Good framework for research and patient safety

The Medical Research Act (MFG) underlines the importance of radiation protection in medicine – for the benefit of patients and Germany as a location for clinical trials.

Dr Inge Paulini Source: Holger Kohl/ Bildkraftwerk

The new Medical Research Act (MFG), which has existed in draft form since January, is intended to optimise the conditions not only for research and development, but also for approvals in medicine. It contains a number of points that would improve the framework conditions for industry in particular, making Germany a more attractive place to produce medicines.

Some of these points are currently the subject of controversy. In their present form, I see the planned new regulations of the MFG regarding radiation protection as a positive thing for Germany as a centre of research, for they provide a good framework for science and patient safety. For example, the new rules make it easier to organise and conduct clinical trials in Germany without compromising on patient safety standards.

However, I have little sympathy for individual demands from the pharmaceutical industry to shift authorisation procedures in the field of radiation protection from the Federal Office for Radiation Protection (BfS) to non-specialist bodies. At this point, it is not in the interest of patients or sustainable radiation research in medicine to be discussing the highest demands of the industry, namely the German Association of Research-Based Pharmaceutical Companies (vfa), instead of looking at sensible and efficient ways of speeding up the process.

In contrast, the planned new regulations on radiation protection for clinical trials involving ionising – i.e. particularly high-energy – radiation provide a solid foundation.

CT scans form part of the accompanying diagnostics Source: Gorodenkoff/Stock.adobe.com

Until now, there have been two different procedures under the Radiation Protection Act: the notification procedure and the authorisation procedure. The MFG includes a reform of notification procedures. For instance, such procedures are necessary if CT scans of study participants are required more frequently in trials of new cancer therapies than is otherwise usual in treatment – for example, in order to monitor a potential therapeutic effect. In future, the MFG provides for the procedures to be assessed as part of the review of the actual clinical trial and to be transferred from the Federal Office for Radiation Protection to the ethics committees, as we have proposed for some time.

For researchers, this bundling of responsibilities is a clear simplification of the process. For radiation protection, it means more efficient processing because the ethics committees are already involved in the overall assessment of research projects, so that duplicate reviews can be avoided in future. Notification procedures currently account for around 85% of the total of 600 procedures that the BfS deals with each year in connection with clinical trials.

Many of these notifiable trials are in the field of oncology, which is of particular relevance to the pharmaceutical industry: in 2022, around a third of all registered trials from the research-based pharmaceutical industry in Germany were oncological in nature.

Representatives of industry and research have already praised the streamlining of the process in the draft MFG. I can only agree with this praise. In its approach to reform, the draft law continues down a path that was adopted in 2018, when the "Act on the Reorganisation of the Law on the Protection against the Harmful Effects of Ionising Radiation" entered into force. Among other things, the new Radiation Protection Act was the first to introduce deadlines for notification or approval procedures for clinical trials involving ionising radiation.

Progress in reducing bureaucracy Source: Suelzengenappel/Stock.adobe.com

Although the number of initial submissions of clinical trials has increased by 65% since the Radiation Protection Act entered into force and although the new deadlines meant that significantly less processing time was available, the BfS has only had to make use of the option to extend the deadline on three occasions.

The planned change to notification procedures will benefit not only research, but also future participants in clinical trials.

It is particularly important that the authorisation procedures for clinical trials, which are central to radiation protection, remain at the BfS.

For example, trials require authorisation in the case of new therapeutic procedures in nuclear medicine or radiotherapy or when new radiopharmaceuticals, i.e. drugs containing radioactive substances, are to be tested. Highly qualified specialists from the BfS, such as nuclear medicine specialists, then check whether it is possible, for example, to reduce serious adverse effects of radiopharmaceuticals for patients participating in the trials by making what are sometimes relatively simple changes to protocols.

This process leverages the entire expertise available at the BfS in the fields of study design, radiation biology and dosimetry. In clinical trials of this kind, radiation protection is synonymous with patient protection – because the safety of the study participants is directly at stake. The BfS pools radiation protection expertise in order to assess advances in radiation research and ensure safe applications in medicine. The further shortening and alignment of deadlines for clinical trials will contribute to the harmonisation of procedures in Europe.

The question of how to get more people to participate in clinical trials in the future is already one of the major challenges facing pharmaceutical research today. Trust is a valuable asset in this context. The Medical Research Act emphasises the importance and value of radiation protection in medicine – for the benefit of patients and of Germany as a location for clinical trials in general.