Earlier this month, we ran across this tweet from Stephanie Fischer (@SDFatPhRMA):
Though the comment may be referring mostly to prohibitive eligibility criteria found in some trial designs, there are many additional factors that make trials “hard to get into,” according to feedback from patients. Inconvenient locations, overly-demanding reporting requirements, and too-frequent lab test appointments are just are few. As technologies that allow data collection and at-home lab tests improve and become more widespread, the rise of online clinical trials may provide more opportunities for researchers to conduct more inclusive studies, and to help patients overcome some of these common barriers to participation.
Open Online Studies
A quick Google search reminded us that discussions about Internet-based clinical trials started as early as 2001. Since then, the increased availability of health tracking devices and smartphone-based health and vital signs tracking apps has made it easier for people to collect and share personal health data in an effort to better understand their conditions and their overall health. And, as patients have gotten access to more personal data, they have started taking more active control of their healthcare decisions. These things have perhaps, in part, paved the way for more online-only studies.
One example is The Lift Diet Challenge (a.k.a. The Quantified Diet.) For the study, the makers of the Lift Goal Coaching App asked participants to use the app to help them build “an ongoing 15,000+ person experiment to compare popular diets.” Perhaps one of the most interesting things about this experiment is that it was designed, and is being ran as a “citizen science” project, meaning that those who conceived of the study are not research scientists by training. They’ve done a great job documenting what they’ve learned about conducting an unbiased study on their blog. It could serve as a valuable resource for others who are interested in doing their own, personalized research.
Another open, online study is the Health eHeart study, being conducted by the University of California San Francisco and the American Heart Association. The trial’s stated aim is to use big data to help develop strategies to prevent and treat all aspects of heart disease. Any person over the age of 18 can join the trial, whether they have a history of heart disease or not. And, the study collects information from participants through a variety of digital channels including online surveys, social media, special sensors and gadgets, mobile apps and more. The researchers hope that participants will stick with the study for many years, to help them understand behaviors that prevent heart disease. And, by giving them many convenient, digital options the likelihood of longterm commitment might be increased.
These studies certainly do away with the barrier of restrictive eligibility criteria–they are open to anyone who wishes to participate. But, what about more selective trials? Is there a place for them as online-only trials too? Or, in situations where the trial cannot be conducted completely online, are there ways that certain stages of the trial, like pre-screening for example, can be done online? It certainly seems so.
Perhaps one of the most promising possibilities within online testing is the ability to prescreen large numbers of patients for participation in clinical trials. This can be especially helpful in highly-selective trials focused on diseases for which finding eligible participants is difficult due to the nature of the disease. With Alzheimer’s disease, for example, its often important for researchers to be able to identify patients who are in the earliest stages of the disease. According to a recent article on Cogstate.com, researchers have typically relied on traditional, paper-and-pencil cognition tests to measure subtle changes in brain function. But, these tests have often proven themselves to be less-than-ideal for screening large groups of elderly patients.
In 2013, a new Internet-based solution was introduced at an annual Clinical Trials Conference on Alzheimer’s Disease in San Diego. Some advantages of the test that were touted during the presentation included the ability to screen large numbers of patients quickly and cost-effectively, the ability to build a database of patients by allowing them to access tests through the Internet, and more frequent testing of patients to help researchers better understand subtle, daily changes in a patient’s brain functioning. All of these things together can lead to a better understanding of the disease and help researchers develop the right treatments for it.
Selective Online Trials
Earlier this year, researchers from UC San Francisco completed an Internet-based trial for children with autism. The main purpose of the study was to test the effects of omega-3 fatty acids on hyperactivity in children with the condition; but, it also served as a good test of whether an online platform could be a reliable method for this type of study. According to the results that were published in the June 2014 issue of the Journal of the American Academy of Child and Adolescent Psychiatry and summary from ScienceDaily.com, they found that the online format was “not only a valuable platform for conducting the randomized clinical trial, but that it was both cost and time effective as well.”
As with many diseases and conditions, recruitment is one of the biggest challenges facing trials focused on children with autism. The lead author of the study, Stephen Bent, emphasized the importance of engaging pre-existing online communities enrollment, and the speed with which he and his team were able to access data once it was entered online by the children’s parents and teachers. He also was quoted as saying that the study “demonstrates there are many advantages [to online studies] including low cost, rapid enrollment, high completion rate, convenience for participating families and the ability to participate from virtually any location.”
It goes without saying that online only formats won’t work for every kind of trial, but it’s probably a good idea for researchers to take a hard look at whether they can find ways to conduct more research online. It seems that online trials give a larger and more diverse patient population the opportunity to participate, which can in turn lead to greater insights about diseases and how to treat them. In the interest of getting better medicines to patients faster, it makes sense to try and get information from them about their conditions faster.
Making Trials More Accessible
All in all, we find the prospect of more digitized clinical trials to be a promising one for the future of medical research. There’s so much we still need to learn about diseases, treatments, and how each can effect people in different ways. It seems that a great way to learn more is to make clinical research more visible and more easily accessible to everyone. Open online trials can be a gateway for people to enter into the worlds of citizen science and gain a greater overall awareness of clinical research. Selective online trials can allow those who live with specific conditions, and have been unable to participate in research due to time, location, or biological factors a chance to contribute and benefit. And, by being able to draw information from a larger and more diverse pool of participants, researchers can discover newer and better treatments for all. So, in the future, when designing clinical trials,it may be important to consider whether all or part of the study can be offered online.
What do you think? Would you be willing to participate in an online clinical trial? Do you think more studies should be offered through the Internet? Sound off in the comments below, or send us a tweet.