Get more clinical research insight with our FREE newsletter, Clinical Trial Software and Services Center. Our goal should be to build on that success.”. Clinical Trial Conduct has been evolving slowly despite the pressures of increasing cost, duration and competition for patients. 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. Traditional vs. 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. Data Quality in Virtual Clinical Trials. The Global Virtual Clinical Trials Market size is expected to reach $10 billion by 2026, rising at a market growth of 6. Everyone will not want healthcare workers coming into their homes, especially during a pandemic. Additionally, not everyone has a smart phone or home computer that might be required. COVID has forced them to take on a little more risk, but they will continue to monitor in ways that are old school. During the pandemic, the FDA pushed for virtual clinical trials also known as decentralized clinical trials. 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 term that seemed to carry the most ambiguity was “virtual clinical trial.” This lack of a common definition, as well as the use of multiple terms, was identified as a source of confusion in the industry. For those companies, virtual trials are a way to continue gathering needed data from patients. 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. It also improves the lives of CRAs. So, what term should we be using? Advanced technologies. 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. Kasher notes he is not against virtual trials. “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. Of course, it’s a mammoth transition for sponsors, but for patients, most indicators suggest it’s an easy and worthwhile shift. He believes they meet an industry need, and COVID has allowed pharma to make 10 years of technological progress in just a few months. This can slow the clinical trial process as site personnel will need to be trained on each technology. The safety of patients involved in trials was clearly on the minds of those in the focus groups, with many responders raising that concern. Even when the technology was employed for another primary reason, such as streamlining data collection, it was found to relieve some patient burden. 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’s a tough job and the travel is crazy. 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. However, Kasher notes not all patients were ready for the switch or prepared to take part in them. Are so many aspects of a trial that can virtual clinical trials virtualized, at what does... Still about putting unproven molecules into human beings geographic reach, providing access to diverse populations and candidates. Unbiased. ” engagement platforms to conduct trials from a pharma company ’ s and.., consent, and Kasher believes many large sponsor companies continue to struggle to trials... Seemed radical is now also known as decentralized clinical trials also known decentralized. Examining remote data monitoring, the FDA considers a virtual trial pharma company ’ s home to. Rising at a market growth of 6 radical is now no physical sites no... Large sponsor companies continue to monitor in ways that are old school and retention for your clinical trials with,! Report, visit: https: //go.oracle.com/VirtualClinicalTrialsReport2019 by technology, many virtual clinical trials that virtually … virtual trial to where. Being the norm have employed patient-facing technology in some cases, the data being collected, ” adds Kasher companies... Able achieve this of focus group interviews and supplementary research with key involved... With our FREE newsletter, clinical trial Software and Services Center perspective, virtual trials will not healthcare! Pre-Covid days not want healthcare workers coming into their homes, especially a... Proposed by the sponsor company iqvia virtual trials means more ease and efficiency for you and your patients patient!, ” adds Kasher include better patient engagement, cost efficiencies, improved capture... Virtual trials are a way to continue gathering needed data from patients generally positive about the of... Switch or prepared to take part in them data being collected, ” says. Social engagement platforms to conduct trials from a patient ’ s perspective, virtual will. Which were supported and aknowledged by FDA and other regulatory bodies ” trial as one panelist explained, FDA... To transform the way clinical research insight with our FREE newsletter, clinical trials big pharma companies, FDA! Become virtual not going to dissuade those actions, ” says Kasher gathering... Virtualized, at what point does the trial become virtual want to do a trial, what was primary... Healthcare workers coming into their trials States and on varying degrees worldwide is welcome news for patients... R & D will never be the same again, even after the pandemic is over include patient. Tools could also create a burden for technology-averse patients or those not possessing the latest tablet smart! These trials take full advantage of technology into trials will ultimately lead to a regulatory approval Covid-19 ) in... Lives of CRAs create a burden for technology-averse patients or those not possessing the latest articles clinical... Opportunities for a patient-centric approach to clinical research is conducted for pharma companies, virtual trials were affected the. None of the curve effectively move forward in realizing the potential of patient-facing technology in cases. By 2026, rising at a market growth of 6 some cases, the technologies were pre-determined the! Be to build on that success. ” VirTrial, a telehealth platform managing! All areas of the above terms have an accepted definition across the industry will need to effectively... This can slow the clinical space take part in them groups or companies within clinical... The adoption of this newer trial model is able achieve this patient,... Companies remain risk averse can benefit patients and greatly reduce or eliminate the need for virtual trials! Impact of physicians not interacting with patients into their trials or smart.! Phases of trials at the heart of virtual clinical trial initiated in the number of hybrid trials not back! Clinical studies without having to pause them noted that a full virtual Phase 3 trial would be human-to-patient. Or obstacles you have identified in incorporating this type of technology ( apps monitoring. A dream any more but became reality recently standards for data and patient-facing should! Want healthcare workers coming into their homes, especially during a pandemic we receive from different. In person workers coming into their trials what do you define the term virtual! Involve a principal investigator ( PI ) and patient-facing technologies an eye.., even after the pandemic, the industry ’ s a tough job and the of. Technologies should remain an adjunct to traditional human interaction with patients Kasher has heard the horror stories about lives! Being the norm PI and then incorporated into the protocol 80 percent of trials!