No. In fact, it may put them in higher demand.
There is no question that decentralized clinical trials are transforming the clinical research environment. This patient-centric approach to research, which leverages telemedicine, home health visits and digital devices to treat patients remotely, is making it possible for sponsors to engage with a more diverse patient population, accelerate recruiting, and lower the burden of trial participation.
It’s a win-win for patients and sponsors, however some investigator site leaders worry that this new paradigm might put them out of business. If research participants no longer attend site visits, they wonder, what is the point of the site in clinical trials?
Investigators need not worry. Demand for sites in clinical research is not slipping away. As long as they are willing to adapt to this new approach of interacting remotely with the patient, virtual trials may even help them grow and participate more effectively in research.
Virtual trials need investigators
A common concern among those new to virtual trials is that patients will never physically meet with their physicians. But today, video conferencing has been proven as an effective mode of telemedicine, where face-to-face communication simply happens through a digital platform. It’s where the world is moving, and it’s where clinical trials are shifting as well.
And when technology simply cannot replace what’s done in person, hybrid models offer a customizable blend of patient-centric approaches and traditional site-based elements. In a hybrid trial, patients participate in most of the study from home and travel to a clinic for a few site-based visits. Hybrid trials still allow sponsors to expand their geographic reach compared to fully site-based trials, and they make participation more flexible for patients to participate.
In their simplest form, hybrid models leverage a handful of virtual elements, such as secure online platforms for document exchange, or wearable health monitors for data collection, while maintaining a traditional on-site model for the rest of the trial. More advanced hybrid models may only require a few on-site visits for initial screenings, or for treatments that require a formal healthcare setting. This means investigator sites will continue to be part of the experience – and that they will be leveraged in more meaningful, value-driven ways. Instead of spending hours collecting data that could be captured remotely, investigators and their staff spend these visits conducting vital treatment steps, educating and engaging with patients, and ensuring all of their medical needs are met. This makes efficient use of the investigator team’s time and creates a more positive site experience for patients.
And, because the time that site staff spend with each patient is reduced, sites can leverage their resources more efficiently and potentially manage more trials simultaneously.
In the case of a completely virtual trial, it will still require an investigator to host telemedicine visits, respond to requests from patients, and oversee data capture and treatment dissemination. Just because patients aren’t on-site, doesn’t mean they don’t need the support and guidance of medical professionals. And clinical research, no matter the venue, will always require the expertise and experience of qualified investigators.
No tech investment required for sites
While the role of the investigator isn’t going away, it will evolve as virtual and hybrid trials become the norm. The sites that adapt quickly will be best positioned to take advantage of this new trial model to grow and diversify their operations.
The good news is that the technology needed to host a virtual trial is neither expensive nor difficult to implement. In most cases, a site’s existing high-speed internet is enough to support the tools used in virtual trial environments. The rest of the technology, including telemedicine platforms, secure online platforms for paperwork, and wearable devices, are generally provided by the sponsor or CRO partner along with technical support staff to manage it. This means sites don’t need to make big investments in technology to engage in decentralized trials.
The biggest investment for sites will be in change management efforts and training on conducting the site remotely while strengthening patient-centricity. Staffers will need to be trained on the technology and data platforms, as well as how to adapt their patient engagement strategies for a virtual environment. That includes learning to maintain eye contact during telemedicine visits, taking advantage of the opportunity to observe a patient in their own home, and recognizing peripheral signs that a patient might need additional support.
Sites that want to embrace virtual trials will also benefit from creating paths to adapt SOPs for these projects. This can include accommodating home health services, supporting televisits, and enabling the use of third-party staff for study services.
Because the virtual trial evolution is new, there are still opportunities for sites to demonstrate leadership in the virtual trial space. The Society for Clinical Research Sites’ (SCRS) most recent Site Landscape Survey found 68 percent of sites that had been approached about conducting a hybrid virtual trial said yes. It also found that more than half of them would do “whatever is required” to prepare to conduct a virtual trial, including actively upgrading their knowledge of technology and the systems used on-site. The high rate of enthusiasm suggests investigator sites are eager to get onboard.
Making these few small technical and cultural changes and demonstrating a willingness to embrace this evolution of clinical research will ensure that interested sites will be well prepared to thrive in the future of virtual research.IQVIA Virtual Trials is uniquely qualified to orchestrate Faster, higher quality patient-centric trials. Learn more about IQVIA Virtual Trials today.