BASG discussion – clinical trials of medicinal products (German only)

in cooperation with the Federal Office for Safety in Health Care

Thursday, October 3, 2024, 1 p.m.
General Hospital Vienna, Lecture Center, Lecture Hall 3
1090 Vienna, Währinger Gürtel 18-20

Program

12:30 Admission

13:00 Current statistics on CTIS procedures
Dr. Stefan Strasser

13:30 Transition of clinical trials from directive to regulation
Dr. Marianne Lunzer

14:15 Erste wesentliche Änderung nach Transition
Dr. Marianne Lunzer

14:45 Pause

15:30 Die neue EU Leitlinie zu Transparenzregelungen
Dr. Stefan Strasser

16:00 Security messages in Eudravigilance for academic sponsors
Dr. Judith Secklehner

16:30 CTR & CTIS – Best Bugs aus Sicht der Behörde
Dr. Eva Jost

17:00 Closing and farewell
PD Dr. Johannes Pleiner-Duxneuner & Dr. Stefan Strasser

Training report

Das BASG Gespräch wurde am 3. Oktober 2024 zum ersten Mal seit einigen Jahren wieder als F2F Veranstaltung im Hörsaalzentrum vom AKH Wien durchgeführt, was sich auch in der hohen Teilnehmerzahl von 120 niederschlug.

Der Fokus lag auf der nicht mehr ganz so neuen Clincal Trials Regulation, die jedoch mit Jänner 2025 schlagend wird, da bis dahin alle noch laufenden Studien ist das CTIS Register überführt werden müssen.

Dr. Stefan Strasser began with an overview of the current procedures from the CTIS process at both the European and Austrian level. Across the EU, there are currently an average of 200 new submissions per month, about 10% of which have to be resubmitted due to rejection at initial submission. Austria has been appointed as Reporting Member State (RMS) 187 times, of which 78 were study transitions. The major hurdle remains the technical requirements and the short deadlines of the CTIS, which results in 15% negative rejections including withdrawals, especially for academic studies. The maximum timeline of 106 calendar days for approval is also fully utilized in most cases.

In terms of the number of international studies conducted in the country, Austria is in a good midfield position per capita, even though in absolute figures, of course, the large countries such as Spain, Italy, Germany and Poland dominate. In contrast, a decline in national studies can be observed, especially in academic studies.

Dr. Marianne Lunzer then gave a presentation on the tips and tricks for dealing with the mandatory transition of ongoing studies.

Currently, less than 60% of studies in Austria have been transitioned, with the academic sector being particularly weak in this regard. All applications submitted by January 30, 2025 will be processed, unless the EU Commission issues a directive to the contrary. All applicants have been contacted by the EMA based on the EudraCT registry. The minimum set of documents to be uploaded includes:

  • Only documents approved under CTD
  • Neues Anschreiben (siehe Vorlage CTCG BP), GDPR-Erklärung, alle strukturierten Daten
    Teil I:
    • Protokoll; Verantwortung des Sponsors, zu entscheiden, ob es sich um eine einzelne Studie handelt (siehe CTCG BP
    • Investigator’s Brochure (IB); konsolidierte IB akzeptiert
    • GMP relevante Dokumente
    • Dossier für das Prüfpräparat (IMPD); konsolidiertes IMPD akzeptiert
    • Dokumente zu non-investigational Arzneimitteln (AxMP siehe CTCG BP)

Part II:

    • Patient information and informed consent
    • The sponsor may submit additional documents authorized under the CTD.
    • MSC may request additional approved Part II documents (CTR Annex I) during validation.

Dr. Lunzer also explained the topic of significant changes after transition in detail and provided essential information. The general requirements are:

  • First substantial change to the file: update of the entire Part I
  • Best Practice guide naming of documents in CTIS
  • comply with transparency rules
  • Rare exception for technical reasons: Multi SM
  • SM I before add MS
  • 3 scenarios: additional MS, recruitment or treatment ongoing in at least one MS, only follow-up

The BASG discussion continued with an update from Dr. Strasser on the new CTIS transparency rules. The database will be made available to the public with the aim of allowing patients to view more details about clinical trials, while also giving HTAs and researchers access to results.

In addition to personal data, confidential communications between member states and monitoring of the conduct of clinical trials are also protected.

The preservation of trade and business secrets is a balancing act, provided that there is no overriding public interest. On the one hand, there was the possibility of deferrals, i.e. later publication depending on the respective study category, and on the other hand, the use of redactions and the associated double uploading of documents. The resulting system overload has now led to a last-minute change by the EU Commission. The deferral mechanism will be abolished and the number and complexity of the published documents is to be reduced. However, the decision on the clinical study as the earliest point in time for publication and the categorization of the studies with regard to the documents to be published will remain unchanged.

Dr. Judith Secklehner provided an insight into the SUSAR (Suspected Unexpected Serious Adverse Event Reactions) assessment, which is one of the authority's main areas of focus in the context of clinical studies. In doing so, she clarified terminology and timelines, as well as explaining common mistakes.

Finally, Dr. Strasser shared his personal insights about “Best Bugs” and gave an outlook on planned changes.

The COLLABORATE project at the European level has set itself the goal of harmonizing cooperation between ethics and authorities, but also processes across member states. By defining problem owners, targeted work can be done on the existing problems. A few improvements to CTIS are already taking shape: possibly changing providers, reducing the number of roles and improving downloads.

From the perspective of the BASG, there is still room for improvement in the areas of timelines (hardly any shorter deadlines than those specified are achieved), validation and assessment (Part I & II alignment often difficult, no support from CTIS for 2nd RFIs). At the same time, Dr. Strasser emphasizes that the BASG acts as a filter for inquiries in the event of problems and, if necessary, forwards them to the ethics committee.

In addition to the costly scientific advice from the SAWP-CTCG (which is not binding for the individual member states), pre-CTA advice, in which the RMS can be contacted on regulatory issues, is a promising format.

In the future, the COMBINE program is intended to facilitate the regulatory IVDR and MDR combination studies with medicinal products. In Austria, the same ethics committee and authority are now conducting the assessment. The EUDAMED database for medical device studies is to follow in 2027 and be structured analogously to CTIS.

All presentations can be found at:

 

Further links on the topic of CTR and CTIS:

Accelerating clinical trials in the EU

Clinical Trials Information System (CTIS): online training modules | European Medicines Agency (EMA)

Revised CTIS transparency rules

Clinical Trials in the European Union – EMA

Bundesamt für Sicherheit im Gesundheitswesen
Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
Traisengasse 5, 1200 Wien, www.basg.gv.at, www.ages.at
Koordinationszentrum für Klinische Studien, 1090 Wien, Währinger Straße 25a, 0G 1
Tel (+43-1)40160 25176, kks@meduniwien.ac.at, http://www.meduniwien.ac.at/kks

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