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.

October 2021: Ireland Update

Health Products Regulatory Authority (HPRA) in conjunction with the National Office for Research Ethics Committees will hold a series of one–hour webinars from November 22 to November 25, 2021, to explain the new Clinical Trial Regulation (CTR) (Regulation No 536/2014) which will come into effect on 31 January 2022.

The aim of the webinars is to present the main changes that those involved in clinical trials in Ireland can expect when the regulation is implemented, and throughout the three-year transition period that will follow. This webinar series will give an overview of the regulation, including post-authorization and compliance aspects, and guidance on the next steps for sponsors and investigators.

The agenda published by HPRA gives more information on the topics to be covered during the webinars.

To attend the webinar series, registration can be done using this registration link.

Further details can be found here.

 

October 2021: What’s New on ClinicalTrials.gov

On October 26, 2021, ClinicalTrials.gov updated about materials of modernization Webinar.  A recording of the October 7, 2021 webinar and slides describing the anticipated launch of beta ClinicalTrials.gov have been added to the ClinicalTrials.gov Modernization page. This webinar provides an update on modernization efforts and information on the anticipated launch of beta ClinicalTrials.gov.

October 2021: EMA Update

European Medicines Agency (EMA) updated the Guide on Access to Unpublished Documents on 21 October 2021. This is the fourth revision to the original guide published on 24 November 2014.

Guide on access to unpublished documents complements Policy 43, EMA’s policy on access to documents (related to medicinal products for human and veterinary use). This guide details the Agency’s process to deal with all written requests, especially requests made electronically, for access to any document originated, received, or held by the Agency (i.e. reactive disclosure).

Following are the updates made in the fourth revision to the Guide:

  1. The ‘Access to Documents Service’ (ATD Service) replaced ‘Document Access and Publication Services’ (DAP Services) throughout the document. DAP Services was a set up to operate the process for requests for access to documents held by EMA.
  2. Guidance related to the use of radio buttons ‘Please select your type of inquiry’  and ‘I want help identifying which unpublished document I need’ in the AskEMA web form. (Please refer to Questions 1 and 4 in the guide for more details).
  3. Guidance on what the EMA considers as ‘one document’. A (non-exhaustive) list of what the Agency considers as one document is provided. (Please refer to Question 18 in the guide for more details).

More information can be found here.

 

 

October 2021: ClinicalTrials.gov Modernization Webinar Update

A Webinar on ClinicalTrials.gov Modernization took place on October 7, 2021.

A summary report on the progress in ClinicalTrials.gov modernization effort from August 2019 to August 2021 is now published by the National Institutes of Health (NIH). This report gives detailed insight into the National Library of Medicine (NLM’s) approach to modernization, presents the Working Group’s input on various aspects of the modernization effort, describes user challenges and modernization priorities by each strategic goal, also shares NLM’s product development plans and progress, and presents future steps for the Working Group and the modernization effort.

Concerning NLM’s product development plans, the first beta release of the PRS website is planned for late fall 2021. NLM’s next steps in ClinicalTrials.gov modernization involve seeking the Working Groups feedback and suggestions for functionalities to be added in future releases and to start public communications related to the beta release of PRS.

Additional information about the ClinicalTrials.gov modernization effort is available on ClinicalTrials.gov.

September 2021: EMA Update

European Medicines Agency’s (EMA) published a Privacy Statement for the clinical data publication website on 28th September 2021.

EMA publishes clinical data on their website in accordance with the Agency’s policy (Policy 0070) on the publication of clinical data for medicinal products for human use.

This privacy statement explains the most essential details of the processing of personal data by EMA in the context of the user registration, access, and activity on the clinical data publication website. It also explains the reason for the processing, the way of collecting, handling, and ensuring protection of all personal data provided, how that information is used, and what rights may be exercised in relation to your data and how.

This privacy statement provides a detailed explanation on the following:

  • Who is responsible for processing the data?
  • Purpose of this data processing
  • Timeline of data retention by EMA
  • Access and disclosure of the information
  • Data protection rights
  • Resources (email and website) in case of any questions or complaints regarding data processing

For more details, please refer to European Medicines Agency’s Privacy Statement.

August 2021: Good Pharma Scorecard 2021

The Good Pharma Scorecard is an initiative by the Bioethics International organization that ranks companies and new medicines on their clinical trial transparency and data-sharing performance, taking into account ethics and legal standards. This scorecard is published by Bioethics International every two years.

The Good Pharma Scorecard for 2021 is now available on their website. The companies with a 100% transparency score, for their clinical trial transparency, with the first ranking on the scorecard are AbbVie, Amgen, Bayer, Merck KGaA / EMD Serono, Novartis, Roche / Genentech, and Takeda. Under the data sharing section companies with a 100% data sharing score are AbbVie, Amgen, AstraZeneca, Bayer, Johnson & Johnson / Janssen, Merck KGaA / EMD Serono, Novartis, Novo Nordisk, Roche / Genentech, Shire, and Takeda.

 

 

July 2021: Germany/WHO Update

An update was posted on the DRKS website on July 29, 2021, regarding the Universal Trial Number (UTN) application. UTN of the World Health Organization (WHO) can now be reached under a new link.

The WHO issues a UTN to each clinical trial upon request.

A UTN is a unique number that is generated by the WHO for every clinical trial that is registered in one of the WHO primary registries. It is intended to facilitate the identification of studies and is displayed on the WHO International Clinical Trials Registry Platform (ICTRP) search portal. As soon as the first version of the study protocol has been created, a UTN can be applied for free and easily via the WHO platform. UTN is included as a secondary ID in DRKS.

The post also includes reference links for UTN and FAQs on UTN.