October 2022: WHO Open Consultation for Harmonization of Clinical Trial Results

The World Health Organization (WHO) has released a consultation page to solicit feedback from stakeholders – including researchers, patients, journal editors, funders, industry sponsors, and regulators. The aim is to promote harmonization of minimum data elements for reporting study results in trial registries.

It accommodates the submission of responses on a scale of 1-5 based on the importance of collecting data for various data elements. It includes the following sections – Trial status and dates, Participant flow, Baseline data, Outcome measures and their results including statistical analysis, Adverse events, and public disclosure of study documents.

The deadline for submitting feedback is 11 November 2022.

September 2022: Thai Clinical Trials Registry (TCTR) Update

The Thai Clinical Trials Registry (TCTR) recently launched its advanced search function with additional search options or tabs for better navigation of clinical studies registered on the registry.

The search option is now capable to analyse the studies based on recruitment status, inclusion criteria, study type, study phase, summary results, deidentified individual participants-level data sharing, sponsor, and first posted date.

The registrant is responsible for the accuracy and the updated data of the trial information on the registry.

June 2022: Australia and New Zealand Update

An update posted on the Australia New Zealand Clinical Trial Registry (ANZCTR) informs users that a series of short, detailed videos for researchers or any authorized representatives explaining steps of registering a new trial on the ANZCTR are now available on their website.

The series feature instructional videos demonstrating how to report interventions, outcome measures, and data sharing statement fields while filling out a registration form on the website.

More information can be found here.

February 2022: Canada Update

As a part of the regulatory modernization process, Health Canada had published a consultation paper in May 2021. Health Canada gathered feedback from stakeholders on the consultation paper through an online questionnaire, email submissions, and interactive webinars. Overall, 122 written submissions and close to 1000 stakeholders participated in webinars.

The respondents agreed with the proposals to modernize the clinical framework. Health Canada posted “What we heard: an executive summary” on their portal on February 23, 2022.  One of the topics in the post was transparency. Most respondents saw value in the new transparency policy/ regulation for registering trials and reporting results. Support from the academic community was 73% and that from the industry was 54%.

Registration:

Most respondents (86%) register their trials with an international registry like ClinicalTrials.gov. Some use the EU Clinical Trial Register and 1 respondent recommended ISRCTN.  For device trials, EUDAMED will be also be used once it becomes a law.

Feedback suggested that academic researchers have challenges in keeping their international registration up to date as compared to the industry researchers. The major challenge included the burden of being required to use multiple registries in different countries for multinational trials. Other challenges included resource requirements to keep up-to-date registry information and some registries being not user-friendly.

Public disclosure of results:

Most respondents (73%) report trial results in the international registries. Respondents explained that reporting results is a part of their good clinical practices and some explained that reporting is an international, research ethics board or publication requirement. Of the 27% of respondents who were contract research organizations (CROs) said they do not report their results. Most of them said it is the sponsor’s responsibility. Some (20%) who do not report their results on international registries said they publish results on their company websites.

The detailed information can be found here.

February 2022: Penalties on Failure to Submit Results in Belgium – A TranspariMED Report

An article “Belgium: What does the new clinical trial transparency law say?” has been published on February 15, 2022, on TranspariMED.

With the European Union Clinical Trial Information System (EU CTIS) coming into force on 31 January 2022, sponsors can face penalties for failure to report results, irrespective of the outcome, within one year of study completion. As laid down in Article 94 of the Regulation (EU) No 536/2014, the Member States shall lay down rules on penalties applicable to infringements and shall take all measures necessary to ensure that they are implemented.

As per the Belgian regulation already published on May 22, 2017, sponsors can be fined between 500 and 250,000 Euros and a prison sentence between one month and two years. Repeat offenders can be imposed up to a maximum fine of 500,000 Euros and a three-year prison sentence. In addition, the judge may prohibit any person convicted under this Act from participating in a clinical trial as a sponsor, investigator, or in any other way, even under the direction of an investigator for a period he determines, which may not be less than three years or more than ten years.

In addition, this report also describes how fines will be imposed, how violations will be detected, and the strengths and weaknesses of Belgium’s law. For more information, please refer to the article “Belgium: What does the new clinical trial transparency law say?” published on February 15, 2022, on TranspariMED.

February 2022: Spain Update

The Spanish Agency of Medicines and Medical Devices (AEMPS) has published an updated version of document of instructions of the Spanish Agency of Medicines and Health Products for the realization of clinical trials in Spain.

As per updated version, from 31 January 2022 until 30 January 2023, the sponsor may request the authorization of a clinical trial, applications for substantial modifications through the CTIS or ECM Portal.

All requests and communications subsequent to the authorization of a clinical trial not uploaded to CTIS must continue to be made through the ECM portal no later than the date on which the transition of the clinical trial was requested in the CTIS Portal.

February 2022: Canada Update

Canadian Institutes of Health Research (CIHR) shared their policy guide on the requirements for the registration and disclosure of results from clinical trials on February 08, 2022.

The policy focuses on the registration of clinical trials and making them publicly available, free to access before the first visit of the first participant.

The following new requirements will be applicable to all clinical trials funded on or after January 01, 2022:

  • Publications including clinical trial results must be open to access from the date of publication.
  • Summary of the clinical trial results must be publicly available within 12 months from the last visit of the last participant.
  • All study publications must include the registration number/trial ID in the article summary or abstract.

More information can be found here.

 

February 2022: Pan African Clinical Trials Registry and South African Clinical Trials Registry Update

The Pan African Clinical Trials Registry (PACTR) and South African Clinical Trials Registry (SANCTR) have made an important announcement on a few enhancements to improve the functionality of the registry.

New filters have been included for easy tracking of the “submitted” or “in process” trials. Researchers should see their trials under “My trials” tab for the new changes. Trials with specific status such as “submitted”, “in process”, “approved”, “denied” or “incomplete” can be viewed using the filters.

The deployment of the changes is expected from February 03, 2022.

The revised enhancements in the registry will be available at www.pactr.org and the SANCTR site.

January 2022: Czech Republic Update

State Institue for Drug Control (SÚKL) specified the requirements for the documents to be submitted with Part II of the application for clinical trial authorization on January 26, 2022.

Requirements to be entered into Clinical Trial Information System (CTIS) in Part II is elaborated for following sections:

  • Patient information sheet / informed consents
  • Materials for trial subjects
  • Recruitment materials
  • Investigator
  • Trial site
  • Insurance
  • Personal data processing
  • Biological samples for future research
  • Trial subject remuneration and compensation
  • Financial coverage – how the clinical trial will be financed
  • Proof of fee payment

For more detailed information, click here.

 

January 2022: Clinical Trial Transparency in Belgium – A TranspariMED Report

A new report launched on January 21, 2022, by three Belgian groups – Cochrane Belgium, consumer group Test Ankoop, and patient group Kom op tegen Kanker – in collaboration with TranspariMED enlists details on Federal Agency for Medicines and Health Products (FAMPH) plans to promote clinical transparency.

The report discusses the clinical trial results reporting the performance of the 9 Belgian non-profit institutions that conduct many clinical trials. It also states in detail the efforts made by Belgium’s national medicines regulator, FAMPH, to encourage the publication of trial results. Results for a trial conducted in Europe or EEA region must be reported on EudraCT within one year of trial completion per European Directive 2001/20/EC.

Report findings show that the Belgian sponsors’ estimated true combined results reporting rate of 43% puts them far ahead of their peers in the Netherlands, whose reporting rate is just 7%. However, this rate still lags other European countries whose results reporting rate is up to 60%.

The article concluded by stating that the Belgian sponsors have made substantial progress, but the trial registry entries still require accuracy and consistency. The report also provides “Recommendations” to improve the quality of Belgian data on the registry.

For more information, please refer to the article published on 21 January 2022 on TranspariMED.