Covid-19 - 1. Belgium: Addendum to EU Guidance on Management of Clinical Trials | 2. Europe: EMA Public Consultation on Ongoing Clinical Trials
The Belgian Federal Agency for Medicines and Health Products (FAGG/AFMPS; FAMHP) published yesterday its national addendum (the Addendum) to the EU Guidance on the Management of clinical Trials during the COVID-19 (Coronavirus) Pandemic that was released on 20 March 2020 (see, Van Bael & Bellis Life Sciences News Alert of 23 March 2020; the EU Guidance).
The Addendum was prepared jointly by the FAMHP, the Clinical Trial College, the Belgian Association of Research Ethics Committees (BAREC) and certain research centres. It complements the EU Guidance with practical guidelines tailored to the Belgian context in relation to the following topics:
1. Procedural matters: The Addendum invites sponsors to contact the FAMHP prior to submitting a COVID-19 related trial. For national COVID-19 related trials, the Addendum “strongly recommends” the use of the ongoing pilot project for the new Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014), which is faster and simpler than the regular application procedure.
2. Restrictions of visits to healthcare facilities: If a Belgian patient is enrolled in a trial in another EU Member State which was not launched in Belgium, and the foreign site closes due to the COVID-19 situation, the Addendum promotes the use of named patient imports or compassionate use programmes to ensure that the patient benefits from continued access to the medication.
3. Direct-to-patient supplies of investigational medicinal product (IMP): Direct shipment from sponsor to patient is not allowed in Belgium for privacy reasons (the sponsor must not be able to identify the patient). In contrast, direct shipments from the trial site to the patients are allowed, subject to the following conditions:
i. the shipment takes place under the principal investigator’s responsibility;
ii. the shipment takes place without sponsor involvement;
iii. the IMP is shipped under correct shipping conditions;
iv. the shipment is accompanied by correct and traceable documentation (the Addendum emphasises that “documentation is paramount”); and
v. the patient is trained for storage and administration at home, or the product is administered by a caregiver, nurse or physician who is trained in terms of the protocol.
4. Notification of temporary halts and urgent safety measures: The Addendum clarifies how and when temporary halts of a trial (e.g., a recruitment halt or halt of the trial at a specific site) should be notified to the FAMHP and the ethics committee and how the trial can be resumed. Urgent safety measures can be taken in the context of the coronavirus situation without prior notification to the FAMHP and the ethics committee (subsequent reporting suffices).
5. Remote source data verification: Remote source data verification (i.e., remote sponsor access to the medical dossier and medical records of trial subjects) is neither allowed (breach of the rights of the trial subjects) nor recommended in Belgium (excessive burden on site staff to redact medical charts at this time and no sufficient verification by sponsor monitors possible).
6. Electronic communication and electronic signatures: The FAMHP is willing to show flexibility and will not require qualified electronic signatures in the present circumstances.
Likewise to the EU Guidance, the Addendum is expected to be updated regularly.
Incidentally, the European Medicines Agency yesterday released for consultation a draft guideline on points that clinical trial sponsors should consider on the implications of the coronavirus disease on the methodological aspects of ongoing clinical trials. The deadline for comments is 25 April 2020.
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