NEJM Retracts Five Studies, Revises A Sixth, After Trial Sampling Errors Discovered

June 18, 2018

The New England Journal of Medicine has retracted five separate papers and reissued a sixth with corrections, nearly a year after an anesthesiologist raised public questions about whether the volunteers in each of the studies had truly been randomly assigned to different treatments. British anesthesiologist, JB Carlisle, built a computer model that helped him analyze sampling in clinical trials. After examining nearly 5,100 trials, he claimed that two percent of them had used nonrandom sampling when researchers claimed the opposite. Carlisle flagged studies in eight journals, 11 of them having been published in the New England Journal. On June 13, the Journal announced that it was retracting five of those studies. A sixth — a 2013 study on the benefits of the Mediterranean diet — was retracted but republished after researchers “reanalyzed” their data.

New Pipeline from Roche, Genentech, Allergan and AMO Pharma

June 18, 2018

Company Drug/Device Medical Condition Status
Alnylam lumasiran Primary Hyperoxaluria Type 1 (PH1) Phase I trial initiated enrolling 25 patients with PH1
Cynata Therapeutics CYP-001 steroid-resistant acute graft-versus-host disease (GvHD) Phase I trial initiated enrolling 8 patients with steroid-resistant acute GvHD
Vizuri Health Sciences VZU00025 osteoarthritis Phase II trial initiated
NeuroRx NRX-101 suicidal bipolar depression Phase IIb/III trial initiated enrolling 12 patients
Allergan atogepant episodic migraine pain Phase IIb/III trial initiated enrolling 795 patients
icotec AG BlackArmor Carbon/PEEK Interbody Cages adults and children with hemophilia A without factor VIII inhibitors 510(k) Clearance granted by the FDA
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA assay Lyme disease bacteria 510(k) clearance granted by the FDA
AbbVie and Roche Venclexta in combination with Rituxan (rituximab) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Approval granted by the FDA
Genentech Rituxan (rituximab) moderate to severe pemphigus vulgaris (PV) Approval granted by the FDA
Fujirebio Diagnostics Lumipulse G B•R•A•H•M•S PCT Assay bacterial infections Clearance granted by the FDA
DyAnsys Drug Relief reduce the symptoms of opioid withdrawal without narcotics Clearance granted by the FDA
Arcus Biosciences AB928 breast and gynecologic malignancies Clearance granted by the FDA
Nordic Nanovector Betalutin relapsed or refractory follicular lymphoma (FL) Fast Track Designation granted by the FDA
Ironwood Pharma olinciguat (IW-1701) sickle cell disease Orphan Drug Designation granted by the FDA
AMO Pharma AMO-04 Rett Syndrome Orphan Drug Designation granted by the FDA
Samus Therapeutics PU-H71 myelofibrosis Orphan Drug Designation granted by the FDA

GT Biopharma Announces Preliminary Clinical Results From Interim Review of Phase I/II Trial

June 18, 2018

GT Biopharma announced preliminary clinical data taken from an interim review, or snapshot, of the OXS-1550 Phase I/II trial for patients with relapsed/refractory B-cell lymphoma or leukemia. OXS-1550 is being evaluated in an open-label, two-stage, investigator-led, Phase I/II trial. The trial has two arms including patients diagnosed with relapsed/refractory B-cell lymphomas (NHL) and leukemias (ALL). 18 patients have been enrolled to date, including 12 NHL and six ALL patients. At the time of the interim review, 13 patients met the evaluation criteria, including nine NHL and four ALL patients. At the interim review more than 50 percent of patients (seven of 13) exhibited a clinical benefit, defined as stable disease plus partial response or complete remission at Day 29. Of the seven patients, one demonstrated a complete remission (CR), one demonstrated a partial response (PR) and five demonstrated stable disease (SD). The efficacy signal was most prominent in ALL patients with 75 percent (three of four) exhibiting clinical benefit including one CR, one PR and one SD. Adverse events were mostly grade 1 and 2 and reversible. One patient had a grade 4 low platelet count, two patients had a grade 3 increase in liver function tests, or LFTs, and one patient had a grade 3 capillary leak.

June 18: Job openings, upcoming industry conferences, webinars and training programs

June 18, 2018

Twice monthly, CWWeekly provides featured listings of clinical research job openings, upcoming industry conferences and educational programs from JobWatch, CenterWatch’s online recruitment website for both clinical research employers and professionals.

  For conferences, webinars, training programs and job postings, join the LinkedIn JobWatch group.
More Jobs

Chief Business Development Officer
Alliance of Multispecialty Research
Knoxville, TN

Regulatory Data Specialist
National Institute of Allergy and Infectious Diseases
Bethesda, MD

Senior Clinical Project Manager
Chimerix, Inc.
Durham, NC

Senior Clinical Trials Associate / Project Manager I
Access Biologicals, LLC
Vista, CA

Senior Clinical Research Coordinator
Elligo Health Research
San Antonio, TX

Data Coordinator — Research
Mayo Clinic
Phoenix, AZ

Clinical Trial Assistant
SillaJen Biotherapeutics Inc.
San Francisco, CA

Clinical Research Assistant
East Coast Institute for Research, LLC
Jacksonville, FL

Upcoming Conference

AUGUST 8-10, 2018
FDAnews — ICH E6 GCP Interactive Workshop
Waltham, MA

SEPTEMBER 10-12, 2018
Mastering EU Medical Device Regulation
Philadelphia, PA

Training Programs

JULY 1-31, 2018
Program Phlebotomy Training — Two Day Training
Various locations


JUNE 21, 2018
The Real Impact of Common Rule in 2018: Understanding Nuances, Facilitating Compliance & Implementing Best Practices
Fully understand the key changes to the Common Rule and how they dramatically impact IRBs and virtually every entity engaged in clinical research. Changes to Informed Consent and Broad Consent, the Implementation of Limited IRB Review and much more.

JULY 11, 2018
Preparing for the MDSAP Audit Process: A Case Study from the Manufacturer’s Perspective
Consultant Connie Hoy takes you through the changes — what’s the same, what’s different about the audit and inspection process as the new Medical Device Single Audit Program (MSDAP).

FDA Plans to Reorganize CDER around Multi-disciplinary Teams and to Streamline Reviews of New Drug Applications

June 11, 2018

A new reorganization at the FDA’s Center for Drug Evaluation and Research will assign multidisciplinary teams to work on new drug applications from the beginning of the regulatory process, will centralize project management under the Office of New Drugs, and increase the number of offices overseeing review divisions from five to nine and increasing the overall number of review divisions from 19 to 30, the agency announced June 4.

Effective Date for Medical Device Clinical Trials Rules Included in HHS Regulatory Agenda

June 11, 2018

HHS will publish its semi-annual regulatory agenda on Monday, and it includes a February 21, 2019, effective date for a new rule that will require that data from medical device studies conducted outside the U.S. be gathered in accordance with good clinical practices, including review and approval from an independent ethics committee and well-documented informed consent. The agency’s final rule applies to data intended to support IDE applications, 510(k) submissions, and de novo classification requests, as well as applications for premarket approval, product development protocols and humanitarian device exemptions. It also applies to bench and in vitro diagnostic studies of de-identified specimens. The new mandates would replace the current pre-market approval regulations that require clinical studies to conform to the Declaration of Helsinki or the law of the country where the research is conducted, whichever carries greater protection for human subjects, the FDA said. The rule does not apply to all clinical investigations performed overseas, but only sets criteria for FDA acceptance of data used to support device marketing applications or submissions.