May 2022: CTIS Update

European Medicines Agency updated about the upcoming event, Clinical Trials Information System (CTIS) bitesize talk: Modifications over the What’s New Section on May 11, 2022.

It notifies that CTIS bitesize talk: Modifications event will be held on May 31, 2022. The sponsors will get an opportunity to learn about the modifications that can be made to a clinical trial application in CTIS. The event will be open to all sponsor organizations, including pharmaceutical companies, contract research organizations, small and medium-sized enterprises (SMEs), and academic organizations. Also available on the event page is the Speaker bios for this event.

It mentions that no registration is required for this event and a video recording will be provided after the event.

For more information, please click here.

March 2022: Germany Regulatory Update

The German authority (BfArM) had recently updated the requirement for results posting according to Section 42b of the German Medicines Act (AMG) for trials conducted for medicinal products in humans on January 27, 2022.

According to this update, as of January 27, 2022, the previously applicable Section 42b paragraph 2 AMG has been repealed, i.e., there is no longer any obligation for the sponsors of clinical trials with medicinal products that have been approved/approved in the central procedure for placing them on the market to submit results reports to the competent higher federal authority.

The German authorities were asked a few questions to clarify the period/timeline from when this new regulation would be applicable.

The authorities confirmed that the new regulations do not provide for a transition period for the amendment of Section 42b AMG. The amendment applies directly as of January 27, 2022. Therefore, any studies that had a deadline to report results after January 27, 2022, no longer have to submit the results after January 27, 2022, regardless of when the study ended.

Further, it was also stated that for submissions of results reports according to Section 42b paragraph 2 AMG, which should have been done regularly until January 27, 2022, and for which the requirement was not met in time, the obligation to submit a result report remains unchanged.

 

March 2022: Peru Regulatory Update

Peruvian Registry of Clinical Trials (REPEC) published a notification (Press release No. 007-2022-OGITT/INS) on March 15, 2022. This details the measures established for the reception of documents by Documentary Procedure (TD) in a virtual and face-to-face manner.

Submissions and Inquiries via Email:

  1. Submission of TD requests, related to all types of new or ongoing clinical trials, not related to COVID-19 can be processed through [email protected].
  2. Inquiries and submission of applications for processing of clinical trials related to COVID-19 can be sent through [email protected].
  3. Inquiries related to all types of clinical trials, new or in progress, not related to COVID-19 can be sent through [email protected].

General Office of Research and Technology Transfer (OGITT) In-person Attention Table:

In-person assistance will be available through the OGITT Documentary Processing Office, Monday through Friday from 08:00 am to 04:15 pm. Address: National Institute of Health, Jirón Cápac Yupanqui 1400, Jesús María, Peru.

Phone numbers for various types of inquiries are also shared:

  1. For inquiries about files: (511) 748 1111 Annex 2155 and 2201
  2. For monitoring of Clinical Trials: 51(1) 748-1111, extension 2191 or Cell 975445205
  3. For inquiries about REPEC: Tel. 478 1111 annex 2616 Cel. 984108368

For receipt of documents and response by TD:

All requests must be addressed to the General Directorate of the OGITT-INS, and must expressly and specifically indicate the reason for the request. The lifting of the observations issued by the OGITT must be uploaded through the Peruvian Registry of Clinical Trials – REPEC and be notified by email at [email protected], in order to have traceability in monitoring their procedures.

March 2022: Germany Regulatory Update

An announcement was published on March 07, 2022, on the BfArM website regarding the publication of the results of clinical trials according to Section 42b of the Medicines Act (AMG).

This announcement is an addition to the update posted by the BfArM on January 27, 2022 (Changes in the legal requirements according to  Section 42b AMG). It mainly addresses questions regarding results reporting that are frequently asked to the authorities. The important question answered in this notice are:

  • Who is legally obliged to submit results reports on clinical trials to the higher federal authority for publication in a database according to Section 67a sub-section 2 AMG?

Section 42b sub-section 1 AMG applies to the pharmaceutical companies based in Germany, in other member states of the European Union, or a Contracting state of the Agreement on the European Economic Area. These companies will need to report the results of clinical trials with medicinal products for human use to the higher federal authority only for trials conducted in any third country.

  • When are the results reports on clinical trials to be submitted?

According to section 42b sub-section 1 AMG, the results reports for clinical trials must be submitted within 6 months after the approval has been granted (this also applies to subsequent changes to the approval). To speed up the process, the results report should preferably be submitted to the competent higher federal authority together with the application for approval of the trial, according to Section 21 AMG.

If a report required under Section 42b sub-section 1 AMG is already published in the database under Section 67a AMG, a reference for the result should be provided. Further details on the referencing will be specified in a separate notice.

In addition to the above-mentioned questions, the notice also clarifies the type of clinical trials requiring results reporting, requirements for bioequivalence studies per Section 42b, the format in which the results need to be reported, etc.

More information on this announcement can be found here.

 

February 2022: Germany Regulatory Update

A notice was published on February 01, 2022, on the BfArM website regarding Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use.

Information in this notice aims to support the harmonization of the application and interpretation of the new regulations on clinical trials by the federal states as they come into force. The BMG and the higher federal authorities BfArM and PEI have provided the following information:

  • Details on the effective date and transitional provisions: As of January 31, 2022, Regulation (EU) No. 536/2014 is applicable. The applications for clinical trial approval can be submitted to the authorities according to the previous law by January 30, 2023, at the latest. Clinical trials started under the previous law can be continued under it until January 31, 2025. Final reports for clinical trials completed under the previous law can still be submitted to the EudraCT database.
  • Details on the application and interpretation of the new law: This provides details for differentiating between clinical trials, clinical studies, and non-interventional studies according to Regulation (EU) No. 536/2014 and the corresponding regulation that will be applicable.
  1.  For studies that are not classified as clinical trials according to Article 2 para 2 No. 1 of Regulation (EU) No. 536/2014, if necessary, a notification as an application observation according to Section 67 para 6 AMG will be required to be submitted to the federal authorities.
  2. If it is a clinical study, it must be checked if it is a trial within the meaning of Article 2 para 2 No. 2 of Regulation (EU) No. 536/2014. If this is not the case, it is a non-interventional study within the meaning of Article 2 para 2 No. 4 of Regulation (EU) No. 536/2014. For non-interventional safety studies within the meaning of Section 63f AMG and for application observations within the meaning of Section 67 (6) AMG, the specifications there apply.
  3. If it is a clinical trial, Regulation (EU) No. 536/2014 applies. If the requirements of Article 2 Paragraph 2 Number 3 of Regulation (EU) No. 536/2014 are met, the clinical trial can be classified as a minimal intervention clinical trial.
  • Additional Clarifications: The application for the approval of a clinical trial in Germany can be submitted via the EU portal according to Article 80 of Regulation (EU) No. 536/2014 in German or English.

Further details of this notice can be found here.

 

January 2022: Changes to Deferrals and an Update on Automatic Registration

On January 28, 2022, UK HRA posted an update regarding the changes to the deferrals process and automatic registration of a research summary on the HRA website.

From January 31, 2022, the rules around deferring registration and publication of a research summary on the HRA website will change. Below are the changes that will be applicable from January 31, 2022 onwards:

  • Publishing limited information: As opposed to the previous process where a deferral from registration of all information was provided, the sponsors will now need to publish a minimum record of the clinical study on a publicly accessible registry if a deferral is agreed by the authority.
  • A new maximum timeline:  A maximum deferral period of 30 months will be applicable for all deferral requests approved from January 31, 2022, onwards. The initial deferral will still last for 12 months. Sponsors can apply to extend the deferral period by 12 months at a time until the study comes to an end. An extension for another 12 months and then up to a further 18 months can be applied for, by the sponsor (a maximum of 30 months in total from the end of the study).
  • How to request a deferral: Trials using combined review can submit a deferral request in the new part of the Integrated Research Application System (IRAS) by answering the deferral question in part C of the study information question set. For all other studies, deferral can be requested by emailing [email protected] Further information on requesting a deferral can be found here.

Update on automatic registration: HRA had started with automatic registration for all new clinical trials of medicines that gained approval through the combined review process since January 01, 2022. Trials submitted through combined review after January 01 that are given approval, are being registered in the ISRCTN Registry.

Automatic registration applies to clinical trials of investigational medicinal products (CTIMPs) and combined trials of an investigational medicinal product and an investigational medical device (IMP/device trials). These trials will be automatically registered once all approvals are in place (HRA/Research Ethics Committee and MHRA approvals) at no cost to the applicant by the authorities. More information related to automatic registration can be found here.

 

 

 

January 2022: Germany Regulatory Update

An update was posted on the Federal Institute of Drugs and Medical Devices (BfArM) website on January 27, 2022, regarding the Change in the legal requirements for reporting results of clinical trials according to Section 42b of the German Medicinal Products Act (AMG).

When the Act for the Restructuring of the Pharmaceutical Market in Statutory Health Insurance came into force on January 1, 2011, Section 42b – Publication of the results of clinical trials was added to the sixth chapter of the AMG.

From January 27, 2022, the legal requirements for publication of results report according to Section 42b AMG will change as follows:

  • According to subsection 1 sentence 1, the sponsors will now be obligated to report results only for confirmatory clinical trials (to prove efficacy and safety) that are carried out exclusively in third countries, i.e. exclusively in countries outside the European Union and the European Economic Area (EEA), to the responsible higher federal authority.
  • The previously applicable Section 42, sub-section 2 AMG has been repealed, ie., Sponsors of clinical trials with medicinal products which are approved/will be approved by the central procedure will no longer have any obligation to submit results reports to the competent higher federal authority for placing them on the market.
  • Furthermore, the previous notification obligation for generic approvals in connection with bioequivalence studies will no longer apply.

The content requirements for the results reports remain unchanged and can now be found in the new Section 42b sub-section 2 AMG,  that is all the results of the clinical trials must be included in the reports, regardless of whether they are favorable or unfavorable. Subsequent significant changes to the protocol as well as interruptions and terminations of clinical trials are to be included in the report. The report can be written in German or English.

An updated announcement for the publication of the results of clinical trials according to Section 42b AMG will be available shortly on the BfArM website.

More details for this article can be found here.

December 2021: CTIS Training Update

European Medicines Agency (EMA) updated the pages Clinical Trials Information System: training and support and Clinical Trials Information System (CTIS): online modular training programme on December 16, 2021, by adding the below documents:

  1. Clinical Trial Information System (CTIS) structured data form – Annual Safety Report (ASR): This document provides guidance on the data fields Sponsors will have to fill in CTIS when creating an ASR and also contains screenshots of different sections of the system (CTIS software version 0.18.35.3).
  2. Clinical Trial Information System (CTIS) structured data form – Request for information (RFI): This document provides guidance on the data fields Sponsors will have to fill in CTIS when responding to an RFI and also contains screenshots of different sections of the system (CTIS software version 0.18.35.3).
  3. Clinical Trial Information System (CTIS) list values: This document contains the terms of all the lists present in the CTIS structured data forms for an initial application (IN), additional MSC application, substantial modification, and non-substantial modification applications, notifications, ASR, and RFIs.
  4. Step-by-step guide: How to manage a CT – Module 05: It provides a stepwise guidance to create notifications, respond to RFIs, respond to request for opinion regarding corrective measures and to submit trail results and results summary for lay person.
  5. Quick guide: How to manage a CT – Module 05: It provides information on the four system functionalities i.e. notifications, RFIs raised, results summary and summary for lay person along with CTIS insights.

Also an updated version of FAQs: How to create, submit and withdraw a Clinical Trial Application – Module 10 was uploaded with an addition of Section 7-Roles and Permission.

December 2021: An IQWiG Update: Call for a Central Portal for Clinical Study Reports

An update about a journal article, Call for a Central Portal for Clinical Study Reports (CSRs) was posted, on the Institute for Quality and Efficiency in Health Care (IQWiG) website on December 01, 2021.

The IQWiG is a professionally independent scientific institute under the Federal Joint Committee (G-BA) or the Federal Ministry of Health (BMG), Germany. Two authors from IQWiG have published an open-access article in the Journal of European CME. This article discusses the need for a central, public, and worldwide portal for accessing CSRs of all the clinical studies carried out worldwide.  The authors also suggest the use of the CSRs not only for dossier assessments but also for developing other information formats such as clinical practice guidelines, continuing medical education (CME) materials, and patient information.

The article acknowledges that the quality of clinical practice guidelines has improved in the form of prospective study registration as a precondition for publication in scientific journals in 2004 and mandatory registration of studies and summaries of study results. Even then, the information related to any intervention, is scattered in different information sources. These sources could be journal publications, public and industry study registries, as well as regulatory and health technology assessment (HTA) agency websites, which results in extensive resources required for retrieving and screening of this information.

As a way of providing a solution to these problems of scattered information sources and the possible influence of the industry on certain scientific materials like the CME, the article suggest establishment of a digitised clinical study portal containing all CSRs which would enable the resource-efficient production of unbiased evidence synthesis, not only to inform health policy decisions, but also for use in other information formats described above, and thus ultimately improve treatment outcomes. The article also provides the basic structure of the portal for each clinical study, including a unique identifier as well as the corresponding CSR (provided proactively) and anonymized IPD (provided on request).

Since experience has shown that voluntary commitments by industry in disclosing trial information are insufficient, the legislators are called upon to establish such a central portal and to make the submission of CSRs mandatory.

For more details of this article can be found here.

November 2021: HRA Announces a New e-Learning Module

The UK, Health Research Authority (HRA) announced a new e-learning module for lay summaries on 26 November 2021.

A plain language summary is mandatory for all the clinical studies registered on the ISRCTN registry. To support researchers in communicating results, the HRA has developed an e-learning module that will give a better understanding of how to produce consistent plain language summaries of research.

For access to the e-learning module, an account needs to be set up on the learning system. This account can be created for free here.