N2’s COVID-19 Webinar Series: Register for the Next Webinar

You are invited to N2’s Next COVID-19 Webinar on July 7th!

Against Pandemic Research Exceptionalism

Speaker: Jonathan Kimmelman, PhD
James McGill professor
STREAM Research Group
Director, Biomedical Ethics Unit
Department of Social Studies of Medicine

July 7, 2020

3:00-4:00 PM EST

Webinar Abstract from Dr. Kimmelman

Register Here

Crisis conditions like pandemics often strain research processes and create pressures to compress research timelines. Some scientists and others have argued that crisis conditions license researchers to relax normal methodological rigour. My presentation will argue that the same standards of design and reporting we maintain in non-crisis conditions should hold in crises as well; what needs to change in crises is how studies are coordinated with each other.

Click to read Dr. Kimmelman’s article on this topic

Submit your COVID-19 related questions for Health Canada by Friday!

To make sure the questions relate to COVID-19 and not the Guide 100 or other Health Canada issues on COVID-19 questions already addressed by the COVID-19 guide, Health Canada would like us to collect questions in advance. We have not received any questions to date, so to ensure Health Canada feels that their time will be of good use, we are encouraging registrants to provide questions. 
Please click here to submit a question, or please feel free to reach out to to provide questions. Please submit questions by May 15, 2020, by end-of-business day. 


Provide Feedback to CTTI’s Draft Master Protocol Resources

Amid the COVID-19 pandemic, the value of master protocol studies has become clear: we need agile clinical trials that foster collaboration to address major public health threats and ongoing research challenges. You are invited to review and provide comments on draft resources created by the Clinical Trials Transformation Initiative (CTTI) to help drive the appropriate use of master protocols in diverse therapeutic areas. The resources include:

• Master protocols roadmap
• FDA engagement tool
• Business & operations plan template
• Protocol development template
• Vendor assessment tool

Click here to Provide Comments

As an important member of the clinical trials ecosystem, your feedback is important – please suggest revisions or additions to our draft resources by next Friday, April 24 at 11:59 p.m. ET. Your feedback will help shape the final materials that we make available to the public this summer.

Other important information:
• The open comment opportunity is only available in English.
• You may provide comments as an individual or an organization.
• There is no compensation.

Webinar: Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID-19 Pandemic

N2 members this message is courtesy of the Clinical Trials Transformation Initiative, who are hosting a webinar to identify best practices for conducting clinical trials with the new FDA guidance during the Covid-19 pandemic.

This week, stakeholders from across the clinical trials ecosystem submitted experiences and insights related to the FDA’s new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. The Clinical Trials Transformation Initiative (CTTI) collated the feedback – including insights on safety considerations, remote study visits, remote consent, consulting with IRBs, and more – and will share the findings and best practices via a webinar on Tuesday, March 31 at 11:15 a.m. EST.

M. Khair ElZarrad, FDA, CDER, will provide opening comments and a full discussion on the findings, along with detailed examples of best practices, will be presented by:

  • David Borasky, WCG
  • Sara Calvert, CTTI
  • Cindy Geoghegan, Individual Patient Representative/Caregiver
  • Colleen Rouse, Cleveland Clinic
  • Pamela Tenaerts, CTTI
By exchanging best practices and insights, we can continue our important work to develop needed medical products during this situation, and perhaps even glean some opportunities to do clinical trials better, now and in the future.

Click here to register for the webinar