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. The FDA says some clinical trials may have to go virtual as coronavirus travel restrictions and supply chain disruptions hit the drug industry. 1 Note: COVID-19 studies only listed on the World Health Organization's International Clinical Trials Registry Platform are not counted in these tables. iframe.setAttribute('height', 850); 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. > 0) { 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. iframe.setAttribute('width', '100%'); 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('type', 'text/html'); > 0) { 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. Customer Care if (form.indexOf('?') iframe.setAttribute('height', 900); Figure 1: Patient devices and telehealth systems are primary data capture tools in virtual trials (Source: ERT Survey, May 2020). 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. Business Intelligence Reports iframe.setAttribute('type', 'text/html'); } iframe.style.border = '0'; Methods to support remote clinical trials may include: remote recruitment and screening; tele-consent Patient recruitment can be significantly expanded and sped up through decentralised means. iframe.setAttribute('src', form + params); params = params.replace(/[? Cardiac Safety News var thisScript = document.scripts[document.scripts.length - 1]; iframe.setAttribute('height', 500); 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. ]/g, "&"); } How Virtual Trial Technology is Changing the Face of Clinical Research, Making the Move to Virtual Visits: Regulatory Considerations, ECG/EKG Advancements in the Era of COVID-19. var params = window.location.search; This is causing principal investigators and research staff to find other ways to keep participants connected with studies. iframe.setAttribute('src', form + params); Leadership ]/g, "&"); iframe.setAttribute('allowTransparency', 'true'); iframe.style.border = '0'; I believe many aspects of modern life will be significantly changed and clinical operations will not be an exception. Are there concerns and challenges? 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. var form = 'https://content.ert.com/l/71652/2019-08-22/6w37fj?Hidden_Product_Line=VirtualVisits'; Legal and Privacy Terms Q: How has the COVID-19 pandemic impacted clinical operations? iframe.setAttribute('type', 'text/html'); The COVID-19 pandemic has changed that, compelling sponsors to go remote where possible and underlining the advantages of at-home data collection and digitally mediated support. var iframe = document.createElement('iframe'); The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the coronavirus disease (COVID-19) pandemic.The impact of the pandemic on European health systems and more broadly on society, will make it necessary for sponsors to … We have accelerated our innovation pipeline to expand our virtual solutions across our endpoint collection modalities and increase the optionality our customers need to successfully execute their specific safety and efficacy endpoint data collection. iframe.setAttribute('type', 'text/html'); Newsletter Signup. iframe.setAttribute('src', form + params); var params = window.location.search; iframe.setAttribute('allowTransparency', 'true'); iframe.setAttribute('height', 850); iframe.setAttribute('width', '100%'); iframe.setAttribute('allowTransparency', 'true'); Login In many cases, the data can be collected and sent for analysis automatically, completely ruling out the ‘I forgot to do it’ element. Patient Support Programs, About across our endpoint collection modalities and increase the optionality our customers need to successfully execute their specific safety and efficacy endpoint data collection. How investigators and sponsors should manage clinical trials during COVID-19. The rising scourge of the unpredictable coronavirus has made remote trials and remote monitoring more attractive concepts to many in recent weeks. > 0) { 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. Jim Corrigan | Read Time: 4 Minutes | June 18, 2020. A COVID-19 patient registry: COVID Active Research Experience (CARE) Project. … 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”. Locations Of course, these examples are just the beginning of our innovations around patient centered end point capture across all modalities. Again, this works particularly well for patient populations that typically have a high risk of study drop-out. Processes, models, technologies, etc. Impressum 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. COVID-19 clinical trials face unique hurdles in enrollment, too. if (form.indexOf('?') This has been made even easier by the rise of eConsent solutions. 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. June 24, 2020 | 1:00-2:00 pm EDT . 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. ERT has always been at the forefront of delivering innovative technology solutions that help our customers accelerate clinical development. 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. Starting a new trial currently, outside of Covid-19 studies, is almost impossible without substantial virtual elements in place. One of the few positives from the pandemic is the opportunity to operate differently. 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. if (form.indexOf('?') params = params.replace(/[? iframe.setAttribute('allowTransparency', 'true'); Solution Specialist As with anything, especially new ways of conducting an old process, there are limitations and concerns. 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. Throughout the pandemic, our imperatives have been ensuring the safety of our employees and our customers while continuing to meet our operational commitments. iframe.setAttribute('type', 'text/html'); 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. What happens if a drug product needs to be refrigerated but the patient’s home has a power cut? iframe.setAttribute('allowTransparency', 'true'); 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. iframe.style.border = '0'; Events Tech, gizmos, and gadgets are at the heart of virtual clinical research, from smartphone apps to wearables and bespoke e-diaries. > 0) { if (form.indexOf('?') In this interview, Jim Corrigan, President and CEO of ERT 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. 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. iframe.setAttribute('frameborder', 0); iframe.setAttribute('type', 'text/html'); iframe.setAttribute('frameborder', 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 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). Q: What do you believe will be the lasting impact on clinical operations/R&D? 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. with consumer and medical data capture tools, all of which will simplify patients’ participation in clinical trials and improve their overall engagement. (Figure 1). iframe.setAttribute('width', '100%'); It seems like for years the virtual clinical trial has been the future, and it is perhaps unsurprising that an industry that is famously quick to discuss but slow to act has only recently seriously started to incorporate ‘siteless’ elements into studies. var params = window.location.search; iframe.setAttribute('height', 850); FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency . The U.S. Food and Drug Administration today issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic. thisScript.parentElement.replaceChild(iframe, thisScript); Yes they are, but they are the present too. var thisScript = document.scripts[document.scripts.length - 1]; var thisScript = document.scripts[document.scripts.length - 1]; 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. iframe.setAttribute('frameborder', 0); Jim Corrigan is the President and CEO of ERT, Safety & Efficacy Endpoint Collection Learn More Share. Saskatoon-based VIDO has received authorization from Health Canada to start Phase 1 of its clinical trials for a COVID-19 vaccine. iframe.style.border = '0'; var params = window.location.search; 11+ trials and studies around the world, including a collaboration with the University of Texas Medical Branch and Q2 Solutions. A COVID-19 trial matcher to help funnel patients to COVID-19 trials 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. Thousands of legitimate trials are … var thisScript = document.scripts[document.scripts.length - 1]; 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. Remote Clinical Trials are led and coordinated by a local investigative team, but are based remotely, within a given community, state, nation, etc. params = params.replace(/[? var iframe = document.createElement('iframe'); 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. Published 19 March 2020 Last updated 21 May 2020 — see all updates. var iframe = document.createElement('iframe'); 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. 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. What happens if a wearable suffers a technical malfunction? var thisScript = document.scripts[document.scripts.length - 1]; Clinical trials. thisScript.parentElement.replaceChild(iframe, thisScript); var form = 'https://content.ert.com/l/71652/2019-08-22/6w37fj?Hidden_Product_Line=VirtualVisits'; 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. The COVID-19 pandemic has disrupted every aspect of the clinical trial ecosystem. Data Exchange, Real-World Evidence Click here to access. iframe.setAttribute('width', '100%'); 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); var form = 'https://content.ert.com/l/71652/2019-08-22/6w37fj?Hidden_Product_Line=COVID'; Guidance for Industry, Investigators, and Institutional Review Boards . 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. iframe.setAttribute('width', '100%'); So, in summary, are virtual/decentralised/DtP trials the future? iframe.setAttribute('width', '100%'); 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. } 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. params = params.replace(/[? > 0) { > 0) { “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. 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