Patient response to new digital components in the electronic informed consent (eIC) process is overwhelmingly positive, with nearly three-fourths of respondents to a recent survey saying they find enhanced eIC more personable, engaging and informative. Read More
This monthly feature presents questions from clinical trial professionals with answers from experts. In this issue, we feature insights from Christopher Doyle, WCG IBC chair and director of IBC services, and Amy Michaud, WCG biosafety analyst lead. Read More
The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing of essential clinical trial information in ways that patients can understand. Read More
The FDA has been busy this month issuing guidances on data monitoring committees (DMC), charging for investigational drugs and assessing COVID-19-related symptoms in outpatient trials. The agency also extended the comment deadline on its guidance for master protocols to March 21. Read More
The utilization of websites for trial recruitment has nearly tripled since 2019, while social media platforms and patient advocacy groups have doubled in use, according to a study that offers new insights into the top recruitment methods used for trials postpandemic, among other data. Read More
This monthly feature presents questions from clinical trial professionals with answers from WCG’s expert staff. This issue features insights from WCG IRB Medical Chair Andrea Itskovich. Read More
A 2023 analysis conducted by clinical research analytics firm Phesi shows that breast cancer was the most heavily researched disease area for the third year in a row, followed by solid tumors and stroke. Read More
Billing federal healthcare programs for ineligible clinical trial-related items over a six-year span has landed a Tampa, Fla., cancer research hospital in hot water with the government, but the nonprofit site has reached a $19.5 million settlement after admitting responsibility for the billing issues, working with the government and taking action on its own. Read More
This monthly feature presents questions from clinical trial professionals with answers from WCG’s expert staff. This issue features insights from WCG IRB Regulatory Chair Ranga Venkatesan, IRB Medical Vice-Chair Geoffrey Browne and Regulatory Chair Director Sheri Spivey. Read More