A new EU regulation is meant to make clinical trials easier and more transparent, a pivotal tool in the fight against deadly diseases like cancer. But researchers in Germany warn that the country may lose its role as a leader in international medicine. EurActiv Germany reports.
Clinical trials are crucial for cancer researche, as demonstrated by numbers which scientists presented in Berlin on Tuesday (17 June).
Over the last three years, 31 drugs intended to treat cancer were approved by the European Medicines Agency (EMA).
Meanwhile, medical treatments were able to considerably extend the survival chances of cancer patients in the past ten years, particularly for those suffering from Leukaemia.
But mortality rates among lung cancer patients remain consistently high, while the total number of clinical trials decreases annually. “As a result there is an immense need for innovation”, said Bernhard Wörmann, medical director at the Deutsche Gesellschaft für Hämatologie und Medizinische Onkologie (DGHO).
The EU’s new Clinical Trials Regulation is intended to meet these demands.
Beginning in 2016, cross-border studies will be simplified. Researchers and pharmaceutical companies from multiple member states will be able to submit one joint application – not in each individual country, as it used to be required.
Accountability for the pharmaceutical industry
In addition, the EMA has an online portal to increase the procedure’s transparency. At least one year after the study’s conclusion, researchers must publish a summary of their study online, regardless of whether or not tests have been completed.
As a result, selective publications will become a thing of the past: Critics repeatedly claim that producers and researchers occasionally omit certain partial results which could be harmful for the producer.
Overall, the process of submitting an application should become more streamlined. From now on, approval in Germany will not only be overseen by the national authorities, but also by the Ethics Committee made up of scientists and doctors.
The DGHO’s cancer researchers “welcome” the new regulations. “The current EU regulation has definitely brought progress for clinical trials”, said Mathias Freund, executive chairman of the DGHO.
The legal integration of so-called minimal interventional studies, Freund said, is particularly commendable. They study the possibilities of expanding the application of a drug already approved in one medical field to other areas. This “off-label-use” can be especially beneficial for children suffering from cancer, said Freund.
DGHO fears time-consuming struggles over jurisdictions
But the DGHO warns that important aspects of the EU document may become blurred during implementation within national law.
In the distribution of authority within the approval process, for example: Many observers fear responsible authorities will attempt to gather as many competences as possible, said Freund, and are calling for an additional coordination point.
“We do not have the time to do this. We need immediate cooperation”, Freund explained.
In the future, there must be a prioritisation of competences, said Freund. “The Ethics Committee should especially play a part in the testing of usage, risk and methods of clinical trials, while the national authorities must keep the entire process in mind.”
Cancer researchers issued harsh criticism over the existing second approval procedure for diagnostic and therapeutic procedures with ionising radiation, including CT scans, x-rays, nuclear medicine and radiation therapy.
This procedure only exists in Germany.
To this day, the Federal Office for Radiation Protection (BfS) has a power of veto in the approval process. That is extremely time-consuming, explained the DGHO, saying that the BfS should only be given an advising role in the future.
Child cancer research neglected
Usually, there are no new medications developed for children suffering from cancer. Instead, already approved treatments are improved or further developed.
Still, cancer researchers continue to face higher costs in this area – administrative costs, but also rapidly rising costs for insurance of test persons. The problem is that clinical trials do not fall under any commercial interest, so they are dependent on the pharmaceutical industry.
Usually doctors from university clinics conduct such tests. The necessary funds are provided to researchers through private donors, like parents associations of children suffering from cancer or from public coffers.
But state support is much too low, criticised Angelika Eggert, chairman of the Society for Pediatric Oncology and Haematology (GPOH).
Even after the new EU regulation, she said this problem will not dissolve into thin air: “Financing of medical innovation does not receive sufficient support from stakeholders of the German healthcare system”, Eggert said.
“That must change if Germany does not want to lose out in medicine internationally,” she contended.
The new EU regulation is directly enforceable in each the 28 EU member states but every country must determine its own implementing acts.
In Germany, these implementing provisions are expected to be formulated in autumn of this year. The new rules are not expected to take effect until the middle of 2016, when the EMA’s electronic portal goes online.
European Union lawmakers reached agreement in December over the revised Clinical Trials Directive.
Under the agreement, pharmaceutical companies and academic researchers will be obliged to upload the results of all their European clinical trials to a publicly accessible database.
A publicly accessible EU database will be set up and run by the European Medicines Agency (EMA) which will contain a register of all trials carried out in the EU, a summary of results for all trials, uploaded one year after the end of the trial at the latest.
- Autumn 2014: Germany to formulate implementing provisions of the EU's new clinical trials regulation
- Middle of 2016: EMA's electronic portal goes online