June 2022: Key Performance Indicators to Monitor European Clinical Trial Environment

European Medicines Agency updated the page, Clinical Trials Regulation: progress on implementation by adding ‘Key performance indicators (KPIs) to monitor the European clinical trials environment (1 – 31 May 2022, edition 2)‘ document over the What’s New Section on June 27, 2022:

KPIs to monitor the European clinical trials environment: It is the second report posted for the period May 01, 2022, to May 31, 2022, consisting of the metrics for the submitted and authorized clinical trial applications along with the non-authorized clinical trials. The data is reported from the two EU clinical-trial databases (Clinical Trials Information System (CTIS)  and European Union Drug Regulating Authorities Clinical Trials (EudraCT)). The data is divided into sponsor type, mono-national or multi-national, clinical trial phase, and therapeutic area. A cumulative data from January 31, 2022, is also available for all the below parameters:

  1. Clinical trials submitted under the Clinical Trials Regulation (CTR)
  2. Clinical Trial Applications submitted under the Clinical Trials Directive (CTD)
  3. Ongoing clinical trials in CTR and CTD
  4. Clinical trials with a decision issued with/without deferrals under CTR and CTD
  5. Submitted, validated, authorized, rejected, lapsed, and withdrawn Substantial Modification (SM) applications
  6. Average time from submission to reporting date, and to first decision for initial applications and Substantial Modifications (Part I or Part I and II): It provides a calculated average number of days required to get a decision on the submitted initial clinical trial application (CTAs) using the dates of 8 authorized initial CTAs.

June 2022: CTIS Update for Organization Management System (OMS) Trouble Shooting Sessions

European Medicines Agency updated about the upcoming events of Organisation Management System (OMS) Trouble Shooting Session for CTIS users to the What’s New Section on June 27, 2022:

EMA will be hosting several OMS trouble shooting sessions on the following dates:

It notifies that these trouble shooting sessions will be held for clarifying the questions reported by clinical trial users and sites. It mentions that the questions related to registering the organization and/or location data in the OMS will be addressed in this event. It also mentions that a video recording will be made available after the event.

June 2022: CTIS Update

European Medicines Agency updated about the upcoming Clinical Trials Information System (CTIS) bitesize talks over the What’s New Section on June 27, 2022:

EMA will host two bitesize talks, CTIS bitesize talks: Notifications – Part 1 and Notifications – Part 2 on September 28, 2022, and October 20, 2022, respectively. The sponsors will get an opportunity to learn about the notifications related to the trial and recruitment period, e.g. start, end, restart and halt of trial, etc., in Part 1 and unexpected event notification; urgent safety measures; serious breach, etc., in Part 2.

These events will be open to all sponsor organizations, including pharmaceutical companies, contract research organizations, small and medium-sized enterprises (SMEs), and academic organizations. A video recording will be made available after the events.

June 2022: CTIS Training Update

European Medicines Agency updated about the events ‘Clinical Trials Information System (CTIS) sponsor end-user training program’ over the What’s New Section on June 27, 2022:

It notifies that EMA will host two sponsor end-user training programs:

  1. CTIS sponsor end user training programme – September 2022: It will be held from September 20 to September 23, 2022. The event page provides the agenda and a registration link
  2. CTIS sponsor end user training programme – November 2022: It will be held from November 07 to November 10, 2022. The event page provides the agenda and a registration link

These training programs provides sponsor users the guidelines to prepare for the new way of submitting clinical trial application and managing the clinical trial lifecycle on CTIS. The event page also highlights the key topics that will be covered during the training programs.

June 2022: Netherlands Update

Netherlands Trial Register (NTR) No Longer Available

As per an update posted on Central Committee on Research Involving Human Subjects (CCMO) website on June 24, 2022, the NTR is no longer available. The National Trial Register, in which the CCMO register and the NTR will be merged, is not yet ready for use.

Guidelines provided to researchers for the time being are as below:

  • For ongoing investigations that were already reported to the NTR: The data as registered in NTR are automatically included in the International Clinical Trial Registry Platform (ICTRP) and can be consulted on the  ICTRP Search Portal. The researcher thus still meets the requirement of prospective registration as required by the International Committee of Medical Journal Editors (ICMJE) for publication in scientific journals. Unfortunately, the data can no longer be edited. If adjustment of the data is nevertheless necessary, the research will have to be registered again with another recognized register, see below. A reference to the trail ID of NTR must be included.
  • For registering new trials: New studies can be registered on any WHO recognized registers, such as  ClinicalTrials.gov. The full list of recognized registries can be found at Primary registries in the WHO registry network.

As soon as this situation changes, the CCMO will inform researchers. Click here for more information.

June 2022: ISRCTN Registry Update

The ISRCTN Registry has recently updated its display of study records for making compliance tracking easier, and to encourage trialists to follow transparency recommendations. Registry records now display green badges to highlight prospective registration, regular updating of ongoing records and posting protocols, statistical analysis plans (SAPs), data links, and results to the record.

June 2022: CTIS Update

European Medicines Agency updated about the upcoming event, Clinical Trials Information System (CTIS) webinar: Six months of CTIS and looking forward over the What’s New Section on June 16, 2022:

It notifies that EMA will host a webinar on July 01, 2022 that will cover topics related to system usage metrics, member state and sponsor experience and reflections, user support feedback, and training environment. The event will be open to all sponsor organizations, including pharmaceutical companies, contract research organizations, small and medium-sized enterprises (SMEs), and academic organizations.

It also encourages interested participants to submit their questions in advance relating to sponsor preparedness by June 24, 2022. Most popular questions will be answered by the speakers during the event. No registration is required for this event. A video recording will be made available after the event.

June 2022: What’s New on ClinicalTrials.gov

On June 15, 2022, the below update was posted on ClinicalTrials.gov, What’s New section

The British Medical Journal (BMJ) has published an article specifying the approaches to report master protocol study designs on ClinicalTrials.gov.

A master protocol is a unified study design and operational aspect conducted with a collection of trials or substudies in patients having same or different diseases and that employ one or multiple drugs to treat them. It helps achieve better coordination than can be achieved in single trials designed and conducted independently.

This article proposes reporting each master protocol research programs (MPRPs) substudy in a separate study record to allow for meaningful descriptions of each substudy and to better support the transparency and accountability. Other factors that require further consideration include coordinating the registration and results reporting of MPRPs, supporting the identification of MPRP related records, and harmonizing trial registries worldwide

Other Publications on ClinicalTrials.gov can be found here: Selected publications

June 2022: EU PAS Update

On June 14, 2022, the following update was posted on the EU PAS, News section.

A list of metadata describing real-world data sources and studies has been published on the EMA website, to help pharmaceutical companies and researchers to identify and use such data when investigating the use, safety and effectiveness of medicines.

Real-world data are observational data stored in repositories such electronic health records and disease registries. Making use of these data sources can improve the evidence available to support benefit-risk decisions and facilitate getting better medicines to patients.

This metadata list will feed into two future EU catalogues on real-world data sources and studies:

Setting up a catalogue of data sources and enhancing the catalogue of studies aims to improve transparency with regard to observational studies, enhanced discoverability of studies and data sources, and contribute to increasing the ability to judge the evidentiary value of studies when used to investigate the use, safety and effectiveness of medicinal products. It also helps regulators, researchers and pharmaceutical companies identify studies and data sources suitable to address research questions, based on the so-called ‘FAIR’ (findable, accessible, interoperable and reusable) data principles.

June 2022: CTIS Update

European Medicines Agency updated about the upcoming event, Clinical Trials Information System (CTIS) bitesize talk: Deferral rules and Public website over the What’s New Section on June 10, 2022:

It notifies that CTIS bitesize talk for deferral rules and public website event will be held on July 20, 2022. The sponsors will get an opportunity to learn about the deferral mechanism and it’s affects on publication of clinical trial data and documents. Sponsors will also be able to ask questions during the event. The event will be open to all sponsor organizations, including pharmaceutical companies, contract research organizations, small and medium-sized enterprises (SMEs), and academic organizations. A video recording will be made available after the event.

Also available on the event page is the Speaker bios for this event.