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
A new benchmarking study that assesses vendor qualification assessment (VQA) practices is aimed at helping sponsors, CROs and sites streamline and reduce the cost of selecting vendors, a task that is increasing in complexity. Read More
This monthly feature presents a variety of questions from clinical trial professionals with answers from WCG Clinical’s expert staff. This issue features advice from Patience Stevens, vice chairperson at WCG Copernicus Group IRB, and Lindsay Abraham, regulatory lead for IRB chairs at WCG Western IRB (WIRB). Read More
COVID-19 has caused nearly half of all trial disruptions in the past five months, with oncology trials being hardest-hit, according to a new study out of Berlin. Read More
The number of women who participated in clinical trials that led to FDA drug approvals increased dramatically in the past year, rising from 56 percent of trial participants in 2018 to 72 percent in 2019, driven more by an increase in testing drugs specifically aimed at women than gender diversity. Read More
When it comes to deciding how to compensate principal investigators (PIs), sites have three factors to consider and getting them wrong carries a high cost, says one expert. Read More
