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. The same is true of smaller companies. Kasher believes many large sponsor companies continue to struggle to implement it in an optimal way. 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. Remote monitoring can benefit patients and greatly reduce or eliminate the need for monitors at sites. Wars and Disasters drive a rapid need to evolve in order to survive, not only for individuals but also for businesses. Risk-based monitoring (RBM) is another advancement to keep an eye on. With the industry’s ongoing emphasis on effectiveness and timelessness, virtual trials will become an important part of clinical research. For pharma companies, the data generated from a trial is what will ultimately lead to a regulatory approval. In fact, each of the terms has a disparate definition attached by various groups or companies within the clinical space. That includes patient recruitment, consent, and data collection. These electronic processes offer new opportunities for a patient-centric approach to clinical research. See more - Virtual Clinical Trials Deliver Better Data The virtual transformation that once seemed radical is now on the fast track. Additionally, not everyone has a smart phone or home computer that might be required. For example, not all areas of the country have the broadband service required to participate in a virtual trial. 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). This is in spite of the fact that the FDA has said it is not necessary. Virtual Clinical Trials. By Ed Miseta, Chief Editor, Clinical LeaderFollow Me On Twitter @EdClinical. 5% CAGR during the forecast period. Further, clinical trials struggle to keep participants engaged in the study and as many as 40% drop out. Everyone will not want healthcare workers coming into their homes, especially during a pandemic. The time for virtual clinical trial adoption is now. How ala carte can we make these trials? 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. 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. “There is still a lot of data verification going on, which is a big revenue driver for CROs. Even when the technology was employed for another primary reason, such as streamlining data collection, it was found to relieve some patient burden. Traditional vs. “CROs are certainly not going to dissuade those actions,” adds Kasher. “We need to know what exactly a hybrid model will do to the integrity of the data. Get more clinical research insight with our FREE newsletter, Clinical Trial Software and Services Center. 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. It also improves the lives of CRAs. COVID has forced them to take on a little more risk, but they will continue to monitor in ways that are old school. 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. Kasher has heard the horror stories about the lives of CRAs. can also bring benefit in conventional clinical trials. The side effects of the pandemic: lights and shadows 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. 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. They also felt these technologies would eventually permeate all aspects and all phases of trials. Potential regulatory, operational, analytical challenges. However, completely virtual clinical trials are still along way from being the norm. 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.. “We assume everyone will welcome the change, but every patient will not want to do a trial in their kitchen. Virtual clinical trials come with advantages. At Virtual Clinical, we’re ahead of the curve. Often, they are described as virtual trials, decentralized trials, remote trials, direct-to-patient trials, and hybrid trials. Your trial technology, our in-home staffing. 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. Most of them also have sufficient funding that they can afford to continue to send people to the sites. For more information and to download the full report, visit: https://go.oracle.com/VirtualClinicalTrialsReport2019. Accelerate patient recruitment. So, what term should we be using? Oracle Health Sciences and the CNS Summit have released a research report on the use of virtual components (patient-facing technologies) in clinical trials. Some respondents noted that a full virtual Phase 3 trial would be unrealistic for many reasons. 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. Work with clinical trials experts to test medical advancements and learn neuroscience along the way. If the drug seems sufficiently safe in laboratory studies, trials generally proceed through stages known as phase I, phase II, and phase III. Therefore, they are not in need of new approaches to perform the monitoring.”. When asked for reasons why they opted to use the technology, the most cited response was the desire to deliver a better patient experience. And the industry will need to identify the areas where patient-facing technologies should remain an adjunct to traditional human interaction with patients. This website uses cookies to ensure you get the best experience on our website. With remote monitoring, the job of CRAs can be performed from almost anywhere, creating a better situation for CRAs, sites, and sponsors. 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 findings are the result of focus group interviews and supplementary research with key stakeholders involved with clinical trials. The report found none of the above terms have an accepted definition across the industry. 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. COVID-19 has made trial virtualization the only safe way of continuing on-going clinical studies without having to pause them. 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. When pausing to assess where we stand, Kasher also recommends examining remote data monitoring and the use of risk-based monitoring (RBM). Of course, it’s a mammoth transition for sponsors, but for patients, most indicators suggest it’s an easy and worthwhile shift. These include better patient engagement, cost efficiencies, improved data capture and empowered research teams. 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. In terms of remote data monitoring, the industry has made great steps forward. 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. What is the impact of physicians not interacting with patients in person? Virtual clinical trials not only a dream any more but became reality recently. Jeff Kasher“Going forward, how are we going to ensure that we get a rich, robust data set?” asks Kasher. Virtual Clinical Trials The dramatic coronavirus (COVID-19) pandemic in recent months has disrupted clinical trials along with all aspects of daily life. There are certainly companies that continue to send people to the site to review source data, apparently feeling more secure about the results. 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. When you have employed patient-facing technology in some aspect of a trial, what was the primary problem you sought to solve? Tech, gizmos, and gadgets are at the heart of virtual clinical research, from smartphone apps to wearables and bespoke e-diaries. The focus group participants were generally positive about the outlook for these technologies to make trials more efficient, cost-effective, and patient-centric. Regardless of how it’s defined, almost none of the participants said they had ever been involved with a “fully virtual” trial. The industry will need to standardize the terminology and data models. However, Kasher notes not all patients were ready for the switch or prepared to take part in them. The Global Virtual Clinical Trials Market size is expected to reach $10 billion by 2026, rising at a market growth of 6. By relying on the new possibilities offered by technology, many argue that virtually … It is certainly timelier and more cost effective for both sponsors and sites. 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. , from smartphone apps to wearables and bespoke e-diaries chains and to hospitals – shaken... 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