Radiation protection is patient protection – and the latter is non-negotiable

How is Germany doing as a research location? The answer is: significantly better, from a radiation protection perspective, than statements from the pharmaceutical industry would have us believe.

President of the Federal Office for Radiation Protection, D. Inge Paulini Source: Holger Kohl/ Bildkraftwerk

In recent years, many things have been said and written about Germany as a research location in all its facets. At times, however, people paint a picture that is much gloomier than the reality.

Let's look at the example of clinical research: "Germany continues to be one of the global pharmaceutical industry's key locations for research and development," according to the German Association of Research-Based Pharmaceutical Companies (vfa). At the same time, representatives of precisely that industry are concerned about Germany's future as a location. The vfa has commissioned and published a study along with survey results from its member companies in relation to pharmaceutical research and development, as well as a position paper.

The hypothesis is that, in particular, poor administrative practice and bureaucratic burden are not only jeopardising Germany as a research location but also putting patient care using innovative diagnostic and therapeutic procedures at risk. A falling number of clinical trials is cited as evidence for this. The authors also believe there is scope for optimisation in terms of radiation protection, so that companies don't fall behind in the "intensified race for marketing authorisation of innovative therapies" in Germany.

Process optimisation in notification and licensing procedures as well

From a radiation protection perspective, good ideas for streamlining processes are to be welcomed if they allow faster progress from research to applications. As a legally mandated verification authority, the Federal Office for Radiation Protection (BfS) itself is very active in this area. However, the BfS is primarily responsible for the protection of patients who are participating in clinical trials and for high standards of radiation protection in medicine. That is non-negotiable.

Focusing too strongly on a criticism of bureaucracy obscures the fact that, in many cases, there is potential for optimisation on the part of not only the authorities but also the applicants when it comes to notification and licensing procedures for clinical trials involving ionising radiation. Specifically, a great deal of effort is required during the process in order to clarify questions arising from incomplete application forms. It is vital to identify a joint solution in this area.

What exactly is the issue? At the end of 2018, the "Act on the Reorganisation of the Protection against the Harmful Effect of Ionising Radiation" entered into force, implementing an EU Directive into national law. Among other things, the new Radiation Protection Act introduced, for the first time, deadlines for notification or approval procedures for clinical trials involving ionising radiation.

An increase in initial submissions and a decrease in processing time

When the Act entered into force, the Federal Office for Radiation Protection was able to prepare itself for the new arrangements effectively, to adapt its personnel capacities, and to set a course for process optimisation. The changes since 2018 are producing visible results today. For example, the number of initial submissions of clinical trials has increased by 65% since the Radiation Protection Act entered into force. In 2022 alone, the BfS processed some 700 applications and notifications, with a simultaneous shortening of licensing deadlines. Since the Act entered into force, the BfS has only had to make use of the option of extending the deadline a total of three times, in order to clarify technical aspects in greater detail.

In parallel, the BfS has developed and implemented ideas as to how the quality of applications can be improved and how medical research in Germany can be actively supported as a partner. For example, the BfS offers training events for submitting parties, as well as a consultation meeting with stakeholders. I would like to invite interested parties to the next training session, which will be held online on 17 October 2023.

It has already come to the attention of research and industry that the BfS has contributed to speeding up the process. At the Bavarian Pharmaceutical Summit in March 2023, praise was expressed for the fact that the new system operated effectively, deadlines were adhered to at the BfS, and further improvements were being implemented.

But we don't want to rest on our laurels. There is also scope for further process optimisation in the field of radiation protection. For example, the notification procedure could be carried out in closer coordination with the ethics committees. It would therefore be possible to avoid the double verification process that is currently necessary in some cases – and to save time.

Digital access: the single digital gateway approach

Moreover, consistent implementation of the single digital gateway approach would represent another – potentially decisive – step forwards in terms of radiation protection and clinical research. The use of a standard digital gateway of this kind would allow submissions to be made for studies in a centralised manner – for example, via the European CTIS submission portal or to the Federal Institute for Drugs and Medical Devices (BfArM). Here, the advantage for applicants is that they would only need to contact one central body. However, no process optimisation can come at the expense of independent technical verification of radiation protection aspects of patient safety.

The fact that compliance with legal requirements is more than just a formality in this context is demonstrated by an example in relation to licensing: the BfS received an application for a large study involving hundreds of patients. However, the planned experimental therapy to treat tumours in the head and neck region with high doses of radiation as part of a new radiotherapy technique had not undergone sufficient clinical testing beforehand. The BfS took a critical view of the application given the apparently high risk of unwanted radiation effects for participants – by its very nature, the head and neck region is particularly sensitive to radiation. To protect patients, the BfS therefore made approval conditional on carrying out a monocentric preliminary study with a reduced therapeutic dose, a fraction of the patients and interim analyses of the data. With the appearance of the first clear side effects even at the first dose level set out in the application, it became clear that the therapeutic concept was medically untenable. Following detailed evaluation of the study data, the recruitment of further patients was abandoned. Although this example is not a general rule, there are others that are highly relevant to patient protection.

The provisions of radiation protection legislation must be adhered to in clinical trials. A consistently high standard of patient safety is essential not only for the willingness of the general public, but also for the recruitment of clinical facilities, to participate in clinical trials. It is the foundation on which successful clinical research is built. Accordingly, it may be worth considering radiation protection as one of Germany's advantages as a location.