Recruiting participants for a virtual clinical trial is even more difficult than recruiting for a typical study. Read the experience of one researcher who overcame this with external help.
An addendum to the Guideline for Good Clinical Practice, the E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1), was created in March 2018 to encourage the use of technology in clinical trials.
Virtual clinical trials are one such example; studies which draw on technology. And in early 2018 Anne Tam was recruiting for her own virtual trial.
Anne was previously in charge of managing clinical trials for a respiratory research site in New York City, including a recent one on asthma. Researchers were looking to recruit 100 study participants nationwide to use, and give feedback, on a smartphone app created to help sufferers manage asthma.
In the United States, about 25.7 million people have asthma, this includes seven million children. For people with persistent asthma, using control medications daily is often the only way to meet their health goals.
The Virtual Study
Anne’s aim was to understand whether the mobile app helped with asthma medication management for adults. She was keen to get feedback on its functionality and practicality.
This technology, able to be used by the asthma sufferer at home, included a Bluetooth sensor that monitored at-home medication use, an app that sent real-time reminders to patients, and a mobile spirometer that measured lung function.
Patients could download the app which would help them manage and stick to taking their medication routinely. The mobile app interacted with the patient’s hardware—a silicone sleeve. This Bluetooth technology allowed the patient to closely monitor their daily dose of medication. And conveniently, the app displayed how well the patient stuck to their medication routine over the past 30 days.
High-Quality Patients for the Virtual Trial
Because Anne’s study was a virtual clinical trial, high-quality patient recruitment was a potential challenge.
Virtual clinical trials are a relatively new method of collecting data from clinical trial participants. Because these trials don’t require an in-person time commitment, for example, the obligation to be at a research clinic or doctor’s office at a particular time, it meant that finding motivated patients, who could stick to using the device and mobile app, could prove to be difficult.
Anne explained, “Some people will just enroll to get the compensation and not participate especially since it’s a virtual trial”.
To make sure the trial had a good sample size, and patients recruited were committed to the study, Anne engaged Trialfacts. Despite some concerns that many patients might not be qualified to participate, the prescreening questionnaire certainly helped to recruit high-quality patients for the trial.
Trialfacts focused on people who were motivated to join the study because of their contribution to asthma research, or to improve their own suffering with asthma.
They were verified as highly qualified candidates after going through the eligibility criteria screening, and because Trialfacts ensured that the required six month commitment to the study was clear. Anne found “The ones that were ultimately enrolled turned out to be pretty good patients. So, I was pleasantly surprised with the enrollments.”
Initial Recruitment Numbers
Recruitment of participants had already progressed halfway when Anne reached out to Trialfacts. “The study had been going on for three to six months but we weren’t getting enough participants enrolled.”
Even after advertising on Facebook and Centerwatch.com recruitment was slow. The study had only recruited about 50 individuals from the original pool of 265 eligible potential volunteers.
“We needed to complete an enrollment of 100 participants but there weren’t enough people who were screening for the study. Not enough people were going to Centerwatch.com or clicking on the Facebook ad. And those that did screen didn’t qualify or for some reason didn’t enroll in the study,” Anne explained.
When researching a few recruitment companies, Anne decided to reach out to Trialfacts for more information. “I was looking for vendors that help with recruitment for clinical trials. I wasn’t looking for a Contract Research Organization (CRO) because CROs are very expensive. Then we did initial calls with Trialfacts and got some pricing information and I did a little bit of a background check.”
Anne’s reasons for going with Trialfacts were based on a few factors, “The price is the first, most important thing. And the fact that it wasn’t a CRO, which I knew I didn’t want to work with”.
The Final Sample Size
The recruitment of high-quality patients was a success. The research team reached 58 enrollments from the 203 referrals Trialfacts delivered. Anne was pleased with the results “Trialfacts was able to screen a lot of people. They were able to get a lot of people to take my screening questionnaire, direct traffic to the trial, and complete enrollment.”
From 203 (100%) Trialfacts referrals:
How we did it
Although a recruitment company may find eligible and high-quality potential patients for your research—the work isn’t over just yet.
Potential study participants could be lost if they’re not contacted immediately and diligently. But it’s also incredibly important to recognize when a significant number of referrals are being lost. It’s just as crucial to addressing any issues immediately as they come up.
For Trialfacts this means throughout the entire recruitment process–ensuring the prescreening information is always updated, and phone screening appointments are set up correctly. Anne found that “It was a pretty easy process. Trialfacts was very responsive. I thought it was very easy with participants setting up the screening call and it just being on my calendar. The spreadsheet was easy to track. Trialfacts was very on top of things, and were always checking in and asking me to update my screening spreadsheet.”
As a recruitment company, it’s important for us to continuously analyze the data to make sure we’re recruiting the right candidates, and these candidates are actually enrolling in the study.
Research teams that we work with appreciate the flexibility we strive to offer. For Anne, this was essential to ensure all referrals were properly prescreened and enrolled in the study. “If I asked for the referrals to stop coming in so I can catch up, Trialfacts would do that for me. It was a smooth and easy process. Trialfacts always checked in with me, they were very diligent about that—checked in to make sure if I needed anything. Respected my requests when there were too many for me to keep up, as I was only one doing these calls.”
The study is near its close. As Anne explained, “The last patient won’t be out of the study until at least December 2018”.
As the managing researcher, she has very a positive outlook. In addition to adopting technology for the management of patients in healthcare, this study also speaks to the future of patient recruitment.
Are You Managing a Virtual Trial?
Patient recruitment and enrollment is often the longest stage of a clinical trial with almost 90% of these failing to meet initial targets. While virtual trial design maximizes patient availability and enrollment in studies, it can still prove difficult to find motivated, high-quality patients.
If your virtual trial is struggling to enroll patients, contact us for a free, no-obligation Due Diligence report, to see how many subjects we can provide for your study, guaranteed.