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Weekly April 12, 2021 Join the CenterWatch Community! Weekly April 12, 2021 COVID-19 Update…2 Industry Briefs …4 Up and Coming…6 Sites Push Back on the Burden of Handling Drug & Device Pipeline News…10 Sponsors’ Unnecessary Safety Reports Forty-four drugs and devices have entered a new trial phase this week. By Charlie Passut “Sites are really starting to take a stand,” Research Center Spotlight…13 ponsors are overwhelming sites said Steven Beales, senior vice president with a growing volume of safety for WCG’s scientific and regulatory division. reports, and sites are fighting back. “Some of the biggest [academic] sites S VIRTUAL WORKSHOP The magnitude of the problem of un- are coming back to sponsors and saying necessary and overly burdensome safety enough is enough. We’re going to see Effective Root Cause Analysis and CAPA Investigations for reporting is getting worse; in the past more and more of this pushback from the Life Sciences three years, some sponsors of oncology nonacademic sites if sponsors don’t do Tuesday, June 22 - Thursday, June 24, 2021 drugs have unleashed a five-fold increase something,” Beales said. Presented by WCG FDAnews and in safety reports. Part of the problem is that some spon- ValSource Learning Solution Safety reporting procedures have always sors and CROs do not differentiate between REGISTER TODAY been a time-consuming challenge for sites, adverse events caused by the investigational but sponsor and CRO safety reports that product and those related to factors outside FREE WEBINAR duplicate information or are not needed the trial, classifying everything as requiring APRIL increase the workload for staff who need to documentation in a suspected unexpected process the reports. The rising complexity of serious adverse reaction (SUSAR) report. 15 trials and the growing number of oncology “Sponsors think they’re following the letter Five Telltale Signs You’re Ready trials is amplifying the problem. see Unnecessary Safety Reports on page 7 » for an Electronic TMF System Deputy Commissioner Says FDA Working at Sponsored by REGISTER Top Speed to Develop RWD Skills Agatha, Inc. By Charlie Passut familiarity with working with RWD to create ore than 60 percent of current an inclusive approach that weighs the total- drug submissions to the FDA ity of the evidence. M include real-world data (RWD) in “You may think that we’ve known the some form, and agency officials are saying scientific methods for observational research the FDA needs to expedite honing its skill set for a very long time, but in fact these data- in regulating the use of it in trials. sets are different,” Abernethy told attendees Amy Abernethy, principal deputy com- of the Pharma Clinical 2021 Conference missioner for food and drugs at the FDA, last week. “We need to develop definitions said the agency needs to strengthen those for variables within the datasets that are skills as soon as possible. “RWD is becoming common and well-understood across differ- Without a working knowledge progressively more common and important,” ent datasets. We need to develop ways of of EU privacy laws and regulations, she said. working with datasets when the informa- you run the risk of not being compliant. Abernethy said the FDA is learning tion is rapidly accumulating and also when If your clinical trials how to analyze real-world datasets better the day-to-day delivery of care is adjusting involve the personal data and how to incorporate them as part of an across time. And we really need to be able of EU-based individuals, you need to understand overall evidence package. But she said the to rapidly convey the methods as they the rules that apply to Data Privacy in the EU see Develop RWD Skills on page 8 data collection. agency still needs to develop a comfort and » A Guide for Clinical Trial Sponsors and Sites ORDER TODAY Vol. 25, Issue 15. Copyright © 2021 by WCG CenterWatch CenterWatch Weekly April 12, 2021 2 of 13 COVID-19 Update COVID-19 Drug Research found that the nasally administered anti-CD3 COVID-19 Vaccines: Roundup antibody treatment was well-tolerated and Johnson & Johnson (J&J) is now dosing COVID-19 Therapies: associated with reduced pulmonary and sys- adolescents with its COVID-19 vaccine can- Eli Lilly’s and Incyte’s Janus kinase (JAK) temic inflammation. Treatment with Foralum- didate Ad26.COV2.S in an ongoing, placebo- inhibitor Olumiant (baricitinib) proved unable ab in this prior study reduced several markers controlled phase 2a trial. The randomized to significantly reduce progression to nonin- of inflammation, including C-reactive protein trial was launched in September and initially vasive ventilation for COVID-19 patients in a and interleukin-6. Another recent study from included healthy adults between 18 and phase 3 trial, though the drug still managed Harvard Medical School and a Brazilian CRO 55 years of age as well as individuals 65 to significantly reduce the risk of death. The also found that Foralumab reduced pulmo- years and older. The amended protocol now companies announced last week that the nary and systemic inflammation. includes adolescents and teenagers between phase 3 study didn’t meet its primary end- Sound Pharmaceuticals is planning to 12 and 17 years of age. Currently, the study is point, with only 2.7 percent of patients given launch two phase 2 trials to study SPI-1005, enrolling participants from the UK and Spain, the JAK inhibitor proving less likely than those an oral capsule comprising small-molecule but J&J expects to soon start enrollment who received standard of care to progress to ebselen, in patients with moderate-to-se- in the U.S., Canada and the Netherlands. In ventilation or death, a finding that was not vere COVID-19. While the therapy was devel- February, the FDA granted an Emergency Use statistically significant, the companies said. oped for neurotologic, neuropsychiatric and Authorization (EUA) to the company’s single- Grifols has announced that its investi- respiratory indications, a Cooperative Grant dose version of its vaccine, but this authoriza- gational immunoglobulin therapy CoVIg-19 award of $3.1 million from the National tion restricts the use of the vaccine to adults. showed no benefit in 593 hospitalized adults Institutes of Health’s National Center for The EUA was based on findings from the with COVID-19 who participated in the phase Advancing Translational Sciences has pro- phase 3 ENSEMBLE trial, which showed the 3 INSIGHT-013 trial. The therapy, which con- vided an incentive for Sound to investigate vaccine was 66 percent effective at prevent- sists of antibodies from patients who have SPI-1005 in treating the novel coronavirus. ing moderate-to-severe COVID-19 approxi- recovered from COVID-19, was developed in A total of 120 patients with moderate-to- mately four weeks following vaccination. partnership with Takeda Pharmaceutical, severe COVID-19 will be enrolled in the The University of Oxford is pausing a trial CSL Behring, Emergent BioSolutions and two randomized, placebo-controlled trials. evaluating AstraZeneca’s COVID-19 vaccine other companies involved in the CoVIg-19 Patients will receive either SPI-1005 or pla- in children and teenagers after concerns Plasma Alliance. The late-stage trial was con- cebo for up to seven or 14 days. The primary were raised that the vaccine may be associ- ducted across 63 sites in the U.S. as well as 10 outcome is the number of participants with ated with rare cases of blood clotting. Back other countries. The investigators assessed treatment-related adverse events. Additional in February, researchers of the study started whether the plasma treatment reduced the secondary study outcomes include clinical to recruit 300 people between the ages of risk of COVID-19 progression when added to improvement and degree of supplemental six and 17 years who were to receive the standard of care, including Gilead Sciences’ oxygen required during treatment. AstraZeneca vaccine or a control meningitis remdesivir. There was no difference between Findings from a phase 1 study show that vaccine. The UK’s Medicines and Healthcare patients who received CoVIg-19 vs. standard UNION therapeutics’ COVID-19 inhaled products Regulatory Agency (MHRA) is now of care only in regard to clinical status at day and intranasal niclosamide candidates are recommending that people under the age seven. Following the announcement of the safe when administered to healthy people. of 30 try to get a different vaccine if pos- study results, the CoVIg-19 Plasma Alliance The study included 44 healthy participants sible. Previously, the MHRA had said that the announced it plans to disband. who were randomized to either one of the benefits of the COVID-19 vaccine outweigh Tiziana Life Sciences announced it will UNI911 candidates (UNI91103 or UNI91104) the potential risks. The World Health Orga- soon launch a phase 2 trial for Foralumab, the or placebo. The trial met its endpoints and nization has also echoed these sentiments. company’s nasal anti-CD3 human monoclo- demonstrated that the niclosamide solution The European Medicines Agency has not nal antibody, in hospitalized patients with was well-tolerated when administered both identified a causal association between moderate-to-severe COVID-19. The random- intranasally and through inhalation. There was AstraZeneca’s COVID-19 vaccine candidate ized, placebo-controlled trial will be conduct- no indication of systemic accumulation of the and blood clots. ed in Brazil. Patients enrolled in the study will products in the blood. These findings pave the A phase 2 study led by the NIH’s National receive standard-of-care background therapy way for future studies that will examine the Institute of Allergy and Infectious Diseases is with or without Foralumab. A previous study prophylactic and treatment efficacy of these looking to assess the risk of allergic reactions in patients with mild-to-moderate COVID-19 drug candidates in patients with COVID-19.
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