for example at certain service centres, hospitals or doctors' practices. The epilepsy study was approved after one month. Reporting obligations then need to be satisfied during the course of a study: Each year, for example, a report on the assessment of safety must be submitted.

And on we go: with spot checks

Inspections are carried out on a random basis to check whether the clinical trials are being conducted in compliance with the law. "Once the study and study protocol have been approved, we need to check that patients’ rights are not being infringed and that their safety is guaranteed", explains Simone Ferbitz. Does the conduct of the clinical trials satisfy the legal requirements in respect of quality and data integrity? Are the legally stipulated obligations to report adverse drug reactions fulfilled? "Of the 200 studies approved each year, we can spot-check ten percent at most", clarifies Ferbitz. The annual inspection programme is compiled on the basis of objective risk criteria; for example, the specific development phase of a future medicine or whether vulnerable trial subjects (e.g. children) are involved. During the inspections Ferbitz and her team visit the hospitals, companies and research groups involved in the implementation and management of the clinical trials.

Conclusion: why inspections are carried out

The fact of the matter is that the monitoring and inspection of clinical trials are essential and extremely important: "If trials conducted according to the rules show that a medicine is effective and safe, the companies can apply for its authorisation", states Alexander Mion in summarising the significance of clinical trials. For the patients and in the name of safety, efficacy and quality.

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