Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 24 September 2012
Biologics manufacturer Peregrine Pharmaceuticals' has informed its investors that its second-line lung cancer drug bavituximab, for which the company just released phase IIb data showing evidence of efficacy, is plagued by faulty data it says is the result of poor work by a third-party clinical trials contractor.
In its 24 September release, Peregrine said it discovered the deficient data when preparing for an end-of-phase II meeting with the US Food and Drug Administration (FDA). The company, it said, "Discovered major discrepancies between some patient sample test results and patient treatment code assignments."
The study, started in June 2012, was a placebo-controlled study comparing a control group with two treatments groups receiving Docataxel plus either bavituximab 1mg/kg or 3mg/kg. The trial was being conducted at 53 study locations throughout the US, India, Russia and the Ukraine. At the time of the study's release, the company's chief of regulatory affairs, Robert Garnick, called the data "robust," and said they were looking to work with FDA to, "Identify the most efficient path toward commercialization."
No information was provided in Peregrine's press release or the www.ClinicalTrials.gov posting regarding the identity of the contractor or contractors.
Peregrine places blame on the as-yet-unnamed contractor or contractors, which it claims was responsible for the trial and subsequent data coding deficiencies.
"Due to the double-blind nature of the trial, Peregrine was not permitted to have access to either patient group assignments or related product coding information," it said. "As part of the trial's execution, Peregrine contracted with independent third-party contractors to execute treatment group assignments and oversee clinical trial material coding and distribution according to established procedures. A subsequent review of information has determined that the source of these discrepancies appear to have been associated with the independent third-party contracted to code and distribute investigational drug product."
Peregrine's stock has since plunged more than 80% after the release of the company's statement, reports Reuters.
The data reporting error is the second major one to plague a drug manufacturer in the last five months. In May, Cambridge, Massachusetts-based Vertex Pharamceuticals was similarly forced to report having overstated the effectiveness of a new cystic fibrosis therapy, also causing its shares to take a hit. Vertex, however, released corrected data that the therapy was still effective when compared to a placebo.
Tags: Problem, Bavituximab, Peregrine, Error, Reporting, Latest News, clinical trial, data, biologic, study
Regulatory Focus newsletters
All the biggest regulatory news and happenings.