As was posted in many of the groups last week, Biohaven Pharmaceuticals answered some of our questions regarding their current drug trial amid the coronavirus pandemic period. They composed their answers into a Q and A document.
TRIAL PARTICIPANT QUESTIONS AND ANSWERS FROM BIOHAVEN:
1. Are different sites handling this differently, or is there a directive from Biohaven on what will happen?
Our top priority is to ensure the health, safety, and well-being of our study participants and site staff. As such, we have offered general principles and guidance to M-STAR study sites in response to the COVID-19 pandemic. As there are many people who depend on the work we do, Biohaven will support sites’ efforts to ensure that participants can safely continue in the study and receive their study medication. We encourage sites to follow institutional policies and procedures regarding conducting inperson study visits. We have asked sites to please communicate any potential issues to us as soon as they are aware of them, and we will work with them on a case-by-case basis to address such issues. Biohaven has implemented workaround measures that we believe are in compliance with guidance from health authorities, including the US Food and Drug Administration and European Medicines Agency. Biohaven has provided guidance to sites regarding alternatives, focusing largely on safety measures. We have asked sites that cannot see patients in person in their clinics due to the COVID-19 pandemic to perform remote visits via phone or telemedicine video, collect safety laboratories at local labs, etc. The Institutional Review Boards (IRBs) for the MSTAR study sites have been informed about these potential modifications to the study conduct.
2. Each study visit involves two blood draws, several hours apart. Is Biohaven expecting people to go to local labs two times in one day for blood draws? If so, this puts people at risk.
During the COVID-19 Pandemic, Biohaven is following the Health Authority guidelines. If patients are unable to go into sites for visits, a remote visit may occur (while the specific details of the patient’s safety are taken into consideration) and blood samples may be collected and analyzed at a local laboratory (such as Quest). These blood draws will be limited to assessing safety laboratories in order to ensure that the participant is tolerating the study drug without negative effects on major organ systems. The two blood draws—one before and one after the dose of study medication—that you are specifically asking about are intended to assess drug levels in the blood. These measurements will not be conducted when blood is drawn at local laboratories during the COVID-19 pandemic. Thus, there will only need to be 1 blood draw at a local laboratory per remote visit.
3. Will the principal investigators be doing neurological exams virtually? (Each visit involves rating scales, and this could realistically be done virtually.)
Remote study visits may be conducted by the site via phone or telemedicine video. Assessments performed during these remote visits will focus largely on ensuring safety of the study participant. If deemed appropriate by the investigator, some aspects of the neurological exam may be performed via telemedicine video. However, we do not
anticipate requiring completion of all the study rating scales via telemedicine video. We are mindful that some participants may not have the same technology resources available. Moreover, the validity and reliability of performing all of these assessments remotely is not ensured.
4. Will the people currently enrolled stay in the study longer than expected as they won’t be able to have visits with their doctors? (This relates to the validity of the study).
Currently, we are focused on ensuring the safety of trial participants and site staff. We believe that the workaround measures that we have implemented (such as remote visits) are in compliance with guidance from health authorities including the US Food and Drug Administration and should not impact the validity of the study. We do not anticipate that participants will remain in the study longer than anticipated, however extended windows to allow flexibility for conduct of visits may be allowed.
5. Does participating in a clinical trial affect the care someone would receive if sick with Covid 19? If a hospital had to make a choice between who gets a ventilator, can it be assumed that the person in a clinical trial (or with a fatal neurodegenerative disease) would not be selected?
Every hospital likely has its own policies regarding the medical care that someone would receive if they develop COVID-19. We do not believe that a patient’s medical care would be affected based on clinical trial participation.
6. How many slots are still available, and will people have to wait until the quarantine is lifted to try to participate in the trial?
Evolving governmental and institutional restrictions implemented due to safety concerns related to the COVID-19 pandemic have limited screening and enrollment of new participants at most, if not all, M-STAR study sites. Once these restrictions are lifted, screening and enrollment will resume. We estimate that approximately half of the target number participants have been enrolled in the study. This study has not officially been put on hold but, due to the restrictions of the institutions involved, the rate of study enrollment has decreased.
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