September 2021: EU CTIS Webinar

European Medicines Agency updated about the upcoming Clinical Trials Information System- Webinar for small and medium-sized enterprises (SMEs) and academia over the What’s New Section on September 10, 2021:

The webinar will be conducted on November 29, 2021, for the small and medium-sized enterprises (SMEs) and academic sponsors of clinical trials. The agenda of the event is uploaded on the event page along with the topics that will be covered during the webinar.

For more information, click here.

September 2021: CTIS Training Update

European Medicines Agency updated the page Clinical trials information system (CTIS): online modular training programme by adding a PDF in Module 19: Quick guide – Introduction: CTIS for SMEs and Academia on September 07, 2021.

The document consists of a brief introduction to CTIS and its timeline. It also explains in detail about clinical trial life-cycle in CTIS, types of roles in CTIS, and interaction of CTIS with different database systems with diagrammatic represent and references links.

For more information, please click here.

September 2021: CTIS Training Updates

European Medicines Agency updated the page name of Clinical Trials Information System: training programme to Clinical trials information system (CTIS): online modular training programme, on September 03, 2021. The below documents were also updated in CTIS Training Module 03 (User access management) and new versions of documents were added in Module 19 (CTIS for SMEs and academia):

  1. FAQs (v1.2): User access management – Module 03: It includes questions related to the processes of self-registration, login to CTIS, basic roles and permissions in CTIS, and user profile management with answers and diagrams.
  2. Quick guide (v1.2): User access management – Module 03: It guides on the process of self-registration, steps to log in to CTIS, understand the roles and permission and in brief about user profile management.
  3. Step-by-step guide 1 (v1.0): User access management and user administration- Module 19: It provides step by step guide for registration on CTIS, viewing roles and managing user profiles. It also explains briefly about CT-centric and Organisation-centric approaches, respectively.
  4. Step-by-step guide 2 (v1.0): CTIS workload functionalities for the sponsor workspace – Module 19: It provides step-by-step guidance on how to use the workload functionalities- notices and alert tab, request for information (RFI) list tab and timetable tab along with screenshots for every step.
  5. Step-by-step guide 3 (v1.0): Search, view and download a CT and a CTA in the sponsor workspace – Module 19: It provides steps for searching, viewing, and downloading CT and/or CTA along with detailed screenshots.
  6. Step-by-step guide 4 (v1.0): Create, submit and withdraw a clinical trial application and nonsubstantial modifications – CTIS Training Programme – Module 19: It provides steps to create and submit different types of CTs (mono-national and multi-national) with screenshots for better understanding.
  7. Step-by-step guide 5 (v1.0): Create and submit an RFI response, including changes to an existing application – CTIS Training Programme – Module 19 It provides steps to view and access RFIs raised by the Member States Concerned (MSCs) during the validation and assessment phases of the evaluation of a CTA, as well as on how to create and submit the responses, and how to modify an existing CTA as part of the response.
  8. Step-by-step guide 6 (v1.0): How to manage a clinical trial – CTIS Training Programme – Module 19 It provides steps for creating different types of notification, responds to RFIs in context with ad hoc assessment, request for corrective measures and steps to submit trial results and lay summary of results.
  9. Step-by-step guide 7 (v1.0): Submit an Annual Safety Report (ASR) and how to respond to related RFIs – Module 19 It provides steps to create and submit ASR submission form, access and respond to RFIs in the context of ASR assessment.

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.

 

 

July 2021: Clinical Trial Results For FDA-Approved Drugs Often Remain Hidden, New Study Finds – A TranspariMed Article

The article, Clinical trial results for FDA-approved drugs often remain hidden, a new study finds, was published on TranspariMed on July 29, 2021.

This article revolves around the study performed by a team of American researchers who examined 62 products by 42 pharma companies approved by the FDA in 2016-2017 and gives key insights on how clinical trial sponsors often violate a pre-eminent transparency law.

According to transparency law, applicable trials should be registered and made public within 21 days of their start date, and their results should be made public on the registry within 30 days of initial FDA approval of a product.

In the above study, it was found that amongst the 62 products, trials of 13 products did not consistently meet legal reporting requirements. At least one relevant trial result among the three-quarters of FDA-approved products still remains unrevealed.  42% of FDA-approved novel drugs and biologics fail to fully meet FDAAA reporting requirements.

While some big pharma companies are in compliance with the legal transparency requirement there are many other large companies that are still non-compliant. Out of 10,792 trials, there are around 2,800 currently missing trials.  The authors of the study raise the question if FDA needs to widen its scope to address the products approved by the FDA by non-US-based companies and also suggests that the FDA may benefit from more stringent reinforcement of transparency law as it has not yet started to collect fines from the non-compliant sponsors.

While comparing the statistics to the European studies, an improvement in compliance was noted. However, after the EU Clinical Trial Regulation that would bind all European countries by the end of January 2022, it will be each country’s independent decision for whether and when to impose sanctions.

For more information, click here.

 

CTIS: Training Update

European Medicines Agency updated the page Clinical Trials Information System: training program, on July 26, 2021, by adding the below documents in CTIS Training Module 18 (How to submit an annual safety report and respond to related RFIs):

  1. Step-by-step guide: How to submit an annual safety report and respond to related RFIs (PDF): It provides step-by-step guidance on how to create and submit annual safety report (ARF). It also provides guidance on how to respond to RFIs during the assessment of an ASR with insights and screenshots.
  2. Instructor’s Guide: How to submit an annual safety report and respond to related RFIs (PDF): It contains an overview on how to create and submit the  ARF form in CTIS and guidance for trainers for disseminating the training materials.
  3. FAQs: How to submit an annual safety report and respond to related RFIs (PDF): It contains questions regarding the sections, creation, submission, assessment, the roles and permissions of ARF form and questions for RFIs related to ARF with diagrams for better understanding.
  4. Process Puzzle: How to submit an annual safety report and respond to related RFIs (PPT): It includes exercises useful for understanding steps for submission of ARF with different case scenarios and its solutions in pictographic form.

July 2021: CTIS Webinar Update

European Medicines Agency updated the Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS event page on July 14, 2021, by adding a EU survey portal for participants interested in the webinar to submit questions in relation to sponsor preparedness in advance of the event, by July 20, 2021. Participants can submit up to 5 questions regarding a pre-specified agenda topic. It was also mentioned that the most popular questions submitted in advance will be answered by the speakers during the webinar.

 

July 2021: CTIS Webinar Update

European Medicines Agency updated the Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS event page on July 12, 2021, by adding a live broadcast section for participants interested in the webinar. This broadcast section will be functional on the day of the webinar i.e., July 29, 2021.

To assist with further queries a point of contact has also been provided.

 

July 2021: CTIS Training Update

European Medicines Agency updated the page Clinical Trials Information System: training programme, on July 09, 2021, by adding new versions of the below documents in CTIS Training Module 17 (Supervise a clinical trial – Ad hoc assessment):

  1. Instructor’s Guide: Supervise a CT – Ad Hoc Assessment: It contains an overview of how to complete the ad hoc assessment form in CTIS including guidance steps, activities, exercises with solutions for trainers and screenshots for better understanding.
  2. Step-by-step guide: Supervise a CT – Ad Hoc Assessment: It provides step-by-step guidance on how to create, search and view an ad hoc assessment, with screenshots.
  3. FAQs: Supervise a CT – Ad Hoc Assessment: It contains questions regarding the creation, requests for information and consultation, the update and completion, the roles and permissions, the search, view, and download of an ad hoc assessment.

July 2021: CTIS Webinar Update

European Medicines Agency uploaded a PDF  Speakers – Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS over the What’s New Section on July 08, 2021.

The document consists of bios of all the speakers that will be articulating in the upcoming CTIS webinar-Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS that will be held on July 29, 2021.

Additionally, the agenda for the event was uploaded on July 06, 2021, on the event page.