Sponsors should think about loosening their exclusion criteria to allow more diverse patient populations—especially when recruiting for later stage trials, the FDA says in new draft guidance published last week. Read More
The Association of Clinical Research Organizations (ACRO) is urging the FDA to place even more emphasis on risk-based monitoring (RBM) of clinical trials, saying a recent study of its members showed a 16 percent reduction in major findings in audits among sites using that method. Read More
Sponsors, sites and CROs have the chance to weigh in on the first draft revision of ICH E8 since it was adopted in 1997. Changes to trial design and conduct in the last two decades have made much of the guideline out of date. Read More
NASHVILLE — Attendees at last week’s ACRP 2019 conference discussed and debated a number of diverse clinical research topics, but the buzz about improving clinical monitor and coordinator training came through loud and clear in several sessions.
The clinical trial professional of the future will need the skills to deal with increasingly complex protocols, risk-driven trial strategies, ever-evolving technologies, virtual environments and more, speakers agreed. Read More
Patient involvement shouldn’t end when a trial closes. If you really want subjects to feel they are part of the team, you need to share the results with them, says one cancer survivor turned trial advocate. Read More
Central laboratories need to be viewed as partners in clinical trials, not simply as vendors doing routine safety work, says a veteran laboratory auditor.
“If the central laboratory understands the objectives and has the opportunity to suggest the best possible means to meet the objectives, the success rate of the study goes up. You need to have a very interactive central laboratory,” says Michelle Sceppa, founder and principal of MSceppa Consulting.
An innovative social media company is developing a new model for matching trial sponsors with patients and caregivers who can offer ideas for making trials more patient-focused.
Inspire, an Arlington, Va.-based social media company, has built a community of 1.5 million people sharing information, opinions and support in therapeutic areas ranging from advanced breast cancer to wound healing.
A survey conducted recently by Metrics Champion Consortium shows most of the responding sponsors — 90 percent — indicate they are implementing ICH’s new centralized monitoring approach to risk management, but only about a third of that number say they have fully integrated it into their trials operations.
Almost all (93 percent) cited detecting risks to subjects and data integrity as the primary reason to conduct centralized monitoring, and three quarters of respondents said it was both a good predictor of the need for individual site visits and detector of potential fraud and/or misconduct among trial staff.