Info & Opinion
March 25, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
Say you need someone to do something for you in Singapore. It turns out it’s rude to leave someone a few voice mail messages. Even several email requests are a bit of a no-no. Instead, communication via so-called “text” or short messaging systems (SMS) is the norm and the Emily-Post approved technique.
That works for Pfizer. The firm has been using the SMS system of Exco InTouch for two years and just decided to roll it out for all Phase I trials worldwide—in the U.S., Belgium and Singapore. We have no knowledge about why Pfizer allowed its name to be used in connection with the small Harlow, U.K. firm, based north of London, but its endorsements have generally been granted infrequently. The Vatican probably pardons more organizations than Pfizer singles out as suppliers.
SMS alerts from Exco are used to recruit patients for trials, and to manage routine communications between patients and sites. The 100 or so character limit to the SMS format is terse. Compact. But it’s enough. The brevity lends itself to simple tasks like reminders about diary entries, missed dosages or clinic visits. (“Your appointment with Dr. Nissen is at 2:00 pm today.”)
Exco InTouch CEO Tim Davis says that sparing sites the headaches of managing routine communications is a key point. “There is nothing worse than sites being told they have to adopt a tricky process or a complex piece of technology,” he says. “It can feel like a chore, for both sites and patients.”
Davis says the response rates using his system are four or five times higher than those of a postal letter, and that the firm has begun tying SMS blasts into more traditional advertising for clinical trials at a fraction of the cost of mass-media campaigns.
The Exco system conforms to HIPAA, European privacy regulations and cellular network procedures that are collectively more rigorous than anything applying to spam-blasting or robo-calling of the sort used by mass marketing firms. As a result, a text message is likely to be sufficiently free of spam and dozens of “cc” recipients that it warrants immediate action. A new email could be to anyone. A new SMS message is just for you.
Ending The Phoneathon?
Pfizer, Exco says, has integrated the Exco SMS system with three patient databases. That allows its Phase I units to pinpoint, say, nonsmoking male asthmatic patients and send an SMS alert only to them. Because the Exco system is 21 CFR Part 11 compliant, there is a full audit trail. Patients’ replies are tracked automatically by the same system. This saves the overburdened office staff in busy clinics—we are estimating this, ok?—18 billion phone calls annually. Such frequent, low-hassle contact with patients helps keep them in the trial, and allows the sites to know when a patient has slipped off track.
Pfizer’s ability to combine SMS and its own databases, which are segmented by patients in various therapeutic areas, appears to be novel and on the frontier of what any company in the industry is doing. There is no need to load or reload the SMS system with names of different lists of patients. The text messages go out automatically. In effect, the patient database and the SMS platform behave as one system. Says Davis: “Pfizer has been the leader here.”
Patrick Hughes, Exco’s senior VP of sales and marketing, runs a U.S. commercial office in Irvine, California and helps to keep tabs on an operational facility in Raleigh-Durham, North Carolina. He notes that the company has also begun to use SMS for simple electronic patient reported outcome (ePRO) studies.
In contrast to most ePRO approaches, which require the lease or purchase of a $1,500 custom-programmed Palm or Windows smartphone, Exco trials often use the patients’ own mobile devices. In deploying its technology to 250,000 patients, Exco has distributed a grand total of 59 mobile phones to patients who did not possess them already.
Edging Into ePRO
The high expense of ePRO, Exco notes, has been a limiting factor for biotech and mid-sized pharmas that want the same high-quality data from their patients. As a result, it can be a bit hard to categorize Exco. In some respects, it is a logistics or clin-ops firm. In other ways, it is a software house and a patient-recruitment consultancy. But making inroads into ePRO could push it into more open competition with the likes of companies such as Arrowhead, CRF, invivodata, Parexel and PHT.
Besides the cost advantage, text messages also present the appealing prospect of requiring no additional training or tutorials. People already know how to use their own phones.
Then there’s the immediacy of a text message. Patients receiving SMS messages reply to them promptly. In an instance where a trial had to be repeated, Hughes says the Exco system delivered a 20 percent improvement in patient compliance with the protocol. “The immediacy of it is a big thing,” Hughes says. “You have got 80 percent or more of the responses in the first three hours of when you sent the message, and the remainder by the end of the working day.”
In a current ePRO hemophilia study, run by Exco for a large international pharma, the web browser built into a mobile phone serves as a simple but useful interface that allows the patients to schedule a therapeutic injection. The use of Java in some projects allows Exco to use a cell phone to replicate much of the functionality of a web page—except on a tiny screen.
There is a caveat. For all the fuss about the iPhone, that device doesn’t support Java for competitive and security reasons. And so there might be a select number of Java-based Exco projects that would not work on iPhones supplied by patients. But the vast majority of other mobile phones around the planet can run Java with no difficulty; and of course the Apple devices handle plain-vanilla SMS communication easily.
Texting, it seems, is now more popular than mobile calling, according to survey data from Nielsen Mobile. With billions of people using SMS already, the Exco technology offers the potential to give clinical research and the pharmaceutical industry a friendly, more contemporary face. “There are something like 40 million new wireless subscribers every month across the globe,” says Hughes. “People don’t go out of their house without their car keys, their wallet and their cell phone. To harness that technology in clinical research is great.”
Editor’s note: Here’s an earlier ClinPage article on Exco In Touch that outlines some of the difficulties it encountered in establishing its access to phones around the world.