• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » AB Science warned about putting study volunteers in danger

AB Science warned about putting study volunteers in danger

July 27, 2015
CenterWatch Staff

The FDA’s Office of Scientific Investigations has issued a warning letter to Paris-based AB Science, a pharmaceutical company that targets cancer and other diseases with high unmet medical need, for compromising the safety of study participants by failing to properly monitor its clinical trials and ensure investigators follow protocol requirements.

An FDA inspection found that AB Science’s monitoring practices were inadequate to detect that investigators failed to report five serious adverse events (SAEs) within the 24-hour timeframe specified in the study protocol; in two instances, the SAEs weren’t reported for at least three years and one wasn’t reported at all. In addition, investigators failed to perform protocol-required laboratory tests designed to identify potential side effects that could put study volunteers at risk.

Violations also included missing timeframes included in the Investigational New Drug (IND) application for writing and approving monitoring reports—in some instances, reports weren’t completed at all—and failing to submit numerous lab results required by the protocol to the data management team.

The FDA violations detailed in the warning letter involved pancreatic cancer and gastrointestinal stromal tumor (GIST) studies conducted by AB Science primarily between 2009 and 2013.

AB Science did not respond to requests from CenterWatch Weekly for comment. In a state­ment posted July 14 on its website, AB Science said the company already has replied to the FDA warning letter and also has implemented “ap­propriate corrective and preventative actions” in response to the deviations. In addition, the company said it’s upgrading its quality assur­ance system to ensure compliance with Good Clinical Practice (GCP) requirements.

“AB Science has been inspected more than a dozen times in the past by numerous health authorities and always responded satisfacto­rily,” the statement said.

FDA spokesperson Stephen King said he is unable to comment on whether the agency will take further regulatory action against AB Science since the compliance matter remains open.

“What we can say is that our focus is on whether the conditions we observe on inspec­tion pose risks to patient health and safety, or to the safety, efficacy and quality of the drug products,” he said. “Our warning letters give notice to sponsors of the types of problems we observe on inspection in order to provide the sponsors the opportunity to take voluntary corrective actions.”

The warning letter was issued June 16 based on violations identified during an FDA inspection of AB Science—which has a U.S. office in Chatham, N.J.—last September. When the inspection ended, AB Science was told to address the deficiencies and establish proce­dures that would prevent similar violations in the future.

AB Science, which acknowledged that its monitoring activities were inadequate in a written statement to the FDA, submitted a corrective action plan to the agency in October that provided for new monitoring strategies and team training practices. While the FDA did not comment on the relevance of the action plan presented by AB Science, the warning letter said the company didn’t adequately address ways to measure effectiveness of the plan or ensure compliance with regulations going forward.

AB Science’s statement said the company has responded to the FDA on these two action items.

The FDA’s crackdown on AB Science’s insufficient monitoring practices comes during a renewed discussion in the clinical research community about the importance of restoring integrity and trust in the enter­prise following the sentencing of ex-Iowa State scientist Dong-Pyou Han for falsifying HIV research data.

Bioethics expert Arthur Caplan, Ph.D., the founding director of the Division of Medical Ethics in NYU Langone Medical Center’s De­partment of Population Health, said the FDA’s warning to AB Science, while unrelated to the HIV research misconduct, sends a serious mes­sage to the industry about the need to take clinical trial monitoring and adverse events reporting seriously.

“Monitoring for adverse events is the strongest moral obligation a company doing research has. It is protecting subjects against harm,” he said. “If they can’t do it, won’t do it or are indifferent about it, they should not be doing research on human subjects.”

AB Science, which already has registered its lead drug masitinib in Europe and the U.S. to treat cancer in dogs, currently is running 11 phase III studies with the compound in hu­mans for a number of oncology indications, as well as for inflammatory and central nervous system diseases.

This isn’t the first time that the FDA has voiced concerns about AB Science’s prac­tices. Last year, the agency issued a warn­ing letter to the company for marketing its Kinavet-CA1 canine drug, conditionally ap­proved to treat mast cell tumors in dogs, for off-label uses, including atopic dermatitis in dogs and asthma in cats. The FDA also cited AB Science for omitting important warning information in marketing materials about how the drug could affect humans in case of consumption.

 

Email comments to Karyn Korieth at karyn.korieth@centerwatch.com.

This article was reprinted from Volume 19, Issue 29, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

Upcoming Events

  • 17May

    Three Data Trends to Consider Now When Developing Your Decentralized Clinical Trial Strategy

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing