Dawn Furey is a collaborative clinical trial operations leader with a demonstrated history of delivering measurable advancements. She has led and individually executed within global trial management, study start-up deliverables, supplier governance collaboration and executive sponsorship of key vendors. She has experience with ICH/GCP, clinical monitoring practices, trial allocation strategy and management, field operations leadership and supply chain management.
For the webinar, Dawn explored the theme of ‘direct to patient’ and home healthcare research initiatives. A key point was that sites remain important, including those that do not continue to see patients, so communication with all sites and being open and listening to sites is crucial for an understanding of best practice and the pertinent regulatory frameworks that sites are concurring with. This becomes increasingly important as nations develop different approaches to COVID-19, so regulators within countries will consequently evolve different regulatory frameworks.
Real world data and evidence including clinical (RWE) in the digital world must assess the benefit/risk for participating patients and optimal ways for mitigation of risks. Within RWE studies, protocols must ensure that the safety of patients has been overseen and obligations of sponsors and the researchers carrying out studies must continue to be fulfilled and documented.
Home healthcare and telemedicine can be utilised in the conduct of RWE studies. Implementation must consider if such an approach will jeopardise patient safety, how much of the study can be conducted in the home environment and what options are provided to the participating patient.
David Borasky leads the quality and compliance activities for all of the WCG institutional review boards (IRBs). David has 20 years of experience in managing IRBs in settings that include global public health organizations, large academic medical centres, and independent IRBs. He has facilitated training activities on basic research ethics and IRB operations and management for IRB staff and members for institutions and IRBs throughout the US and abroad. He has served as a consultant for the Office for Human Research Protections, the US Department of Energy, the World Health Organization, and numerous other institutions. He currently serves as co-chair of the Subpart A Subcommittee of the DHHS Secretary’s Advisory Committee on Human Research Protections.
David confirmed that the COVID-19 pandemic has affected nearly every study that was in planning or underway during late March and into April (the webinar took place in late April). Regulators have been responsive, as an example the FDA guidance for on-going trials has been updated three times since the first issue in March 2020. Similarly the research community has demonstrated agility and the ability to react quickly to the rapidly changing research framework.
Patterns have emerged as the research framework evolves, including reduction in the number of protocol-mandated visits, use of alternative patient engagement approaches including home visits and telemedicine. Communication with research participants is an area of necessary focus, for example when considering how information should be conveyed to study participants. New trends include adjustments to compensation, options for the consent process including e-consent and whether future protocols need to include provisions for similar scenarios. In all cases, the key question is whether IRB approval is required in these cases.
The regulatory position is that changes in research may not be initiated with IRB approval. The COVID-19 challenge arises when events move so quickly that there isn’t time to implement IRB review. Regulations allow for exceptions when it is necessary to ‘eliminate apparent immediate hazards to the human subjects’ this can be interpreted as follows, ‘immediate changes may be needed for the best interest of those involved in the research’.
David also provided a summary for approaches to compensation and informed consent. The slides from both presentations are available from WCG. Summary points included ‘sponsors and sites should remain in close contact’, ‘when in doubt err on the side of subject safety’ and ‘document everything’.
This short report is the first in the HCD ‘Rare Disease Community – COVID-19 update series’, sharing the personal recollection of HCD Real World Evidence Manager, Hayley Hubberstey, as an attendee at a series of COVID-19 response webinars hosted during April 2020 by a range of groups, in support of the patient communities which HCD are currently undertaking or planning RWE research.
For more information on all of the April webinars attended and for information on information resources and links publicised during the webinars, please contact Hayley Hubberstey at HCD Economics Hayley.firstname.lastname@example.org