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Research Center Spotlight CenterWatch Join the CenterWatch Community! Weekly November 9, 2020 COVID-19 Update…2 Industry Briefs …3 Up and Coming…4 Complex Safety Reporting Processes Drug & Device Pipeline News…8 Overburden Sites, Experts Say Thirty-five drugs and devices have entered a new trial phase this week. By Charlie Passut safety issues with little or no evidence of cau- Research Center Spotlight…10 linical trial safety reporting proce- sality or relevance to the site, leaving trial staff dures have always been a challenge to investigate and determine if they need C for sites, taking a disproportionate to report the issues to their IRBs. Without VIRTUAL WORKSHOP amount of time and money, but three fac- causality, “most sponsors will take the most DATA INTEGRITY FOR GCP tors are making the task even more difficult conservative approach and call it related,” says PROFESSIONALS: CORE and lengthy for today’s sites: sponsors that Leslie Williams of Pharmacovigilance Consult- REQUIREMENTS, EXPECTATIONS AND CHALLENGES over-report, lack of global harmonization of ing. “That’s usually outlined in the protocol.” Tuesday, Dec. 1 and Thursday, Dec. 3, 2020 reporting rules and the pressures of a global “Many companies still distribute all safety Presented by WCG-CenterWatch and pandemic that require rapid response. reports to all sites and ethics committees Cerulean Associates LLC Safety reporting is one of the largest hid- due to a literal interpretation of [good clini- REGISTER TODAY den costs in drug development. And staying cal practice rules],” a practice that Steven on top of dozens of countries’ rules is a Beales, senior vice president for WCG Clini- daunting task, but it is essential to streamlin- cal’s scientific and regulatory division, refers ing the reporting process and alleviating the to as “brute force distribution.” burden on sites. Beales says one of the largest reporting Part of the problem lies with sponsors costs he has ever seen for a single clinical that pepper sites with unnecessary reports of see Complex Safety Reporting on page 5 » Questions of Cost, Accountability Dominate Discussion of Trials’ Post-Pandemic Future By Leslie Ramsey changed, said Karri Venn, CEO of site NEW WHITE PAPERS AVAILABLE s the industry moves beyond the network HyperCORE International. On the pandemic, sites and sponsors must other hand, Venn said, some innovations People Behind A ask themselves which practices de- that lessen the need for on-site operations the Platform veloped to meet the needs of remote opera- actually can save money. From LMK Clinical tions should carry forward and, ultimately, “I think there’s a nervousness, even Research Consulting who will cover the cost of new technology as you add in virtual telemedicine, that LEARN MORE and methods. the budgets will actually decrease,” she The telemedicine and home patient told attendees at the 2020 MAGI Clinical centerwatch.com/whitepapers visits, remote monitoring, electronic Research vConference last week. “These consent systems and direct-to-patient are real things that we have to think FREE WEBINAR delivery arrangements that have proven about” when deciding how to continue so successful in keeping trials operating and survive. NOVEMBER during the crisis all come with additional Still, many sites say they are ready to 17 expenses that may not be covered in cur- take on the challenge of new methods. rent site budgets. Asked who should manage direct-to-home Vendor Oversight New methods and technology can visits, for example, 56 percent of attendees Ensuring Regulatory Compliance by Assessing Study Risks be expensive, and site budgets haven’t see Questions of Cost on page 6 » Sponsored by Oracle Health Sciences REGISTER Volume 24, Issue 43. © 2020 CenterWatch WCG | CWWeekly November 9, 2020 2 of 10 COVID-19 Update COVID-19 Drug Research the vaccine, and Chile’s president has also An interim analysis of data from No- Roundup said the country should have access to 7.6 vartis’ canakinumab trial shows it failed COVID-19 Vaccines: million doses through the World Health to meet its primary endpoint, indicat- The Coalition for Epidemic Prepared- Organization’s COVAX initiative. The Astra- ing that canakinumab plus standard of ness Innovations (CEPI) has agreed to Zeneca trial will follow a COVID-19 vaccine care did not demonstrate a significantly invest up to $328 million to help China’s trial in Chile by Johnson & Johnson, which greater chance of survival for patients Clover Biopharmaceuticals develop SCB- is currently under way, as well as another without the need for invasive mechani- 2019, a COVID-19 vaccine candidate. The trial by Sinovac. cal ventilation compared with placebo CEPI funding will support a global phase Anvisa, Brazil’s health regulator, has plus standard of care. The trial also did 2/3 study and will also finance licensing said Johnson & Johnson’s clinical trial of not meet its key secondary endpoint of and distribution. The late-stage study of its COVID-19 vaccine can resume after it reducing the COVID-19-related death the vaccine is planned to start before the was paused in mid-October following an rate during the four-week period after end of the year and will enroll vulner- unexplained illness in one participant. The treatment. The results do not affect any able patients, including autoimmune and planned 60,000-person phase 3 trial is be- other ongoing trials for canakinumab, immunocompromised patients, as well as ing conducted in 11 states in Brazil and is the company says, including investiga- children and pregnant women. expected to enroll up to 7,560 adults. tions for the treatment of nonsmall-cell A phase 1 trial of CureVac’s COVID-19 The first doses of CanSino Biologics’ lung cancer. vaccine candidate CVnCoV shows the vac- COVID-19 vaccine have been delivered A data monitoring committee review- cine generates immune responses and is to Mexico for a late-stage trial. The trial ing safety and efficacy data from the generally well-tolerated in healthy volun- is set to enroll between 10,000 and UK-based RECOVERY trial evaluating teers. The early-stage trial included more 15,000 volunteers. Regeneron’s REGN-COV2 in hospitalized than 250 healthy patients between the COVID-19 Treatments: patients has given the trial the go-ahead ages of 18 and 60 and studied CVnCoV Vancouver-based Algernon Pharma- to continue recruitment of eligible doses ranging from 2µg to 12µg. Accord- ceuticals plans to conduct a late-stage patients to all study arms. Researchers in ing to the company, the positive interim study to evaluate an orally delivered drug, the trial are also planning to test whether results support the move to assess the NP-120 (ifenprodil), as a COVID-19 treat- aspirin can reduce the risk of blood clots highest dose level, 12µg, in a pivotal ment. The drug was originally developed in COVID-19 patients. More than 2,000 phase 2b/3 trial. Currently, CureVac’s vac- in the 1990s by Sanofi to treat peripheral patients will receive a daily 150mg aspi- cine is being tested in a phase 2a trial in circulatory disorders and it is still used in rin dose in addition to standard of care to Peru and Panama. generic form in Japan. Participants in the see if the drug improves mortality rates A COVID-19 vaccine candidate devel- phase 3 study will receive either standard after four weeks compared to standard of oped jointly by the Chinese Academy of of care, standard of care plus ifenprodil 60 care alone. Sciences and Chongqing Zhifei Biological mg or standard of care plus ifenprodil 120 Eli Lilly has received permission to Products has been proven safe and ca- mg. The researchers hope to determine conduct phase 3 trials of baricitinib in pable of generating immune responses in whether the drug improves blood oxygen India. The trials will compare the effect of a healthy participants, according to findings levels and reduces mortality, as well as daily 4mg dose of the drug to placebo on from phase 1 and 2 trials. time spent in an intensive care unit. disease progression. Symvivo has dosed the first healthy volunteer in the company’s phase 1 clinical trial of oral COVID-19 vaccine candidate bacTRL-Spike. The phase 1 trial is being CenterWatch Weekly conducted in Australia with Symvivo’s (ISSN 1528-5731) CenterWatch Main and Editorial Offices 300 N. Washington St., Suite 200, Falls Church, VA 22046 Beth Belton Editorial Director partner Nucleus Network. Tel: 866.219.3440 • 617.948.5100 Stephanie Akers Production [email protected] / [email protected] Chile’s health regulators have given Russell Titsch Business Development Director Permission requests can be emailed to [email protected]. AstraZeneca the green light to conduct © 2020 CenterWatch. No part of this publication may be distributed clinical trials of its COVID-19 vaccine. Previ- 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. ously, Chile reserved 14.4 million doses of © 2020 CenterWatch CWW2443 WCG | CWWeekly November 9, 2020 3 of 10 Industry Briefs RWD in Randomized Trials Industry Backs Direct-to-Patient inventory management. In addition, around Must Apply Conventional Trial Clinical Supply in Remote Trials 21 percent of respondents indicated that Standards, UK Says Clinical trial sites are backing the concept of using a central pharmacy could help reduce Randomized clinical trials (RCT) in the UK offering direct-to-patient (DTP) options for the number of needed sites/pharmacies. can use real-world data (RWD) as long as delivering clinical supplies in a remote or The survey also found that a signifi- they apply the same data standards used home-based study, a new survey shows.
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