IRB Review of Social Media Recruitment and Retention Programs
Social media can be a valuable tool for researchers to connect with and recruit potential clinical trial participants. However, US regulations
recruitment
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.
Q&A – Site and Patient Engagement
CEO Gadi Saarony and Deb Tatton, Parexel Senior Vice President of Global Clinical Operations, consider ways to improve site and patient engagement in this Fireside Chat Q&A blog part 2.
Q&A – The New Normal: Considerations for Restarting Research
In a recent webinar, Advarra IRB and research compliance experts discussed key areas to consider as we look to ramp up research in the COVID-19 pandemic’s “new normal.” In this blog our experts answer some of the most popular audience questions.
Patient Engagement and the IRB
Recent years have seen increased efforts to engage with patient and participant communities and include them more closely in research. This approach is reflected in the founding of the Patient Centered Outcomes Research Institute (PCORI) as well as statements from the US Institute of Medicine and Food and Drug Administration (FDA) on the importance of including participant perspectives at every stage of the research process—from the design of studies through their implementation and the dissemination of research results.
Making Sense of the New HUD Guidance
For almost a decade, the FDA guidance on humanitarian use devices (HUDs) dated July 8, 2010 has been the go-to document for industry, FDA staff, clinicians/users, and IRBs to understand how to apply the regulations at 21 CFR 814.100, which govern the approval, use, and review of HUDs. Since then, amendments to the HUD program have been made by a variety of federal actions.
Should Social Media Be Part of Your Research Toolbox?
Social media holds tremendous promise in the research sphere but requires sensitivity to pertinent regulatory and ethical considerations. Sponsors and investigators looking to incorporate social media into their research toolbox should devote themselves to understanding the details of particular social media platforms and work closely with their IRB to understand and apply the regulatory framework.