Virtual or traditional trials: Considerations for making trial design decisions
When it comes to running a clinical trial, researchers have been getting creative, trading traditional processes for virtual opportunities. This has become especially apparent in light of the COVID-19 pandemic.
But many considerations must be taken into account when deciding on trial design going forward: Is it safe for your patient population to come physically into a site? How will you handle patient recruitment? How will you ensure that you’re getting reliable lab results?
We take a look at two critical questions worth asking when designing your trial.
What kind of trial is best for your patients?
The first question you should ask focuses on your patients, because, let’s face it, without them, there can be no clinical research! What kind of trial – traditional or virtual – is best for your patients?
The clinical research industry has pivoted toward decentralized and virtual trials due to the circumstances of COVID-19. One major advantage of virtual (or siteless) trials is that they minimize health risks for patients taking part, many of whom have conditions that make them especially vulnerable to COVID-19. This benefit removes the burden and any accompanying anxieties from patients and encourages participation from wherever they may be.
On the other hand, your target patients might not prefer the virtual environment. Remote trial operation can involve a very steep learning curve for patients. Participants need to have access to any technologies required for the trial (internet and smartphones, for example), and they need to be savvy enough to use these technologies as the trial protocol dictates, which might include the use of a complicated app or logging into multiple platforms. For these folks, a traditional trial might be the best and most straightforward option.
Patient centricity is critical to the research process, and designing a virtual or traditional trial should take this matter into account first and foremost.
Do you have the tools to run a trial?
Once you’ve figured what kind of trial your patients prefer, you must ask this question to yourself: “Do we have the tools to run a trial virtually or traditionally?”
It seems funny to question whether or not you have the tools to run a trial traditionally, but it’s a relevant question to ask due to the COVID-19 pandemic. If you are running a traditional trial, do you have proper PPE and social distancing measures? Is your site in a crowded city where patients might be more at risk? Does your team have the ability and bandwidth to contact trace if someone at your site tests positive for COVID-19? These are all legitimate questions to answer when evaluating the traditional vs. virtual trial debate during the COVID-19 pandemic.
On the other hand, with virtual trials, the learning curve isn’t just steep for patients, it’s steep for research teams, too. Study teams need to be trained on telework, network access including electronic health records (EHRs), and patient privacy (such as turning off smart speakers at home). And, this all assumes that study teams have the right tools to be trained on in the first place. It is worth evaluating the costs of enterprise software and privacy tools (like virtual private networks) before choosing the virtual route. At the heart of it, your teams must feel comfortable and confident that they will be able to properly run these systems remotely to ensure data integrity.
Another key component to consider is whether or not you have a reliable partner and vendor network. You’ll want reliable lab solutions, electronic medical records platforms, and transportation companies in your back pocket to meet the different needs of patients taking part in both virtual and in-person studies.
There is interest in virtual trials across the healthcare spectrum — from pharmaceutical companies, health tech innovators, national care providers and hospital administrators. With the above considerations in mind, you’ll be able to decide the best route to take for your study.
Clinical trials cannot move forward without volunteers. Antidote can help with clinical trial recruitment for both virtual and traditional trials, so get in touch!