Joint Statement on Retina Clinical Trials and COVID-19
To our Colleagues in the Retina Clinical Trials Community:
We all take the health and safety of patients, healthcare providers, and our local communities very seriously, and the ongoing pandemic is challenging healthcare delivery and infrastructure worldwide. With that in mind, we wanted to speak with one voice in providing information and perspective about ongoing clinical trials for retinal diseases in the setting of the COVID-19 pandemic.
Here are some guiding principles that we all agree are important for continuing to care for clinical trial patients during this crisis, recognizing that each trial patient has a serious disease and has volunteered to participate.
• The safety of patients and study site staff is paramount in all decision making
• For patients enrolled in clinical studies who are able to attend study visits, try to minimize time in the clinic to reduce exposure risk. This is especially important because many patients in trials for retinal disease treatments are in high-risk categories for COVID-19 complications based on age, comorbidities, or both
• For efficient study visits, consider prioritizing assessments that are required for patient safety or to assess primary study outcomes at key timepoints, along with continued provision of study treatment when possible
• For patients unable to attend research study visits, safety data may be collected by phone, and patients are encouraged to self-monitor vision and report any changes via phone.
• As per this week’s FDA Guidance, reasons for missed visits, missed study assessments, missed study treatment doses, or safety events that are due to the COVID-19 pandemic should all be documented.
• To minimize travel and the number of personnel at sites, consider monitoring studies using remote procedures, working in conjunction with the sponsor/CRO.
• For studies that are open for enrollment of new patients, use discretion in screening and enrollment of new patients, considering the local situation, disease severity/urgency, and the availability of non-investigational treatment alternatives
We also wanted to encourage you to review the following information resources:
• Guidelines from the American Academy of Ophthalmology about COVID-19 are available at https://www.aao.org/headline/alert-important-coronavirus-context.
• The American Society of Retina Specialists has information available at https://www.asrs.org/clinical/clinical-updates/1962/asrs-releases-guidelines-to-help-retina-practices-navigate-covid-19-pandemic.
• The UK Royal College of Ophthalmologists has issued guidelines for ophthalmologists available at https://rcophth.ac.uk/2020/03/covid-19-update-and-resources-for-ophthalmologists/. All of these documents have up-to-date and useful information.
• On March 18, the U.S. FDA issued a Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic. This Guidance, which is short and cogent, is for the broad audience of Investigators, Industry, and Institutional Review Boards, and is available at https://www.fda.gov/media/136238/download.
In this unprecedented time, we thank you for your commitment to our ongoing clinical research collaborations aimed at improving vision for patients with retinal diseases. As clinical study sponsors, the safety of all patients and healthcare providers is of great importance to us. We look forward to continuing to work closely with you to ensure retina clinical trial participants receive the best possible care.
Christopher Brittain, MBBS MBA
Vice President, Global Head of Ophthalmology Product Development
Genentech, Inc., a Member of the Roche Group
Victor Chong, MD
Global Medical Head, Retinal Health
Boehringer Ingelheim International GmBH
Jason Ehrlich, MD, PhD
Chief Medical Officer & Chief Development Officer
Kodiak Sciences Inc
Federico Grossi, MD, PhD
Chief Medical Officer
Chief Executive Officer
Aaron Osborne, MBBS
Chief Medical Officer
Adverum Biotechnologies Inc
Sherri Van Everen, Pharm.D.
Vice President, Ophthalmology Clinical Development