Ethics/Regulatory

FDA issues rule on safety reporting

Tuesday, October 5, 2010 08:51 AM

The FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. “These changes will better protect people who are enrolled in clinical trials,” said Rachel Behrman, M.D., associate director for medical policy in the FDA’s Center for Drug Evaluation and Research. The new rule requires certain safety information be reported to FDA within 15 days of becoming aware of an occurrence, including: findings from clinical or epidemiological studies that suggest a significant risk to study participants; serious suspected adverse reactions occurring at a rate higher than expected; serious adverse events from bioavailability studies that determine what percentage and at what rate a drug is absorbed by the bloodstream, and bioequivalence studies that determine whether a generic drug has the same bioavailability as the brand name drug. The rule also provides examples of evidence suggesting an investigational product may be the cause of a safety problem. Currently, sponsors often report all serious adverse events, even if there is little reason to believe the product caused the event. This complicates and delays the FDA’s ability to detect a safety signal. The examples address when a single event should be reported and when to wait for more than one occurrence.

More... »

Yale Medical Group adopts conflicts-of-interest policy

Monday, September 27, 2010 07:00 AM

Yale Medical Group, affiliated with Yale University’s medical school, has adopted a new conflicts-of-interest policy to regulate relationships between its doctor-academics and industry, Pharmalot reported. The new policy comes on the heels of a similar move at Harvard Medical School, and after a handful of other academic medical centers have reviewed their own rules. Yale Medical’s new regulations attempt to tread a fine line, designed to fend off accusations that industry money and relationships unduly influence its doctors without cutting pharma out of the equation completely. It addresses financial ties to drug and device makers; gifts, meals and other goodies from industry; ghostwriting; samples; consulting and continuing medical education. According to Pharmalot, drug sales reps bear the brunt of the rules; they’ll be allowed to visit only by invitation and with an appointment. Companies can still sponsor CME programs and provide meals during CME events. “We wanted to upgrade the guidelines to a full-blown policy so that faculty and others understand that these are no longer electives, because the landscape has changed,” CEO David Leffell said. The Yale Medical Group is staffed by roughly 800 academic physicians from the Yale School of Medicine; it is not a separate practice or foundation. The move reflects ongoing debate over the interactions between academics and drug and device makers. The National Institutes of Health has proposed new conflict rules for researchers. “Our view is that we continue to respect the role the pharmaceutical industry plays in contributing to and investing in the health of people,” Leffell said.

More... »

Chicago HIV researcher ‘vindicated’ by FDA in clinical trial fraud case

Tuesday, September 21, 2010 07:27 AM

Daniel Berger is a happy man. The FDA has ruled that the Chicago internist and thought leader in the area of HIV can continue conducting clinical trials without any restrictions, despite evidence that his clinic submitted bogus data along with failing to perform basic tests including physical exams and electrocardiograms during one particular trial. Additionally, 200 tablets of the investigational drug went missing at his clinic during that trial.

More... »

CenterWatch Monthly September 2010

Wednesday, September 1, 2010 11:31 AM

"Sunshine law" puts cloud of concern over sponsors, sites

More... »

First commercial IRB opens in Indiana to fill geographic gap and attract clinical research

Tuesday, August 31, 2010 08:00 AM

Indiana now has its first commercial Institutional Review Board (IRB). Indiana and its surrounding region, that is. Diana Caldwell and Gretchen Miller Bowker—both Eli Lilly alum and former coworkers at the regulatory compliance consultancy Safis Solutions—have launched Pearl IRB to fill what they say is the commercial IRB gap that stretches north to Minneapolis, east to Philadelphia, south to Cincinnati and west all the way to San Diego.

More... »

Competitors MDCI and CDSS form cross-continental CRO partnership

Monday, August 30, 2010 08:48 AM

U.S.-based Medical Device Consultants (MDCI), which provides contract research and regulatory consulting services to the medical device industry, has formed a strategic partnership with a former competitor, U.K.-based contract research organization (CRO) Clinical Development & Support Services (CDSS).

More... »

CenterWatch Monthly August 2010

Wednesday, August 4, 2010 09:18 AM

Spike in Warning Letters Sends Tremors Through Industry

More... »

PPD, Microsoft help manage REMS programs

Wednesday, August 4, 2010 08:07 AM

PPD and Microsoft have entered into an agreement to jointly implement a technology solution designed to improve efficiency in managing U.S. Food and Drug Administration-mandated Risk Evaluation and Mitigation Strategy (REMS) programs.

More... »

Duke puts PI on leave, suspends enrollment in three studies

Monday, August 2, 2010 08:16 AM

A high-profile principal investigator in oncology at Duke University has been placed on administrative leave while the university investigates whether he lied about Rhodes Scholar status on several grant applications. The university has also suspended patient enrollment in three trials he was involved in. 

More... »

ACRO hails proposed privacy rule to help simplify clinical research

Monday, July 26, 2010 08:00 AM

The Association of Clinical Research Organizations (ACRO) has commended the long-awaited privacy rule issued by the Department of Health and Human Services (HHS), saying the proposal strikes an “appropriate balance” between protecting patients and allowing researchers access to health information critical for drug safety monitoring and comparative effectiveness studies.

More... »