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May 1, 2019

FDA webinar on Risk-based Monitoring
USFDA launched a webinar on risk-based approach to monitoring clinical investigations

As a follow up on their recently published Q&A paper, in this webinar, FDA discusses the new draft guidance, A Risk-Based Approach to Monitoring of Clinical Investigations - Questions and Answers, released in March 2019. FDA will also review the importance of a risk-based approach to clinical trial monitoring and how to provide feedback on this draft guidance.

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When is a REMS necessary?
In a guidance to industry USFDA explains the application of statutory factors in determining when a REMS is necessary

This guidance is intended to clarify how the US Food and Drug Administration applies the factors set forth in section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks. This guidance fulfills one of the performance goals that FDA agreed to satisfy in the reauthorization of the Prescription Drug User Fee Act (PDUFA) V.

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Health Canada adopts ICH E6R2
HC implements E6R2

Health Canada, in a press release on their homepage, adopted the ICH E6R2 Guideline. The press release was posted on April 3rd.

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ICH E19 released for comments
ICH released the draft guidance for comments expected by September 29th, 2019

At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures.

This Guideline is intended to provide internationally harmonized guidance on an optimized approach to safety data collection in some late-stage pre-approval or post-approval studies when the safety profile of a drug is sufficiently characterized. Optimization of safety data collection using a selective approach may improve the efficiency of clinical studies while reducing the burden to study participants. Adoption of an internationally harmonized approach to selective safety data collection may facilitate global participation in clinical studies.

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New EMA Policy on publication of clinical data
European Medicines Agency policy on publication of clinical data for medicinal products for human use effective March 21st, 2019

The Agency is committed to continuously extend its approach to transparency and has, therefore, taken the initiative to develop a policy on publication of clinical data, in accordance with article 80 of Regulation (EC) No 726/2004. Consultations with a broad range of stakeholders and European Union (EU) bodies have taken place in drafting this policy. It should be noted that this policy is without prejudice to Regulation (EC) No 1049/2001, and, therefore, it does not replace the existing 'Policy on access to documents (related to medicinal products for human and veterinary use)’ (POLICY/0043) (EMA/110196/2006), which came into effect in December 2010. Moreover, the provisions of this policy are not intended in any manner to limit the application or the rights given by Regulation (EC) No. 1049/2001. Any natural or legal person may continue to submit a request for access to documents to the Agency independently of the proactive publication mechanisms established by this policy

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New EMA Guideline on the investigation of subgroups in confirmatory clinical trials
New guideline will become effective August 1st, 2019

This document is intended to provide assessors in European regulatory agencies with guidance on assessment of subgroup analyses in confirmatory clinical trials that are presented in a Marketing Authorisation Application. These considerations impact on the planning of the clinical trial and hence the document should also be useful to clinical trial sponsors and to assessors engaged in providing Scientific Advice. This guidance document describes principles and assessment strategies and does not dictate the use of any particular statistical methodology for estimating or testing the treatment effect and its consistency in subgroups of the trial population.

An important distinction is made between investigation of a subgroup as part of the confirmatory testing strategy and an exploratory investigation of subgroups during risk-benefit assessment. Whilst a number of the considerations outlined in this document will apply to the former, investigation of a subgroup as part of the confirmatory testing strategy is principally a problem related to multiple-testing because the trial seeks to test hypotheses relating to both the subgroup and the full trial population. Recommendations regarding pre-planned approaches for decision making in a confirmatory testing strategy based on subgroups are therefore not discussed in this guidance document: the guiding principles and examples for multiple-testing procedures that control the overall false positive rate are described in the Guideline on multiplicity issues in clinical trials.

More details on the EMA homepage:

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Update on EMA’s Clinical Trial Regulation
Progress on the CTIS (Clinical Trial Information System) is reported on the EMA homepage

EMA has revised the Clinical Trials Information System project plan to improve delivery and to ensure that stakeholders can give feedback more regularly so that their expectations can be taken into account, whilst enabling the Clinical Trials Regulation to come into application as early as possible, but retaining the possibility to extend functionalities in the future.

It restructured the contract for the system's delivery, so that the code for safety reporting can be merged with EU Clinical Trials Portal and Database system modules and key bug fixing can be carried out. The system can then enter a phase of iterative, agile development as of June 2019.

This approach will support the further enhancement of the system, in close interaction with the user community, through the audit and until after the system has gone live and the Clinical Trials Regulation has entered into application.

EMA will make further announcements before user acceptance testing commences. The Agency and the Member States are fully committed to ensuring the success of this project and its delivery.

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