Jim Corrigan is the President and CEO of ERT, Safety & Efficacy Endpoint Collection if (form.indexOf('?')  iframe.setAttribute('height', 850); > 0) { iframe.setAttribute('src', form + params);  iframe.setAttribute('frameborder', 0); Q: How has the COVID-19 pandemic impacted clinical operations? Post-Approval Login The FDA says some clinical trials may have to go virtual as coronavirus travel restrictions and supply chain disruptions hit the drug industry. Imaging across our endpoint collection modalities and increase the optionality our customers need to successfully execute their specific safety and efficacy endpoint data collection. params = params.replace(/[? Throughout the pandemic, our imperatives have been ensuring the safety of our employees and our customers while continuing to meet our operational commitments.  var params = window.location.search;  iframe.setAttribute('allowTransparency', 'true'); We anticipate that many in the industry will continue to leverage virtual trial capabilities well after the pandemic ends, based on the improved efficiencies these technologies offer to all clinical trial stakeholders. Leadership The generator back-up of hospitals and clinics doesn’t exist in private homes. For example, we’ve recently launched additional, that are enabling patients to easily interact with investigative sites, and our COVID-19 Dashboard is integrating data on coronavirus infection rates in geographic areas surrounding study investigative sites, so sponsors and CROs can identify and proactively intervene where patient and site compliance to study protocols may be at risk. Peru has temporarily suspended clinical trials of a COVID vaccine made by Chinese drug giant Sinopharm after detecting neurological problems in one of its test volunteers. It’s worth noting, however, that both the FDA and the UK’s MHRA have released guidance pointing to an element of regulatory “flexibility” when it comes to moving elements of ongoing trials to a virtual set up while the world is gripped by the Covid-19 crisis. eCOA  iframe.setAttribute('src', form + params); Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine. if (form.indexOf('?')  var iframe = document.createElement('iframe'); Learn More Share. Effective virtual enablement requires collaboration and planning between all trial stakeholders.  iframe.setAttribute('frameborder', 0); }  iframe.setAttribute('height', 500); params = params.replace(/[?  var params = window.location.search; ClinOne Partners with CQuentia to Add COVID-19 and Comprehensive Precision Medicine Testing to Their Suite of Clinical Trial Operating Services and Virtual Trials . Shifting the entire company to working from home was essentially seamless. Free Webinar | Managing Clinical Trial Data Collection for Success During and After COVID-19: From Virtual Trials, EDC to DDC, BYOD, and Beyond.  iframe.setAttribute('type', 'text/html'); Siteless trials mean (mostly) no medical staff, so patients are responsible for receipt and storage of IMPs, dosage adherence, and entering and (often) transmitting their own data at the right intervals; that is a lot of trust placed in a patient that is usually placed in trained medical staff. Will a vaccine for COVID-19 be safe? Impressum How investigators and sponsors should manage clinical trials during COVID-19. Virtual is now, in many cases, the only way to complete an ongoing study, to start a new one, and to avoid haemorrhaging cash and opportunity.  iframe.style.border = '0';

They conducted a randomized, controlled, virtual trial of the malaria drug hydroxychloroquine to find out if it was effective at protecting people from COVID-19 (the results found that it was not). Remote Clinical Trials are led and coordinated by a local investigative team, but are based remotely, within a given community, state, nation, etc. Careers  iframe.setAttribute('frameborder', 0); ]/g, "&");  var thisScript = document.scripts[document.scripts.length - 1]; (Figure 1).  var thisScript = document.scripts[document.scripts.length - 1]; thisScript.parentElement.replaceChild(iframe, thisScript); var form = 'https://content.ert.com/l/71652/2018-07-18/5wcs1t'; } While regulators everywhere have issued guidance on virtual/decentralised trial processes, they are as new to the regulator as they are to the sponsor. Scott Gottlieb: Expect delays in clinical trials unrelated to Covid-19 However, virtual trials have their own barriers to entry. I see a post-pandemic scenario where the industry emphasizes optionality and leverages advanced technologies to better engage patients in clinical trials and optimize in-person investigative site visits for important complex trial aspects that uniquely require the capabilities of site personnel. LENEXA, KS — The U.S. Food and Drug Administration approved Moderna’s COVID-19 vaccine Friday, after months of data collection from clinical research sites like the Johnson County Clin-Trials. thisScript.parentElement.replaceChild(iframe, thisScript); var form = 'https://content.ert.com/l/71652/2019-08-22/6w37fj?Hidden_Product_Line=COVID'; The device cannot be easily replaced – at best, delivery of a new device is hours away, and that is once the patient and the study team know it has a fault. ERT has always been at the forefront of delivering innovative technology solutions that help our customers accelerate clinical development. enables patients to easily conduct their own cardiac safety assessments from home by themselves, via a novel hand-held ECG device deployed in partnership with AliveCor (Figure 2).  iframe.setAttribute('height', 900);

 iframe.setAttribute('src', form + params); > 0) { Solution Specialist COVID-19, however, threw a wrench in the traditional method of clinical trials, in which participants usually travel to a clinical site for an in-person evaluation. Figure 2: Cardiac data from the KardiaMobile 6Lis captured by patients and integrated into ERT’s software to ensure patient safety during virtual clinical trials. Reliance on technology away from the site can present significant challenges, especially so in populations where not having to visit a site is of the most benefit, like the elderly. Q: How is ERT innovating in light of the global pandemic? Animal testing, human clinical trials and post-approval surveillance give us good grounds to believe that a future approved vaccine will work and be safe. What happens if a drug product needs to be refrigerated but the patient’s home has a power cut? Patient Support Programs, About  var iframe = document.createElement('iframe'); iframe.setAttribute('src', form + params); Again, this works particularly well for patient populations that typically have a high risk of study drop-out. So, virtual trials – so far, so easy? Published 19 March 2020 Last updated 21 May 2020 — see all updates. COVID-19 clinical trials face unique hurdles in enrollment, too. 11+ trials and studies around the world, including a collaboration with the University of Texas Medical Branch and Q2 Solutions. Improve patient recruitment and retention for your clinical trials with VirTrial, a telehealth platform for managing decentralized and virtual clinical trials. In many cases, the data can be collected and sent for analysis automatically, completely ruling out the ‘I forgot to do it’ element. PHILADELPHIA (WPVI) -- The Action News Troubleshooters are warning about phony clinical trials for COVID-19 that promise big bucks to participants.  iframe.setAttribute('width', '100%'); With Covid-19 delivering a great big slap in the face to ongoing and planned studies, the future of clinical trials as virtual has rapidly become the very urgent present. ERT has always been at the forefront of delivering innovative technology solutions that help our customers accelerate clinical development. So what are the options for virtualising your study? Virtual trials have long been technically feasible, but cultural barriers have slowed their uptake.  var iframe = document.createElement('iframe'); A clinical study is nothing without data, and a considerable amount of heavy lifting in the value of virtual trials is done via the ease and speed of data collection afforded by the wealth of technology on the market. iframe.setAttribute('src', form + params); Even the largest organisations can be hacked, as has been shown on repeated occasions, and one can understand the pause for thought created by the risks here. The remote approach affords many of the benefits of multi-site trials without the same barriers. }  iframe.setAttribute('allowTransparency', 'true'); Click here to access.  iframe.setAttribute('width', '100%');  iframe.setAttribute('height', 850); However, with Covid-19 delivering a great big slap in the face to ongoing and planned studies, the future of clinical trials as virtual has rapidly become the very urgent present. Data protection laws and requirements are tightening everywhere, and there are definitely concerns about the sharing of patients’ personal and biometric data over the internet. However, with Covid-19 delivering a great big slap in the face to ongoing and planned studies, the future of clinical trials as virtual has rapidly become the very urgent present. Social media, the untapped golden goose of patient engagement, allows for global contact with prospective subjects and the targeting of them using a plethora of AI-driven tools. iframe.setAttribute('src', form + params);  iframe.setAttribute('width', '100%');  var thisScript = document.scripts[document.scripts.length - 1];  iframe.setAttribute('height', 850); if (form.indexOf('?') While not technically a virtual aspect, in-home nursing for clinical trials provides a hybrid element that is being chosen by more and more studies. params = params.replace(/[? The impact of COVID-19 on ongoing trials, on opening new trial sites in an existing trial, on ongoing recruitment and continued involvement of participants in the trial, or on starting of new trials needs to be considered. By doing so, the industry will benefit from more streamlined clinical trials, expanded patient engagement and accelerated clinical development times.  var thisScript = document.scripts[document.scripts.length - 1]; Of course, these examples are just the beginning of our innovations around patient centered end point capture across all modalities. shares his thoughts on how COVID-19 has impacted clinical development, how ERT is responding, and what we can expect in a post-pandemic world.  var params = window.location.search;  var iframe = document.createElement('iframe'); Business Intelligence Reports The COVID-19 pandemic has disrupted every aspect of the clinical trial ecosystem.  var params = window.location.search; Methods to support remote clinical trials may include: remote recruitment and screening; tele-consent if (form.indexOf('?')  iframe.setAttribute('allowTransparency', 'true'); In addition to our ‘At-Home’ solutions that enable investigative site personnel to capture respiratory and cardiac safety data when they visit patients’ homes, our Patient-Administered ECG Solution enables patients to easily conduct their own cardiac safety assessments from home by themselves, via a novel hand-held ECG device deployed in partnership with AliveCor (Figure 2). ]/g, "&"); As a result, they are now considering, much more ambitiously, the role that virtual capabilities can play in keeping their studies on track, running more efficiently, and offering added patient convenience during and after the pandemic. are all being reimagined and companies are rising to the challenge to seize this opportunity to create positive and sustainable changes. Siteless trial set-ups also significantly speed up enrolment timelines, with patients not having to travel to a site to enrol and give their consent. Partnerships, Contact In a retrospective study published in early October in F1000Research, Ioannidis and his colleagues reviewed COVID-19 clinical trials that occurred within the first 100 days of the pandemic. }  iframe.setAttribute('frameborder', 0); With the time and cost of preparing a clinical trial, sponsors are understandably wary of slipping up when it comes to unfamiliar processes so plenty are still opting for the devil they know. ]/g, "&"); There is no denying that the COVID-19 pandemic has spurred tremendous innovation across our industry. Patient recruitment can be significantly expanded and sped up through decentralised means. Though not without its risks and considerations around staff safety, in-home nursing is by all accounts booming in the Covid-19-impacted trial world.  var params = window.location.search; thisScript.parentElement.replaceChild(iframe, thisScript); var form = 'https://content.ert.com/l/71652/2019-08-22/6w37fj?Hidden_Product_Line=partnershipspage';  var iframe = document.createElement('iframe'); Virtual trial recruitment also has a significant edge on traditional recruitment when it comes to difficult-to-approach patient groups; the elderly, for example, can be recruited and enrolled in the comfort of their own homes, without ever having to visit a site. So, in summary, are virtual/decentralised/DtP trials the future? Processes, models, technologies, etc. with consumer and medical data capture tools, all of which will simplify patients’ participation in clinical trials and improve their overall engagement. As a result they are now adopting, much more ambitiously, virtual trial technologies for  keeping their studies on track, running more efficiently, and offering added patient convenience. Shipping can be direct from manufacturer or pharmacy, or from the clinical trial site – the latter of significant assistance at present for trials that have been interrupted by the Covid-19 pandemic. It’s not all plain sailing. Virtual is now, in many cases, the only way to complete an ongoing study, to start a new one, and to avoid haemorrhaging cash and opportunity.  iframe.setAttribute('height', 850); Wearables and Digital Biomarkers, Data Analytics  iframe.setAttribute('width', '100%'); Figure 1:  Patient devices and telehealth systems are primary data capture tools in virtual trials (Source: ERT Survey, May 2020). Pandemic-driven stay home mandates are causing clinical trial sponsors and CROs to question their dependence on patients’ access to investigative sites for routine aspects of clinical trial data collection. There will be more virtual site visits, which will minimize the need for patients to travel to investigative sites, and increased. The COVID-19 pandemic has turned research business-as-usual upside down.  iframe.setAttribute('width', '100%'); var form = 'https://content.ert.com/l/71652/2019-08-22/6w37fj?Hidden_Product_Line=wearbablesandbiomarkers'; > 0) { There will be more virtual site visits, which will minimize the need for patients to travel to investigative sites, and increased device integrations with consumer and medical data capture tools, all of which will simplify patients’ participation in clinical trials and improve their overall engagement.  iframe.setAttribute('allowTransparency', 'true'); if (form.indexOf('?') thisScript.parentElement.replaceChild(iframe, thisScript);   iframe.style.border = '0'; FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency . Our operations team took extra critical steps to ensure our supply chain was secured with redundant inventory geographically dispersed, and we deployed our business continuity plan to ensure we had safe staffing approaches in place to continue our logistics activities. Q: Have ERT’s business operations changed in light of COVID-19? Events We use cookies to ensure that we give you the best experience on our website. Notably, when asked how they are collecting patient data during virtual trials, the majority of survey respondents indicated patients will use devices and/or telehealth systems for important study data capture. Customer Care  iframe.setAttribute('allowTransparency', 'true'); Yes they are, but they are the present too.  iframe.setAttribute('frameborder', 0); params = params.replace(/[? Locations Direct shipping of investigational medicinal products (IMPs) to the patient is perhaps the aspect of decentralised trials that has been in place the longest. Saskatoon-based VIDO has received authorization from Health Canada to start Phase 1 of its clinical trials for a COVID-19 vaccine.  iframe.setAttribute('type', 'text/html');  iframe.setAttribute('frameborder', 0); Absolutely, but I imagine the Wright brothers had some concerns to start with, and look how that idea took off.  thisScript.parentElement.replaceChild(iframe, thisScript); COVID-19 and the Industry’s Leap into Virtual Clinical Trials, The COVID-19 pandemic has disrupted every aspect of the clinical trial ecosystem. The clinical trial space (and pharma generally) often talks a big game on innovations but fails to implement. params = params.replace(/[? ]/g, "&"); This is causing principal investigators and research staff to find other ways to keep participants connected with studies. For example, we’ve recently launched additional Virtual Visit capabilities that are enabling patients to easily interact with investigative sites, and our COVID-19 Dashboard is integrating data on coronavirus infection rates in geographic areas surrounding study investigative sites, so sponsors and CROs can identify and proactively intervene where patient and site compliance to study protocols may be at risk. > 0) { } We anticipate that many in the industry will continue to leverage virtual trial capabilities well after the pandemic ends, based on the improved efficiencies these technologies offer to all clinical trial stakeholders. Elderly people are the least likely to be tech-savvy, and training them on new devices can be a time-consuming (and therefore expensive) process.  var params = window.location.search;  iframe.setAttribute('allowTransparency', 'true');  iframe.style.border = '0'; Virtual clinical research is still relatively new, and there is a clear hesitance from sponsors to move away from more established models.  iframe.setAttribute('height', 850); We can help you adapt to the new realities of clinical research. A virtual clinical trial is one where patient assessment and data collection do not occur in traditional settings, such as a health centre or hospital, and are instead facilitated via remote interaction.  iframe.setAttribute('type', 'text/html'); Notably, when asked how they are collecting patient data during virtual trials, the majority of survey respondents indicated patients will use devices and/or telehealth systems for important study data capture. All stakeholders have been forced to adapt and in many instances been surprised by the enduring benefits of digital virtual technologies. … Respiratory In this interview, Jim Corrigan, President and CEO of ERT.  iframe.setAttribute('width', '100%'); thisScript.parentElement.replaceChild(iframe, thisScript); var form = 'https://content.ert.com/l/71652/2019-08-22/6w37fj'; Even down to wearables; the first FitBit, a goldmine of personal health data, was released in 2009, but is still not a go-to product for collecting research data. Perhaps one of the most interesting virtual technologies I have personally seen is a ‘smart fridge’ to ensure that temperature-sensitive IMPs are delivered directly to the patient’s home, stored correctly, and with all potential temperature excursions monitored by tracking the opening and closing of the fridge door – the fridge even featured a touch screen that collected data from the patient each day when they removed their dose. As a technology company, we’ve always embraced a flexible approach to work arrangements and many of our employees already work remotely. Starting a new trial currently, outside of Covid-19 studies, is almost impossible without substantial virtual elements in place.  iframe.style.border = '0'; Clinical trial service providers report a spike in demand for virtual trials as pharmaceutical companies try to prevent the coronavirus outbreak from derailing their drug rollouts.  iframe.style.border = '0'; In addition to our ‘At-Home’ solutions that enable investigative site personnel to capture respiratory and cardiac safety data when they visit patients’ homes, our.  iframe.setAttribute('width', '100%'); Processes, models, technologies, etc. Are there concerns and challenges? Clinical trials. About ERT Data Insights Virtual Clinical Trials COVID -19 has accelerated industry efforts to implement trial design, but ERT has collected data outside of site visits for decades. Legal and Privacy Terms “We’ve seen a lot of interest in telemedicine” and virtual clinical trials, says Kim Kundert, RN, BSN, vice president of operations at VirTrial, a technology firm with a virtual care platform customized for clinical trial use. 2 Note: Standardized drug names automatically assigned by the National Library of Medicine based on drug names provided by the Responsible Party.  iframe.setAttribute('frameborder', 0); One of the few positives from the pandemic is the opportunity to operate differently. COVID-19 has impacted essentially all clinical operations to some extent and accelerated the evolution in virtual engagement dynamics between patients, sites, and sponsors. I see a post-pandemic scenario where the industry emphasizes optionality and leverages advanced technologies to better engage patients in clinical trials and optimize in-person investigative site visits for important complex trial aspects that uniquely require the capabilities of site personnel.  iframe.setAttribute('allowTransparency', 'true'); A COVID-19 trial matcher to help funnel patients to COVID-19 trials 3D print of a spike protein of SARS-CoV-2, the virus that causes COVID-19, in front of a 3D print of a SARS-CoV-2 virus particle. } Volunteer for COVID-19 Clinical Trials NIAID is conducting and supporting clinical trials evaluating therapies and vaccine candidates against severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), as well as studies of people who have recovered from infection. if (form.indexOf('?')  iframe.setAttribute('width', '100%'); Clinical Trial Continuity During COVID-19 COVID-19 is driving change in clinical development, bringing trials closer to patients and expanding regulatory guidance to include virtual trial capabilities – from remote monitoring to telemedicine, direct-to-patient shipment of investigational medicines and the use of home health nurses in clinical research. There are numerous way in which a clinical trial can be made virtual, and I’ll explore some of those here; I’m including in my broad definition of “virtual” anything that can be considered ‘siteless’, or decentralised, including aspects that can be made “direct-to-patient”.  var iframe = document.createElement('iframe');

Guest Column | April 27, 2020 Clinical Trials At Home — Implementing Telemedicine & Virtual Visits During COVID-19 By Hannah Yee and John Ferraro, Halloran Consulting Group, Inc. Learn More About Janssen's Phase 3 COVID-19 Vaccine Candidate Clinical Trials Please note that by clicking this link, you’ll be leaving jnj.com and going to a third-party website not governed by the jnj.com privacy policy. Simultaneously, we are expanding our partnerships and collaborations with technologies that further increase flexibility and information capture.  var thisScript = document.scripts[document.scripts.length - 1]; COVID-19 has impacted essentially all clinical operations to some extent and accelerated the evolution in virtual engagement dynamics between patients, sites, and sponsors. ]/g, "&"); As a result they are now adopting, much more ambitiously, virtual trial technologies for keeping their studies on track, running more efficiently, and offering added patient convenience.  iframe.style.border = '0';  var iframe = document.createElement('iframe');  iframe.setAttribute('height', 850); June 24, 2020 | 1:00-2:00 pm EDT . 日本語 ]/g, "&");  iframe.setAttribute('type', 'text/html'); The time taken to identify, recruit and enrol patients is a huge pressure on clinical research; something like 30% of Phase III failures are down to problems with patient numbers.  iframe.setAttribute('frameborder', 0); UCLH initiates dosing in AstraZeneca’s Covid-19 antibody trial, CAS’ Covid-19 vaccine ZF2001 triggers immune response in trials, SII and Dynavax dose first subjects in Phase I/II Covid-19 vaccine trial, Novo Nordisk’s makes strides into Alzheimer’s with anti-diabetic drug, Roche’s Ocrevus set to top $7.6bn in sales by 2028 backed by new dosing approval, Hope for chronic kidney disease as KBP Biosciences’ KBP-5074 shows promise, TG Therapeutics’ umbralisib, ublituximab likely to face market hurdles but FDA approval highly expected, GlaxoSmithKline/Vir Biotechnology’s and AstraZeneca’ mAbs eyed in early COVID-19, Dicerna’s best hope for nedosiran use likely in non-responders to Alnylam’s Oxlumo in primary hyperoxaluria type 1, Investment firm GI Partners closes Clinical Ink acquisition, Investment firm GI Partners to acquire minority interest in Clinical Ink, IVI and SNU partner to trial Inovio’s Covid-19 vaccine in Korea, T1Detect screening could have lasting effects on T1D awareness and management, UNITY Biotechnology initiates dosing in diabetic macular edema drug trial, How Covid-19 has accelerated ‘digital health’ and the evolution of clinical trials, CureVac begins Phase III trial of Covid-19 vaccine candidate, Boehringer initiates trial of novel SARS-CoV-2 neutralising antibody.

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