September 2021: Switzerland Update

New Application (VO) Form and New Format for Authorisation Applications and Changes/Notifications/Reports Regarding Clinical Trials with Medicinal Products as of 13 September 2021

According to an update posted by Swissmedic (Swiss Agency for Therapeutic Products), authorisation applications and changes/notifications/reports regarding clinical trials with medicinal products must be submitted to structure (“eDoc” structure), a new application form (“VO form”), and to a new address for submissions from 13 September 2021. Any submissions according to the old submission procedure will be deemed to be formally deficient. However, purely paperless submissions will not yet be possible as of 13 September 2021 and will be implemented at a later date. Therefore, the submissions would still be made on paper and on CD even after 13 September 2021, confirming that the files on the CD are identical with the paper documents.

For more information on the documents and instructions needed for the new procedure, please refer Clinical Trials on Medicinal Products.

August 2021: CTIS Webinar Update

European Medicines Agency updated the Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS event page with details pertaining to the webinar that took place on July 29, 2021.

It includes the following details provided for easy understanding of the working and functionalities of EU CTIS;

  1. Event Summary
  2. Documents inclusive of the agenda, list of speakers, and presentations over different aspects of EU CTIS
  3. Video recording of the webinar

August 2021- CTIS Highlights

The fourth issue of CTIS Highlights was published on August 06, 2021. It briefly discusses the new timeline for CTIS, confirming the go-live date of CTIS and the initial submission date followed by a three-year transition period for submission of ongoing trials through CTIS.

Additionally, the newsletter spans over the training programme updates, CTIS Sponsor handbook details, CTIS July Webinar in a word, and the importance of CTIS in harmonising the clinical trial regulatory submission process in the EU and EEA. It also fore say about another webinar that will be conducted on October 26, 2021, that will concern the preparation of CTIS from the end-user perspective. Further information on this will be provided on the EMA event page and future CTIS newsletters.

For more information, click here.

 

 

August 2021: CTIS Training Update

Dissemination guidelines for training materials: CTIS training programme

European Medicines Agency published a new guideline document related to the Clinical Trial Information System (CTIS) training programme, on August 05, 2021.

This guide is intended to support instructors in using the training materials prepared for the CTIS Training Programme. It is suggested that trainers follow a blended learning approach combining asynchronous with synchronous activities for an optimal learning experience of end-users while making efficient use of their time.

Combining the two training methods, by sharing some materials with participants ahead of a real-time training session, will ensure that participants can assimilate some contents individually and reflect on questions they may have. The training session can then be used to check participants’ knowledge absorption, address their questions, and collect input on the training materials and methodology.

For more information, refer to the guideline here.

July 2021: Clinical Trial Data Reporting in EU Countries

In Europe, the enthusiasm for trials is not matched with a zeal for reporting the results to the public. Nearly 28% of completed European trials in the EU Clinical Trials Register (EUCTR) on 1 July—had not posted their results according to the latest data from the EU Trials Tracker, set up by U.K. researchers in 2018. Public research hospitals and universities are responsible for the vast majority of the lapses, which appear to violate European rules that require sponsors to post their results within 1 year of a trial’s conclusion.

Some researchers from public trial centers aren’t keen to disclose negative results and others believe publishing results in a journal fulfills the reporting requirement, even though journal articles can come years later and are often not made public. The Public Assistance Hospitals of Paris (AP-HP), the largest clinical trial center in Europe has reported results for just one of 35 trials completed more than 12 months ago, according to the EU tracker. More than 200 of the center’s trials are listed on EUCTR as ongoing, even though more than half of them began more than 10 years ago.

The current rules stem from 2001 European guidelines are considered as “soft legislation” and some nations seem to be taking advantage. According to current French regulations, there is no obligation to post results in the EU database, their priority has been to publish both positive and negative results in peer-reviewed journals. In the Netherlands, it is sufficient if sponsors post results in the Dutch trial registry, run by the Central Committee on Research Involving Human Subjects (CCMO). The CCMO website states that sponsors must also post results of medicines trials in the EU database, but Amsterdam University Medical Center (AUMC) does not follow that rule seeing any advantage in double registrations or in doubling researchers’ administrative burden.

Europe is getting more serious about enforcing the reporting requirements. Since the launch of the EU tracker in 2018, timely reporting of results has risen from 50% to 72% of completed trials. The European Medicines Agency (EMA) has stepped up reminders to trial leaders and has sent out about 30,000 reminders to overdue trial sponsors since 2018, another possible driver of improvement. Special notices go out for COVID-19 trials.

EMA’s new trial registry Clinical Trials Information System (CTIS) launch scheduled for Jan 2022 will eventually replace the EUCTR portal after a 3-year transition period and will end the tedious process of registering trials in each participating country. Sponsors will upload all trial data, from start to finish and the relevant national regulators will review the data before the information becomes public in one, linear, straight-through process. Once CTIS goes live, a 2014 European regulation will take effect, empowering national regulators in the European Economic Area to enforce the reporting of results. It will be for governments to decide how the national regulators should enforce reporting and what penalties they should impose for lapses.

Denmark, known for its vigilant regulation of drugs and trials already has a law that allows authorities to fine or imprison clinical trial leaders who do not meet deadlines for reporting results.

Additional details are found here.

June 2021: CTIS Update

The third issue of CTIS Highlights was published on June 23, 2021.

It discusses two user management approaches (organization-centric and trial-centric) and the process of assigning roles in CTIS.

The other topics covered are CTIS system functionalities, Initial clinical trial application process in CTIS, Training Programme update and Audit updates. Additionally, it announces the availability of a CTIS Sponsor Handbook. EMA, in a collaborative approach including sponsor representatives, will prepare a sponsor handbook to provide sponsors with an overview of materials available to help them prepare for and use CTIS. A first version is expected to be published in Q3 2021.

April 2021: Switzerland Regulatory Update

Updates on Medical Device Regulation (ClinO-MD)

In the course of adapting Swiss legislation to the new EU Medical Device Regulation (MDR), clinical research with medical devices (with the exception of in vitro diagnostics) in Switzerland will be regulated in a separate ordinance. The new “Medical Device Regulation” (ClinO-MD) will come into force on May 26, 2021, at the same time as the MDR.

According to the update posted on the Swiss National Clinical Trials Portal (SNCTP) on April 20, 2021, in addition to the existing obligation to prospectively register the clinical trial, the results of the trial must now also be published in a trial registry. This will also apply to clinical trials which will be still underway when the ClinO-MD enters into force on May 26, 2021. As Eudamed cannot currently be used for this purpose, the registration and publication of results must therefore be carried out in an international trial registry, such as ClinicalTrials.gov.

Other than the disclosure requirements other changes regarding clinical trials with medical devices under the ClinO-MD are:

  • Updated categorization of the medical devices
  • Differentiating clinical trials as  conformity-related and non-conformity-related
  • Adaptation of application documents to be submitted
  • Reply deadline for sponsors

For more details, please refer to Clinical trials with medical devices: Expected changes in the legal requirements.

July 2020: EMA Exceptional Transparency Measures

During the COVID-19 pandemic, EMA is implementing exceptional measures to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19 that are approved or are under evaluation.

EMA is achieving this by shortening its standard publishing timeframes and publishing information it does not normally publish for other medicines.

Under this practice, the clinical trial data for COVID-19 medicines will be published on clinical data website after marketing authorisation. As a standard practice, such publication is suspended until further notice for other medicines.

July 2020: EU Fine-Tunes Guidance For New Clinical Trials System – A Pink Sheet Article

The Pink Sheet article dated July 17th reported on a July 1st session at the DIA Europe 2020 Conference on “Clinical Trial Regulation: State of Play – Are We Ready?”. Judith Creba speaking on behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA) addressed industry’s preparedness for the new legislation noting “We are as ready as possible, but there are still some unclear aspects, mostly related to CTIS which is understandable as it is still under development.”  Creba, who is leading the CTR’s implementation within Novartis, said the key thing needed to help get the industry fully ready was to provide companies with access to a ‘test’ CTIS database to help them understand how the system works in practice. Both Creda and Rüdiger Pankow of Parexel, raised concerns that many in industry have previously echoed concerning lack of any inside knowledge of the CTIS under development which makes it challenging to have updated internal standard operating procedures to reflect the new procedures and allow for training prior to implementation of the CTR.

Agnès Mathieu-Mendes, deputy head of the unit dealing with the quality, safety and innovation of medicinal products in the Commission’s Directorate General on Health and Food Safety, also stated that a number of new guidance documents and templates are being prepared to help the industry prepare for the legislation.  Work is ongoing to develop new Q&A documents on CTR “hot topics,” such as classification of substantial and non-substantial amendments to a clinical trial, and allowing post-trial treatment access to participating subjects.

The CTIS audit is slated to begin in December 2020 with a proposed ‘Go-Live’ date of CTIS (as well as CTR implementation) in December 2021.

July 2020: Medical Device Regulation (MDR) Update

As per the State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR, the priority action for transparency was to issue a fact sheet on information to become publicly accessible.

This Factsheet on MDR requirements for Transparency and Public Information has been published on July 15, 2020. Most of the requirements on Transparency and public access to information are linked to the Eudamed, which is planned to become fully functional by May 2022.

The transparency requirements under the MDR can be divided into different categories:

  • Information on medical devices made accessible to the public in Eudamed
  • Information which is pro-actively made publicly available outside Eudamed by the Commission, the national competent authorities, the industry or the notified bodies

Thus, the fact sheet has presented the MDR transparency requirements separately depending on whether they will be available in or outside the Eudamed database.