News and Notes: Contents (Updated August 7, 2020)
- EU Implications of COVID-19 – Methodological Aspects of Ongoing Clinical Trials
- EU Guidance on remote GCP inspections during the COVID-19 pandemic
- Inspection Updates – Domestic and International Inspections and Meetings
- Health Canada (including Health Canada Guidance)
- US Food and Drug Administration
- Innovative Medicines Canada
- Research Ethics BC
- The Society for Clinical Data Management (SCDM)
- MHRA (UK)
- The International COVID-19 Trackers for Vaccines and Therapeutics (updated August 7)
- Research Canada: Recommended Viewing
- International Coalition of Medicines Regulatory Authorities (ICMRA) (updated August 7)
- EMBL-EBI International COVID-19 Research Portal
- World Health Organization (WHO)
- Pan American Health Organization (PAHO)
June 30, 2020
EU Implications of COVID-19 – Methodological Aspects of Ongoing Clinical Trials
Please see the revised document here.
EU Guidance on remote GCP inspections during the COVID-19 pandemic
June 10, 2020
The European Medicines Agency (EMA) posted a newly adopted guidance on June 10, 2020 explaining how remote good clinical practice (GCP) inspections will be conducted during the coronavirus disease (COVID-19) pandemic. It will be interesting to see if other health authorities follow suit in the near future. Many international health authorities have been conducting remote GMP inspections and have indicated plans for remote or hybrid GCP inspections.
More info is listed in our EMA Section.
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.
Posted July 20
MedDRA update for COVID-19
The Medical Dictionary for Regulatory Activities (MedDRA) is a rich, very specific, standardized medical dictionary developed by the International Council for Harmonisation (ICH). Health Canada is a member of the MedDRA management committee and a standing member of ICH.
A large number of terms specific to COVID-19 are being added to the MedDRA database. Common definitions are used to ensure consistency in activities like adverse event reporting. This helps industry and regulators more effectively monitor the safety of drugs throughout their lifecycle, from clinical trials to post-market surveillance.
Posted April 1, 2020
New MedDRA for COVID-19
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.
Posted July 10, 2020 Update Report
Health Canada has published a Report which is a mid year update on the drugs and medical devices approved in 2020. Many of these are related to COVID-19.
Posted July 3 Health Canada General Regulatory Update for COVID-19
Health Canada Guidance HC regulatory response to Covid-19 Access to health products
One of Health Canada’s roles is to regulate and authorize health products that improve and maintain the health and well-being of Canadians. The COVID-19 pandemic has created an unprecedented demand on Canada’s health care system and has led to an urgent need for access to health products. Health Canada has update its regulatory response page for COVID-19.
Posted May 27, 2020
Applications for drug clinical trials under the Interim Order: Guidance document
Health Canada has developed this guidance document specific to support the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 (Interim Order) pursuant to subsection 30.1(1) of the Food and Drugs Act. The document provides guidance to applicants for seeking authorization of and conducting COVID-19 drug clinical trials under the new Interim Order. This is quite detailed and is a must read:
Posted May 27, 2020
Applications for medical device clinical trials under the Interim Order: Guidance document
Health Canada has created a guidance document that is intended to support applicants who wish to sell or import a COVID-19 medical device for the purposes of a clinical trial (also known as investigational testing), or to conduct a clinical trial in respect of a COVID-19 medical device, as authorized under the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 (“Interim Order”). This is an updated document:
Vaccines and Treatments for COVID-19
Posted April 23, 2020
Health Canada has created and posted a database or listing of all authorized Clinical Trials approved by Health Canada. This listing is updated weekly. At present date there are 18 entries. This is a separate listing from the Health Canada Clinical Trials Database.
Facilitating Clinical Trials
Posted April 23, 2020
Health Canada has reissued a notice for Companies and researchers with drugs, medical devices, or natural health products that may be effective in treating or diagnosing COVID-19 are encouraged to contact us to facilitate clinical trials.
Clinical trials are studies to find out whether a drug or medical device is safe and effective for people. We can authorize a clinical trial quickly in urgent situations. Please contact us at:
- trials using pharmaceutical drugs: OCT_BEC_Enquiries_Enquetes@hc-sc.gc.ca
- trials using biologics or radiopharmaceuticals: email@example.com
- trials using natural health products: NHPD-CTA.DEC-DPSN@canada.ca
- investigational testing of medical devices: firstname.lastname@example.org
Management of Clinical Trials during the COVID pandemic
Reposted April 24, 2020 (reminder as requested)
Health Canada issued A Notice to Clinical Trial Sponsors on the impact of the pandemic on the conduct of clinical trials, including the need for: participants to self-isolate deployment of healthcare personnel involved in clinical trials to other duties during this public health emergency. There is important site information contained in this notice. We have reposted this notice for site review.
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
- Therapeutic Products Directorate:
- Biologic and Radiopharmaceutical Drugs Directorate
- Bureau of Gastroenterology, Infection and Viral Diseases
- Natural and Non-prescription Health Products Directorate (NNHPD)
Regulatory Project Management Unit, servicing Non-prescription Drug Evaluation Division
Telephone: 613-957-6801 for the Regulatory Project Management Unit
- Medical Device Directorate:
- Bureau of Device Licensing Services
- Investigational Testing
- Bureau of Device Licensing Services
- Special Access Program – Medical Devices
US Food and Drug Administration:
Posted July 18
Coronavirus (COVID-19)Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing
The U.S. Food and Drug Administration reissued an emergency use authorization (EUA) to Quest Diagnostics to authorize a test for use with pooled samples containing up to four individual swab specimens collected under observation. The ‘’Quest test’ is the first COVID-19 diagnostic test to be authorized for use with pooled samples.
Sample pooling is an important public health tool because it allows for more people to be tested quickly using fewer testing resources. Sample pooling does this by allowing multiple people – in this case four individuals – to be tested at once. The samples collected from these four individuals are then tested in a pool or “batch” using one test, rather than running each individual sample on its own test. If the pool is positive, it means that one or more of the individuals tested in that pool may be infected, so each of the samples in that pool are tested again individually. Because the samples are pooled, it is expected that fewer tests are run overall, meaning fewer testing supplies are used and more tests can be run at the same time allowing patients to receive their results more quickly in most cases. This testing strategy is most efficient in areas with low prevalence, meaning most results are expected to be negative.
Guidance on the use of non-invasive remote monitoring devices for patient care during the Coronavirus public health emergency was expanded and updated by the US FDA.
Posted July 21, 2020
The US Food and Drug Administration (FDA) has updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic again to clarify how sponsors can obtain informed consent from patients in isolation or who can receive electronic copies of informed consent documents but due to time constraints cannot print or electronically sign the documents. This document has been update frequently. Two methods are recommended.
Posted June 8, 2020
This guidance was originally published in March 2020. It permits in and outpatient management and use of monitoring devices to .
The use of non-invasive patient monitoring technology will help eliminate unnecessary patient contact and ease the burden on hospitals, other health care facilities, and health care professionals. The updated document now includes: both diagnostic and monitoring spirometers and peak-flow meters, apnea monitors, telephone ECG transmitting and receiving equipment, Electroencephalographs (EEGs) and non-EEG seizure monitoring systems, biofeedback and sleep assessment devices, audiometers, vestibular analysis apparatuses, and computerized cognitive assessment aids.All of the devices are Class II medical devices.
In the first edition only thermometers; ECGs, cardiac monitors, and ECG software; pulse oximetry and non-invasive blood pressure devices; and electronic stethoscopes and respiratory rate/breathing frequency monitors were acceptable.
The devices that are noted in this guidance may be connected to wireless networks through Bluetooth, cellular access or WiFi.
Posted May 14, 2020
Clinical Trial Guidance Update
The US Food and Drug Administration (FDA) has updated its guidance on conducting clinical trials on May 13, 2020. This fourth edition for the coronavirus disease (COVID-19) pandemic addresses new questions, including:
- the use of alternate laboratory or imaging centers,
- video conferencing and
- post-marketing requirements.
The update also features clarifications to questions addressed in previous versions of the guidance on managing protocol deviations and amendments and on steps sponsors should take when considering administering investigational products at home instead of at clinical trial sites. While this guidance comes from the US, it offers great practical advice to others in the same global region.
New Guidance Document
Posted week of May 11, 2020
The US Food and Drug Administration released a new Guidance this week titled ‘COVID-19: Developing Drugs and Biological Products for Treatment or Prevention. This Guidance for Industry, has been developed quickly in response to COVID-19 pandemic, without public or stakeholder review. It is intended to assist sponsors in the clinical development of drugs for the treatment or prevention of COVID-19. This guidance does not apply to vaccines.
Posted April 2020
Updated FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards
In April, the US Food and Drug Administration (FDA), added seven new questions and answers to its guidance document on the conduct of Clinical Trials during the COVID-19 pandemic. These include guidance on obtaining informed consent during the pandemic; considerations for remote clinical outcome assessments; remote site monitoring; electronic common technical document (eCTD) waivers; and other issues. Similar to the EU Commissions guidance document for conduct of clinical trials during the pandemic, this one also provides some practical suggestions.
New regulatory information on AE reporting during COVID-19 pandemic
Posted April 17, 2020
The US Food and Drug Administration revised its guidance on post-market adverse event reporting for medicinal products and dietary supplements during a pandemic to apply the guidance to the ongoing coronavirus disease pandemic.
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.
- Read the new guidance here (PDF, April 2, 2020).
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.
- Read the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic posted on March 18, 2020.
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.
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.
European Commission Guidance
Posted July 21: EMA infrastructure for Covid-19 Real-World monitoring of treatments and vaccines
The EMA has set up an infrastructure to support the monitoring of the efficacy and safety of Covid-19 treatments and vaccines when used in day to day practice. This is supported by academic and private partners with the EMA.
Posted April 28, 2020
Guidance on the Management of Clinical Trials during the COVID-19 (coronavirus) Pandemic Version 3: 28/04/2020
The European Commission and European Medicines Agency (EMA) updated their guidance on managing clinical trials during the coronavirus disease (COVID-19) pandemic, adding advice on distribution, data verification and communicating with authorities.
This is the third update of the guidance from the Commission, EMA and the Heads of Medicines Agencies which was previously updated on 27 March 2020. This version provides recommendations on the distribution of investigational medicinal products (IMPs) and data verification under social distancing measures and resource limitations. The guidance also clarifies how clinical trial sponsors should communicate urgent issues to regulatory authorities.
While this guidance specific to Europe, it offers some good general advice applicable to other jurisdictions and is a recommended read. It provides recommendations on effective mitigation related to the disruptions associated with the pandemic, to ensure that quality and safety are not compromised during the adapted conduct of clinical trials.
Update of the EMA Q&A guideline on COVID-19 regulatory expectations – medicinal products
Posted April 20, 2020
The European Medicines Agency (EMA) updated its recent question and answer guideline on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic.
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.
Posted July 13:
Guidance for patients, the public and professional users guide to COVID-19 tests and testing kits
The MHRA issued a new very practical and well layed out guide for COVID-19 tests and testing kits.
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.
The International COVID-19 Trackers for Vaccines and Therapeutics
The International COVID-19 Trackers Vaccine and Therapeutics Trackers are now separated and are now being managed by Jeff Craven and team at the Regulatory Affairs Professional Society (RAPs).
International Vaccine Tracker – Excerpt by Jeff Craven, RAPs
Posted 6 August
The International tracker lists COVID-19 vaccine candidates that are registered and currently in Phase 1-3 trials, as well as major candidates in pre-clinical stages of development and research. This edition includes new information on vaccine candidates from University of Melbourne and Murdoch Children’s Research Institute/Radboud University Medical Center/Faustman Lab at Massachusetts General Hospital, Moderna, Johnson & Johnson, Merck, ImmunityBio, and Bharat Biotech/National Institute of Virology. We gratefully acknowledge the work that the RAPs Focus team has done on collating this information for the global regulatory authorities and community.
Meanwhile, International regulatory agencies and the WHO are working to secure a supply of vaccine for their regulatory jurisdictions. In Canada, the Federal Government announced on August 5, 2020 deals with two international companies for COVID-19 vaccines. The details of the agreements reached with Moderna and Pfizer have not been posted. It is understood that the supplies will be available for 2021 if all proceeds well in Phase III trials and the approval process.
The Globe and Mail: https://apple.news/A0KwSoaleQNiGN6WNOceVug
Posted July 23, 2020
The International vaccine tracker was updated and posted on July 23, 2020.
Posted July 16, 2020 by RAPS with International contributions
In this edition there is new information on vaccine candidates from: Chulalongkorn University, Zydus Cadila, Moderna, Pfizer and BioNTech, AstraZeneca and IQVIA, Anhui Zhifei Longcom Biopharmaceutical, Imperial College London, Medicago, Altimmune, University of Queensland,and Bharat Biotech. There are now 41 entries in the tracker which includes vaccines in Phase 1-3 trials and the pre-clinical categories.
Posted June 25 2020
It is interesting watching the progress made over the last three months. This tracker now lists COVID-19 vaccine candidates currently in Phase 1-3 trials, as well as major candidates in pre-clinical stages of development and research. The tracker has new information on vaccine candidates from Genexine, Gamaleya Research Institute, Anhui Zhifei Longcom Biopharmaceutical/Chinese Academy of Sciences, Sanofi/Translate Bio, GlaxoSmithKline/Clover and AstraZeneca/University of Oxford.
Posted June 11, 2020
This tracker lists COVID-19 vaccine candidates currently in Phase 1-3 trials, as well as major candidates in pre-clinical stages of development and research.
The tracker now include new information on vaccine candidates from Moderna, University of Oxford/AstraZeneca, Sinopharm/Wuhan Institute of Biological Products, Sinopharm/Beijing Instittue of Biological Products, Novavax, Imperial College London, Johnson & Johnson, Altimmune, CSL/University of Queensland and Massachusetts Eye and Ear/Massachusetts General Hospital/University of Pennsylvania.
International Therapeutics Tracker – Excerpt from Jeff Craven, RAPs
Posted July 31, 2020
This version of the therapeutics tracker includes new information on dexamethasone, RLF-100, Actemra, lenzilumab, convalescent plasma, Pepcid, TXA127, LAM-002A and DNL758. We again thank the RAPs Focus team for maintaining this rapidly changing information tracker which is used as source for the global regulatory authorities and regulatory community.
Evidence of progressing therapeutics was seen last week here in Canada when Health Canada (HC) granted conditional approval NOC(c) to Gilead Sciences Inc’s antiviral treatment Remdesivir to treat patients with severe symptoms of COVID-19. This is the first approved treatment for the fast-spreading illness in Canada. Remdesivir has become the treatment of choice for many countries against severely ill COVID-19 patients after the intravenously-administered medicine helped shorten hospital recovery times in a clinical trial. The drug, Remdesivir, has been granted emergency or conditional authorization in several countries including from the ACSS Coalition: Singapore and Australia along with Canada. Japan and the USA have also approved it.
Posted July 17, 2020 by RAPS with international contributions
We all thank RAPS for their continued COVID-19 support in collating the information on behalf of the international regulatory community. The treatment candidates that lower mortality rates and lessen the severity of COVID-19 are under investigation worldwide. In this update we see new information on: Veklury, dexamethasone, Avigan, RLF-100, INOpulse, JS016, and Actemra (tocilizumab). There are now 31 entries in this tracker.
Posted June 26, 2020 RAPS
The world is looking at treatments that could lower mortality rates and decrease the severity of COVID-19. Only three therapeutics have to date been approved to treat COVID-19.
Avigan (Italy, China and Russia),
Veklury (aka remedesivir) in Japan
There are several potential therapies in several large international trials.
Updated June 5 2020
Two therapeutics are approved to treat COVID-19:
Avigan (favilavir) in three countries – Italy, Russia and China
Veklury (remdesivir) in Japan
Potential therapies are being examined in several large international trials. The largest, SOLIDARITY, is sponsored by the World Health Organization (WHO). This Global initiative is evaluating the high-profile treatment candidates for COVID-19. One of the arms evaluating Hydroxychloroquine/chloroquine, was paused temporarily and resumed last week with modification on June 3, 2020.
Many agencies and sponsors also are investigating other therapeutic products for possible repurpose. In particular they are looking at products that have worked against similar coronaviruses, or are hypothesized to address SARS-CoV-2 based on the mechanism of action.
Update from May 28, 2020
The International Vaccine Tracker was updated this week to include new information on vaccine candidates from Merck, Moderna, CanSino Biologics and ImmunityBio. Again, thank you to Jeff Craven and the RAPs team for their efforts to update this tracker this week.
Update from May 27th, 2020
This edition includes new information on remdesivir, hydroxychloroquine and EIDD-2081. Thank you to RAPs Focus team for updating and maintaining this for the international regulatory community.
Update from May 14, 2020
The International COVID-19 Vaccine Tracker has been redesigned and classes Vaccines into: early development, pre-clinical, Phase I, Phase II and Phase II/III. The Tracker now includes content on Company or Organization, candidate name or number, investigational product details, status and newly added is the clinical trials registry notation which is a very convenient addition.
Update from May 8, 2020
The International COVID-19 Therapeutics Tracker has also been redesigned and classes COVID-19 therapeutics into two categories: Frontline Therapeutics and Novel Therapeutics. The tracker features content on: Name or Number, Class, Developer, Rationale, Regulatory action, Trials, Outcome and Status.
Both Trackers include international content from all Regions. Clinical Trials BC will post the trackers weekly. New content is being noted at the top of the tracker as it is updated. Any group or company with an update or content to add to the tracker can now do so by sending a note to Focus magazine to the attention Jeff Craven at the following email address: email@example.com
A special Thank You to the RAPS Focus COVID-19 team for doing such a fabulous job at setting up and maintaining these two worldwide trackers on the FOCUS page and making this available to the research community during the COVID-19 pandemic.
Race Against the Clock: COVID-19 Vaccine and Treatment R&D in Canada
Posted: May 22, 2020
Research Canada hosted a COVID-19 webinar in the end of May. This is the first in a planned series of Research Canada’s Virtual Expert Panels, A Race Against the Clock: COVID-19 Vaccine and Treatment R&D in Canada, features four of Canada’s top health researchers who are working to understand and treat this disease, and who are contributing to the global effort to ultimately defeat COVID-19. It is well done and runs 1hr 30 min including the Q&A session. There are two BC speakers on the agenda.
Posted August 6, 2020
Covid-19 Vaccine Development
Medicines regulatory authorities from around the world have published a summary report on August 6, 2020 highlighting the outcomes of the second workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).
ICMRA meeting: COVID-19 Real-World Evidence and Observational studies meets Regulation
Building International Cohorts
The ICMRA posted on August 6, 2020 a summary of the July 22, 2020 meeting on Covid-19 Real World Evidence and Observational studies meeting. There are three work streams led by the regulatory authorities and regulatory experts in this working group:
- Vaccine surveillance and vigilance (Lead: MHRA),
- Collaboration on pregnancy studies (Lead: MA),
- Building international cohorts (Lead: Health Canada)
Canada is the lead for the International Cohorts working group. Gayatri Jayaraman of Health Canada (HC), announced that the COVID-19 international cohorts working group had an initial meeting on 9 July 2020. Membership in this working group includes representation from EMA (Europe), FDA (USA), AEMPS (Spain) and Health Canada (Canada). The WG agreed on a set of criteria which will ‘enable the prioritisation of key regulatory/public health research question(s) for international collaboration, including the need for a large sample size, important rather than urgent research topics, regional comparisons, development of novel methodologies or infrastructure, overall impacts on public health and need for sub-cohorts’.
From the summary, it is anticipated that regulatory authorities and their stakeholder representative councils internally review and prioritises research questions/sub-questions for international collaboration based on the agreed upon criteria. The key questions were submitted and finalised on 29 July 2020. Common methodologies/approaches to optimise the use of observational data to address these questions in relation to regulation were discussed.
Global regulatory – COVID-19 therapeutics agreement on acceptable endpoints for clinical trials
International regulators have published a report on August 6, 2020 on the acceptability of various primary endpoints in the clinical trials conducted for the development of treatments for COVID-19 as agreed upon at the second workshop.
Many developers of medicines for the treatment of COVID-19 have regulatory process of conducting clinical trials or have approached their regulatory authorities with proposals for phase 3 clinical trials.
An agreement by regulators on acceptable endpoints will facilitate rapid and consistent implementation of future clinical trials for COVID-19 medicines across the world. There were two endpoint discussion areas: hospitalized patients with moderate to severe COVID-19 and outpatients with mild COVID-19.
Published July 17, 2020
A new international report provides a roadmap for Phase 3 clinical trials for developers of candidate vaccines for the novel coronavirus SARS-CoV-2. The report indicates which clinical and preclinical data will indicate a vaccine is ready for Phase 3 trials; it also lays out key considerations in designing Phase 3 clinical trials of vaccines for COVID-19.
The report reflects consensus reached at a 22 June 2020 teleconference under the auspices of the International Coalition of Medicines Regulatory Authorities and Councils. At the workshop, 100 representatives from 28 countries, regulatory councils and 20 of 57 regulatory authorities worked together to “harmonize regulatory requirements and streamline the development of COVID-19 vaccines.”
HC Canada was a participant as were two representatives from the Regulatory Canada Council.
EMBL-EBI International COVID-19 Research Portal
Posted week of July 21
EMBL’s European Bioinformatics Institute (EMBL-EBI) and partners today launched the COVID-19 Data Portal, which enables the sharing and analysis of data related to the new coronavirus, SARS-CoV-2. The initiative aims now to facilitate international collaboration to accelerate scientific discovery, monitor the pandemic and help develop treatments and a vaccine for the new coronavirus.
World Health Organization (WHO)
Posted July 21
Canada is one of the countries participating in the World Health Organization’s (WHO) research and development (R&D) blueprint vaccines plan to develop a COVID-19 vaccine. Canada’s contributions include helping to develop the blueprint, a global strategy and preparedness plan. This is intended to help countries quickly undertake R&D activities during epidemics. Canada is also participating in the WHO’s blueprint vaccines subgroup to keep up to date with COVID-19 vaccine technologies.
The WHO is conducting the well know Solidarity trial, an international clinical trial of candidate vaccines against COVID-19.
Pan American Health Organization (PAHO)
Posted July 21, 2020
The Pan American Health Organization (PAHO) is an international health agency for the Americas. It specializes in engaging in technical cooperation with member countries to:
- fight communicable and non-communicable diseases and their causes
- strengthen health systems
- respond to emergencies and disasters
PAHO’s national regulatory pandemic response framework helps to guide the PAHO region during a pandemic. Health Canada is a member of its COVID-19 task group, which consists of representatives from each national regulatory authority in the PAHO region.