Lara Fux: What do Clinical Project Managers do?

Ms Fux, how many studies are you and your team currently responsible for?

We’re currently overseeing 64 studies. About half of them are open for patient recruitment. The other studies are either in preparation – meaning we are working towards opening them for patient recruitment soon – or they have completed the recruitment phase. In this case patients who have already been recruited receive their entire treatment as part of the study and are followed up afterwards. The collected data are then analysed.

Which tasks does the Clinical Project Manager team at SPOG do for the paediatric oncologists at the member hospitals?

The Clinical Project Managers relieve the researchers at the hospitals from regulatory and administrative tasks so that they can concentrate on looking after the patients. For example, we submit documents and reports to the Swiss authorities collectively for all the member hospitals. Otherwise every hospital would have to do this individually. Study coordination is centralised and standardised, making it more efficient and improving quality. Furthermore, we act as the liaison between the member hospitals and the international study management centres, also known as sponsors. It makes things easier for the international sponsors if they only have one contact in each country.

Why are most of the SPOG studies international study protocols?

Cancer is fortunately very rare in children and adolescents. In research terms, the small number of patients means that it is difficult to perform meaningful studies in Switzerland. This is why we usually get the study protocols from international sponsors, in the United Kingdom or Germany for example. The studies are performed in several countries at the same time, which increases the number of patients. International collaboration advances childhood cancer research more quickly.

Each SPOG study has a national study lead. How do the Clinical Project Managers collaborate with the National Study Chairs?

Collaboration is particularly close during the preparation phase of the studies before opening. We start with a kick-off meeting during which the Clinical Project Manager and the National Study Chair discuss and plan how the study will be conducted in Switzerland. They may discuss, for example, which study medication will be needed for the study, or which analyses need to be carried out for diagnosis. After this phase, task allocation is quite straightforward. The study manager is responsible for all medical aspects and the Clinical Project Manager for regulatory questions and quality management.

How often are your team in contact with the member hospitals?

The Clinical Project Managers are in touch with the member hospitals on a daily basis. For example, to clarify questions or so that new findings and protocol changes can also be implemented in Switzerland as quickly as possible. In my experience, collaboration with the hospitals has been both very productive and pleasant. After all, we all have the same objective – to give a future to children and adolescents with cancer.

Why does it take a relatively long time to prepare a study?

The contracts with the international sponsors are particularly time-consuming. Without these contracts we are not allowed to submit the study to the Swiss authorities and can therefore not recruit patients. Unfortunately it often takes a very long time to finalise the contracts because of the different legislation and regulations in each country.

How is the cooperation with Swissmedic and the ethics committees?

Our cooperation with Swissmedic and the ethics committees is well established. Thanks to many years of experience we are familiar with the requirements of these authorities and can prepare the study dossiers accordingly. If we have questions in special cases, we can contact these authorities for a constructive dialogue.

Why is childhood cancer research so heavily regulated?

Research involving humans is regulated by comprehensive legislation in Switzerland. This kind of research is only permitted if it has been reviewed and approved in advance by the authorities. The Swiss Human Research Act forms the basis of this approach. Its objective is to protect the dignity, personality and health of patients. Children and adolescents are considered to be especially vulnerable persons, which is why research in this area is subject to additional regulations.

Is the work at the coordination centre also audited?

SPOG organises regular audits at the coordination centre itself and at each member clinic. These are carried out by external, independent service providers. The results of the audits help SPOG to maintain and continuously improve the quality of study conduct.

In addition, both the Swiss authorities and international sponsors have the right to inspect the SPOG Coordination Centre and the member clinics at any time. Swissmedic carries out such inspections regularly.

What changes have occurred in recent years with respect to study coordination?

Clinical research is – rightly – a heavily regulated field. Over the past few years the national and international legislation and its implementation have become increasingly strict. It is rare for a requirement to be omitted when laws or guidelines are revised. This makes it more demanding to perform studies, and it increases the administrative effort required both in the hospitals and at the Coordinating Center.

What tasks do the Clinical Project Managers still need to complete once a study has been opened?

We support the studies through all the cycles of their implementation. Once a study has been opened the structure may change, for example, or a new study arm may be opened or the study may be extended. We submit every major change of this kind to the Swiss authorities in advance for approval. We also inform the authorities on an ongoing basis about all the safety aspects of clinical studies. Here we submit a report at least once a year.

How long do trials actually run for?

The duration of a trial can vary greatly depending on its objective. Clinical trials that test and compare different treatments usually have a recruitment phase of around five years. This is followed by a follow-up phase for the participating patients, lasting around three years.

However, it is also important to document possible long-term consequences of cancer and its treatment. Projects with this aim can run indefinitely.

What happens when a study comes to an end?

Closing a study involves several steps. Firstly, recruitment is stopped. This means that no more new patients are included in the study. Patients who have already been included finish their treatment and are followed for several years to see how they are doing. As soon as this follow-up is complete, the study is formally terminated. At this point, all available data are analysed and the results of the study are published. The study is then officially closed.

How are the study results communicated?

For clinical studies, a final report containing all the study findings has to be produced within one year after the study has ended. This report is sent to the doctors at the member hospitals and must be submitted to and acknowledged by the Swiss authorities. The study results are usually also published in scientific journals that are accessible to all oncologists. A more recent development is the preparation of clinical study summaries in lay language. They are published on the human research platform in Switzerland.

What are the more difficult aspects of working as a Clinical Project Manager? What’s great about it?

The most rewarding aspect of Clinical Project Management is knowing that, through our work, children and adolescents with cancer have access to the best possible, state-of-the-art therapies. This thought is a great source of daily motivation and encourages productive work. On the other hand, it is frustrating when participation is not possible because the opening of a study is delayed by contract negotiations.