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
The CenterWatch Monthly provides clinical research professionals with valuable and exclusive content on clinical trial news, trends, analyses and regulatory guidance, as well as expert insights not found anywhere else. The following commentary on DE&I by Rachel Rangel, clinical trial specialist at Curavit Clinical Research, is an excerpt from the December issue’s Year in Review feature. Read More
Staffing and retention topped the list of site struggles in 2023, with such terms as “rusting out,” quiet (and loud) quitting and “bare-minimum Mondays” now figuring prominently in the workforce lexicon. To weather these challenges, sites should cross-train their staff on all aspects of their protocols, experts say. Read More
Sponsors of drugs being developed to treat or prevent COVID-19 should strive to enroll populations at greatest risk in their trials, including older adults, ethnic and racial minorities, children and pregnant/lactating women, the agency advises in a straight-to-final guidance. Read More