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.

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: Netherlands Update

Dutch Institutions Finally Make Progress on Clinical Trial Reporting

As per the news article posted on TranspariMED on 14-Dec-2021, over 700 clinical trials run by the ten largest Dutch institutions are still missing results, but major institutions are now working to fix the problem, new data suggest.

Full results are publicly available on the European trial registry for only 52 clinical trials run by the Dutch cohort, less than 7% of all due trials. This is still far below the European average reporting rate of 28% for major non-commercial trial sponsors.

The country’s largest sponsor, Radboudumc, has the strongest transparency record with 21 reported trial results, while estimated 102 Radboudumc trials are still missing results or are not marked as completed and 124 trials are not yet due to report results.

On the positive side, nearly all major Dutch institutions have uploaded additional results over the course of 2021. Between February and November 2021, Radboudumc uploaded 10 due trial results as part of an ongoing systematic effort to clear its backlog of unreported trials. Erasmus University uploaded 6 additional due results. Only HOVON Foundation has made no visible progress.

Netherlands may finally be starting to catch up with the rest of Europe in terms of clinical trial transparency.

For additional details, please follow this link.

December 2021: Netherlands Update

Transition from NTR to CCMO

Some additional information is available in continuation to the service announcement displayed on the Netherlands Trial Registry (NTR) website:

  • It is currently not possible to register a new study with the NTR since it is permanently closed for new study registrations
  • The NTR will get a restart with the Central Committee on Research Involving Human Subjects (CCMO) registry. The new Dutch Trial Register is not yet available and there is no clarity as to when it will go live
  • New studies cannot be registered in the NTR during the transition phase, however, studies already registered in the NTR will be included in the New Trial Register and the registration number (NL XXXX) can continue to be used when publishing the study in a scientific journal
  • In addition, as a researcher it remains possible to make changes to already registered studies in NTR
  • It is further advised to register studies with another WHO recognized registry, such as ISRCTN Registry or Clinicaltrials.gov

For more details, please follow this link.

November 2021: Netherlands Update

Information on EU Clinical Trial Regulation available on CCMO’s website

On 31 January 2022, the EU Clinical Trial Regulation (CTR) 536/2014 will apply in the European Union. All required information for investigators is available on the Central Committee on Research Involving Human Subjects (CCMO) website in a special section for research with medicinal products in accordance with the CTR.

The section consists of six parts:

The information is currently only available in English. A Dutch translation will be published soon.

The CTR replaces the current Clinical Trials Directive 2001/20/EC, which has been embedded in the Dutch Medical Research Involving Human Subjects Act (WMO). In contrast to the Clinical Trials Directive, the CTR stipulates that the procedures for the submission, assessment and conduct of research with medicinal products are the same throughout the EU. A transition period of three years applies. Partly due to the transition period for the CTR, the page Guide to the review procedure has been revised. Here you can find information on the legal frameworks and procedures for medical research, including research with medicinal products.

October 2021: Netherlands Update

Online symposium on EU Clinical Trial Regulation on 11 November 2021

An online symposium on the EU’s Clinical Trial Regulation (CTR) will take place on November 11, 2021, which will come into effect on January 31, 2022.

The symposium will provide more information about the procedures that will apply to various parties under the CTR, such as doctors, science offices, CROs, pharmaceutical companies, the CCMO and the accredited MRECs.

The symposium is organized by Association of Clinical Research Organisations in the Netherlands (ACRON) in collaboration with the Dutch Clinical Research Foundation (DCRF) and its partners.

Follow this link to the Registration Form.