The last year and a half have been a whirlwind, particularly for clinical researchers. While the trial landscape is ever-evolving, efforts to “slow the spread” of COVID-19 have accelerated the process.
That’s especially true when it comes to trial design. In an effort to recruit a more diverse set of patients, including people who are elderly and/or immunocompromised, many pharmaceutical companies and medical device manufacturers are experimenting with virtual, decentralized, or hybrid trials.
Each of these trial models offers advantages and downsides. In this blog, we define each trial model and make recommendations for choosing the one that best aligns with your company’s needs.
What are some of the most common clinical trial models?
In the time of COVID, social distancing is more important than ever. Though vaccines have helped things return to some semblance of normalcy, variants of concern like Delta and Mu threaten a lengthy battle that could last well into 2022.
In an effort to advance research (and keep participants safe) many trial managers are transitioning to alternative models, including:
Virtual trials. A virtual trial occurs in a fully remote setting, like your home or a hospital room. There’s very little (if any) contact with the medical team and all paperwork is filled out and submitted electronically. During the course of a virtual trial, you regularly check in with the research team via telephone, Zoom, or another form of telecommunication.
Decentralized trials. A decentralized trial allows for a little more flexibility. It combines remote consultations with in-person visits and (if necessary) lab work. This trial model makes the transition from traditional research to remote research easier. It also allows you to try some new things without diving in headfirst.
Hybrid trials. Think of a hybrid trial the way you would the goldilocks principle. Hybrid trials combine elements from traditional trials and virtual trials, allowing for a trial model that’s “just right.” There’s not a set definition for hybrid trials, so you can get as creative as you want.
What factors should I consider when selecting a clinical trial model?
There are several important factors to consider when selecting a clinical trial model, including:
The ideal patient or participant. Who is the trial designed for? What’s their age, race, and gender? Are they fluent in modern technologies like the internet and email or do they primarily use traditional means of communication like letters and the telephone? Make sure to answer these and other questions when determining your trial model.
Access to facilities and equipment. Will your trial participants need to meet with medical staff in person? If it’s a decentralized trial or a hybrid trial, patients may need to visit the hospital or another medical facility to participate in lab tests and other types of exams. If you’re testing a new medical device, consider whether or not participants will be able to store (and maintain it) at home.
Past performance. One of the easiest ways to select the right clinical trial model is to evaluate your past work. What types of trials has your organization successfully completed in the past? Pay special attention to those trials with similar enrollment targets, enrollment timelines, and levels of complexity. You can use that past experience to make tweaks that will help streamline your trial’s efficiency.
Budget. What type of funding do you have? Virtual trials and decentralized trials are usually more cost-effective than traditional in-person trials. They eliminate the need for transportation and there are rarely in-person visits. As a result, you can invest in better communications technology. What’s more, since there’s no official trial site, you don’t have to worry about keeping the facility staffed.
Competition. Don’t forget to look into what your competitors are already doing. You may be able to save a significant amount of time and energy by mimicking organizations that are already implementing virtual, decentralized, or hybrid clinical trials.
What if I still have questions?
Designing and implementing a clinical trial is hard work. If you’re exhausted by decision fatigue and don’t know where to start, get in touch. At Harbor Clinical, we have more than a decade of experience executing clinical trials. As functional service providers, we offer a variety of services to ensure all aspects of your trial meet quality assurance and regulatory standards.
To learn more about our capabilities, please fill out an online contact form by clicking here. Or, give us a call at (781) 755-0342.