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Gov’t Shutdown Puts INDs, Trials in Limbo

January 7, 2019

Gov’t Shutdown Puts INDs, Trials in Limbo Clinical trials executives are scrambling to understand the effects of the now two-week-old federal shutdown on their studies and applications, with the only FDA advice coming via Twitter.

Last week, FDA Commissioner Scott Gottlieb announced on Twitter that the agency couldn’t accept any new drug products that would be filed under NDAs or BLAs, Gottlieb said.

The shutdown also appears to have stranded drug sponsors who applied to begin trials before it began on Dec. 22. Under federal law, trials can begin 30 days after an IND application if regulators don’t respond, but it’s not clear what happens to that timeframe in a lengthy shutdown.

The situation has left a multibillion industry parsing tweets for answers. “It’s unfortunate that this information is being related by tweet rather than by a more formal communication,” says David Forster, chief compliance officer at WCG Clinical.

Bristol-Myers Sees $15B Pipeline in Celgene Merger

Bristol-Myers Squibb has acquired Celgene Corporation in a $74 billion cash and stock deal that includes six drugs nearing the end of Phase III trials, the companies announced last week.

Bristol-Myers estimates the drugs could bring in more than $15 billion in revenue once approved and on the market. The drugs are TYK2, an immunology candidate; ozanimod, an anti-inflammation drug; and four hematology treatments — lustpartercept, liso-cel (JCAR017), bb2121 and fedratinib.

Celgene also claims to have at least 50 “high potential assets” in early trials across solid tumors, hematologic malignancies, immunology and inflammation.

The companies hope to close the deal by the third quarter of this year.

Colorado Pain Researcher Cited for Failing to Monitor Trial Progress
A Colorado pain researcher has been cited by the FDA for failing to monitor progress in her cannabis/opioid trial following a July 2018 inspection.

Emily Lindley, an assistant professor at Colorado University’s Anschutz Medical Campus, failed to review case report forms, didn’t verify the information on her team’s worksheets and didn’t properly review electronic case reports, the FDA says in a Form 483 dated July 17.

“Additionally, you stated that you were not aware of the need to monitor a clinical trial,” the FDA says.

Lindley is part of a team that won $2.7 million in state funds to study whether cannabis can be as effective at relieving pain as opioids. The trial, which began in June 2017, recruited 100 patients with a history of lower back or neck pain. It randomly assigned patients into the cannabis, opioid or placebo group and will monitor their pain through June, 2019.

Lindley couldn’t be reached for comment at press time.

View the 483 here: https://bit.ly/2SDk0bU.

Kentucky Neurologist Offers Plan to Improve Minority Recruitment in MS Trials
Drug companies should be required to collect postmarket data on how multiple sclerosis drugs affect minorities, and MS drugs’ responsiveness should be classified based on ethnicity as a way to improve minority enrollment in clinical trials, a University of Kentucky neurologist is arguing.

In an editorial published in CNS Spectrums, Jay Avasarala also argues that drug sponsors should be required to include MS drugs’ efficacy data for minority groups and that no publication should accept study data “without a clarifying statement that acknowledges the lack of sufficient data to make reasonable conclusion in non-Caucasian minorities.”

Minority enrollment in MS trials plunged from nearly 8 percent in 2002 to about 2 percent in 2013, Avasarala says. MS is typically more aggressive in African-American patients.

“The scientific community has published reams of data, but all that matters to a patient is, ‘OK, doc, how can you treat me?’” Avasarala says in a release accompanying his op-ed. “And we fall short for African-Americans, because we simply don’t have the data.”

CISCRP Launches Virtual Fundraiser for Trial Volunteer Education
The Center for Information and Study on Clinical Research Participation (CISCRP) will host its first virtual fundraiser to help raise public awareness of the essential role of clinical trial volunteers in medical research.

CISCRP has hosted run-and-walk marathons in support of trial volunteers since 2013, but this year’s “Medical Hero Appreci-a-thon” is its first virtual challenge. Participants will follow a virtual Route 66 course by logging on to track their fitness routines every day.

Proceeds from the fundraiser will go toward educational programs for trial volunteers and their families. The challenge officially begins Feb. 1 and runs through the end of the month.

You can check out the Appreci-a-thon here: www.MedHero.org.