Omniscience Mobile's upcoming clinical trial app.
Mobile technology presents a sorely-needed, long-awaited opportunity for innovating the clinical trial – making it cheaper, easier, and even more accurate. But there are a lot of pieces to a clinical trial, and, according to some, mobile technology has the capacity to influence almost every one. Different companies are experimenting with these different aspects: Only time will tell which of these pieces might fit together to create the clinical trial of the future.
Working with investigators
Clinical trials are typically conducted on behalf of pharmaceutical companies, but they're often conducted by third-party investigators – a broad group of care providers that include private practitioners, hospitals and universities.
Ideally, great care is taken to make sure investigators have good and consistent training in procedures for conducting a trial, not to mention great expense. Janssen R&D's Clinical Trial Innovation Unit, a division of Johnson & Johnson, is leveraging digital technology to streamline this process in two ways. The first is a shared online databank of all non-proprietary clinical information. This includes investigator training and capabilities and standard trial practices and procedures – nearly anything that isn't related to particular drugs.
“The idea was welcomed and embraced immediately, but then there are the technical and legal hurdles,” Andreas Koester, head of the Clinical Trial Innovation unit, told MobiHealthNews. “Everyone we talked to said 'It's great that finally somebody is tackling it.'”
The second initiative is to create a standard online portal for investigators to communicate with pharmaceutical companies. The company is working on this initiative with TransCelerate BioPharma, an alliance of several large drug companies. Rather than having a different system and a different login username and password for each drug company an investigator works with, the initiative would create a single sign-in that would give investigators access to all the drug companies they're working with. The data, including proprietary information on specific drugs, would still be firewalled and stored separately, but it would be accessed uniformly.
Reaching out to participants
Other companies are focusing on implementing mobile technology to enhance communication between participants and investigators. Omniscience Mobile has been working in that field for about three years, working with companies like Pfizer and Merck.
For recruitment, the company provides texting as a contact option for eligible participants, listing a text option in addition to the phone number and website on posters and billboards. When someone texts in, an automated system texts them back a series of eligibility questions about age, sex, and geographical location.
“What we find is if you give someone the option to call or text, the vast majority are going to text,” said Omniscience CEO Jeff Lee. “You texted, you had this nice impersonal experience, and by seven or eight questions in, you're feeling very engaged.”
If a person's answer determines that they are eligible for the trial, someone from Omniscience is alerted, either immediately if it's during business hours or the next day. The operator calls the potential participant back and finalizes the sign up.
When a patient joins a trial through Omniscience for the first time, they have to sign a lengthy informed consent form, and they're given a packet of trial information. The informed consent form can be daunting and the information packet is easily lost over the course of a multi-year trial.
Janssen is working on digitizing their informed consent form.
“Of course, there's no value added if you just transfer the paper copy onto a screen,” Koester said. “At the end of the process you can ask questions about key messages, risks, opportunity to withdraw without having an impact on care. We make sure the patient really understands what the trial is about.”
Later this year, Omniscience is releasing an app that it can offer instead of the information packet. As well as having all the information in the welcome packet, the app will keep track of participants' appointments and store contact information and directions for the trial site. Lee said the app will be a “Trojan Horse” for other capabilities.
The company hopes to include a digital version of the diary that many clinical trial patients are expected to keep. These diaries, for keeping track of medication adherence, are often inaccurate because many participants forget about them and fill them out while they are in the parking lot right before their visit. An app could remind a participant to make entries or only allow them to fill it in within a certain time window.
At Janssen, Koester's team is working on a similar measure to ensure medication adherence during clinical trials: electronic blisters. Patients would be given their medication in “smart” packaging that would automatically send a text if the pill was opened at a different time than it was meant to be taken.
Telemedicine and remote monitoring are both increasingly well-established mobile health technologies, but their adoption in clinical trials is just beginning.
The FDA just approved its first remote monitoring trial, a 12-month Phase 2 trial by biopharma startup Transparency Life Sciences, MedCityNews reported. For the trial multiple sclerosis patients will take the blood pressure drug lisiniprol and wear vital sign monitors provided by AMC Health. The trial will include 180 subjects and those with wearable vital sign monitors will transmit their data to investigators and also conduct secure video conferences with them. The trial is estimated to save $3.5 million over a traditional trial, AMC senior vice president for research and business development John Holland said, according to the report.
Lee said Omniscience is looking at pairing its offering with remote monitoring technologies, as well as employing passive monitoring of phone use, like what Ginger.io does, to keep tabs on mental health patients in clinical trials.
During a recent webinar, Mark Brincat of mobile clinical trial company Exco InTouch said that mobile-enabled data collection could make clinical trials easier all around once the practice becomes accepted.
“One of the areas that we're certainly looking [at], and we're not the only company looking in this area is whether, by collecting realtime data from within clinical trials, we're able to more effectively make decisions.” Brincat said. “Whether we're able to start to think about having smaller trials, even, because you're collecting more accurate data, and also, trying to improve adherence in clinical trials, which again ought to be able to drive down sample sizes and patient numbers in those trials.”