Worldwide Covid-19 Clinical Trials for June

 

July update: Worldwide Covid-19 Coronavirus Clinical Trials

We continue to provide updated reports on Clinical Trials focused on Covid-19. Our reports are co-published with our friends at the Clinical Research Organization, McDougall Scientific. We have taken clinical trial data directly from clinicaltrials.gov provided by the National Institutes of Health and published a summary of the data in a format that is hopefully useful to digest.

We will continue to publish Covid-19 Clinical Trial updates as data of new Trials are made available.

 

Download the Covid-19 Worldwide Clinical Trial report, updated as of July 2nd.

Some of the data provided includes:

  • # of Covid-19 Clinical Trials by Country
  • # of Covid-19 Clinical Trials by Sponsors/Collaborators
  • # of Covid-19 Clinical Trial by Drug Interventions

 

Covid-19 Clinical Trials around the World for May

June update: Worldwide Covid-19 Coronavirus Clinical Trials

We continue to provide updated reports on Clinical Trials focused on Covid-19. Our reports are co-published with our friends at the Clinical Research Organization, McDougall Scientific. We have taken clinical trial data directly from clinicaltrials.gov provided by the National Institutes of Health and published a summary of the data in a format that is hopefully useful to digest.

The number of Covid-19, coronavirus clinical trials has significantly grown since March. In April were about 1134 active Clinical Trials from around the world focused on Covid-19 and in May there were about 1703 trials from around the world, a 50% increase.

We will continue to publish Covid-19 Clinical Trial updates as data of new Trials are made available.

 

Download the Covid-19 Worldwide Clinical Trial report, updated as of June 1st.

Some of the data provided includes:

  • # of Covid-19 Clinical Trials by Country
  • # of Covid-19 Clinical Trials by Sponsors/Collaborators
  • # of Covid-19 Clinical Trial by Drug Interventions

 

Covid-19 Coronavirus Clinical Trials in Canada

 

Covid-19, Coronavirus Clinical Trials in Canada

With the pandemic of Covid-19 continuing across the globe, pharmaceutical companies, scientists, hospitals and health care organizations around the world continue to accelerate clinical research to find a treatment and possible vaccine. In Canada, the number of Covid-19, coronavirus clinical trials has been steadily growing.

As of May 1st, 2020, there were 29 active Clinical Trials operating in Canada focused on Covid-19. (See the report below).

Although Clinical Trials take time, we expect further growth over the next few months in the number of Clinical Trials for Covid-19 in Canada and around the world. We will publish any updates as data of new Clinical Trials are made available.

Health Canada has published certain guidelines as it pertains to the management of clinical trial applications (CTA) during the Covid-19 pandemic. Such guidelines include:

  • Health Canada will prioritize the review of clinical trial applications designed to investigate the diagnosis, treatment and/or prevention of COVID-19.
  • Sponsors may continue to file other CTA and CTA amendments according to Health Canada guidance.
  • During the course of a CTA review, if sponsors are unable to respond to an Information Request (IR) within specified time lines, consider withdrawing the submission without prejudice and refiling when the information is available.

Please visit Health Canada’s information page for further details on their guidelines for clinical trials during the Covid-19 pandemic.


Download the Covid-19 Clinical Trial in Canada summary report

We have co-published a report on Covid-19 Clinical Trials in Canada with our friends at the Clinical Research Organization (CRO) McDougall Scientific. We have taken clinical trial data for Canada directly from clinicaltrials.gov provided by the National Institutes of Health and published a summary of the data in a format that is hopefully useful to digest.

Some of the data provided includes:

  • # of Covid-19 Clinical Trials by Canadian Province
  • # of Covid-19 Clinical Trials by Sponsors/Collaborators
  • # of Covid-19 Clinical Trial by Drug Interventions

 

Covid-19 Coronavirus Clinical Trials around the World

Covid-19, Coronavirus Clinical Trials Worldwide


With the pandemic of Covid-19 continuing across the globe, pharmaceutical companies, scientists, hospitals and health care organizations around the world continue to accelerate clinical research to find a treatment and possible vaccine.

The number of Covid-19, coronavirus clinical trials has been steadily growing since January 2020. As of March 31st, there are 287 active Clinical Trials around the world focused on Covid-19.

These Clinical Trials are being conducted across most regions of the world; Europe has 100 going on, Asia has 79 and North America has 56. Within each of these regions we can also find the number of Covid-19 Clinical Trials by Country.

We expect further growth over the next few months in the number of Clinical Trials for Covid-19 around the world. We will publish any updates as data of new Clinical Trials are made available.

We are actively consulting on how to successfully fast-track market access of health product developed for addressing the current pandemic. Communicate with us to see how we can help.

 

Download a Covid-19 Clinical Trial summary report

We have co-published a report on Covid-19 Clinical Trials with our friends at the Clinical Research Organization, McDougall Scientific. We have taken clinical trial data directly from clinicaltrials.gov provided by the National Institutes of Health and published a summary of the data in a  format that is hopefully useful to digest.

Some of the data provided includes:

  • # of Covid-19 Clinical Trials by Country
  • # of Covid-19 Clinical Trials by Sponsors/Collaborators
  • # of Covid-19 Clinical Trial by Drug Interventions
  • # of Covid-19 Clinical Trials that have been completed

 

 

Clinical Trial Site Information Forms – a Health Canada update

 

Update: Clinical Trial Site Information Forms (CTSIFs)

We recently communicated with our clients and partners about the recent changes Health Canada has made regarding the electronic submission of Clinical Trial Site Information Forms (CTSIFs), and we share them now with you.

First is a reminder that CTSIFs must be provided to Health Canada prior to commencement of the trial.

The new CTSIF is already available for submissions and will be mandatory as of January 2nd, 2020. The current form will not be accepted after that date.

3 changes:

There are 3 changes to be aware of in the new form and for online submissions:

  1. Drug Product and Sponsor information sections have been removed, as they are already found with the Clinical Trial Application.
  2. Previous versions of a completed form can be used to make revisions and it will be possible to identify precisely which sections of the form are revised.
  3. ‘Submit’ buttons on the form allow for direct electronic filing to Health Canada. An application control number is required prior to submitting a CTSIF, so that Health Canada can make the necessary link between the application and relevant CTSIFs.

Have questions?

Want to walk through the changes specifically for your trials? The experts at SPharm are available to discuss your needs.

How does Canada rank as a country for conducting Clinical Trials?

 

 How does Canada rank as a country for conducting Clinical Trials?

 


 

DOES CANADA RANK FAVOURABLY AS A GOOD CHOICE TO CONDUCT CLINICAL TRIALS?

We know we can’t compete in terms of population, but Canada does have numerous strengths, making it a very attractive host for early phase clinical trials. These strengths include highly trained clinicians, the presence of key opinions leaders, world-class investigators, renowned medical care standards and a well-diversified population, all of which are desirable for testing new drugs. In addition, Canada is one of the top countries for biomedical research productivity and international reputation.

Recognized worldwide for its research excellence and the quality of its research clinicians, Canada has proven to be a world-class location for pharmaceutical and medical device companies to conduct their clinical trials. In fact, the majority of the world’s top pharma companies choose Canada as one of their top clinical trial locations.

We recommend that drug developers come to Canada early in their drug development process, for many reasons.

First of all, we have expert physicians in various therapeutic fields, key opinion leaders with internationally renowned reputations, that are clearly interested in participating in Canadian clinical trials. In addition, we have efficient regulatory experts, CROs and clinical trial start-up facilitators helping with the Canadian process efficiency.

Adding Canadian sites to a multi-centre trial is a great initiative to expose expert physicians as well as patients to novel therapies that will eventually come to market, raising interest, awareness and knowledge. The fact that the Canadian population is very similar to that of the US, makes Canada an interesting extension of the U.S. initiative for patient recruitment.  This way, our Canadian population can benefit from these novel therapies, while adding to the global clinical trial recruitment initiative.

In addition, the Canadian regulatory agency provides a decision within an efficient standard review of 30 days. Also, early Canadian initiative can build the health authorities’ confidence with a sponsor and product by raising awareness, interest and knowledge. This can translate into facilitating the accelerated access to the Canadian market, should the product meet the requirements.

Should the drug be innovative and / or life-saving, we would recommend a strategic registration regulatory strategy, because of the possibility of having a faster approval granted either during the clinical trial phases or immediately upon completion. A meeting with Health Canada would be recommended to validate the strategy, secure agreements that would be part of meeting minutes, included in the upcoming registration initiative.

According to the Government of Canada, the country captures 4% of global clinical trials, is also fourth in number of clinical trial sites and has a world-class contract research sector with extensive capabilities in phase I-IV clinical trials.

Canada is regarded as a leader in scientific research due to a number of factors including the diversity of its population, its educated labour force, world leading universities, hospitals and research centers as well as its robust health care system. In addition, Canadian universities consistently rank among the top in the world. Educational rankings worldwide continue to place the University of Toronto, McGill University, University of British Columbia and McMaster University in the top 50 Universities in the world for medical research.

Designing and managing global clinical trials has large expense considerations. Independent studies continue to show Canada as having significant cost advantages as a location for clinical trials. KPMG’s Competitive Alternatives study, for instance, compares business costs and other competitiveness factors in more than 100 cities in ten major countries, puts Canada as 2nd as the country with the lowest business costs. The US is 10th. On a per city basis, Montreal, Toronto and Vancouver were ranked 3rd, 4th and 5th respectively. Most of the cities in the US were ranked in the 20s.

Whether it is patient diversity, the industry’s reputation, its infrastructure, it’s quality researchers, it’s cost competitiveness or Health Canada’s 30 day target to review Clinical Trial Applications, these advantages lead pharmaceutical companies and research institutions to continue making significant investments in Canadian clinical research.

 

 


 

 

For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.

 
 


What adjustments are made for Targeted Therapeutics?

 

What adjustments do drug developers make associated to Targeted Therapeutics?

 


 

WHAT ADJUSTMENTS HAVE DRUG DEVELOPERS HAD TO MAKE TO RESPOND TO CHALLENGES ASSOCIATED WITH TARGETED THERAPEUTICS?

The key adjustments for drug developers have been to increase transparency with the authorities and open up to pre-submission or scientific advice meetings. These meetings become even more efficient when you bring in local experts and key opinion leaders.

The purpose of this is to discuss strategies and requirements with the authorities and to come up with agreements for the drug development activities. Meeting with Health Canada is not a requirement, but it’s highly recommended for novel therapies that would not have the same clinical data package that would usually be required or expected in Canada for market access.

With regards to submission content, contrary to common belief, Health Canada follows similar requirements to those of the FDA and EMA, therefore, usually only minor adjustments are necessary from a FDA or EMA dossier when submitting a marketing application in Canada.


 

 

For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.

 


Will Health Canada approve Trials with multiple investigational products?

Will Health Canada approve Clinical Trials designed with more than one investigational product?

 

WILL HEALTH CANADA APPROVE CLINICAL TRIALS DESIGNED WITH MORE THAN ONE INVESTIGATIONAL PRODUCT?

Yes, definitely. With the appropriate quality information for both investigational products, Health Canada will review the dossier and approve it if it meets the Canadian requirements, and that will be under the same 30-day default review period.


 

For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.

 


Does Health Canada prefer early phase or late phase trials?

 

Does Health Canada prefer early phase trials or late phase studies close to approval?

 


 

DOES HEALTH CANADA PREFER EARLY PHASE TRIAL DESIGNS OR LATE PHASE STUDIES CLOSE TO APPROVAL?

Health Canada is very open to all phases of clinical trials for both early and late phase. If the product is innovative or has the potential of being granted an NOC/c, we do recommend that sponsors meet with Health Canada early to ensure that the study trial design and the clinical development plan is aligned with the requirements for an accelerated access to market.


 

For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.

 


Why does Health Canada ask for Foreign Reviews?

Why does Health Canada ask for Foreign Reviews?

 

 


 

WHY IS IT THAT HEALTH CANADA ASKS FOR FOREIGN REVIEWS?

The provision of foreign review reports in an NDS is not mandatory, but highly recommended. Indeed, they are usually requested at screening if not included within the original submission.

In addition, within the Screening Acceptance letter, Health Canada usually requests the sponsor to share the Questions from foreign regulatory agency reviews and the sponsor’s answers, during the review of the NDS.

In my experience and through my discussions with Health Canada, when the Canadian agency has questions that have already been addressed in a response to questions from a foreign agency, it likely reduces the number of questions to be raised to the sponsor, accordingly.

 


For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.