US Academic Collaboration Trial – Safety Reporting Experiences

This is email correspondence from our Pharmacovigilance Manager in Glasgow regarding our recent experiences with a trial in which we are collaborating with the US. Let me know if you have any questions.

Thanks, Michaela

Michaela Rodger

Quality Assurance Manager

Cancer Research UK Clinical Trials Unit Glasgow (partner in CaCTUS – Cancer Clinical Trials Unit Scotland)

Beatson West of Scotland Cancer Centre

Gartnavel General Hospital

Glasgow

G12 0YN

Telephone: 00 44 141 301 7941 (internal 57941) (Mondays and Fridays 01852-200341)

Facsimile: 00 44 141 301 7187 (internal 57187)

E-mail address: michaela.rodger@glasgow.ac.uk

Visit our web site at: http://www.crukctuglasgow.org

The University of Glasgow, charity number SC004401

Please note that patient identifiable data (such as a full name and/or initials with date of birth) should not be sent in any email correspondence. If you need to refer to a patient please use Trial/Patient Number.

.

From: Lindsey Connery
Sent: 08 July 2016 15:43
To: ‘CANCERPVFORUM-request@JISCMAIL.AC.UK’; CANCERPVFORUM@JISCMAIL.AC.UK
Subject: US Academic Collaboration Trial – Safety Reporting Experiences

Dear All

I was recently in contact with the MHRA regards a trial we are collaborating on with US Sponsors and the MHRA recommended I pass on our experiences.

The trial is a phase II/III academic trial in a rare form of ovarian cancer comparing the efficacy of a novel IMP with standard care treatments. The overall legal Sponsor of the study is the NCI Cancer Therapy Evaluation Program (CTEP) and the lead coordinating group, is the Gynecologic Oncology Group (GOG). Both groups are based in the US where the study is being conducted under a National Cancer Institute (NCI) Investigational New Drug (IND) Research Application. The trial is sponsored in the UK by NHS Greater Glasgow & Clyde with the co-ordination of UK sites being performed by us (CRUK Clinical Trials Unit, Glasgow) on behalf of the UK Sponsor. The lead US Sponsors, who are managing pharmacovigilance for the trial, have been unwilling to assist the UK Sponsor with meeting EU SUSAR and DSUR reporting requirements. Therefore we have been reviewing SAEs reports submitted by US trial sites to the US Sponsor to check if they meet the criteria for SUSAR reporting in the EU as well as preparing and submitting the DSUR.

We had anticipated the US Sponsors  would identify and report unexpected reactions in a similar way to what we do in the UK and we had been (mis)informed that US regulations were tight and therefore thought the chances of the US Sponsor not identifying an event that would meet the criteria of a SUSAR in the UK, as being very low. However we have found the US Sponsor is identifying and reporting far fewer events as serious unexpected drug reactions than we are and none as yet for the novel IMP ( which is under an IND). Thus far of the 89 SAEs reported (84 originating in the US and 5 in the UK) we have identified and reported 24 SUSARs (23 originating from the US and I originating in the UK). The US Sponsors have identified none. Can I highlight there is no suggestion that the trial is not meeting US regulatory reporting requirements.

We had expected some variation in what was identified and reported as a SUSAR between the UK and US as the US Sponsor is permitted to down grade the Reporting Investigators causality assessment to the IMP from related to unrelated, which is not permitted in the EU. Also, whilst both the US and UK Sponsors are using the same Reference Safety Information (RSI) for the novel IMP, it was not possible to use the same documents as the RSI for the standard care treatments, with SmPCs being used in the UK and Data Sheets in the US.  However even allowing for these differences we had not anticipated such variation.

Can you forward this email to any relevant staff or groups in your units?

Thanks and kind regards

Lindsey

Lindsey Connery
Pharmacovigilance Manager
Cancer Research UK Clinical Trials Unit
(partner in CaCTUS – Cancer Clinical Trials Unit Scotland)
Level 0 Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12  0YN

Tel  No. 0141 301 7209
Pharmacovigilance Fax No. 0141 301 7213
E-mail address: lindsey.connery@glasgow.ac.uk

Pharmacovigilance email address: mvls-ctu-pv@glasgow.ac.uk

Visit our web site at: http://www.crukctuglasgow.org

The University of Glasgow, charity number SC004401

Please note that patient identifiable data (such as a full name and/or initials with date of birth) should not be sent in any email correspondence. If you need to refer to a patient please use Trial/Patient Number.

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