COVID-19 has given the clinical trials industry the push it needed to go paperless, with 84 percent of sites, CROs and sponsors already doing so or poised to make the switch to electronic data management (EDM) systems. Read More
The first wave of COVID-19 vaccine development has not monitored the response of T cells to the virus, a missed opportunity that should be addressed in the next wave of COVID-19 research, two experts said last week. Read More
While the FDA and other regulators have been flexible as clinical trials adapt to the strictures caused by the COVID-19 pandemic, experts say they are drawing the line at data integrity lapses. Read More
Dwindling clinical trial financial resources caused by COVID-19 and declining investigator participation are clashing with sponsors’ demand for more — and more complex — trials, creating a “perfect storm” of pressure that threatens to overwhelm the research industry if sites and sponsors don’t work together to adjust to the realities of life in a pandemic. Read More
The FDA has finally put muscle behind its authority to fine flouters of the ClinicalTrials.gov reporting requirements, issuing a final guidance last week that confirms penalties of up to $10,000 per violation. Read More
Sites that rarely, if ever, conducted virtual patient visits via phone or video prior to the pandemic have been convinced of the value of the technology for clinical trials in the future. Read More
Sites that rarely, if ever, conducted virtual patient visits via phone or video prior to the pandemic have been convinced of the value of the technology for clinical trials in the future. Read More
Attendees at the recent MAGI Clinical Research Cloud Conference heard advice from a variety of industry experts on running clinical trials now and into the “new normal.” The following is a selection of speakers’ thoughts on subjects from patient recruitment to negotiating clinical trial agreements (CTA).Read More
New recommendations for the collection, reporting, management and analysis of patient experience data to be used in trial design are outlined in a final guidance the FDA released last week. Read More
With the International Council on Harmonization (ICH) poised to begin work on another revision to its good clinical practice (GCP) guideline, ICH E6, sites and sponsors have questions about what they can expect from upcoming changes while they still are struggling to interpret requirements placed on them by the previous 2016 revision. Speakers at two recent CenterWatch webinars provided some insight. Marina Malikova is executive director of surgical translational research, operations and compliance at Boston University School of Medicine, and Steve Whittaker is a senior consultant at The Avoca Group. Read More