Updates regarding COVID-19

This page was last updated April 3, 2020 at 11:30am.

We are in an unprecedented situation. Our federal and provincial governments and health care agencies and authorities are taking action to slow down the spread of the Coronavirus.  We are continually assessing how we at Clinical Trials BC can support the clinical trials community. This page will be updated regularly with resources and news.

Contents:


Clinical Trials BC Fast-Track COVID-19 Training

Posted April 2, 2020

Clinical Trials BC is launching Clinical Trials Fast-Track Training for COVID-19 in April 2020. The program is comprised of 10 condensed education modules on clinical trial compliance topics. Research team leads can select the pertinent topics applicable to their team member’s role in the COVID-19 research trial. More information can be found here.

 


Priority Reads

 


Institutional and Academic Notices and Advisories

Week of March 25, 2020

The majority of the health authorities, universities and research institutions in British Columbia have issued statements and or guidance on the conduct of research and clinical trials within their facilities during this provincial state of emergency related to the Coronavirus outbreak.  The guidance and advisory documents have been posted internally within each institution and are subject to change and updates. Researchers and Research Teams are therefore strongly advised to read their institutional specific directives from the institutional source and most importantly to keep up to date with new incoming advisories. Several have been updated.

 


Recommended Documentation Practices From Clinical Trials BC

Current advisories limits visitors to the institutions, suggesting that all non-urgent in-person study visits, procedures, and tests be rescheduled. The institutions are recommending that in-person clinical trial participant interactions could be reduced and/or replaced with telephone or online communication.  In most cases, this constitutes a protocol violation and may also require a change to the informed consent.

An explanatory note to file should be added to the investigative site file (ISF) or trial master file (TMF) explaining the health crisis situation, date range, measures taken, overall standard operational procedure deviations, impact on the site participants and trial conduct and planned and unplanned actions.  A copy should be sent to the REB and Sponsor to be filed with the study documentation at that level and the original should be filed to the Investigative Site File (ISF) or Trial Master File (TMF) as applicable for retention and archive.

All protocol deviations related to the Coronavirus pandemic should be logged.  Research teams should follow the reporting timelines and logging instructions provided by their institutional or central REB as applicable.

All external correspondence to the REB and/or sponsor that is related to the Coronavirus should be identified in the subject line as such, and a copy filed in either the Trial Master File (TMF) or Investigative Site File (ISF) as applicable.

References to institutional directives or REB directives pertaining to coronavirus should be included in correspondence.

A copy of institutional or agency or REB directives on the coronavirus that affect the clinical trial should be filed in the TMF or ISF in the correspondence section during the trial and for archive.

 


Regulatory Consulting Services

Clinical Trials BC offers regulatory and compliance consulting services for domestic and international trials within BC.

At this time priority is given to ongoing studies with concerns over participant safety and safety reporting.  The following are also be considered priorities: maintenance of IP (security, environmental conditions, accounting), label changes, collection of the critical data elements/safety determinants, documentation of deviations from SOPs (planned and unplanned), updates of risk management plans and documentation of protocol deviations (i.e. excursions from visit schedules, in person versus virtual visits).

If you have a question or concern related to clinical trials regulation or compliance we are happy to respond and assist you to navigate to a resource or the appropriate contact person or other services. Please contact Jean Smart for questions, concerns and assistance.

 


Trial Linking Services

Clinical Trials BC links sponsors, investigators and sites with one another. Any COVID-19 studies are a current priority. Please contact Alison Orth if you require linking or navigation. We are setting up a COVID-19 specific Clinical Trial Listing for the province. For more information about clinical trial capacity in BC please visit our BC Showcase website which includes a directory of clinical trial investigators, sites and research institutions.

 


Clinical Trials BC Conference

Travel restrictions and calls for social isolating have led us to the difficult decision of postponing our ‘Modernization of Clinical Trials’ Conference which was scheduled to take place in Vancouver, 17-18 of June 2020.  We are working hard to arrange another date to reconvene this Fall.  We will do our best to communicate our updated plans to you. Please keep checking our conference page for more details (https://www.clinicaltrialsbc.ca/conference/).

 


News and Notes

Inspection Updates – Domestic and International Inspections and Meetings:

Week of March 16, 2020

Most domestic and international inspections have been temporarily postponed (Canada, Europe, Japan and US). Notices have been sent out by email to affected sites, investigators, facilities and sponsors booked for an inspection.

Posted March 19, 2020

Most, if not all, in person pre-submission and pre-trial meetings have been confirmed as postponed domestically and internationally. Priority meetings and safety meetings will be scheduled virtually.

ICH:

New MedDRA for COVID-19

Posted April 1, 2020

The International Council for Harmonisation (ICH) on Wednesday announced that the Medical Dictionary for Regulatory Activities (MedDRA) is being updated with new supplemental terms and corresponding codes related to coronavirus disease (COVID-19).

“The coronavirus pandemic has prompted an urgent need for a harmonised, standardised approach to coding and reporting the infection as a global health issue,” ICH says, noting that more terms are in the process of being reviewed.

The new supplemental terms are already available via the MedDRA Maintenance and Support Services Organization’s (MSSO) web-based browser, but will not become official until the release of MedDRA Version 23.1 in September. They are also posted on the ICH website under MedDRA.

The proposed supplemental terms aim to be more specific than existing terms related to COVID-19. For instance, an existing term “LLT viral test” will be replaced with a supplemental term for “PT SARS-CoV-2 test.”

ICH says it will continue to provide updates as the new terms are added.

Health Canada:

Posted March 24, 2020

Health Canada Guidance on Management of Clinical Trials during the COVID-19 Pandemic

Health Canada has released a Notice ‘Management of Clinical trials during the COVID-19 pandemic: Notice to sponsor. This two-page document shows the pragmatic response of Health Canada on key impacted areas. Health Canada makes concise suggestions on actions to mitigate compliance items that may need adjustment.  This is a must read article for sponsors and investigative research teams alike.


Posted March 20, 2020

Health Canada Notice regarding Medical Devices and COVID-19

On March 18, 2020, the Minister of Health approved an Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. The order file number for reference is 20-104980-839  The interim order will enable an expedited review of medical devices indicated to diagnose, treat, mitigate or prevent COVID-19, at no cost.

COVID-19 is a new disease not previously identified in humans. Currently there is no vaccine or therapeutic product for COVID-19 that is authorized to treat or prevent the disease. The outbreak of COVID-19 has resulted in a global review of therapies that could be used to treat or prevent the infection.

Sponsors wishing to file a submission or application should contact the appropriate review bureau.

Review Bureau Contact Information:

  • Biologic and Radiopharmaceutical Drugs Directorate
    Office of Regulatory Affairs
    Tel: 613-957-1722
    Fax: 613-946-9520
    Email: hc.brdd.ora.sc@canada.ca
  • Therapeutic Products Directorate:

  • Natural and Non-prescription Health Products Directorate (NNHPD)
    Regulatory Project Management Unit, servicing Non-prescription Drug Evaluation Division
    Fax: 613-946-9614
    Telephone: 613-946-9315
    Telephone: 613-957-6801 for the Regulatory Project Management Unit
    Email: hc.nnhpd-dpsnso.sc@canada.ca

US Food and Drug Administration:

Posted April 2, 2020

The US Food and Drug Administration (FDA) updated its guidance from from earlier in March on conducting clinical trials during the coronavirus disease (COVID-19) pandemic.

The new version, features a new appendix with ten questions and answers offering more specifics on how sponsors should manage clinical trials amid the pandemic based on questions the agency has received from sponsors so far. The remainder of the guidance is unchanged from the previous version.


Posted March 20, 2020

On March 19, 2020 The US Food and Drug Administration (FDA) revised its guidance on post-market adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the ongoing coronavirus disease (COVID-19) pandemic.
The guidance, applies to drugs, biologics, medical devices, combination products and supplements, outlines how the US FDA intends to prioritize adverse event reporting requirements during a pandemic.

Note for Clinical Trials BC: There has been some ‘local confusion’ about this guidance.  Please note for clarification purposes:

  • This guidance does not apply to clinical trials.
  • The revised guidance does apply to all pandemics, including COVID-19.

Posted March 18, 2020

The US FDA issued a new final guidance to help clinical trial sponsors assure the safety of trial participants, maintain compliance with good Clinical practice (GCP) and minimize the risks to trial integrity during the COVID-19 pandemic. This guidance is good reference for practice as related to trials conducted during the pandemic, and not necessarily for trials related to COVID-19 treatments.

Innovative Medicines Canada:

Posted March 23, 2020

Innovative Medicines Canada (IMC) issued the following statement in response to the federal government’s announcement of measures to aid in the rapid mobilization of large-scale efforts by Canadian researchers and life sciences companies working to combat COVID-19, including through the development of solutions to diagnose, treat and prevent the virus.

http://innovativemedicines.ca/blog/


Posted March 19, 2020

IMC’s statement on Canada’s drug supply in response to this crisis. The IMC’s statement notes that there are no COVID-19 related shortages being reported, or current constraints on our member’s ability to supply innovative medicines to Canadians. IMC’s full statement on drug supply can be viewed here – IMC’s statement on Canada’s drug supply.

EMA:

Posted March 27, 2020

EMA Releases a Second Guideline Clinical Trials Methodological Aspects during a COVIC-19 pandemic

The EMA has acknowledged the impact of the Coronavirus disease (COVID-19) on trial participants and now as well as of the resulting measures taken to address the pandemic on methodological aspects of ongoing trials. This new three page guidance provides guidance on the collection, analysis and the interpretation of clinical trial data and safety. Sponsors are strongly recommended to integrate all available knowledge from the ethical, the medical, and the methodological perspective into decision making about the future conduct of a trial while carefully considering advice from regulatory and healthcare authorities responsible for patient and employee safety. Reference is made to other guidance related to the COVID-19 pandemic, including (Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic (EMA/141885/2020).


Posted March 22, 2020

New EMA Guidance Document of Management of Clinical Trials during the COVID-19 Pandemic

The European Commission, European Medicines Agency (EMA) and the Head of Medicines Agencies released guidance for biopharma companies that may need to adjust their clinical trials during the COVID-19 pandemic. This 8-page guidance is similar to the one issued by the US FDA.

It contains specific advice on measures that sponsors may want to consider, including the conversion of physical patient visits into phone or video visits, a temporary halt of a trial at some or all trial sites, the suspension or slowing down of recruitment of new trial participants, the extension of the duration of the trial, and/or the postponement of trials or activation of sites that have not yet been initiated.

The guidance also covers the COVID-19 challenges of: clinical trial monitoring, protocol deviations and administering informed consent to participants in COVID-19 trials.  It properly references The International Harmonization Council (ICH) E6R2 Good Clinical Practices and ICH E3 Clinical Study Report requirements.

EMA, in releasing this document, notes that there may be updates the guidance.


Posted March 20, 2020

This week global health authorities and the World Health Organization (WHO) held a workshop on facilitating global collaboration on vaccine development for COVID-19.

In response, The European Medicines Agency (EMA) on March 19, 2020 called on EU-based researchers to pool their resources to conduct large, multi-center, multi-arm clinical trials for potential treatments for coronavirus disease (COVID-19).

These types of studies are identified as the most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments but small studies and compassionate use programs may also generate robust enough data to draw conclusions from.  Specifically, EMA’s Committee for Medicinal Products for Human Use (CHMP) says randomized controlled studies featuring a control arm without antivirals or other experimental therapies would provide the most reliable evidence in support of an investigational product.

The call for a coordinated approach comes as companies and researchers around the globe scramble to develop treatments and vaccines for the virus. While the virus originated in China, Europe has become the epicenter of the pandemic, with major outbreaks in Italy, Spain, France and Germany, with the death toll in Italy surpassing China’s as of March 20, 2020.

European regulatory agencies are giving priority to all requests regarding regulatory aspects in clinical trials” for products intended for COVID-19.

Research Ethics BC (REBC):

Posted March 18, 2020

Research Ethics BC has issued recommendations regarding COVID-19.

The Society for Clinical Data Management (SCDM)

Posted March 27, 2020

The SCDM has issued a statement which outlines the risk categories related to methodology and their impact on the practices of clinical data collection and management due to COVID-19.  They are also encouraging Senior Data Managers to be involved in the development of mitigation strategies in site and sponsor level risk management.

https://scdm.org/covid-19-risk-areas-and-potential-impact-to-clinical-data/

 

MHRA (UK)
COVID-19 Risk Assessments Required

Posted April 1, 2020

The MHRA announced it has written to all sponsors conducting Phase I clinical trials to confirm they have conducted a risk assessment for the potential impact of COVID-19 on their studies.

“This action will help to ensure the safety of participants and the public, as well as avoid any adverse impacts on the capacity of [National Health Service] NHS front line services at this very challenging time.”  MHRA says it expects that some trials “may be temporarily halted or terminated,” while others may continue if “clearly justified.”

Note: Clinical Trials BC would like to clarify that that the action outlined by the MHRA does not apply to studies for potential treatments for COVID-19 for this health authority.  However, update of risk management plans is a trend and expectation in other jurisdictions at the institutional and site levels as well as sponsor level.

 


Resources and Articles

Below are a selection of articles that may provide some practical tips on management of a clinical trial during the Coronavirus pandemic.