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. 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. Processes, models, technologies, etc. ]/g, "&");  iframe.style.border = '0';

 iframe.setAttribute('allowTransparency', 'true');  iframe.setAttribute('type', 'text/html');  iframe.setAttribute('width', '100%'); 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. One of the few positives from the pandemic is the opportunity to operate differently. Methods to support remote clinical trials may include: remote recruitment and screening; tele-consent 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. Jim Corrigan | Read Time: 4 Minutes | June 18, 2020. ]/g, "&"); 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. 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. Events PHILADELPHIA (WPVI) -- The Action News Troubleshooters are warning about phony clinical trials for COVID-19 that promise big bucks to participants. Virtual Clinical Trials COVID -19 has accelerated industry efforts to implement trial design, but ERT has collected data outside of site visits for decades. 1 Note: COVID-19 studies only listed on the World Health Organization's International Clinical Trials Registry Platform are not counted in these tables. 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.  iframe.style.border = '0';  iframe.style.border = '0'; 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. } We can help you adapt to the new realities of clinical research. Q: Have ERT’s business operations changed in light of COVID-19? “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. Published 19 March 2020 Last updated 21 May 2020 — see all updates.  iframe.setAttribute('height', 850); About ERT Learn More Share.  var iframe = document.createElement('iframe');

Imaging thisScript.parentElement.replaceChild(iframe, thisScript); var form = 'https://content.ert.com/l/71652/2018-07-18/5wcs1t'; Careers  var thisScript = document.scripts[document.scripts.length - 1]; > 0) { Thousands of legitimate trials are … 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.  iframe.style.border = '0'; Q: How is ERT innovating in light of the global pandemic? I believe many aspects of modern life will be significantly changed and clinical operations will not be an exception. 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. 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Newsletter Signup. params = params.replace(/[?  var params = window.location.search; if (form.indexOf('?') There will be more virtual site visits, which will minimize the need for patients to travel to investigative sites, and increased. params = params.replace(/[? Clinical trials. 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). 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. 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. The COVID-19 pandemic has turned research business-as-usual upside down. 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.  iframe.setAttribute('frameborder', 0); The recent release of a white paper by Science 37, a provider of multiple remote trial solutions, on navigating the COVID-19 era through virtual trials might provide an indication that telehealth providers are already anticipating this transition.  iframe.setAttribute('frameborder', 0);  iframe.setAttribute('width', '100%'); 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. So, in summary, are virtual/decentralised/DtP trials the future? By doing so, the industry will benefit from more streamlined clinical trials, expanded patient engagement and accelerated clinical development times. Q: How has the COVID-19 pandemic impacted clinical operations? Improve patient recruitment and retention for your clinical trials with VirTrial, a telehealth platform for managing decentralized and virtual clinical trials.  iframe.setAttribute('height', 850); 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. eCOA Business Intelligence Reports thisScript.parentElement.replaceChild(iframe, thisScript);  If you continue to use this site we will assume that you are happy with it.  iframe.style.border = '0'; thisScript.parentElement.replaceChild(iframe, thisScript); var form = 'https://content.ert.com/l/71652/2019-08-22/6w37fj?Hidden_Product_Line=COVID';  iframe.setAttribute('width', '100%'); Virtual trials have long been technically feasible, but cultural barriers have slowed their uptake. } Starting a new trial currently, outside of Covid-19 studies, is almost impossible without substantial virtual elements in place. In many cases, the data can be collected and sent for analysis automatically, completely ruling out the ‘I forgot to do it’ element. 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.  iframe.setAttribute('type', 'text/html'); Wearables and Digital Biomarkers, Data Analytics 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. thisScript.parentElement.replaceChild(iframe, thisScript); var form = 'https://content.ert.com/l/71652/2019-08-22/6w37fj?Hidden_Product_Line=VirtualVisits'; 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('width', '100%'); GlobalData's TMT Themes 2021 Report tells you everything you need to know about disruptive tech themes and which companies are best placed to help you digitally transform your business.  iframe.setAttribute('allowTransparency', 'true');  iframe.setAttribute('frameborder', 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). Q: What do you believe will be the lasting impact on clinical operations/R&D? A COVID-19 patient registry: COVID Active Research Experience (CARE) Project. 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.  iframe.setAttribute('height', 850); params = params.replace(/[? 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. Customer Care iframe.setAttribute('src', form + params); All stakeholders have been forced to adapt and in many instances been surprised by the enduring benefits of digital virtual technologies. Cardiac Safety How investigators and sponsors should manage clinical trials during COVID-19. 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 … 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.setAttribute('height', 850); Remote Clinical Trials are led and coordinated by a local investigative team, but are based remotely, within a given community, state, nation, etc. As with anything, especially new ways of conducting an old process, there are limitations and concerns. Saskatoon-based VIDO has received authorization from Health Canada to start Phase 1 of its clinical trials for a COVID-19 vaccine. 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. Jim Corrigan is the President and CEO of ERT, Safety & Efficacy Endpoint Collection  iframe.style.border = '0'; There is no denying that the COVID-19 pandemic has spurred tremendous innovation across our industry.  iframe.setAttribute('type', 'text/html'); 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. Tech, gizmos, and gadgets are at the heart of virtual clinical research,  from smartphone apps to wearables and bespoke e-diaries.  iframe.style.border = '0'; So, virtual trials – so far, so easy? if (form.indexOf('?') thisScript.parentElement.replaceChild(iframe, thisScript); var form = 'https://content.ert.com/l/71652/2019-08-22/6w37fj?Hidden_Product_Line=partnershipspage';  iframe.setAttribute('width', '100%'); ]/g, "&"); 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('allowTransparency', 'true'); 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. 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.  var iframe = document.createElement('iframe');  var thisScript = document.scripts[document.scripts.length - 1]; ERT has always been at the forefront of delivering innovative technology solutions that help our customers accelerate clinical development. Effective virtual enablement requires collaboration and planning between all trial stakeholders.  var thisScript = document.scripts[document.scripts.length - 1]; FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency . 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. 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”.  iframe.setAttribute('src', form + params); 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. 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. 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. 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. > 0) {  iframe.setAttribute('width', '100%');  iframe.setAttribute('height', 850); if (form.indexOf('?') The EY global roundtable Virtual clinical trials — now, next and beyond on June 24 drew representatives from a diverse group of organizations, including biopharmas, health providers, contract research organizations, tech companies and others, to discuss the impact of COVID‑19 on the clinical trials sector. (Figure 1). ]/g, "&"); Solution Specialist The generator back-up of hospitals and clinics doesn’t exist in private homes. Processes, models, technologies, etc. if (form.indexOf('?') 日本語  iframe.setAttribute('type', 'text/html'); var form = 'https://content.ert.com/l/71652/2019-08-22/6w37fj?Hidden_Product_Line=wearbablesandbiomarkers'; iframe.setAttribute('src', form + params); 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.  iframe.setAttribute('type', 'text/html');  iframe.setAttribute('allowTransparency', 'true'); Virtual clinical research is still relatively new, and there is a clear hesitance from sponsors to move away from more established models. Guidance for Industry, Investigators, and Institutional Review Boards . iframe.setAttribute('src', form + params); 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. are all being reimagined and companies are rising to the challenge to seize this opportunity to create positive and sustainable changes. Simultaneously, we are expanding our partnerships and collaborations with technologies that further increase flexibility and information capture. Locations thisScript.parentElement.replaceChild(iframe, thisScript); var form = 'https://content.ert.com/l/71652/2019-08-22/6w37fj'; While regulators everywhere have issued guidance on virtual/decentralised trial processes, they are as new to the regulator as they are to the sponsor. In this interview, Jim Corrigan, President and CEO of ERT.  var iframe = document.createElement('iframe');  var thisScript = document.scripts[document.scripts.length - 1]; 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'); Scott Gottlieb: Expect delays in clinical trials unrelated to Covid-19 However, virtual trials have their own barriers to entry. COVID-19 clinical trials face unique hurdles in enrollment, too. There are limitations and concerns the sponsor new, and gadgets are at the forefront of delivering technology... 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