Q&A – The New Urgency of Clinical Trials: How Oncology Leads the Evolution
In Advarra’s recent virtual symposium, experts from industry and academia met to discuss how oncology research has influenced agility in clinical trial design, particularly during the COVID-19 pandemic. Panelists talked about how the COVID-19 pandemic has impacted oncology research and propelled the field’s groundbreaking contributions to research. They also explored ways the pandemic response has shaped the future of oncology research—and research in general.
Following the presentation, panelists participated in a Q&A session to address questions submitted by the audience. Due to time constraints we weren’t able to answer all audience questions during the Q&A period, so our experts have answered some of the most popular questions in this blog.
Note: Institutional review board (IRB) policies vary; please contact your IRB regarding any specific questions.
Q: How has adoption of solutions such as telemedicine, at-home nursing, direct-to-patient study drug shipment, etc., impacted your IRB review? Specifically, has adopting these new ways of working resulted in any change in the IRB’s position on participant reimbursement for time/burden?
A: At Advarra, the IRB has been accepting of these types of solutions, providing that issues of safety and confidentiality have been addressed. We have not yet seen changes to reimbursement requests.
Q: Have approaches to post-approval outcomes studies changed in the era of COVID-19?
A: It is our impression that the number of post-approval outcomes studies has decreased, at least temporarily. For Advarra’s IRB, our approach to these studies has not been different than other studies.
Q: How can clinical trials best maintain the momentum, improved public perceptions, and increased flexibility in operations?
A: There is certainly daily discussion about research in social media and in newspapers, particularly regarding best treatments for COVID-19 and vaccines for COVID-19. There is perhaps more awareness than ever before that scientific progress and cures come only with sound research. Innovative use of social media for education and frank discussions with pharma colleagues may result in some flexibility of operations. On the local site level, preparedness will be crucial. Traditionally, site activation has been a source of time delay in getting innovative treatments to participants.
Q: Since there is an increase in the use of technology (in the form of telemedicine, eConsent, etc.) due to the pandemic, what methods are being implemented to ensure there is not a greater increase in disparity in research participation among under-represented or socio-economically disadvantaged groups, as well as a lack of access to oncology trials for those same groups and those residing in rural areas?
A: In our opinions, we are just beginning to get a handle on the impact of technology on participation in clinical trials. Since trial design will inevitably be influenced by current events, one must really wait for the next generation of cancer trials to be submitted. We anticipate the IRB commenting on such things as diversity and internet access. Broadband access is already a political issue, and it will be important for those who design trials to be aware and creative in trial design.
Q: How does the IRB review an eConsent app?
A: In our experience, the IRB reviews the written consent, if there is one, and then reviews screenshots of the eConsent app.
Q: If all auditing is remote now, who actually checks out the site?
A: The remote auditing process should be sufficiently designed to provide adequate information about the site. While we are not directly involved with auditing/monitoring of trials, we’ve heard technology has allowed for an experience similar to that of in-person. This is not necessarily something we could have said 10 years ago.
Q: If a site does not have direct electronic medical record (EMR) access for monitors, how are you reviewing/confirming informed consent form (ICF) signatures? If they scan the document and send via email, it has to be de-identified, and you cannot confirm participant signatures.
A: Sites have come up with really novel ways to allow monitors access to source information in lieu of direct EMR access; it’s gratifying to see sponsors, CROs, and sites thinking so far outside the box. While we can’t speak for all sites’ processes, we’ve seen some using virtual meetings to physically walk through the data as if the monitor were there in person.
Q: How is personally identifiable information handled when shipping investigational product (IP) directly to participants? Are shipments managed by the investigator or the sponsor?
A: We have seen the use of third-party vendors to protect protected health information (PHI) as well as sites dispensing and shipping to participants. There are likely other options/resources available, but that is what we’ve seen to date.
Q: When shipping IP directly to participants, how do we ensure participant compliance in taking the drug?
A: This is indeed a concern and requires extra education and attention from the site team and the principal investigator (PI). All remote activities come with the addition of logistical complexities.
Q: Could an intravenous (IV) cancer drug theoretically be given at home by a visiting nurse if the first one or two doses were given in clinic without issue? Or is this never allowed?
A: This depends on the specific nature of the trial in question, but in our opinions, we do not foresee this happening any time soon. There are too many issues with drug preparation, stability, toxicity monitoring, recording of infusion times, drug accountability, and nursing education (as the visiting nurse would need to be trained on the protocol and be on the 1572).
Want more perspectives from our expert panel? Watch the on-demand symposium The New Urgency of Clinical Trials: How Oncology Leads the Evolution.