Clinical Trials and COVID-19: FAQs from Patients to Sponsors March 31, 2020 by Kylie Karley In response to the COVID-19 crisis, NephCure Kidney International has prepared a list of FAQs, solicited from patients in our community, to pharmaceutical companies sponsoring clinical trials. We urge sponsors, with patients currently enrolled in studies, to be proactive in your communications. This may be addressing these questions via email, phone conversations, orthrough in-person discussions. For our patient community, we are doing our best to provide these answers to you and/or direct you to the appropriate resources. As you review these questions, you will see that many of these require answers specific to your studies (i.e. the introduction of virtual clinic visits or offering reimbursement for alternative travel arrangements). I am worried about leaving my house to go to my scheduled appointment. What should I do? Assuming you are not exhibiting symptoms of the virus and are able to get to your appointment, we encourage you to keep all previously scheduled appointments. Should there be a change in operating procedures at your clinic, your healthcare provider should notify you in advance. Some clinics are offering virtual visits. Please contact your study coordinator for more information about your specific site. My state/city/county has placed restrictions on ‘non-essential’ travel. Do my study visits fall into this category? Like grocery stores and pharmacies, medical facilities and hospitals remain open. Clinical study appointments are essential to your overall health so you should plan to attend your scheduled appointments unless otherwise directed. Be sure to contact the study team immediately should you experience any symptoms of the virus at any time. Can I avoid coming to the clinic for study appointments during the COVID–19 outbreak? We encourage you to try to attend your study visits. These appointments will occur unless something changes at your clinic, in which case you will be notified in advance. Some Sponsors may move to virtual visits to protect the health of study participants. You can contact your study coordinator to further discuss your options. I am afraid to take public transportation given the number of people and concern over being exposed to the COVID-19 virus. Are there alternate ways for me to get to my appointments? This feeling is perfectly understandable during this time of uncertainty. If you can avoid public transportation, we strongly encourage you to do so. Should you choose to take an Uber, Lyft, or other mode of transportation to attend your appointments, the company conducting your trial will most likely reimburse you for the full amount. Be sure to contact your study coordinator before you make this decision so you can to fill out the appropriate forms for changing your mode of transportation. What happens if I miss a study visit? Can I just pick up at the next one? It is important for you to notify your study coordinator if you are unable to make an appointment. The coordinator can assist you with scheduling another appointment and/or help with travel arrangements if needed. However, we strongly encourage you to try to attend all of your regularly scheduled study visits. Why is it important for me to continue participating in the trial as scheduled? We are thankful to all the volunteers who are participating in our study. Clinical studies are developed with scheduled procedures and visits in mind from the beginning. For this reason, we hope that you will do your best to adhere to your study visit schedule to the best of your abilities. Questions best addressed by individual sponsors If I need to change my travel arrangements to my appointments, who do I contact? Is the study medication I am taking an immunosuppressant? In other words, am I immunocompromised right now? OR Does the trial medication put me at greater risk of contracting Coronavirus? What type of financial compensation can I receive if the Coronavirus affects my travel plans? If I am under quarantine, can I still participate in the trial? Who should I contact with questions? Can I have labs drawn and/or medication administered at home? Can I complete my study visits virtually through telemedicine visits? If I can get to my study visit, will face masks be available when I arrive?