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Home » Authors » William Myers

William Myers

Articles

ARTICLES

Top Academic Centers Flouting Trial Reporting Requirements, Report Shows

April 1, 2019
William Myers
Top U.S. academic centers are routinely ignoring federal rules requiring them to report clinical trial data, a new analysis by a pair of nonprofit advocacy groups finds. Read More

FDA Guidances Recommend Broadened Eligibility, New Strategies for Trials

March 18, 2019
William Myers

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.

Read More

CROs Deliver Shorter Cycle Times, Says New Tufts Report

March 11, 2019
William Myers

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.

Read More

Social Media Company Matches Sponsors with Patients to Advise on Trial Design

March 11, 2019
William Myers and Leslie Ramsey

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.

Read More

Remotely Monitored Sites Must Maintain Vigilance and Communication, Expert Says

March 4, 2019
William Myers

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.

Read More

Sponsors Increasing Their Focus on Patient Centricity

February 25, 2019
William Myers and Cindy Carter

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.

Read More

Drug Industry Comments on FDA’s Real-World Evidence Program

February 18, 2019
William Myers

Drug sponsors are eager for the FDA to embrace real-world evidence (RWE), but several companies are asking the agency to clarify how it can be used in clinical trials.

Late last year, the FDA invited public comments on a plan for its real-world evidence framework, and it received 30 overall, nine from drugmakers.

Read More

Patients Are Eager for Trials But Aren’t Getting the Word, Survey Finds

February 18, 2019
William Myers

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.

Read More

New Collaboration Aims to Use Advanced Data Analysis to Speed Trials

February 4, 2019
William Myers

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.

Read More

Sites and Sponsors Need to Collaborate on Staff Training

February 4, 2019
William Myers

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.

Read More
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