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New ICH E6 to Place More Demands on Trials, but COVID-19 Could Help Ease Adjustments

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New ICH E6 to Place More Demands on Trials, but COVID-19 Could Help Ease Adjustments CenterWatch Join the CenterWatch Community! Weekly May 11, 2020 COVID-19 Update…2 Industry Briefs …3 Up and Coming…5 Pandemic Is Expediting Protocol Finalization Drug & Device Pipeline News…10 in COVID-19 Studies Twenty-eight drugs and devices have entered a new trial phase this week. By James Miessler weeks, says Suzanne Caruso, WCG Clinical Research Center Spotlight…12 he worldwide rush demanded by the vice president of clinical solutions. pandemic to develop and/or identify “We have a virus that basically didn’t exist T a potential treatment or vaccine five months ago, and now we have more WEBINAR has culminated in remarkable success in than 950 active trials,” Caruso said at a WCG expediting COVID-19 trials, and the lessons Clinical webinar last week. “Those are indus- Final ICH E6 (R2) Guideline learned are likely to be applied even after try-sponsored trials, those are investigator- on Good Clinical Practices the pandemic is over. initiated trials. I think [the pandemic] forced The Real Impact of The pandemic has led to a rapid speed- a speed, and speed to getting trials ongoing the Changes MAY up in the time it takes to get from protocol is going to have a lasting impact on the clini- finalization to first patient visit for COVID-19 cal trial landscape beyond COVID.” REGISTER 27 studies. Investigators normally would finalize The numbers show that non-COVID, their trial protocols in a six-month process — industry-sponsored trials have seen an perhaps three with great efficiency — and enormous deceleration in participant en- LEAD GENERATION then proceed with site selection, contracting, rollment and a massive increase in holds as Generate Leads budgeting and other tasks. Now, the majority a result of the pandemic. Prior to January, While Building of COVID trials are going from having a final seven clinical trials were put on hold per Credibility and Trust protocol to first patient first visit in just four see Pandemic Is Expediting on page 7 » Webinars White papers New ICH E6 to Place More Demands on Trials, but COVID-19 Could Help Ease Adjustments POSITION YOURSELF AS A THOUGHT LEADER By Elizabeth Tilley Hinkle The introduction in E6(R2) of risk-based ust two years after releasing a major re- management and quality tolerance limits vision of its good clinical practice (GCP) (QTLs) caused the biggest problems, Crissy J guideline, the International Council MacDonald, vice president of client delivery June 22 – July 2, 2020 on Harmonization (ICH) is planning a new at life sciences consulting firm The Avoca update that would require additional adjust- Group, said at a CenterWatch webinar last MAGI's Clinical Research ments from sponsors and sites that still may week. She noted that difficulties in these Cloud Conference 2020 be trying to catch up with the first revision. areas could, in fact, greatly affect individual 48 sessions and workshops Surprisingly, the COVID-19 pandemic could organizations’ ability to comply with the over eight days in eight tracks REGISTER end up making that task easier. upcoming E6(R3). ICH announced in November 2019 that According to a poll of 188 industry repre- it planned to again revise ICH E6 — Good sentatives attending the May 5 CenterWatch Clinical Practice, to fill gaps in areas of the webinar on the forthcoming E6(R3) guid- guideline that were not addressed in a 2016 ance, a mere 8 percent have successfully The CRC’s Guide to Coordinating revision. ICH’s announcement that it would completed adoption of the current E6(R2) The CRC’s Guide Clinical Research to Coordinating Clinical Research revise E6 again caused consternation within and 17 percent were less than halfway Stay informed and be an industry still grappling with challenges pre- through that process. Another 31 percent prepared to respond to sented by the 2016 revision, known as E6(R2). see New ICH E6 on page 8 industry changes. » FOURTH EDITION Sandra “SAM” Sather, MS, CCRC ORDER TODAY Volume 24, Issue 19. © 2020 CenterWatch WCG | CWWeekly May 11, 2020 2 of 12 COVID-19 Update COVID-19 Drug Research London’s Guy’s and St. Thomas’ Hos- agent and have advanced it to testing. The Roundup pital will run a trial of convalescent plasma drug is designed to disrupt interaction of Below is a roundup of research activity for treating COVID-19. The treatment uses do- the virus’ endoribonuclease with a protein on COVID-19 vaccines and treatments for nated blood plasma from patients that have necessary for its replication. the past week. To see last week’s column, recovered from the virus and transfuses it Amgen said it has plans to test its block- click here. into COVID-19 patients whose bodies are not buster psoriasis drug Otezla (apremilast) as COVID-19 Vaccines: making enough antibodies to fight the virus. a possible coronavirus treatment. The com- Pfizer and BioNTech have begun a U.S. Glenmark Pharmaceuticals has re- pany expects to begin trials of the drug in trial of COVID-19 vaccine candidates at the ceived approval from the Indian government the coming weeks and is looking to study the NYU Grossman School of Medicine and the to conduct COVID-19 trials of the antiviral drug in multiple scenarios. Amgen CEO Rob- University of Maryland School of Medicine. favipiravir, which is approved for treating ert Bradway said the drug could help prevent The phase 1/2 study will assess four mRNA influenza in Japan. The randomized study will respiratory stress in late-stage patients. vaccine hopefuls in one continuous trial have 150 mild-to-severe coronavirus patients. Incyte and Novartis plan to initiate that will involve 360 healthy subjects be- Massachusetts General Hospital will another phase 3 COVID-19 trial of their JAK tween 18 to 55 and 65 to 85 years of age. conduct a trial of Mallinckrodt’s INOmax inhibitor Jakafi (ruxolitinib). The study will Predictive Oncology is developing a (nitric oxide) for treating low blood-oxygen evaluate the drug in coronavirus patients on COVID-19 vaccine using a novel nanopar- levels in patients with severe COVID-19 mechanical ventilation and ones who have ticle vaccine platform. The company said lung complications. Mallinckrodt previously acute respiratory distress syndrome. The two its next move is to seek quotes for a phase received Canadian approval for a trial of have already launched a trial of the drug on 1 trial from CROs approved by the HHS’s high-dose inhaled nitric oxide therapy to COVID-19 patients with cytokine storm. Biomedical Advanced Research and Devel- treat COVID-19 infections and associated Researchers at Royal Oak, Mich.’s Beau- opment Authority (BARDA). lung complications. mont Hospital are enrolling patients in a Moderna is planning to begin phase Eli Lilly and Junshi Biosciences have phase 2 trial to evaluate a combination of 3 trials of its coronavirus vaccine by early teamed up to develop antibodies that can naltrexone and ketamine as a COVID-19 summer, speeding up its original timeline potentially prevent and/or treat COVID-19. treatment. The study is trying to determine that had the trials starting in the fall. The Eli Lilly and Junshi plan to begin clinically if the combination can lessen the severity of agency recently cleared a phase 2 trial for testing the lead antibody, JS016, in the symptoms by reducing inflammation. the vaccine candidate, mRNA-1273, which second quarter of this year. CSL Behring Australia said it is cur- involves approximately 600 participants. Vir Biotechnology and Alnylam Phar- rently developing an anti-coronavirus COVID-19 Treatments: maceuticals have identified an investiga- plasma product for potential use in Aus- Montefiore Health System, Albert tional therapeutic, VIR-2703, as a possible tralia. The treatment, known as COVID-19 Einstein College of Medicine and NYU COVID-19 treatment. The inhaled SARS-CoV- Immunoglobulin, is being designed for Langone have launched a clinical trial 2-targeting small-interfering RNA (siRNA) severely ill patients, particularly ones studying the effectiveness of convalescent blocks production of specific proteins and that are progressing toward being put on plasma in COVID-19 patients. The trial will could prevent or treat a coronavirus infection. ventilation. It is being developed at the enroll 300 people that have COVID-19 Anixa Biosciences and OntoChem have company’s advanced manufacturing site in respiratory symptoms, with half of them identified a potential COVID-19 therapeutic Broadmeadows, Victoria. receiving a placebo. CTI BioPharma has begun a phase 3 trial to evaluate its oral multikinase inhibitor pacritinib in patients hospital- CenterWatch Weekly ized with severe COVID-19. The trial, (ISSN 1528-5731) CenterWatch Main and Editorial Offices 300 N. Washington St., Suite 200, Falls Church, VA 22046 Beth Belton Editorial Director which is expected to enroll patients in Tel: 866.219.3440 • 617.948.5100 Stephanie Akers Production [email protected] / [email protected] both the U.S. and Europe in May, will Russell Titsch Business Development Director Permission requests can be emailed to [email protected]. compare pacritinib plus the standard of © 2020 CenterWatch. No part of this publication may be distributed care to placebo plus standard of care in or reproduced in any form or by any means without the express Advertising packages and reprints are available: written consent of the publisher. Email [email protected] or call 703.538.7651. 358 hospitalized patients. © 2020 CenterWatch CWW2419 WCG | CWWeekly May 11, 2020 3 of 12 Industry Briefs WHO Outlines Criteria for recruitment, enrollment, site visits New Transplant Guidance COVID-19 Vaccine Challenge and monitoring. PPD says it is working Recommends Endpoints, Trial Trials closely with customers to minimize Designs for CMV Drugs A working group of the World Health Orga- trial disruptions and ensure continued Sponsors of drugs to treat or prevent cyto- nization (WHO) has indicated its support access to drug supplies for patients in megalovirus (CMV) disease in organ or stem of COVID-19 vaccine challenge studies, but ongoing studies.
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