In the past few years, new regulations and policies have been announced and implemented to address the challenges of conducting clinical trials involving multiple research sites. Chief among these requirements is the use of a designated sIRB for multisite research.
Cannabis use has become widespread. As such, we are seeing an uptick in research examining the therapeutic effects of cannabis
In clinical research, institutional review boards (IRBs) a vital role in ensuring participant rights and ethical standards are upheld throughout the trial.
Decentralized clinical trials (DCTs) are transforming clinical research by allowing data collection from participants outside traditional settings, such as
Social media can be a valuable tool for researchers to connect with and recruit potential clinical trial participants. However, US regulations
How should sites conducting planned emergency research approach community consultation in the time of COVID-19?
Our webinar proved so popular, we thought a deeper dive would be appropriate. In this post we explore some key issues IRBs face when reviewing research involving virtual trial technology.
The opioid crisis in particular is staggering in the number of lives it has claimed. Combating the crisis requires urgent, evidence-based approaches that addresses clinical, research, and education issues.
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.
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.
Complex trial designs can eliminate less-promising investigational treatments quickly to speed development, but they remain under-utilized. The current pandemic offers a chance to consider strategies for facilitating adoption of such innovative designs.
Recent regulations and policies have ushered in the era of mandated single IRB (sIRB) review. Many institutions must now establish policies and processes for working with an external sIRB.
