August 2021: Canada Update

On August 23, 2021, Health Canada posted an update on the consultation paper that was released on May 20, 2021. This consultation paper focuses on the key policy proposals to modernize Canada’s clinical trials regulatory framework. One of the points discussed was clinical trial transparency. Along with the consultation paper, an online questionnaire was provided to seek feedback from the interested industry and non-industry stakeholders including all interested Canadians.

Interested stakeholders could refer to the consultation paper and send feedback either via an online questionnaire or by sending a written submission by email. The consultation feedback ran from May 20, 2021, till July 04, 2021.

The feedback received during this consultation will help make a decision with respect to outstanding proposed regulatory policy, and program consideration for each product line in the future.

A summary report on the discussions and comments received named “What we heard” is planned to be published in fall 2021.

July 2021: EMA Management Board Meeting on CTIS Audit

European Medicines Agency (EMA) published a document on the minutes of the management board meeting on the Clinical Trial Information System (CTIS) audit on July 14, 2021.

The meeting was held virtually on April 21, 2021. The main aim of this meeting was to confirm if the EU clinical trials Portal and Database (EUPD) are fully functional and meet the functional specification. EUPD is one of the deliverables and a key component of the Clinical Trials Information System (CTIS).

Publication of the European Commission (EC) notice confirming full functionality of the EUPD will start as soon as the Management Board letter of endorsement is received. The Commission will draft an act that is intended to be published on 31 July 2021, so that the Clinical Trials Regulation can start to apply 6 months later. Also, a Joint Action for clinical trials will be launched by the EC in 2021. Additionally, the EC declared that they would be providing the legal support required for the national implementation of Regulation (EU) No 536/2014.

The timelines of the CTIS application were reemphasized in the meeting. The system is set to go live by 31 January 2022 and in the first year after CTIS is live, the sponsor will have a choice to select the old or new system. From 31 January 2023, all the new applications will be submitted to the new system, and the old system will be available only for ongoing studies. From 31 January 2025, all the ongoing studies will need to move on to the new system and the EU Directive will no longer apply.

The document also provides a summary of EUPD independent audit methodology and findings, project release plan for go-live and post-go-live, CTIS training and communication programs and confirmation on EUPD functionality as per the Clinical Trial Regulation.

Detailed information on the above-mentioned points can be found here.

July 2021: Regulatory Update

Health Research Authority (HRA) “Make it Public” 1st Virtual Conference

HRA is hosting its first virtual conference, “Make it public: transparency and openness in health and social care research” on November 3 and 4, 2021.

In this conference, HRA will display UK-wide case studies for transparent research and discuss working together on improving the visibility of studies. One can submit the case study as an example of transparency done well by following the guidance for submitting case studies. The deadline for submission is July 23, 2021.

May 2021: Canada Update

Health Canada launched a consultation paper on May 20, 2021. This paper outlines the key policy proposals for the modernization of Canada’s clinical trials regulatory framework. One of the points discussed is clinical trial transparency.

Currently, Health Canada’s Clinical Trials Database provides information related to Phase I, II and III clinical trials involving drugs and conducted in patients. Health Canada also encourages the sponsors to register the clinical trials on public registries like ClinicalTrials.gov and ISRCTN. Health Canada is examining options for how to best design and implement measures to promote the registration of Canadian clinical trials in public registries as well as public disclosure of the results (results reporting). These measures may include the development of new policies and regulations while making clinical trial information more accessible to the public with help of information technology such as artificial intelligence (AI).

One approach being considered would be to develop a new policy that would guide sponsors step by step with processes related to registration and results reporting.  Alternatively, the department could begin with new regulatory requirements for registration in the initial phase, with policy measures to address results reporting.

Some of the elements of registration and results reporting under consideration are outlined below:

Registration
Health Canada is exploring policy and regulatory options for the registration of authorized Canadian clinical trials investigating drugs, medical devices and natural health products (NHPs). Canadian trial sponsors may be asked to register their trials in an existing, international registry that has been deemed eligible by the department within a prescribed timeframe. The trial sponsor might also be asked to notify Health Canada with proof of their registration (e.g., registry link and trial identifying number), within a certain timeframe after completing registration.

Public Disclosure of Results
Health Canada is also exploring policy and regulatory options for the requirement of public disclosure or reporting of trial results. This would mean that Canadian trial sponsors would be asked to publicly report trial results, and may be asked to notify Health Canada within prescribed timeframes once the results have been made public.

May 2021: Belgian drug regulator under fire for inaction on missing clinical trial results

Overall, the 14 largest trial sponsors based in Belgium have registered 1,098 clinical trials of investigative medicinal products on the EU Clinical Trial Register. Of these, 292 trials have verifiably been completed more than a year ago and should thus have results available. Results are verifiably missing for 64 of these trials (22%). The true number of missing trial results is substantially higher, but cannot be precisely determined due to weak data management by some sponsors and AFMPS.

Over four thousand drug trials run in the European Union are currently in violation of European Union transparency rules, leaving large gaps in the evidence base that often make it impossible for doctors and health agencies to precisely determine how safe and effective medicines are, slowing down medical progress and putting patients at risk.  For more details please follow the link.

May 2021: Statement on transparency and data integrity by ICMRA and WHO

Joint Statement on transparency and data integrity – International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO)

New guidance from the EU tells sites and sponsors of medical device trials how to communicate with regulators about trial progress, submit safety reports, request permission for protocol amendments and draft trial summary reports under the new Medical Device Regulation (MDR) scheduled to take effect on May 26.

The 19-page document from the union’s Medical Device Coordination Group (MDCG) answers such questions as whether sponsors of trials conducted in one or more EU member states need to notify regulators of the end of the trial in each country.

The common aim of these initiatives is to ensure that results of research are accessible to all those involved in health care decision-making. The priority should be for new innovative medicines and vaccines. This improves transparency and strengthens the validity and value of the scientific evidence base.

In addition to enhance patient understanding about the clinical trials in which they have participated, biopharmaceutical companies are collaborating with national regulatory authorities to adopt mechanisms for providing lay summaries of clinical trial results to research participants consistent with applicable laws and rules.