The FDA has issued several guidance documents in the past week that the agency hopes will help researchers get a handle on patient selection for increasingly complex trials.
Five of the guidances — four draft and one final — focus on giving access to experimental medicines to traditionally more vulnerable cancer patients, including children, HIV patients and hepatitis C sufferers. The guidances underline an emerging truth that trials are increasingly becoming front-line care to many patients.
Contract research services are now the largest single cost category in pharma R&D spending, accounting for almost $90 billion last year, according to Tufts Center for the Study of Drug Development.
All in, CROs raked in about $33 billion last year for services including project management, trial monitoring, biostatistics, site management and medical writing — an increase of 12 percent from 2017, Tufts researchers found.
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.
Multi-site trials rely on experienced remote monitors to coordinate their activities and communications, but that doesn’t mean the individual sites can slack off. The absence of face-to-face communication can magnify seemingly simple errors, a veteran trial monitor warns.
Barbara Winter, an independent consultant and remote monitor based in Sacramento, Calif., urges sites to improve their internal communications and training strategies if they don’t have a dedicated monitor on-site to keep a careful eye on things.
Orlando, Fla. — From comic books for kids in pediatric trials to including patients in protocol design, this year’s SCOPE conference revealed a fresh commitment to making trials more patient-centric.
At TESARO, executives see several areas where patient centricity can improve trial speed and efficiency: ensuring that the protocol is simple to administer for the patient; enhancing convenience so the patient stays in the study; using the patient community to identify the most important unmet need and building patient ownership and commitment to the trial.
Patients are eager to participate in clinical trials, but they’re having trouble finding the information they need — not just on social media, but from their own doctors, a new survey suggests.
Many respondents said they’d be interested in joining trials — nearly three-fifths said they would be willing to share genetic information or their health records as part of a trial — and one in five said they had proactively asked their doctors about trials, but only 15 percent had ever enrolled in one. Fewer than one in five said their doctor had suggested trials for them.
A Michigan CRO is teaming with MIT’s Computer Science and Artificial Intelligence Laboratory and the University of Maryland’s Center for Transitional Medicine (CTM) to create what organizers are calling “a supergroup” that will help speed drugs through the clinical trials pipeline.
Officials at MMS Holdings of Canton, Mich., MIT and Maryland’s CTM call their new venture the Health Analytics Collective. Its goal is to help use data — particularly real-world data — to help cut down on the time spent in trials, to augment label claims and to support new drug applications.
Gaps and gray areas in federal training requirements wind up putting pressure on principal investigators when the burden rightly belongs on sponsors’ shoulders.
But in practice, says Jan S. Peterson, vice president of regulatory affairs and quality for Global Regulatory Partners, investigators may find themselves taking on responsibility for training the rest of the staff.