Clinical research: Strengthening the research location with Pilot
EU Regulation 536/2014 is expected to standardize the approval procedure for clinical trials throughout the EU from fall 2018. These are an essential part of drug development and, not least, provide objective proof of the effect and side effects of drugs, which ultimately benefits patients. As a result of the EU regulation, domestic companies, authorities and ethics committees are now required to restructure the complex approval process. DI Dr. Christa Wirthumer-Hoche, Business Unit Manager of AGES Medical Market Surveillance, says: "Unfortunately, the number of clinical trials in Austria has been declining in recent years. In order for us to catch up again internationally here, there is a pilot project with which we want to prepare for the new challenges posed by the EU regulation and show that Austria is an attractive research location. After all, investments in clinical research are direct investments for patients." As study participants, they can benefit in particular from early access to innovative therapies under the best possible medical care. The regulation standardizes throughout the EU the process of how and in what time an application for a clinical trial must be evaluated by the authority and ethics committee. The deadlines in particular are a major challenge for everyone involved, including the sponsors of clinical trials, which pharmaceutical companies, for example, often act as. "It is therefore all the more important that as many Austrian companies as possible take the opportunity to prepare for the new requirements through this pilot project, better today than tomorrow," explains Dr. Jan Oliver Huber, Secretary General of Pharmig. The pilot project for processing initial applications was launched by the Federal Office for Safety in Health Care (BASG), together with a working group consisting of members of the Forum of Austrian Ethics Committees. On behalf of the BASG, AGES Medizinmarktaufsicht handles these applications and monitors the implementation of clinical trials. In the course of the pilot project, practical scenarios will be developed and tested so that the assessment can be carried out in unison by BASG and ethics committees within the short period of 26 days envisaged and the applicant can respond to any deficiencies identified within 12 days.Participation in the pilot is open to both commercial and academic applicants. Says Wirthumer-Hoche, "The more applicants who agree to participate in the pilot, the greater the mutual gain in experience." The first application for approval of a clinical trial processed in Austria via this pilot project has already proceeded satisfactorily for all sides. The decision issued by the BASG in the course of the pilot application also has legal force. A second procedure in the "normal" way is unnecessary and therefore saves the applying company valuable time.The pilot project is an important step to give Austria an advantage in the European competition. Countries such as Belgium, France, Spain and Germany have been preparing intensively for this regulation for some time with comprehensive implementation measures. "Therefore, we must do everything in our power to make the processes in Austria efficient. In addition, politicians should also become aware of the immense importance of clinical research," says Huber. And Wirthumer-Hoche adds, "In any case, a fundamental research strategy should also include the professionalization of organizational units. I'm talking here about human resources at the authority, the ethics committees and, not least, in the centers where clinical trials are conducted. Otherwise, other countries will outrun us as an attractive research location." For information on the pilot project, visit www.basg.at.
Inquiries (technical)BASG - Bundesamt für Sicherheit im GesundheitswesenHR Dr. Christoph Baumgärtel, MScTel. 050555-36004christoph.baumgaertel@ages.atRückfragen (for media)Communications Management, Tel.: 050555/25000E-Mail: presse@ages.at
