July 2022: China Registry Update

Suspension of Supplementary Registration

From July 05, 2022, the Chinese Clinical Trial Registry (ChiCTR) has suspended supplementary registration of Clinical Trials.

Supplementary registration is defined as the registration done after the first case of candidate is recruited.

There have been no other changes made to the information available for supplementary registrations on the ChiCTR website.

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.

April 2022: Netherlands Update

Performance studies on in vitro diagnostics (IVDR)

On 26 May 2022, the EU Regulation on Medical Devices for In Vitro Diagnostics, also known as the In Vitro Diagnostics Regulation (EU no 2017/746, IVDR) will come into effect. The IVDR contains specific rules for the submission, assessment and execution of performance studies on in vitro diagnostics, IVDs. On the CCMO website, the necessary information for researchers is available on the special theme page Performance studies for in vitro diagnostics as of 29 April 2022.

Performance studies on in vitro diagnostics are divided into different legal frameworks. These frameworks are described in Legislation and regulations, guidelines and standards .

For information about the submission and content of the research file, please visit the Primary Submission and Standard Research File page.

On the During and after page, you will find information about what to report during and after an IVD performance study.

Results:

  • The client must submit a report on the performance study within one year of the end of the performance study. The requirements for the report are set out in Annex XIII of the IVDR (section 2.3.3 of Section A).
  • The sponsor must submit a layperson summary of results within one year of the conclusion of the performance study.
  • If it is not feasible for scientific reasons to submit the report and the lay summary within one year of the end of the performance study, the client must have laid down a different period with reasons in the plan for the performance study (Clinical Performance Study Plan — CPSP). The review committee assesses whether the extension of the term is justified.
  • If the performance study been suspended or terminated prematurely, a period of three months instead of one year applies for submitting the report and the lay summary.
  • If the performance study been suspended and restarted within three months, the client does not have to submit a report and a lay summary.

Once Eudamed is operational, the results of the performance study must be uploaded in Eudamed and the report and the lay summary will be made public via Eudamed (IVDR Article 73.7).

Information about starting an appeal or objection procedure against a decision by the accredited MREC or the CCMO can be found under  Appeals and objections.

April 2022: Netherlands Update

As of April 4, 2022, the CCMO’s 2021 Annual Report will be available and presented to the Minister of Health, Welfare and Sport, Ernst Kuipers and the presidents of the Senate and House of Representatives. In the annual report, the CCMO reports on its activities in the past year.

In addition to the introduction of the new legislation for research with medical devices, the MDR (Medical Device Regulation), 2021 was dominated by preparations for the European Medicines Regulation, the CTR (Clinical Trial Regulation) for everyone involved in clinical research. The CCMO pays extra attention to this subject in this annual report. In three interviews, professionals talk about the challenges of the CTR, but also about the opportunities that this regulation offers for clinical research in the Netherlands.

The annual report also provides insight into the legal duties of the CCMO. In addition, important national and international developments of the past year are discussed that have consequences for the Dutch assessment system and the CCMO. The annual report also contains figures and data about the research files that were assessed in 2021 by the recognized medical ethics review committees (MRECs) and the CCMO on the basis of the Medical Research Involving Human Subjects Act (WMO) and the Embryo Act.

Here is a quick link to the Annual Report.

February 2022: MHRA Consultation On Proposals for Legislative Changes For Clinical Trials

In February 2022, the MHRA has released a consultation page for users to submit their responses online to their eight weeks of public consultation for the UK clinical trial legislations.

It accommodates for the submission of responses in a ‘Yes or ‘No’ format along with a justification for three important transparency-based questions in the proposal. Questions involving the requirement in their law for registering trials, summary results posting within 12 months of the end of the trial, and sharing trial findings with participants.

January 2022: MHRA Proposal for Legislative Changes for Clinical Trials

On 17 January 2022, MHRA UK launched eight weeks of public consultation for the UK clinical trial legislations. The proposal invites views on various parameters including research transparency and the clinical trial approval process.

In line with the Make it Public strategy, proposal for a ‘requirement’ in the legislature for trial registration, summary results posting within 12 months of the end of the trial, and sharing trial findings with participants have been discussed. Views on the response and timelines to MHRA queries, decisions, and other responses applicable as per the newly introduced Combined Review have also been called for. Detailed guidance can be accessed here.

February 2022: UK HRA Combined Review Webinar Update

On January 15, 2022, HRA announced the Combined review webinar on upcoming changes is now open for booking. All applicants, sponsors, and NHS/HSC participants can apply on various dates between February and March 2022 via their Learning Management System (LMS). The webinar will be recorded and a version will be made available for anyone who cannot attend a live session.

The webinar will provide an introduction to the upcoming changes, the impact of these changes on the organization, and any internal processes or procedures that might need to be updated and provide guidance for available resources providing further information and support.

Approvals Of Medicines from Regulatory Agencies Despite Omitted Clinical Trials

As per a post dated 3rd January, 2022 on TranspariMED, a drug to treat attention deficit hyperactivity disorder (ADHD) was approved by several regulatory agencies without all relevant clinical trials having been reviewed, a study published in November 2021 suggests.

The omitted trials accounted for a median of 45% of all data from participants in relevant studies, raising concerns that regulators may not be looking at all relevant trials when assessing the safety and efficacy of new treatments.

Six regulators did not consistently list all relevant trials in public approval documents: BfArM (Germany), FDA (United States), Health Canada, MHRA (United Kingdom), PMDA (Japan) and TGA (Australia). With the exception of Health Canada, regulators did not explain why certain trials were omitted.

The researchers identified 18 relevant trials and 13 drug applications filed with 7 different regulators by four pharma companies: Janssen, Medice, Novartis, and Purdue. They found that in just over half of regulatory documents, relevant clinical trials were not mentioned.

The authors recommend that regulatory agencies should systematically search for trials themselves, rather than relying on drug companies to identify all relevant studies, and that pharma companies should be held accountable if they fail to inform regulatory agencies about all available evidence.

For more details, please refer to this post on TranspariMED.

 

December 2021: Netherlands Update

New online tool provides insight into the scope of CTR

The CCMO on December 23, 2021, has released an update to provide information about the Clinical Trial Decision Tool which was jointly developed by the Paul Janssen Futurelab and the CCMO.

The new Clinical Trial Decision Tool helps determine whether the drug research falls within the scope of the Clinical Trial Regulation (CTR). The CTR will become applicable in the European Union on January 31, 2022.

After answering a maximum of 13 questions, the Clinical Trial Decision Tool shows whether or not the research falls within the scope of the CTR. The tool also shows whether that is a low-intervention clinical trial. Adapted rules apply to such research.

For more information, follow this link.

December 2021: UK Update

Changes to the Rules on Deferring Research Registration and Publication

On 24 December 2021, UK HRA published a new maximum timeline for deferrals. Deferrals have a validity of 12 months and applicants request their extension for deferral every 12 months. Under the new policy, this will be a maximum of 30 months after the study ends. When the deferral ends the research sponsors are required to add full information onto the registry, along with the summary of results which will then be published on the HRA website. Trials not deferred are registered on the ISRCTN registry automatically.

For clinical trials where deferral is approved, researchers are yet required to upload reduced information in an approved registry. For deferrals approved after 31 January 2022, the minimum information expected to be published on a registry is available here-Research registration and research project identifiers – Health Research Authority (hra.nhs.uk)