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. 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