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. Virtual clinical trials come with advantages. 5% CAGR during the forecast period. About Us Awards From a pharma company’s perspective, virtual trials were a way to keep trials going and keep patients engaged. Their responses were incorporated into the final report. If the drug seems sufficiently safe in laboratory studies, trials generally proceed through stages known as phase I, phase II, and phase III. This likely comes from the fact that Big Pharma companies remain risk averse. Virtual Clinical Trials. For more information and to download the full report, visit: https://go.oracle.com/VirtualClinicalTrialsReport2019. Your trial technology, our in-home staffing. These trials take full advantage of technology (apps, monitoring devices, etc.) It’s a tough job and the travel is crazy. These efforts are also expected to improve the quality of patients participating in trials. Others defined a “fully virtual” trial as one where there would be no human-to-patient interaction at all. How do you define the term “virtual clinical trial” for trials that involve a principal investigator (PI)? Although there will likely be some forgiveness by regulators for data gaps that occurred during the COVID crisis, Kasher believes drug developers need to take a hard look at the data currently being generated. Even when the technology was employed for another primary reason, such as streamlining data collection, it was found to relieve some patient burden. The same is true of smaller companies. Get the latest articles from Clinical Leader delivered to your inbox. These new tools could also create a burden for technology-averse patients or those not possessing the latest tablet or smart phone. It is certainly timelier and more cost effective for both sponsors and sites. That meant a continued flow of vital data that is necessary for regulatory approval. 5% CAGR during the forecast period. This is a huge step forward for healthcare, clinical trials, and patient convenience. It also improves the lives of CRAs. Virtual Clinical Trials. With the industry’s ongoing emphasis on effectiveness and timelessness, virtual trials will become an important part of clinical research. Now is a good time to pause, look at the methodology, and ask ourselves if we are still ensuring their safety and wellbeing.”, Changes In Remote Data Monitoring And RBM. “It’s important, from a clinical development standpoint, that we have contingencies in all of our trials to help us avoid the massive shutdowns that we saw in the second quarter of 2020. However, Kasher notes not all patients were ready for the switch or prepared to take part in them. Patient recruitment remains a challenge for pharma companies, and some participants felt greater patient centricity in trials would improve recruitment and retention. But clinical trials are still about putting unproven molecules into human beings. For those trials that were not “fully virtual” but involved a patient facing technology, the preferred term was “hybrid trial.” Those trials still included direct-to-patient interaction by the PI or participating physicians. The third question asked focus group participants about the obstacles to incorporating virtual components into their trials. As one panelist explained, the FDA considers a virtual trial to be one where there are no humans involved. Additionally, when there are so many aspects of a trial that can be virtualized, at what point does the trial become virtual? While some respondents felt the use of almost any patient-facing technology constitutes a virtual trial, others felt the term should only be used for those studies where every aspect of it, post protocol design, was technology based. Companies may add RBM to the mix, but they will not eliminate sending people to sites. There are certainly companies that continue to send people to the site to review source data, apparently feeling more secure about the results. Therefore, they are not in need of new approaches to perform the monitoring.”. At Virtual Clinical, we’re ahead of the curve. Medical staff are being redeployed within health organizations to support the care of those infected. Virtual trial model is able achieve this. When pausing to assess where we stand, Kasher also recommends examining remote data monitoring and the use of risk-based monitoring (RBM). IQVIA Virtual Trials can expand your geographic reach, providing access to diverse populations and difficult-to-recruit candidates. The Oncology market dominated the Global Virtual Clinical Trials Market by Indication in 2019. The safety of patients involved in trials was clearly on the minds of those in the focus groups, with many responders raising that concern. Get more clinical research insight with our FREE newsletter, Clinical Trial Software and Services Center. “We assume everyone will welcome the change, but every patient will not want to do a trial in their kitchen. However, there was one caveat. This model delivers multiple benefits including access to larger patient populations, easier recruiting, more and better data collection, lower levels of attrition, and ultimately lower costs. Virtual clinical trials and remote monitoring measures result in the need for virtual data collection and management. “We are definitely going to see an increase in the number of hybrid trials. Most participants seemed to prefer the term “decentralized trial.” That also seemed to be the consensus of a panel on this topic at the 2019 CNS Summit. One of the most interesting sections of the report is the discussion around defining the term “virtual clinical trial.” A variety of terms have been used to describe trials that incorporate patient-facing technologies, such as tablets, smartphone apps, or wearable sensors. Improve the entire patient, CRO, and sponsor experience with Medidata's Virtual Clinical Trials. The primary challenges identified by focus group participants were the following: The prospect of dealing with multiple technologies was also a concern, with participants noting some hybrid trials may require dozens of different technologies, each with a separate portal and login credentials for sites. Kasher believes many large sponsor companies continue to struggle to implement it in an optimal way. Progress is being made in virtualizing components of clinical trials to deal with these changes. COVID has forced them to take on a little more risk, but they will continue to monitor in ways that are old school. The time for virtual clinical trial adoption is now. Virtual clinical trials use tech devices and social engagement platforms to conduct trials from a patient’s home. By Ed Miseta, Chief Editor, Clinical LeaderFollow Me On Twitter @EdClinical. Accelerate patient recruitment. Virtual trials promise to transform the way clinical research is conducted. “We did not ask patients their opinion of these trials before making the switch,” says Kasher. When you have employed patient-facing technology in some aspect of a trial, what was the primary problem you sought to solve? These electronic processes offer new opportunities for a patient-centric approach to clinical research. “We need to perform robust validation of the data being collected,” he says. and inclusion platforms (recruitment, informed consent, counselling, measurement of endpoints and any adverse reactions) to allow the patient to be homebased at every stage of clinical trial. The question we need to be asking ourselves is whether the data we receive from those different visits is unbiased.”. To overcome these challenges pharmaceutical companies and research institutions (e.g., universities) increasingly use an emerging concept: virtual clinical trials (VCT) based on a … The findings are the result of focus group interviews and supplementary research with key stakeholders involved with clinical trials. In fact, he strongly supports the use of them across all disease states. VCT: VIRTUAL CLINICAL TRIALS — Web Adventures © 2020 Center for Technology in Teaching and Learning, Rice University Web Adventures games are now generously hosted by The Rice University School Mathematics Project (RUSMP). Several fully virtual clinical trial initiated in the last year which were supported and aknowledged by FDA and other regulatory bodies. Work with clinical trials experts to test medical advancements and learn neuroscience along the way. Everyone will not want healthcare workers coming into their homes, especially during a pandemic. Virtual clinical trials are a relatively new method of conducting a clinical trial to collect data on the safety and efficacy of a molecule or medical device. Advanced technologies. While virtual clinical trials and decentralized research are both still emerging areas, we’ve set ourselves up as pioneers within the virtual sector, and are amongst the first CROs to offer these remote services. Our goal should be to build on that success.”. For pharma companies, the data generated from a trial is what will ultimately lead to a regulatory approval. Clinical Virtual Trial Benefits. The side effects of the pandemic: lights and shadows “When we migrated from sites faxing in case report forms to putting them in an EDC, that shifted work/responsibility from sponsors to sites,” he says. There were also critical issues addressed using these technologies, including site staff inconvenience, improved patient safety monitoring, the elimination of second-hand data sources, improved patient literacy of the study, and improved screening and diagnostic methods and tools. Although not new, virtual clinical trials have gone from being an interesting option to a pure necessity in 2020. This can slow the clinical trial process as site personnel will need to be trained on each technology. The focus group found the degree to which technology has been employed or integrated into a trial to have increased significantly over that past few years. In this article, we will use the term “virtual clinical trial” as a collective term for various types of trials that are supported by patient-facing technologies, such as decentralized trials, remote trials, digital trials, hybrid trials or direct-to-patient (DTP) trials. The damage done by Covid-19 – to patient engagement, to supply chains and to hospitals – has shaken the industry. With the COVID-19 pandemic’s impact on clinical trials in the U.S. and around the world, everyone is suddenly focused on virtual (decentralized) clinical trials. Get more clinical research insight with our FREE newsletter, Clinical Trial Software and Services Center. There needs to be a concerted effort across the industry to determine how these trials should be conducted. This is in spite of the fact that the FDA has said it is not necessary. Finally, the report attempted to determine what would need to be done for the industry to effectively move forward in realizing the potential of patient-facing technologies in clinical trials. What Is A Virtual Trial? One site representative noted she would not participate in a trial where there was no direct contact with patients. According to a McKinsey report, the clinical trial industry has moved 5 years forward in terms of digital transformation over the past few months. Most of them also have sufficient funding that they can afford to continue to send people to the sites. Virtual clinical trials not only a dream any more but became reality recently. In terms of remote data monitoring, the industry has made great steps forward. In Trial 1: Spinal Cord Injury, help a Principal Investigator and Research Coordinator set up a clinical trial exploring a new therapy to treat spinal cord injury patients. These are things the industry will have to consider when moving forward.”. Imagine it’s 2025. These include better patient engagement, cost efficiencies, improved data capture and empowered research teams. For those companies, virtual trials are a way to continue gathering needed data from patients. Clinical Trial Conduct has been evolving slowly despite the pressures of increasing cost, duration and competition for patients. Arguably no other area in pharmaceutical science has suffered under Covid-19 like clinical trials have. Electronic platforms are making virtual trials possible and are facilitating the adoption of this newer trial model. By Ed Miseta, Chief Editor, Clinical LeaderFollow Me On Twitter @EdClinical. The Global Virtual Clinical Trials Market size is expected to reach $10 billion by 2026, rising at a market growth of 6. All the participants had significant experience in both clinical trials and the use of patient-facing technologies. The focus group participants were generally positive about the outlook for these technologies to make trials more efficient, cost-effective, and patient-centric. This website uses cookies to ensure you get the best experience on our website. Rather, based on our experience at Advarra, we anticipate seeing a slow and steady march on the part of sponsors and investigators to use technology smartly to improve the efficiency of clinical trials while at the same time easing the burden to participants. The Global Virtual Clinical Trials Market size is expected to reach $10 billion by 2026, rising at a market growth of 6. Potential regulatory, operational, analytical challenges. “We need to know what exactly a hybrid model will do to the integrity of the data. Built on a foundation of global clinical operations capabilities and deep therapeutic expertise, IQVIA Virtual Trials help solve some of the toughest clinical study challenges. Get the latest articles from Clinical Leader delivered to your inbox. Virtual Clinical Trials The dramatic coronavirus (COVID-19) pandemic in recent months has disrupted clinical trials along with all aspects of daily life. But with such a crisis comes opportunity. This website uses cookies to ensure you get the best experience on our website. Wars and Disasters drive a rapid need to evolve in order to survive, not only for individuals but also for businesses. Virtual Clinical Trials Are Patient-Centric Still, he believes it is time to pause and reassess where we are and where we need to go from here. The 28 executives participating included representatives from pharma companies, CROs, sites, and independent consultants. But if you plan to move your trials to a virtual model, at least one industry executive is recommending that you use caution when doing so. And the industry will need to identify the areas where patient-facing technologies should remain an adjunct to traditional human interaction with patients. For example, not all areas of the country have the broadband service required to participate in a virtual trial. According to a new report Global Virtual Clinical Trials Market, published by KBV research, The Global Virtual Clinical Trials Market size is expected to reach $10 billion by 2026, rising at a market growth of 6.5% CAGR during the forecast period.. Data Quality in Virtual Clinical Trials. Often, they are described as virtual trials, decentralized trials, remote trials, direct-to-patient trials, and hybrid trials. So, what term should we be using? The report found none of the above terms have an accepted definition across the industry. Virtual Clinical Trials The specific form of a clinical trial can vary quite a bit, and the number and type of participants enrolled will depend on which phase the trial is currently in. What is the impact of physicians not interacting with patients in person? Further, clinical trials struggle to keep participants engaged in the study and as many as 40% drop out. That is welcome news for many patients, and Kasher believes clinical trials will not regress back to the pre-COVID days. With remote monitoring, the job of CRAs can be performed from almost anywhere, creating a better situation for CRAs, sites, and sponsors. “CROs are certainly not going to dissuade those actions,” adds Kasher. Respondents felt the use of patient-facing technologies helped widen the pool of trial participants, increase retention, improve the quality of data, and improve the overall patient experience. Risk-based monitoring (RBM) is another advancement to keep an eye on. Virtual Clinical Trials (VCTs), also called remote or decentralized trials, are a relatively new and yet underutilized method of conducting clinical research taking full advantage of technologies such as apps, electronic monitoring devices, and online social engagement platforms. When asked for reasons why they opted to use the technology, the most cited response was the desire to deliver a better patient experience. Tech, gizmos, and gadgets are at the heart of virtual clinical research, from smartphone apps to wearables and bespoke e-diaries. The ability of patient-facing technologies to generate regular patient interactions and provide reminders was cited as integral to keeping patients motivated to continue with the trial. In fact, each of the terms has a disparate definition attached by various groups or companies within the clinical space. I have even heard people discussing an ala carte approach, where patients could opt to do all of their site visits at home, in the clinic, or select a mixture of both. COVID-19 has made trial virtualization the only safe way of continuing on-going clinical studies without having to pause them. They have one molecule and don’t want to mess it up. That includes patient recruitment, consent, and data collection. Remote monitoring can benefit patients and greatly reduce or eliminate the need for monitors at sites. In fact, in the world of clinical research, a significant paradigm shift is taking place as more and more CROs, and pharmaceutical companies are considering alternative ways of conducting clinical trials (e.g., siteless, digital, virtual). The focus groups consisted of a two-hour facilitated discussion that centered on four questions: Oracle Health Sciences also asked professionals attending the 2019 Global Site Solutions Summit to fill out a survey concerning their use of technology in clinical trials. Regardless of how it’s defined, almost none of the participants said they had ever been involved with a “fully virtual” trial. By that definition, a true virtual trial would be one where there were no physical sites and no face-to-face interactions with patients. We saw a lot of trials flip over to the virtual model, but I think we need to take a closer look at that and ask ourselves if it is sustainable.”. How ala carte can we make these trials? “There is still a lot of data verification going on, which is a big revenue driver for CROs. By relying on the new possibilities offered by technology, many argue that virtually … See more - Virtual Clinical Trials Deliver Better Data The virtual transformation that once seemed radical is now on the fast track. Our flexible virtual trials approach eases the burden of clinical trial participation on the patients, allows trials stalled by COVID-19 to move forward, and improves overall clinical trial conduct efficiency.” It also affected clinical trials on Alzheimer’s and dementia. “Everyone wants to migrate to virtual trials, but when doing so I think we need to be careful,” says Jeff Kasher, president of Patients Can’t Wait. One of the most interesting sections of the report is the discussion around defining the term “virtual clinical trial.” A variety of terms have been used to describe trials that incorporate patient-facing technologies, such as tablets, smartphone apps, or wearable sensors. Oracle Health Sciences and the CNS Summit have released a research report on the use of virtual components (patient-facing technologies) in clinical trials. Traditional vs. For a Phase 3 trial involving an experimental drug, not one participant reported being involved in a trial that completely separated patients from a direct contact with a site or provider. Kasher has heard the horror stories about the lives of CRAs. What are the challenges or obstacles you have identified in incorporating this type of technology into trials? During the pandemic, the FDA pushed for virtual clinical trials also known as decentralized clinical trials. More flexibility in virtual trials means more ease and efficiency for you and your patients. In others, they were proposed by the PI and then incorporated into the protocol. Chances are pharmaceutical and medical R&D will never be the same again, even after the pandemic is over. can also bring benefit in conventional clinical trials. They also felt these technologies would eventually permeate all aspects and all phases of trials. What do you believe needs to be done in order to effectively move forward in realizing the potential of patient-facing technology in clinical trials. With the COVID-19 pandemic’s impact on clinical trials in the U.S. and around the world, everyone is suddenly focused on virtual (decentralized) clinical trials. About 80 percent of clinical trials were affected in the United States and on varying degrees worldwide. Participants believe that a move from hybrid trials to fully decentralized trials should be gradual, moving into Phase 3 trials only after successful use in a Phase 2 study. While trial sites remain an important and often essential component of clinical trials, the choice to conduct a virtual trial can bring with it many advantages. He believes they meet an industry need, and COVID has allowed pharma to make 10 years of technological progress in just a few months. In some cases, the technologies were pre-determined by the sponsor company. Improve patient recruitment and retention for your clinical trials with VirTrial, a telehealth platform for managing decentralized and virtual clinical trials. “We cannot allow the changes we are making with virtual trials to have a negative impact (add additional burden) on the work sites are required to perform. The global virtual clinical trials market size was estimated at USD 7.0 billion in 2019 and is expected to expand at a compound annual growth rate (CAGR) of 5.1% from 2020 to 2027. Even with comprehensive technology, these trials nearly all require some in-home clinical trial … For that to happen effectively, a few things need to happen. Participants in the focus groups also felt the development of standards for data and patient-facing technologies should be made a priority. Jeff Kasher“Going forward, how are we going to ensure that we get a rich, robust data set?” asks Kasher. As the industry begins to adopt new distance technology, clinical studies will become more widely available to many more people who may have been disqualified due to distance or inability to attend multiple visits. But if you plan to move your trials to a virtual model, at least one industry executive is recommending that you use caution when doing so. Clinical trials would otherwise require multiple visits to a local study center, but with virtual clinical trials, that obstacle becomes much less of an issue. Of course, it’s a mammoth transition for sponsors, but for patients, most indicators suggest it’s an easy and worthwhile shift. Kasher notes he is not against virtual trials. The industry will need to standardize the terminology and data models. However, completely virtual clinical trials are still along way from being the norm. 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