Featured article by Cher Zevala, Independent Technology Author
Clinical trials are an integral part of the process of bringing new drugs and treatments to market. Even so, the vast majority of clinical trials fail for one reason or another. For example, more than 80 percent of clinical trials never actually get past the patient recruitment phase; challenges in matching eligible patients to appropriate trials or attracting enough interest often mean that a trial never even gets off the ground.
And once a trial has enough participants, it can often be a challenge to keep them engaged with the study. In fact, as many as 40 percent of participants in Phase III of a trial will drop out or stop participating, due to issues such as challenges meeting all of the requirements of the study, traveling to provider appointments, or complex requirements for data collection.
Because getting, and keeping, patients involved with clinical trials is so important to the success of the study, researchers are constantly looking for ways to improve patient engagement. Based on evidence from a few completed studies, it looks like virtual clinical trials could be the answer they are looking for.
What Is a Virtual Clinical Trial?
In the typical clinical trial, patients must devote a significant amount of time to the study process. In additional to regular provider visits for testing and follow up, they often must keep extensive diaries of their symptoms and experiences to submit to the study coordinators. In some cases, completing these activities requires a great deal of time, as well as travel to meet with study doctors.
A virtual clinical trial, on the other hand, uses technology, from study start-up through execution to follow-up. By using apps, wearable devices and other monitors, and social engagement platforms, patients can complete every phase of the trial from home. Everything from recruitment and informed consent and counseling, to measuring clinical endpoints and adverse reactions uses an electronic process, is submitted electronically, by a mobile device or computer.
The idea of a virtual trial was pioneered in 2011 by Pfizer, with their Research On Electronic Monitoring of Overactive Bladder Treatment Experience (REMOTE) trial. REMOTE was the first randomized clinical trial to recruit patients using the web and smartphones, and to collect study data entirely remotely. Patients in this study never actually visited an actual study site. While the study faced challenges in actually recruiting eligible patients, most of whom were older and uncomfortable with using technology, the study showed that the idea of a virtual trial was possible.
Benefits of Virtual Trials
Conducting a virtual trial offers a number of advantages over traditional clinical trials.
More Patient Centered. Many researchers argue that virtual clinical trials offer a more patient-centered approach to clinical research, as it is more flexible and doesn’t require as much of an investment of time and money. By allowing patients to use devices they are already familiar with, and are comfortable using, the study becomes friendlier and less intrusive.
Improved Recruitment. By switching to electronic methods, it becomes easier to recruit patients due to patient friendliness, but also because physicians can more effectively match potential participants to studies using electronic medical records. There is also potentially a larger subject pool, since researchers are not limited to specific geographic areas to find participants.
Reduced Risk. When study participants submit data electronically, the clinical outcome assessment takes place in real time, allowing researchers to make changes to the study faster to reduce the risk to participants.
Reduced Costs. While there are some costs associated with virtual studies, there is a significant reduction in expenses when the study is virtual. Virtual studies don’t require physical study sites, and the need to reimburse patients for travel expenses decreases.
Increased Engagement. When participating in a clinical study is easy, patients are more likely to stick with it. Entering information into an app, and sending vital information wirelessly via wearable monitors simplifies participation. Study participants will no longer be required to take time away from work or school to visit doctors, or fill out cumbersome paper surveys. When participation is simple, attrition decreases.
There are still kinks to work out in the realm of virtual clinical trials, but so far the protocol is showing great potential for improving study outcomes. It remains to be seen if they reach widespread adoption, but more researchers are moving in this direction for better engagement, lower costs, and better outcomes.
